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2026 Volume 42 Issue 4  Published: 2026-02-28
    Clinical and Basic Bridging Research
  • Hou-tong ZHAO , Lu HAN , Bi CHEN , Hao CHEN , Li-xiang SUN
    doi: 10.13699/j.cnki.1001-6821.2026.04.001
    Objective

    To observe the clinical efficacy and safety of posaconazole injection and voriconazole injection in the treatment of patients with pulmonary tuberculosis complicated with invasive pulmonary aspergillosis (IPA).

    Methods

    Patients with pulmonary tuberculosis complicated with IPA were divided into control group and treatment group according to the treatment methods. Both groups maintained standardized anti-tuberculosis treatment. At the same time, the control group was given voriconazole for injection at a dose of 6 mg·kg-1 ivgtt, q12 h on the first day; from the second day, 4 mg·kg-1 ivgtt, q12 h. When the patient’s clinical condition was stable, switched to oral voriconazole tablets, 200 mg per dose, q12 h. Treatmen group was also given posaconazole injection, initially intravenously, with a dose of 300 mg ivgtt, q12 h on the first day; from the second day, 300 mg ivgtt, qd; when the patient’s clinical condition was stable, oral posaconazole oral suspension were switched to, 400 mg each time, bid. Both groups were treated for 12 weeks. The clinical efficacy, clinical symptom relief, galactomannan (GM) and 1-3-β-D glucan (BG) levels, lung function parameters, immune and inflammatory indicators were compared between the two groups of patients, and safety evaluation was carried out.

    Results

    A total of 84 patients were enrolled, with 43 cases in control group and 41 cases in treatment group. The clinical effective rates in control group and treatment group were 79.07% (34 cases/43 cases) and 87.80% (36 cases/41 cases), respectively, with no statistically significant difference (P>0.05). The fever subsided time in control group and treatment group were (7.53±1.39) and (8.37±1.65) d, respectively; the recovery time of respiratory function were (5.26±1.66) and (4.44±1.70) months, respectively; the GM levels were (0.44±0.13) and (0.36±0.11) ng·mL-1, respectively; BG levels were (25.62±5.86) and (22.77±5.34) pg·mL-1, respectively; the arterial oxygen saturation (SaO2) levels were (95.63±1.70)% and (96.56±1.70)%, respectively; the pulmonary dynamic compliance (Cdyn) levels were (32.25±4.65) and (34.72±4.49) mL·cm H2O-1, respectively; the levels of response frequency (Fres) were (11.39±1.78) and (10.46±1.75) Hz, respectively; the levels of maximum ventilation (MVV) were (78.12±8.87) and (83.68±8.19) L·min-1, respectively; the carbon monoxide diffusing capacity (DLCO) levels were (62.93±4.37)% and (65.44±4.11)%, respectively; the levels of interleukin 5 (IL-5) were (1.31±0.38) and (1.11±0.32) ng·L-1, respectively; the levels of interleukin 17 (IL-17) were (14.54±2.83) and (13.22±2.57) ng·L-1, respectively; the levels of dendritic cell-associated C-type lectin-1 (Dectin-1) were (11.86±2.25) and (10.58±2.13) ng·L-1, respectively; the immunoglobulinM (IgM) levels were (1.13±0.33) and (1.33±0.26) g·L-1, respectively; the immunoglobulin E (IgE) levels were (1.09±0.27) and (0.90±0.25) g·L-1, respectively. There were statistically significant differences in the above indexes between treatment group and control group (P<0.05, P<0.01). Regarding adverse drug reactions, control group primarily experienced nausea, elevated alanine aminotransferase, increased alkaline phosphatase and hallucinations, whereas the treatment group mainly reported nausea, vomiting, elevated alanine aminotransferase, elevated aspartate aminotransferase and hypokalemia. The total incidence of adverse drug reactions was 13.95% (6 cases/43 cases) in control group and 14.63% (6 cases/41 cases) in treatment group, with no statistically significant difference between two groups (P>0.05).

    Conclusion

    Both posaconazole injection and voriconazole injection can achieve good clinical responses in the treatment of patients with pulmonary tuberculosis complicated by IPA. Posaconazole has advantages in reducing fungal burden, improving lung function, and regulating immune inflammation. The safety of the two groups is equivalent. Posaconazole may have a slower onset of action, manifested by a longer time to resolve fever, but the long-term benefit in lung function is more significant.

  • Clinical and Basic Bridging Research
  • Li-na KANG , Fei-fei ZHANG , Hong AN , Shu-qing FENG , Chun-zhe GUO
    doi: 10.13699/j.cnki.1001-6821.2026.04.002
    Objective

    To observe the efficacy and safety of salmeterol/fluticasone propionate inhalation powder combined with cetirizine oral solution in the treatment of allergic rhinitis (AR) complicated with small airway dysfunction (SAD) in children.

    Methods

    Children with AR and SAD were divided into control group and treatment group using a random number table method. Both groups were given montelukast sodium chewable tablets as basic treatment, taken before bedtime, 4 mg each time, once a day; children in the control group were additionally treated with cetirizine oral solution on the basis of the basic medication, 2.5~10 mL per dose according to age once a day, for 12 consecutive weeks. The treatment group was given salmeterol/fluticasone propionate inhalation powder inhalation powder by oral inhalation on the basis of the control group’s treatment, 1 inhalation each time, twice a day, for 12 consecutive weeks. The clinical efficacy, lung function, eosinophil (Eos) count, inflammatory response indicators, recurrence rate were compared between the two groups, and safety evaluation was conducted.

    Results

    A total of 83 cases were enrolled, with 39 cases in the control group and 44 cases in the treatment group. After treatment, the total effective rates of the control group and the treatment group were 74.36% (29 cases/39 cases) and 90.91% (40 cases/44 cases), respectively, with statistically significant difference (P<0.05). After treatment, the forced expiratory volume in 1 second (FEV1) of the control group and the treatment group were 88.75±3.20 and 90.49±3.26, respectively; FEV1/maximal vital capacity (VCmax) were 89.47±10.83 and 94.57±10.21, respectively; maximal mid-expiratory flow (MMEF) pred were (61.06±6.72)% and (64.39±6.34)%, respectively; Eos counts were (4.81±0.72)% and (4.45±0.68)%, respectively; fraction of exhaled nitric oxide (FeNO) were (24.92±3.30) and (22.86±3.18) ppb, respectively; T-cell immunoglobulin domain and mucin domain protein-1 (Tim-1) were (125.08±20.19) and (113.27±18.06) ng·L-1, respectively; high mobility group box 1 protein (HMGB1) were (5.12±0.94) and (4.65±0.79) ng·L-1, respectively, with statistically significant differences (P<0.05, P<0.01). The main adverse drug reactions in the control group were headache, drowsiness, nausea and vomiting, and the main adverse drug reactions in the treatment group were nausea and vomiting, headache and oropharyngeal candidiasis. The total incidence of adverse reactions in the control group and the treatment group were 7.69% (3 cases/39 cases) and 11.36% (5 cases/44 cases), respectively, and the difference was not statistically significant (P>0.05). The recurrence rates of the control group and the treatment group were 33.33% (13 cases/39 cases) and 13.64% (6 cases/44 cases), respectively, with statistically significant difference (P<0.05).

    Conclusion

    Salmeterol/fluticasone propionate inhalation powder combined with cetirizine oral solution in the treatment of children with AR complicated with SAD can significantly improve efficacy, relieve clinical symptoms, improve lung function, reduce inflammation levels, and has good safety and a low recurrence rate.

  • Clinical and Basic Bridging Research
  • Ning-ning WANG , Hong-fen DUAN , Qian LI , Li-min WANG , Ming-wei QU , Chao-ping YANG , Huan ZHANG
    doi: 10.13699/j.cnki.1001-6821.2026.04.003
    Objective

    To analyze the therapeutic effects and safety of ticagrelor tablets combined with aspirin enteric-coated tablets on young patients with first-onset atherosclerotic acute cerebral infarction.

    Methods

    According to different treatment plans, the patients with first-onset atherosclerotic acute cerebral infarction were divided into the treatment group and the control group. The treatment group was treated with aspirin enteric-coated tablets combined with ticagrelor tablets (initial dose: aspirin enteric-coated tablets 100 mg·d-1 and ticagrelor tablets 180 mg·d-1, maintenance dose: aspirin enteric-coated tablets 100 mg·d-1 and ticagrelor tablets 90 mg·d-1). The control group was treated with aspirin enteric-coated tablets combined with clopidogrel tablets (initial dose: aspirin enteric-coated tablets 100 mg·d-1 and clopidogrel tablets 300 mg·d-1, maintenance dose: aspirin enteric-coated tablets 100 mg·d-1 and clopidogrel tablets 75 mg·d-1). The courses of treatment for both groups were 3 months. After 3 months of treatment, the efficacy, National Institutes of Health stroke scale (NIHSS) scores, cerebral hemodynamics, Barthel index, platelet aggregation rate, modified Rankin scale (mRS) scores, adverse cardiovascular events, and adverse reactions were observed.

    Results

    A total of 103 patients were enrolled, with 53 cases in treatment group and 50 patients in control group. After 3 months of treatment, the total effective rates in the treatment group and the control group were 92.45% (49 cases/53 cases) and 88.00% (44 cases/50 cases), with no statistically significant difference between groups (P>0.05). After 3 months of treatment, the mean blood flow velocities (Vmean) of the middle cerebral artery (MCA) in the treatment group and the control group were (56.73±11.05) and (50.50±10.33) cm·s-1, respectively; the Vmean of the anterior cerebral artery (ACA) were (45.92±9.83) and (41.28±8.22) cm·s-1, respectively; the Vmean of the posterior cerebral artery (PCA) were (50.11±10.33) and (45.59±9.12) cm·s-1, respectively; the Vmean of the vertebral artery (VA) were (52.67±10.49) and (47.81±9.63) cm·s-1, respectively; the Vmean of basilar artery (BA) were (53.75±10.28) and (48.29±9.60) cm·s-1, respectively; the platelet aggregation rates were (22.71±7.33)% and (26.47±7.35)%, respectively; the above indexes in the treatment group were significantly different from those in the control group (P<0.05, P<0.01). After 3 months of treatment, the NIHSS scores of the treatment group and the control group were (1.23±0.47) and (1.38±0.49) points, respectively, and the Barthel indexes were (92.17±5.17) and (90.08±6.37) points, respectively. There was no statistically significant difference in the NIHSS score and Barthel index between the treatment group and the control group (all P>0.05). The incidences of adverse cardiovascular events in treatment group and control group were 0% and 8.00% (4 cases/50 cases), respectively, with no statistically significant difference (P>0.05). Adverse drug reactions in the treatment group included gastrointestinal reactions, bleeding tendency, hyperuricemia, and bradycardia, with a total incidence of 13.21% (7 cases/53 cases); adverse drug reactions in the control group included gastrointestinal reactions and bleeding tendency, with a total incidence of 10.00% (5 cases/50 cases); there was no statistically significant difference between groups (P>0.05).

    Conclusion

    Applying ticagrelor tablets to treat young patients with first-onset atherosclerotic acute cerebral infarction can significantly improve cerebral hemodynamics, with more advantages.

  • Clinical and Basic Bridging Research
  • Wen-xin LIU , Shan LI , Li-fei WANG
    doi: 10.13699/j.cnki.1001-6821.2026.04.004
    Objective

    To observe the efficacy of semaglutide injection combined with letrozole tablet in the treatment of obese polycystic ovary syndrome with insulin resistance (PCOS-IR) patients.

    Methods

    Patients with PCOS-IR were divided into treatment group and control group according to the treatment regimen. The control group was administered oral dydrogesterone tablets (10 mg per dose, twice daily) for 14 days to induce withdrawal bleeding. Starting from the 5th day of withdrawal bleeding, letrozole tablets were given orally at a dose of 2.5 mg per day for 5 consecutive days. Two days after drug withdrawal, transvaginal ultrasound monitoring was performed. When the dominant follicle reached or exceeded 18 mm in diameter, human chorionic gonadotropin for injection (1.0×104 U) was intramuscularly injected to induce ovulation. If ovulation did not occur, the dose of letrozole tablets was increased to 7.5 mg per day in the next menstrual cycle. The treatment group received subcutaneous injections of semaglutide (0.25 mg per dose, once weekly for 4 consecutive weeks; starting from the 5th week, the dose was adjusted to 0.5 mg per dose, once weekly for another 8 consecutive weeks). After a 1-week drug withdrawal period (washout period), the same ovulation induction protocol as that for the control group was adopted. Both groups received treatment for 3 to 6 menstrual cycles, and the medication was discontinued immediately once ovulation or pregnancy was achieved. Clinical efficacy, clinical manifestations, reproductive hormone levels, insulin resistance, inflammatory marker levels, follicular development, and the adverse drug reactions were compared between the two groups.

    Results

    A total of 93 cases were included, with 48 cases in the control group and 45 cases in the treatment group. After treatment, the total effective rates of the control group and the treatment group were 70.83% (34 cases/48 cases) and 88.89% (40 cases/45 cases), respectively; the Rosenfield acne scores were (1.56±0.62) and (1.29±0.59) points, respectively; the Ferriman-Gallwey hair scores were (13.31±3.25) and (11.89±2.85) points, respectively; the follicle-stimulating hormone was (6.86±1.24) and (7.50±1.13) IU·L-1, respectively; the levels of luteinizing hormone were (8.18±1.52) and (7.48±1.63) IU·L-1, respectively; the levels of fasting blood glucose (FPG) levels were (4.86±0.97) and (4.36±0.69) mmol·L-1, respectively; the fasting insulin (FINS) levels were (9.25±1.96) and (8.41±1.87) μIU·mL-1, respectively; the insulin resistance indexes were 1.83±0.39 and 1.63±0.27, respectively; the vascular endothelial growth factors were (92.17±10.82) and (87.45±10.36) ng·L-1, respectively; the levels of interleukin-6 were (6.74±0.93) and (6.32±0.99) pg·mL-1, respectively; the number of follicles were (8.44±1.35) and (7.93±1.01), respectively; the maximum follicle diameters were (11.68±2.44) and (13.05±2.69) mm, respectively; the above indicators in the treatment group were compared with those in the control group and it showed statistically significant differences (all P< 0.05). The total incidences of adverse drug reactions in the experimental group and the control group were 8.89% (4 cases/45 cases) and 10.42% (5 cases/48 cases) (P>0.05).

    Conclusion

    Semaglutide injection combined with letrozole tablets has significant efficacy in the treatment of PCOS-IR patients, can effectively improve insulin resistance, and has relatively good safety in non-pregnant or non-lactating women.

  • Clinical and Basic Bridging Research
  • Xin-jü ZHAO , Qiao-ping ZHAO , Yong-wu YÜ , Ling WU , Rong LI , Ming WANG , Qun LUO , Yi-lun ZHOU , Bing LIU , Wen-juan QIAN , Wen-hong SHAN , Jian-gen YÜ , Qing-ling ZOU , Si-yuan TENG , Ying-chun MA , Wei-ping WANG , Tao YANG , Li-hong ZHANG , Wei LI , Ren-huan YÜ , Li LIU , Jun SHI , Li TANG , Yong-qiang WANG , Song WANG , Jing-wei ZHOU , Li ZUO
    doi: 10.13699/j.cnki.1001-6821.2026.04.005
    Objective

    To evaluate the safety, tolerability, treatment patterns, and effectiveness of calcium polystyrene sulfonate (CPS) and sodium polystyrene sulfonate (SPS) in the management of hyperkalemia (HK) among Chinese patients with renal insufficiency.

    Methods

    Patients with chronic kidney disease (CKD) or acute kidney injury (AKI) with HK in 26 hospitals in China were included in the study. Two full analysis sets (FAS), FAS-P1 (stage 1, followed up for 3 days) and FAS-P2 (stage 2, followed up for 6 months) were defined. Fas-P1 includes all new users taking at least one dose of CPS/SPS 1-3 days after the initial treatment of CPS/SPS, FAS-P2 includes all patients receiving at least one dose of CPS/SPS after enrollment in the user group, and patients receiving at least one dose of CPS/SPS after the initial treatment period in the new user (Fas-P1). The drug use, serum potassium (sK+) level and clinical efficacy of the two data sets were observed, and the safety was evaluated.

    Results

    A total of 892 patients were selected in the study. 390 patients (CPS 385 cases, SPS 5 cases) and 814 patients (CPS 811 cases, SPS 3 cases) were included in FAS-P1 and FAS-P2, respectively. In FAS-P1 and FAS-P2, the average daily doses of CPS were (7.28±6.24) and (5.13±5.15) g, respectively; and the average daily doses of SPS were (10.75±6.23) and (8.36±7.59) g, respectively. In FAS-P1, the change of sK+ from baseline to day 3 was (-0.72±0.61) mmol·L-1; in FAS-P2, the mean value of sK+ was (5.17±0.68) mmol·L-1 (95% CI: 5.12-5.22). In FAS-P1 and FAS-P2, 56.15% and 55.16% patients had adverse events (AEs), respectively, and the incidence of serious adverse events (SAEs) were 29.23% and 29.24%, respectively. The researchers determined that the incidence of adverse events related to CPS/SPS was low, which was 2.56% in FAS-P1 and 2.09% in FAS-P2. The most common CPS/SPS related AEs were gastrointestinal discomfort (FAS-P1: 2.05%; FAS-P2: 1.70/100 person years) and hypokalemia (FAS-P1: 0.51%; FAS-P2: 2.10/100 person years).

    Conclusion

    In this study, over 50% of patients with renal insufficiency and hyperkalemia experienced AEs, reflecting the high burden of underlying disease in this population. However, the incidence of AEs related to CPS/SPS was low (approximately 2%), predominantly presenting as gastrointestinal discomfort and hypokalemia.

  • Clinical and Basic Bridging Research
  • Zhao XIE , Xin-yang HE , Hai ZHU
    doi: 10.13699/j.cnki.1001-6821.2026.04.006
    Objective

    To investigate the efficacy and safety of sintilimab injection combined with S-1 capsules/oxaliplatin injection (SOX) regimen as neoadjuvant therapy for patients with locally advanced gastric cancer (LAGC).

    Methods

    LAGC patients were divided into control group and treatment group based on treatment methods. The control group received neoadjuvant chemotherapy with the SOX regimen, with intravenous infusion of oxaliplatin injection 135 mg·m-2 on the first day of each cycle, and S-1 capsules were administered orally according to the patient’s body surface area (40 mg each time for <1.25 m2, 50 mg each time for 1.25-1.50 m2, and 60 mg each time for >1.50 m2), twice a day, for 1-14 days, with every 3 weeks as one cycle. The treatment group received sintilimab injection 200 mg intravenously on the first day of each cycle (every 3 weeks as one cycle) in addition to the control group’s treatment. After both groups completed 4 cycles of treatment, radical gastrectomy+D2 lymph node dissection was performed. The clinical efficacy, tumor marker levels, safety, and survival status of the two groups were compared.

    Results

    The control group included 48 cases, and the treatment group included 52 cases. The effective rates of the control group and the treatment group were 52.08% (25 cases/48 cases) and 73.08% (38 cases/52 cases), respectively, After treatment, the levels of carcinoembryonic antigen (CEA) in the control group and the treatment group were (21.08±3.30) and (19.52±2.90) ng·mL-1, respectively; the levels of carbohydrate antigen (CA) 19-9 were (43.89±5.11) and (41.57±4.73) U·mL-1, respectively; the levels of CA 72-4 were (24.82±3.15) and (23.18±2.79) U·mL-1, respectively; the median progression-free survival was 27 and 40 months, respectively; and the median overall survival was 33 and 46 months, respectively. The above indicators of the treatment group were all statistically significantly different from those of the control group (P<0.05, P<0.01). The incidence rates of nausea and vomiting in the control group and the treatment group were 25.00% (12 cases/48 cases) and 15.38% (8 cases/52 cases), respectively; the incidence rates of diarrhea were 14.58% (7 cases/48 cases) and 11.54% (6 cases/52 cases), respectively; the incidence rates of bone marrow suppression were 29.17% (14 cases/48 cases) and 32.69% (17cases/52 caes), respectively, with no statistically significant difference (all P>0.05).

    Conclusion

    Sintilimab combined with SOX regimen as neoadjuvant therapy for LAGC patients can achieve good clinical efficacy, improve functional status, prolong survival, reduce tumor marker levels, and has fewer surgery-related complications and good safety.

  • Clinical and Basic Bridging Research
  • Wen-hui XU , Rong HU
    doi: 10.13699/j.cnki.1001-6821.2026.04.007
    Objective

    To investigate the clinical efficacy and safety of venetoclax tablet combined with azacitidine for injection in the treatment of newly diagnosed acute myeloid leukemia (AML) patients unsuitable for intensive chemotherapy.

    Methods

    Newly diagnosed AML patients unsuitable for intensive chemotherapy were divided into control group and treatment group based on treatment regimen. The control group received 75 mg·m-2 azacitidine for injection by subcutaneous injection or intravenous infusion for 7 consecutive days per 28-day cycle. The treatment group received oral venetoclax tablet (dose escalation: 100 mg on day 1, 200 mg on day 2, and 400 mg daily from day 3 onwards) plus 75 mg·m-2 azacitidine for injection, by subcutaneous injection or intravenous infusion for 7 consecutive days per 28-day cycle. Both groups were treated for 2 cycles. Clinical efficacy, hematological parameters [hemoglobin (Hb), platelet count (PLT), absolute neutrophil count (ANC), white blood cell count (WBC)], bone marrow morphology and cytogenetic assessments (proportion of bone marrow blasts, bone marrow cellularity), liver function indices [alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL)], renal function index [serum creatinine (SCr)], coagulation parameters [prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), D-dimer], survival outcomes [overall survival (OS), event-free survival (EFS)], and safety indicators were compared between the two groups.

    Results

    A total of 230 patients were enrolled with 112 in the control group and 118 in the treatment group. After treatment, the overall response rate (ORR) in the treatment group was 74.58% (88 cases/118 cases), significantly higher than the control group’s 53.57% (60 cases/112 cases). The complete remission (CR) rate in the treatment group was 49.15% (58 cases/118 cases), significantly higher than the control group’s 26.79% (30 cases/112 cases); both differences were statistically significant (P<0.05). After treatment, Hb levels of treatment group and control group were (94.85±18.67) and (85.51±17.84) g·L-1, respectively; PLT counts were (125.51±35.24) ×109·L-1 and (78.22±29.77) ×109·L-1, respectively; ANC levels were (4.23±1.87) ×109·L-1 and (2.79±1.16) ×109·L-1, respectively; WBC levels were (5.89±2.72) ×109·L-1 and (6.85±2.73) ×109·L-1, respectively;. the proportion of bone marrow blasts were (16.90±8.98)% and (29.16±14.18)%, respectively; the proportion of patients with active bone marrow hyperplasia were 80.51% (95 cases/118 cases) and 69.64% (78 cases/112 cases), respectively;. ALT levels were (58.56±25.14) and (45.78±16.57) U·L-1, respectively; AST levels were (52.34±17.07) and (41.12±17.31) U·L-1, respectively; TBIL levels were (31.65±12.10) and (25.33±9.12) μmol·L-1, respectively; SCr levels were (84.32±19.19) and (82.13±17.55) μmol·L-1, respectively; PT were (14.12±2.42) and (13.78±2.29) s, respectively; APTT were (34.12±5.10) and (33.22±4.65) s, respectively; FIB were (3.56±0.97) and (3.53±0.81) g·L-1, respectively; D-dimer levels were (0.58±0.22) and (0.52±0.21) mg·L-1, respectively. Except SCr, PT, APTT, FIB and D-dimer levels, comparion of other indicators between two groups showed statistically significant differences (all P<0.05). The median OS of treatment group and control group were 34.0 and 21.0 months, respectively;, median EFS was 28.0 and 11.0 months. Both median OS and median EFS were significantly longer in the treatment group compared to the control group (both P<0.05). The adverse event (AE) incidence rate was 28.57% (32 cases /112 cases) in the control group and 32.20% (38 cases/118 cases) in the treatment group, with no statistically significant difference (P>0.05).

    Conclusion

    Venetoclax tablet combined with azacitidine for injection significantly improved the ORR, CR rate, survival outcomes (OS, EFS), hematological recovery, and reduced bone marrow leukemic burden in newly diagnosed AML patients unsuitable for intensive chemotherapy. Although associated with an increased risk of liver toxicity, the overall safety profile was manageable. This combination regimen demonstrates significant clinical value.

  • Clinical and Basic Bridging Research
  • Liu-ping WU , Cheng CHEN , Wan-yu ZHOU , Hu-yun XIE , Yu-ran ZHOU , Jia-wei YU
    doi: 10.13699/j.cnki.1001-6821.2026.04.008
    Objective

    To investigate the effect and safety of subanesthetic-dose esketamine combined with subcostal transversus abdominis plane block (STAPB) on postoperative delirium in patients undergoing radical resection for colorectal cancer (CRC).

    Methods

    Patients scheduled for radical CRC resection were divided into control group and treatment group according to the anesthetic regimen. The control group received conventional anesthesia, while the treatment group was intravenously administered 0.2 mg·kg-1 esketamine hydrochloride injection before endotracheal intubation on the basis of the conventional anesthesia protocol. Both groups underwent STAPB after intubation and before skin incision. The excellent and good rate of anesthesia, surgical parameters, hemodynamic indices, postoperative recovery quality-related indicators, incidence of delirium, analgesic efficacy parameters, and adverse reactions were compared between the two groups.

    Results

    A total of 52 patients were enrolled in the control group and 48 in the treatment group. The excellent/good rates of anesthesia of treatment group and control group were 91.67% (44 cases/48 cases) and 88.46% (46 cases/52 cases), respectively (P>0.05). The fluid infusion volume of treatment group and control group were (1 412.69±38.27) and (1 428.63±35.47) mL, respectively; the heart rates at T3 were (76.19±8.56) and (80.69±9.14)beats·min-1, respectively; systolic blood pressure at T3 were (131.08±10.39) and (138.52±13.78) mmHg, respectively; diastolic blood pressure at T3 were (79.94±7.27) and (82.35±8.25) mmHg, respectively; the extubation time were (16.75±2.71) and (15.54±2.42) min, respectively; the recovery time were (18.63±2.81) and (20.40±2.86) min, respectively; the Quality of Recovery-40 (QoR-40) scores on postoperative day 2 were (160.79±18.70) and (154.35±20.56) points, respectively; the lower Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) on postoperative day 7 were (6.25±1.76) and (7.10±2.05) points, respectively; the Depression subscale (HADS-D) on postoperative day were (6.13±1.82) and (7.15±1.95) points, respectively; the total incidences of delirium were 10.42% (5 cases/48 cases) and 26.92% (14 cases/52 cases), respectively; the Numerical Rating Scale (NRS) scores for resting pain were (2.00±0.41) and (2.17±0.47), respectively; the dynamic pain at 48 h postoperatively were 2.60±0.54 and 2.81±0.60), respectively; the differences of above indicators between two groups were all statistically significant (P<0.05, P<0.01, P<0.001). The main adverse drug reactions included dizziness, tachycardia, bucking, nausea and vomiting in the control group, and dizziness, tachycardia, hypertension, nausea and vomiting in the treatment group. The total incidence of adverse drug reactions was 9.62% (6 cases/52 cases) in the control group and 12.50% (6 cases/48 cases) in the treatment group, with no statistically significant difference (P>0.05).

    Conclusion

    Subanesthetic-dose esketamine combined with STAPB for patients undergoing radical CRC resection can reduce intraoperative fluid requirements, stabilize perioperative blood pressure and heart rate fluctuations, improve postoperative recovery quality, alleviate postoperative anxiety and depression, and decrease the incidence of postoperative delirium. This combined regimen also yields definite postoperative analgesic effects and does not increase the risk of adverse reactions, thus exhibiting favorable clinical safety and tolerability.

  • Clinical and Basic Bridging Research
  • Si-yu SUN , Nan LI
    doi: 10.13699/j.cnki.1001-6821.2026.04.009
    Objective

    To investigate the distribution patterns of pharmacogenomic characteristics in hypertensive patients treated and to evaluate the differential benefits of genotype-guided therapy in calcium channel blocker (CCB) strategy versus beta-blocker strategy.

    Methods

    In the first phase, pharmacogenomic data of patients with primary hypertension treated at our hospital were analyzed. In the second phase, treatment-naive hypertensive patients were enrolled and randomly assigned in a 1∶1∶1∶1 ratio to four groups: genotype-guided CCB strategy, standard CCB strategy, genotype-guided beta-blocker strategy, and standard beta-blocker strategy. Seven key pharmacogenomic loci, including adrenergic beta-1 receptor (ADRB1) rs1801253 (1165G>C) and cytochrome P450 3A5 (CYP3A5) rs776746, were genotyped using polymerase chain reaction (PCR)-melting curve method. Primary outcomes included time to blood pressure control, incidence of treatment-related adverse events (TRAEs), and length of hospital stay.

    Results

    In the retrospective phase, 2 783 patients were enrolled. The C allele frequency of ADRB1 rs1801253 was 76.02% (4 231 cases/5 566 cases), and the G allele frequency of CYP3A5*3 was 72.97% (4 062 cases/5 566 cases). In the prospective phase, 300 patients were enrolled. The genotype-guided therapy significantly shortened time to blood pressure control (mean difference: -2.10 days, 95% confidence interval (CI): -2.80 to -1.40, P<0.001), with a significant interaction between therapy approach and treatment strategy (P<0.05). Specifically, in the CCB strategy, genotype-guided therapy reduced control time by 3.20 days (95% CI: -4.10 to -2.30) versus standard therapy, whereas in the beta-blocker strategy, the reduction was only 0.90 days (95% CI: -1.70 to -0.10). Genotype-guided therapy also significantly lowered TRAEs incidence [12.67% (19 cases/150 cases) vs. 25.33% (38 cases/150 cases), P<0.001].

    Conclusion

    Hypertensive patients at our hospital exhibited a distinct pharmacogenomic profile. Genotype-guided therapy demonstrates substantially greater clinical benefits when applied to CCB strategy than to beta-blocker strategy, providing robust evidence for precision hypertension management within this single-center clinical setting.

  • Clinical and Basic Bridging Research
  • Huan HE , Han-lin FANG , Wei CHEN , Rong XU , Shuang-shuang WU , Wen-kai LIU , Jing PING
    doi: 10.13699/j.cnki.1001-6821.2026.04.010
    Objective

    To investigate the effect and mechanism of kurarinone on bone marrow-derived macrophages (BMDM) cells through regulating toll-like receptor 9 (TLR9) signaling pathway via cathepsin K (Ctsk).

    Methods

    BMDM cells were divided into control group, model group [receptor activator of nuclear factor-κB ligand (RANKL) 50 ng·mL-1], kurarinone group (RANKL 50 ng·mL-1, kurarinone 10 μmol·L-1), kurarinone+oe-NC group (infected oe-NC, RANKL 50 ng·mL-1, kurarinone 10 μmol·L-1), and kurarinone+oe-Ctsk group (infected oe-Ctsk, RANKL 50 ng·mL-1, kurarinone 10 μmol·L-1). Quantitative real time polymerase chain reaction (qRT-PCR) was used to detect the relative expression level of Ctsk mRNA; Western blot was used to detect the expression levels of tartrate-resistant acid phosphatase (TRAP) and TLR9 signaling pathway-related proteins; immunofluorescence was used to detect the expression levels of osteoclast differentiation-related proteins; enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of inflammatory factors; in vitro bone resorption assay was used to detect bone resorption.

    Results

    The relative expression levels of Ctsk mRNA in the control group, model group, kurarinone group, kurarinone+oe-NC group, and kurarinone+oe-Ctsk group were 1.00±0.15, 2.07±0.28, 1.31±0.18, 1.34±0.14 and 1.79±0.27, respectively; the relative expression levels of TRAP protein were 1.00±0.16, 2.31±0.44, 1.43±0.17, 1.38±0.22 and 1.91±0.30, respectively; the relative fluorescence levels of matrix metalloproteinase-9 (MMP-9) protein were 1.00±0.15, 2.18±0.37, 1.33±0.19, 1.28±0.17 and 1.62±0.31, respectively; the relative fluorescence levels of nuclear factor of activated T-cells 1 (NFATc1) protein were 1.00±0.13, 1.87±0.39, 1.13±0.21, 1.18±0.19 and 1.38±0.22, respectively; the relative fluorescence levels of integrin beta-1 (Itgb1) protein were 1.00±0.19, 1.49±0.25, 1.19±0.22, 1.14±0.17 and 1.32±0.18, respectively; the levels of interleukin-1β (IL-1β) were (15.28±2.05), (44.68±7.93), (31.40±6.08), (33.75±5.76) and (39.62±5.52) pg·mL-1, respectively; the levels of interleukin-18 (IL-18) were (122.45±22.39), (317.56±51.51), (191.72±33.34), (185.93±32.19) and (217.89±33.58) pg·mL-1, respectively; the levels of tumor necrosis factor-α (TNF-α) were (81.36±12.27), (216.93±34.39), (130.89±16.18), (125.76±15.15) and (162.94±26.59) pg·mL-1, respectively; the number of bone resorption pits were (35.26±6.35), (84.72±16.10), (50.38±9.07), (47.85±9.09) and (61.63±10.89) per piece, respectively; the relative area of bone resorption pits were (0.26±0.05)%, (1.38±0.24)%, (1.04±0.18)%, (1.06±0.16)% and (1.27±0.19)%, respectively; the relative expression levels of TLR9 protein were 1.00±0.15, 2.05±0.31, 1.32±0.16, 1.27±0.15 and 1.53±0.24, respectively; the relative expression levels of myeloid differentiation factor 88 (MyD88) protein were 1.00±0.13, 2.18±0.33, 1.42±0.18, 1.36±0.17 and 1.62±0.26, respectively; p-p65/t-p65 were 1.00±0.11, 2.22±0.34, 1.40±0.19, 1.39±0.19, 1.76±0.27, respectively. Compared model group with control group, compared kurarinone group with the model group, compared the kurarinone+oe-Ctsk group with the kurarinone group, the differences of above indicators were all statistically significant (P<0.05, P<0.01, P<0.001).

    Conclusion

    Kurarinone can inhibit RANKL-induced osteoclast differentiation, inflammatory factor secretion, and bone resorption function by suppressing Ctsk, which may be achieved through inhibiting the TLR9 pathway.

  • Clinical and Basic Bridging Research
  • Qing-yu HU , Wen-juan LIU , Zong-li LÜ
    doi: 10.13699/j.cnki.1001-6821.2026.04.011
    Objective

    To investigate the effect and mechanism of gastrodin regulating synaptopodin 2 (SYNPO2) on hypoxic-ischemic brain damage (HIBD) in neonatal rats.

    Methods

    The left common carotid artery of neonatal rats was ligated, and the rats were placed in a hypoxic chamber for 40 minutes to establish the HIBD model. Rats were randomly divided into sham operation group (no common carotid artery ligation or hypoxia treatment), model group (HIBD model established), gastrodin group (intraperitoneal injection of gastrodin 100 mg·kg-1 1 hour before common carotid artery ligation, 1 hour after hypoxia, and 12 hours after hypoxia), gastrodin+oe-NC group (3 days before modeling, 3 microliters oe-NC was transplanted intracerebroventricularly in rats, subsequent treatment same as the gastrodin group) and gastrodin+oe-SYNPO2 group (3 days before modeling, 3 microliters oe-SYNPO2 was transplanted intracerebroventricularly in rats, subsequent treatment same as the gastrodin group), with 10 rats in each group. Western blot was used to detect the levels of SYNPO2 and phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mechanistic target of rapamycin (mTOR) signaling pathway-related proteins; short-term behavioral tests were used to detect neurological function in each group; the dry-wet weight method was used to detect brain water content; TdT-mediated dUTP nick end labeling was used to detect the apoptosis rate of brain tissue cells in each group; immunofluorescence was used to detect the levels of lysosomal associated membrane protein 1 (LAMP1) and microtubule associated protein 1 light chain 3 beta (LC3B) proteins in brain tissue of each group.

    Results

    The relative expression levels of SYNPO2 protein in the sham operation group, model group, gastrodin group, gastrodin+oe-NC group and gastrodin+oe-SYNPO2 group were 1.00±0.16, 2.05±0.34, 1.38±0.18, 1.35±0.17 and 1.68±0.22, respectively; the relative expression levels of phosphorylated PI3K (p-PI3K)/PI3K protein were 1.00±0.19, 0.25±0.04, 0.65±0.08, 0.68±0.07 and 0.35±0.05, respectively; the relative expression levels of phosphorylated Akt (p-Akt)/Akt protein were 1.00±0.13, 0.28±0.04, 0.49±0.06, 0.51±0.07 and 0.31±0.04, respectively; the relative levels of phosphorylated mTOR (p-mTOR)/mTOR protein were 1.00±0.16, 0.22±0.04, 0.52±0.06, 0.54±0.07 and 0.29±0.05, respectively; the righting reflex latency periods were (2.56±0.33), (14.86±2.12), (5.66±0.75), (5.23±0.79) and (10.33±1.56) s, respectively; the negative geotaxis latency periods were (17.86±2.44), (56.33±8.22), (22.12±3.56), (23.05±3.22) and (40.22±5.66) s, respectively; the cliff avoidance reflex latency periods were (7.11±0.85), (16.55±2.32), (7.22±0.85), (7.83±0.96) and (13.55±2.45) s, respectively; the water contents were (51.56±6.47)%, (62.16±6.22)%, (55.02±6.25)%, (54.63±7.22)% and (61.98±5.17)%, respectively; the apoptosis rates were (5.17±0.65)%, (75.32±9.65)%, (25.65±3.89)%, (23.85±2.98)% and (50.56±6.89)%, respectively; the relative fluorescence intensity of LAMP1 were 1.00±0.15, 3.85±0.44, 1.14±0.15, 1.18±0.19 and 3.22±0.39, respectively; the relative fluorescence intensity of LC3B were 1.00±0.18, 3.45±0.52, 1.25±0.16, 1.21±0.15 and 1.68±0.19, respectively; the above indicators of the model group were statistically significant compared with the sham operation group, the above indicators of the gastrodin group were statistically significant compared with the model group, and the above indicators of the gastrodin+oe-SYNPO2 group were statistically significant compared with the gastrodin+oe-NC group (P<0.05, P<0.01, P<0.001).

    Conclusion

    Gastrodin inhibits SYNPO2, alleviates brain edema and neurological dysfunction in HIBD rats, protects neuronal structural integrity, reduces neuronal apoptosis, and alleviates excessive autophagy, which may be achieved by activating the PI3K/Akt/mTOR pathway.

  • Research Method
  • Fa-shuang LI , Lin-bo LI , Hui-ying LI , Shao-chun YU , Yan LEI , Hong-min LU , Yi RU , Li-lin ZHANG , Ping LU , Jie KONG , Jin ZHOU
    doi: 10.13699/j.cnki.1001-6821.2026.04.012
    Objective

    To establish an ultra performance liquid chromatography (UPLC) method for determining the concentration of pazopanib in human serum.

    Methods

    Carbamazepine was used as an internal standard (IS), and acetonitrile as a protein precipitant. Separation was performed on an Agilent InfinityLab Poroshell 120 EC-C18 column (2.1 x 50 mm, 1.9 μm) with a mobile phase of 0.1% aqueous formic acid-acetonitrile solution in gradient elution mode. The flow rate was 0.25 mL·min-1, detection wavelength was 268 nm, column temperature was 40 ℃, and injection volume was 25 μL. The specificity of the method, the standard curve and the lower limit of quantification, the accuracy and precision and the stability of the sample were investigated.

    Results

    Under the established chromatographic conditions, the analyte and internal standard exhibited satisfactory separation without interference from endogenous substances. Pazopanib demonstrated good linearity within the concentration range of 0.5-100 μg·mL-1. The standard curve was y=63.37×10-2x-0.49×10-2 (r2=0.999 9) and the lower limit of quantification can reach 0.25 μg·mL-1. The relative standard deviations (RSD) for both intra-day. and inter-day precision were less than 12.02%, with extraction recovery rates exceeding 86.44%. Stability was good, with RSD below than 8.80%.

    Conclusion

    The established UPLC method is simple, selective, sensitive, accurate, and reliable for determining pazopanib in human serum.

  • Reader’s Field
  • Xin LUO , Jiu-long LI , Yu CHEN , Zhe WANG , Zhi-wei QIU , Qian XIANG , Huan MENG , Yi-min CUI
    doi: 10.13699/j.cnki.1001-6821.2026.04.013
    Objective

    To establish a radiation injury model using primary human lung fibroblasts and screen for key genes driving radiation-induced pulmonary fibrosis through transcriptome sequencing, thereby elucidating their potential mechanisms and providing new therapeutic targets and strategies for the clinical prevention and treatment of radiotherapy-induced lung injury.

    Methods

    Primary human lung fibroblasts were isolated by collagenase digestion and serially passaged. Cell purity was confirmed by flow cytometry prior to establishing an in vitro radiation model. Transcriptome analysis was performed based on qualified sequencing data. DESeq2 was used for differential expression analysis to identify upregulated genes, which were subsequently validated. Protein-protein interactions (PPI) among the differentially expressed gene sets were predicted using the String database and visualized using the igraph package. Finally, functional and pathway enrichment analyses of the core genes were performed via gene ontology (GO), Kyoto encyclopedia of genes and genomes (KEGG) and gene set enrichment analysis (GSEA) using the clusterProfiler software.

    Results

    All samples met the quality control standards. Transcriptome analysis identified three significantly upregulated key differentially expressed genes: sulfatase 1 (SULF1), sulfatase 2 (SULF2), and oligodendrocyte myelin glycoprotein (OMG). These findings were consistently validated in a public dataset. PPI network analysis constructed with Cytoscape revealed that SULF1 occupied a central hub position within the network, exhibiting a strong connection with SULF2, and both directly interacted with OMG. GSEA indicated that SULF1/2 and OMG were significantly enriched in pathways related to DNA function, glutathione transferase activity, and neuroimmune regulation. These results suggested that SULF1/2 and OMG may function in radiation-induced lung injury by participating in processes such as DNA damage response, oxidative stress, and neuroimmune interactions.

    Conclusion

    SULF1, SULF2 and OMG are key molecules in human lung fibroblasts responding to radiation injury and may drive the progression of radiation-induced lung injury through multiple pathways. As potential therapeutic targets, they provide a novel theoretical basis for the clinical prevention and treatment of radiotherapy-induced lung injury.

  • Reader’s Field
  • Liang-xiu LI , Shi-yao SU , -Yu LI , Li-ying ZHANG , Hao-jing SONG , Cai-hui GUO
    doi: 10.13699/j.cnki.1001-6821.2026.04.014
    Objective

    To evaluate and analyze quality assessment tools for informed consent and provide a reference for selecting appropriate tools.

    Methods

    A systematic search was conducted in Chinese and English databases, including CNKI, VIP, Wanfang, PubMed, Web of Science, and Embase, covering the period from database inception to July 23, 2025. Basic information on the included studies and assessment tools was extracted, and the dimensions covered by the tools as well as their reliability and validity were summarized.

    Results

    A total of 23 articles and 18 informed consent quality assessment tools were included. The evaluations primarily focused on levels of understanding, information provision, and therapeutic misconception. The information content commonly addressed study objectives, study duration, procedural steps, risks and inconveniences, and potential benefits.

    Conclusion

    Although numerous quality assessment tools for informed consent are available, many lack sufficient validation in terms of reliability and validity. Future research should prioritize the validation and refinement of existing tools while developing or introducing culturally adapted assessment instruments.

  • New Drugs Introduction
  • Ting-ting RUAN , Yan-yan JIA , Hua-qing DU , Ting-ting BIAN
    doi: 10.13699/j.cnki.1001-6821.2026.04.015

    Narsoplimab was first approved by the U.S. Food and Drug Administration (FDA) on December 24,2025, for the management of thrombotic microangiopathy following hematopoietic stem cell transplantation (TA-TMA) in children aged 2 years and older and adults. As a serious complication of hematopoietic stem cell transplantation (HSCT), TA-TMA is characterized by high mortality. TA-TMA is associated with endothelial injury and can activate the complement agglutinin pathway, where mannose-binding agglutinin-related serine protease-2 (MASP-2) is a key enzyme. Narsoplimab is a humanized monoclonal antibody that specifically binds to and inhibits MASP-2, thereby reducing complement activation in damaged tissues without compromising the beneficial role of complement in anti-infection. Multiple real-world studies have demonstrated a high response rate. This article provides an overview of the mechanism of action, pharmacodynamics, pharmacokinetics, clinical studies, and safety profile of Narsoplimab.

  • Review
  • Hong-yu ZHANG , Nan WANG , Sha SHA , Fei JIA
    doi: 10.13699/j.cnki.1001-6821.2026.04.016

    Brexpiprazole, a novel atypical antipsychotic drug, has therapeutic effects in the treatment and prevention of relapse of schizophrenia. It exerts its efficacy through partial agonism of dopamine D2 receptor and 5-hydroxytryptamine receptor 1A (5-HT1A), as well as antagonism of 5-HT2A receptor. In terms of pharmacokinetics, it features high oral bioavailability, a long half-life, and minimal influence of food on its absorption. Multiple clinical trials have confirmed its effectiveness in the acute treatment (2-4mg every day) and maintenance treatment (1-4mg every day) of schizophrenia. Regarding safety, common adverse reactions include akathisia and weight gain, with a relatively low risk of metabolic abnormalities. No systematic review of brexpiprazole has been published in China. This article conducts a systematic search for the first time and reviews it from aspects such as its mechanism of action, pharmacokinetic characteristics, clinical efficacy, and safety, providing a reference for rational clinical use.

  • Review
  • Hui LI , Yong-li ZHAO , Xing-wen XIE , Ning LI , Peng-cheng SONG , Ya-xiong GAO
    doi: 10.13699/j.cnki.1001-6821.2026.04.017

    Rheumatoid arthritis is a multifactorial autoimmune disease with an unknown etiology. In recent years, an increasing number of research findings have indicated that matrix metalloproteinase-3 (MMP-3) is most closely related to the pathogenesis of rheumatoid arthritis and is a key enzyme involved in joint destruction in patients with rheumatoid arthritis. A large number of studies have shown that traditional Chinese medicine can play a role in the prevention and treatment of rheumatoid arthritis by regulating the expression of MMP-3 in rheumatoid arthritis. This article explores the possible molecular mechanisms by which MMP-3 causes rheumatoid arthritis and systematically summarizes the literature on the regulation of MMP-3 by traditional Chinese medicine in the prevention and treatment of rheumatoid arthritis in recent years, with the aim of providing a theoretical basis for the research and clinical treatment of rheumatoid arthritis.

  • Review
  • Yan LIN , Qiao-hui LIANG , Zhi-xia JIANG , Jing CAI , Guang-ji WANG , Jin YANG
    doi: 10.13699/j.cnki.1001-6821.2026.04.018

    Novel drug research and development has high failure rate and “a narrow escape from death”, which needs to strike a balance between rapid progress, development risk and cost reduction and scientific decision-making, it is necessary to achieve "two early": eliminate drugs that may fail as early as possible with little investment, obtain key evidence as early as possible to enhance confidence in subsequent research and development, which is also known as "Quick win, fast fail" concept. Phase 0 clinical trial, as an early exploratory research tool, has the characteristics of low dose, short cycle, small number of subjects, and flexible application requirements. It is mainly used to rapidly evaluate the potential of drug candidates for further development, and more efficiently screen and develop potential drug candidates. The Phase 0 clinical trial strategy requires a variety of specific technologies and qualified personnel, including radiopharmaceutical labeling techniques, high-sensitivity analysis techniques, imaging techniques, pharmacokinetic and pharmacodynamic modeling, ethical review and subject recruitment, as well as multidisciplinary team collaboration and highly specialized research institutions. The effective integration and collaboration of these technologies and personnel is the key to the success of Phase 0 clinical trial. This paper mainly introduces the benefit-risk assessment strategy, required technologies, application requirements, and case analysis of the new paradigm for novel drug development incorporating phase 0 clinical trial.

  • Review
  • Ze-yang ZHANG , ABUDUKEREMU Dawuti , Yu-lin JIN , Hui ZHAO , Qi FU , Chao ZHANG
    doi: 10.13699/j.cnki.1001-6821.2026.04.019

    Bone and joint diseases encompass conditions such as osteoporosis, osteoarthritis, rheumatoid arthritis, and gouty arthritis. With high prevalence rates and a significant burden of disability, they have become a major global public health issue. Current treatment approaches primarily rely on drug interventions and surgical procedures, with relatively limited options for comprehensive intervention strategies. Psoralea corylifolia L. (Buguzhi), a traditional Chinese medicinal herb, is rich in various flavonoid small-molecule compounds. Its multi-targeted, multi-step regulatory advantages have drawn significant attention in the prevention and treatment of bone and joint diseases. Existing evidence indicates that these compounds exhibit comprehensive effects including osteogenesis promotion, osteoclast inhibition, anti-inflammation, antioxidant activity, and metabolic regulation, However, its key active substances and functional networks have yet to be systematically elucidated. Based on this, this paper aims to systematically elucidate the pharmacological actions and molecular mechanisms of psoralen flavonoids in the treatment of osteoarthritis, with the goal of providing novel research perspectives and potential strategies for the clinical prevention and treatment of this condition. Furthermore, it explores the prospects for clinical translation and the primary challenges encountered.

  • Drug Evaluation and Administration
  • Yuan WANG , Hong WANG , Rong GAO
    doi: 10.13699/j.cnki.1001-6821.2026.04.020

    The drug clinical trial institution serves as the management entity for the trial site and the responsible unit for protecting the rights and interests of the subjects. The investigator is responsible for the quality of clinical trials and the rights and safety of subjects at the clinical trial site. The depth and precision of quality management in both aspects determine the reliability of the trials data and the level of safety and rights protection for the subjects. This study introduced the quality management requirements and inspection focus of relevant regulations for drug clinical trial institutions and investigators from the perspective of inspection. Meanwhile, this study analyzed reasons and provided suggestions based on relevant risks identified during the inspection, with the aim of offering reference for conductors and supervisors of drug clinical trials.

  • Drug Evaluation and Administration
  • Rui-rui HE , Li LI , Ying-qi ZHAI , Chun-min WEI
    doi: 10.13699/j.cnki.1001-6821.2026.04.021

    Eliglustat is a first-line oral small molecule drug for the treatment of type 1 Gaucher disease, which can reduce the volume of spleen and liver, and improve anemia and thrombocytopenia. Eliglustat is mainly metabolized by cytochrome P450 2D6 (CYP2D6), and its systemic exposure is significantly affected by CYP2D6 phenotypes. The bioavailability is extremely low in CYP2D6 extensive metabolizers, resulting in the bioequivalence (BE) study results being easily affected by factors other than the preparation itself. This paper analyzed the potential risk factors in the BE study of eliglustat capsules from the aspects of molecular characteristics, biopharmaceutics, pharmacokinetics, food-drug interaction and genetic polymorphism of metabolic enzymes, so as to provide a practical reference for the BE study of the generic research and development of this variety.

  • Drug Evaluation and Administration
  • Xin-zhu NA , Jian-zhen LIU , Jun-lin ZHANG
    doi: 10.13699/j.cnki.1001-6821.2026.04.022

    Proteasome inhibitors have become key drugs in the targeted therapy of multiple myeloma in current clinical applications. Based on the publicly available information on the domestic and foreign official websites of drug regulatory authorities regarding currently marketed proteasome inhibitor drugs, such as bortezomib for injection, carfilzomib for injection, and ixazomib citrate capsules, this article proposes the key points of attention in the research of drug substances and drug products for these three agents in pharmaceutical development, in order to promote the marketing of generic drugs.

  • Special Column of Clinical Trials Administration
  • Qian LI , Xiao-yuan GUAN , Di ZHANG , Ying LOU , Lei TIAN
    doi: 10.13699/j.cnki.1001-6821.2026.04.023
    Objective

    To systematically analyze the longitudinal characteristics and development trends of registered clinical trials of lipid-lowering drugs in China from 2013 to 2025, and to provide evidence-based data for clinical researchers, policy-makers, and pharmaceutical companies.

    Methods

    Data were retrieved from the National Medical Products Administration (NMPA) Clinical Trial Registration and Information Disclosure Platform. Clinical trials related to lipid-lowering drugs with the first public disclosure date ranging from January 1, 2013 to December 31, 2025 were included. Trials with indications containing keywords such as "cholesterol" and "hyperlipidemia" etc. were screened. After excluding duplicate registrations, comparative analyses were conducted on data regarding basic trial information, drug characteristics and the design of innovative drug trials.

    Results

    A total of 748 clinical trials were included, of which 68.45% (512 cases/748 cases) were bioequivalence (BE) trials, while phase Ⅰ, Ⅱ, and Ⅲ trials accounted for 125, 47, and 64 trials respectively, totaling 31.55% (236 cases/748 cases). BE trials increased significantly from 2016 to 2019, declined during 2020 to 2022 due to the COVID-19 pandemic, and surged again after 2023. The number of innovative drug trials grew steadily, peaking in 2025. Ninety-four innovative lipid-lowering drugs identified covered diverse therapeutic targets, including proprotein convertase subtilisin/kexin type 9 (PCSK9), angiopoietin-like protein 3 (ANGPTL3), lipoprotein(a) [Lp(a)] and apolipoprotein C3 (APOC3), with 71.28% (67 cases / 94 cases) developed by domestic companies and injections dosage form accounting for 52.13% (49 cases /94 cases). The primary endpoints of phase Ⅲ trials were predominantly the percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline, accounting for 65.52% (38 cases /58 cases), while hard endpoints such as major adverse cardiovascular events (MACE) accounted for only 15.52% (9 cases /58 cases). Target exploration showed a trend of diversification. Novel modalities such as small interfering RNA (siRNA) experienced explosive growth after 2023, with 24 registered trials in 2025. Only 8 innovative drug trials included subjects under 18 years old, all targeting familial hypercholesterolemia.

    Conclusion

    From 2013 to 2025, China’s lipid-lowering drug clinical trials underwent a critical transformation, shifting from generic drug expansion to active innovative drug research and development. Therapeutic targets have diversified, and novel drug modalities have developed rapidly.