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