Home Latest Articles
Latest Articles
  • Yan LI, Xin HE
    Chinese Journal of Clinical Pharmacology. 2026, 42(6): 860-864.
    Objective

    In November 2025, the US Food and Drug Administration (FDA) officially approved Kygevvi oral solution powder for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and children with onset age ≤ 12 years old. Kygevvi is the first and only targeted therapy approved for the treatment of TK2d, consisting of two types of pyrimidine nucleosides, doxecitine and doxribtimine. Its function is to integrate doxecitine and doxribtimine into skeletal muscle mitochondrial deoxyribonucleic acid (DNA), thereby bypassing defective thymidine kinase 2 (TK2) and helping to repair and increase the quantity of mitochondrial DNA, and fundamentally improving cellular energy supply. Here is an introduction to its mechanism of action, pharmacodynamics, pharmacokinetics, clinical research, and safety.

  • Xiao-han FAN, Zhuo-yuan CAO, Jie DENG, Zhi-chao ZHOU, Fei YU, Zhao YANG
    Chinese Journal of Clinical Pharmacology. 2026, 42(6): 850-855.
    Objective

    This study used bibliometric methods to analyze the quality and influence of SCI papers, publication patterns, and funding sources in the cardiovascular field published by a Grade A tertiary hospital in Beijing and its international counterparts from 2015 to 2024, aiming to provide insights for future development.

    Methods

    This study retrieved the cardiovascular-related literature published by 11 medical institutions in the Web of Science Core Collection database from January 1, 2015 to December 31, 2024, and imported it into the InCites database for analysis from three aspects: research paper quality, academic quality, collaborative networks, publication source, and funding agency.

    Results

    The cardiovascular department of the hospital has room for improvement in terms of the quality and international influence of research papers. The main source of research funds relies on government institutions.

    Conclusion

    In the future, the cardiovascular department in domestic hospitals needs to further enhance the quality of published papers, expand international cooperation, raise the level of published journals, broaden the research funding system, and continuously enhance its global academic influence.

  • Na XIE, Min-guang ZHANG, Run NAN, Si-qi WANG, Ya-he ZHU, Ying WU, Heng-hui LIU
    Chinese Journal of Clinical Pharmacology. 2026, 42(6): 820-827.
    Objective

    To establish a population pharmacokinetic-pharmacodynamic (PK-PD) model of a novel glucagon-like peptide-1 (GLP-1) analogue in patients with type 2 diabetes mellitus (T2DM), using HbA1c levels after 52 weeks of treatment as the efficacy endpoint and based on a nonlinear mixed-effects model (NLME).

    Methods

    A population PK-PD linkage model was developed via the NLME approach, utilizing 1 967 plasma concentration data points and 1 813 observed HbA1c data points from 409 T2DM subjects enrolled in a Phase Ⅲ clinical trial. Model robustness and predictive performance were comprehensively validated using diagnostic plots, visual predictive check (VPC), and the Bootstrap method.

    Results

    The PK characteristics were best described by a one-compartment model with first-order absorption and first-order elimination, while the PD model was a plasma concentration-driven indirect response model. Key parameters were estimated as follows: apparent volume of distribution (V/F)=11.28 L, apparent clearance (CL/F)=1.11 L·day-1, maximum inhibitory effect (Imax)=0.30, and half-maximal inhibitory concentration (IC50)=37.77 ng·mL-1. Covariate analysis revealed that baseline body weight was a significant factor affecting CL/F, and baseline HbA1c (group 1: HbA1c < 8.5%; group 2: HbA1c ≥ 8.5%) influenced the parameter kin.

    Conclusion

    The nonlinear mixed-effects model effectively utilizes sparsely sampled data, and the obtained PK-PD parameter estimates are robust and reliable.

  • Zhuo SUN, Peng-jiao AN, Bo ZHANG, Yi-li SHI
    Chinese Journal of Clinical Pharmacology. 2026, 42(6): 835-839.
    Objective

    This article aims to explore the medication strategy for the treatment of type Ⅱ Crigler-Najjar syndrome (CNS II) during pregnancy with phenobarbital, focusing on the relationship between treatment dosage, treatment duration, and gestational stage of the patient with maternal and neonatal outcomes, providing a reference for the treatment of this rare disease during pregnancy.

    Methods

    : This study systematically searched the PubMed, Embase, Web of Science, and Cochrane Library database using the keywords “Pregnancy” and “Crigler-Najjar syndrome Ⅱ” with the logical connector “and”. The time range covered from the establishment of the database to March 2025. A total of 11 articles were screened.

    Results

    A total of 11 patients with CNS Ⅱ during pregnancy were included. Among them, 3 cases did not receive drug treatment, and 2 cases had known total bilirubin levels, which were 7 mg·dL-1 and 8.5 mg·dL-1, respectively. Among the 3 cases, 1 newborn was healthy, 1 had jaundice that could subside on its own, and 1 had jaundice that required ursodeoxycholic acid treatment. The total bilirubin levels of the remaining 8 cases were between 6.85 and 21.5 mg·dL-1, and all received phenobarbital treatment, with a dosage of 25-60 mg·d-1. After treatment, 1 out of 8 newborns was completely healthy, 4 had varying degrees of jaundice, and all received 1-3 days of phototherapy and recovered. Follow-up was conducted for 6 months to 11 years for 3 of the infants, and no neurological damage was observed. During the treatment process, 5 patients received bilirubin level monitoring, once a week in the first month and once a month thereafter.

    Conclusion

    The current evidence suggests that the maternal bilirubin level may be one of the key factors influencing the neonatal outcome. When the bilirubin level remains above 8-10 mg·dL-1, some studies recommend considering drug intervention under multidisciplinary assessment. However, due to the extremely small sample size and the lack of controlled studies, the causal relationship between the use of phenobarbital and maternal and infant outcomes cannot be clearly determined. The clinical benefits of phenobarbital use still need to be verified by more research. After thorough assessment by the treatment team, if phenobarbital intervention is chosen, it can be started in the early stage of pregnancy and continued until delivery, with a recommended dose of less than 60 mg·d-1. During the treatment period, the maternal total bilirubin concentration should be closely monitored, once a week in the first month and once a month thereafter, to ensure the safety of medication.

  • Di ZHOU, Yin-xia LI, Yü-ming XIA, Hui-juan QU, Zhao-yi YANG
    Chinese Journal of Clinical Pharmacology. 2026, 42(6): 812-819.
    Objective

    To study the bioequivalence of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets (I) from two different manufacturers in healthy Chinese participants under fasting conditions.

    Methods

    A randomized, single-center, open-label, single-dose, two-sequence, two-period, two-way crossover design. Forty-two eligible healthy subjects were enrolled. In each period, subjects received a single oral dose of the test or reference formulation of efavirenz lamivudine tenofovir tablets (specification: each tablet contains 0.4 g efavirenz, 0.3 g lamivudine and 0.3 g tenofovir disoproxil fumarate) under fasting conditions. The plasma concentrations of efavirenz, lamivudine and tenofovir was performed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that had been fully validated. Pharmacokinetic parameters were calculated and the bioequivalence and safety of the two efavirenz lamivudine tenofovir tablets were evaluated.

    Results

    For efavirenz, the key pharmacokinetic parametersderived from the test and reference formulations were as follows: Cmax were (1 710.25±430.44) and (1 851.26±505.57) ng·mL-1, AUC0-72 h were (37 571.38±8 747.34) and (39 391.65±8 746.77) ng·mL-1·h, tmax were [3.23±1.13 (1.00, 3.17, 5.00)] and [3.12±1.30 (1.25, 3.00, 6.03)] h, and t1/2 were (77.08±61.79) and (71.11±39.45) h, respectively. For lamivudine: Cmax were (2 397.22±689.34) and (2 388.23±618.71) ng·mL-1, AUC0-t were (12 134.48±2 526.28) and (12 324.11±2 891.50) ng·mL-1·h, tmax were [1.97±0.70 (0.67, 1.88, 4.00)] and [2.04±0.90 (0.67, 2.00, 4.51)] h, and t1/2 were (11.07±11.10) and (11.46±11.90) h, respectively. For tenofovir: Cmax were (287.40±86.07) and (304.71±91.49) ng·mL-1, AUC0-t were (2 516.91±583.47) and (2 507.40±573.45) ng·mL-1·h, tmax were [1.40±0.74 (0.50, 1.13, 3.00)] and [1.39±0.84 (0.33, 1.25, 4.00)] h, and t1/2 were (22.95±4.26) and (21.88±2.99) h, respectively. Under fasting conditions, the 90% confidence intervals of the main PK parameters of the test and reference formulations were all within 80.00% to 125.00%.

    Conclusion

    The test and reference formulations are bioequivalent under fasting conditions.

  • Yan-ping YIN, Song SUN, Shuo LIU, Shou-lin SUN
    Chinese Journal of Clinical Pharmacology. 2026, 42(6): 865-872.

    Cancer is one of the major global health burdens, with its incidence and mortality rates continuing to rise. In exploring cancer prevention and treatment strategies, natural products derived from plants have shown great potential. Over long-term evolution, plants have produced a rich array of bioactive compounds, some of which have been successfully developed into anticancer drugs, such as vinca alkaloids. This article focuses on glycosidic alkaloids contained in Solanaceae plants, α-Solanine. Due to its chemical structure similarity to human steroid hormones, this substance is believed to possess various biological activities, including anti-inflammatory and antimicrobial effects. Recent studies have further revealed that α-Solanine exhibits significant antitumor activity in both in vitro and in vivo experiments, capable of inhibiting the proliferation of multiple types of cancer cells. Therefore, this review systematically summarizes the latest advances in α-Solanine’s anticancer properties and highlights its development prospects as a potential anticancer therapeutic agent.

  • Xiao-li ZHANG, Yun-li REN, Yan WANG
    Chinese Journal of Clinical Pharmacology. 2026, 42(5): 619-624.
    Objective

    To observe the clinical efficacy and safety of tocilizumab injection combined with iguratimod tablets in the treatment of elderly patients with rheumatoid arthritis (RA) complicated with interstitial pneumonia.

    Methods

    Elderly patients with RA complicated with interstitial pneumonia in our hospital were divided into control group and treatment group according to the treatment methods. The control group was given iguratimod tablets 25 mg bid, orally after breakfast and dinner, for a total of 12 weeks on the basis of the conventional treatment plan. The treatment group was given tocilizumab injection 8 mg·kg-1 intravenously every 4 weeks on the basis of control group. When abnormal liver enzymes, decreased neutrophil count, or decreased platelet count occurred, the dose of tocilizumab injection was reduced to 4 mg·kg-1, for a total of 12 weeks. The clinical efficacy, lung function and inflammatory response indicators of the two groups were compared, and the safety was evaluated.

    Results

    A total of 84 cases were included in this study, with 39 cases in control group and 45 cases in treatment group. After treatment, the overall clinical response rates were 74.36% (29 cases /39 cases) in control group and 91.11% (41 cases /45 cases) in treatment group, respectively. The overall clinical response rate of treatment group was statistically significant higher than control group (P<0.05). After treatment, the levels of vital capacity (VC) in control group and treatment group were (2.25±0.34) and (2.38±0.30) L, respectively; the levels of forced expiratory volume in 1 second (FEV1) were (2.71±0.39) and (2.85±0.36) L, respectively; the high-resolution CT (HRCT) scores were (1.59±0.68) and (1.49±0.59) points, respectively. There was no statistically significant difference in the above indicators between the two groups (all P>0.05). After treatment, the levels of interleukin-6 (IL-6) in control group and treatment group were (13.27±1.95) and (12.05±1.72) pg·mL-1, respectively; the levels of rapid C-reactive protein (CRP) were (16.09±2.44) and (14.83±2.15) mg·L-1, respectively; the levels of matrix metalloproteinase-3 (MMP-3) were (60.32±9.59) and (55.61±8.27) μg·mL-1, respectively; the levels of tissue inhibitor of metalloproteinase-1 (TIMP-1) were (86.79±14.58) and (79.83±13.27) pg·mL-1, respectively. All the aforementioned indicators in treatment group were statistically significant lower than control group (P<0.05, P<0.01). The main adverse drug reactions in control group were elevated aminotransferase, leukopenia and upper abdominal pain. The main adverse drug reactions in treatment group were elevated aminotransferase, leukopenia, decreased neutrophil count and upper abdominal pain. The total incidence of adverse drug reactions was 7.69% in control group and 11.11% in treatment group, with no statistically significant difference (P>0.05).

    Conclusion

    Tocilizumab injection combined with iguratimod tablets is effective in the treatment of elderly patients with RA complicated with interstitial pneumonia, and can effectively improve their clinical symptoms, serum marker levels, and lung function, reduce inflammatory responses, and has good safety.

  • Zhen-wei ZHAO, Yan-jie LIU, Jing-wen LI, Wei-dong ZHOU
    Chinese Journal of Clinical Pharmacology. 2026, 42(5): 625-629.
    Objective

    To observe the efficacy and safety of bifidobacterium triple viable capsule in patients with type Ⅲ prostatitis.

    Methods

    Patients with type Ⅲ prostatitis in the hospital were retrospectively selected and divided into treatment group and control group. The two groups of patients both took sertraline tablets 0.05 g, once daily. Patients in control group were given oral administration of 0.2 mg of tamsulosin sustained release capsule once a day, while patients in treatment group received oral administration of 0.42 g of bifidobacterium triple viable capsule twice a day on the basis of control group. Both groups were treated for 4 weeks. The efficacy, clinical symptoms scores, urodynamic parameters and inflammatory factors were compared between the two groups, and the safety was evaluated.

    Results

    A total of 200 patients were enrolled, including 97 cases in control group and 103 cases in treatment group. After 4 weeks of treatment, the total effective rate in treatment group was 88.35% (91 cases/103 cases), which was statistical significant higher than 79.38% (77cases/97 cases) in control group (P>0.05). After treatment, the scores of the pain domain of the national institutes of health chronic prostatitis symptom index (NIH-CPSI) in treatment group and control group were (4.37±1.42) and (5.04±1.56) point, respectively; the self-rating depression scale (SDS) scores were (38.20±5.38) and (40.63±5.54) point, respectively; the levels of interleukin-6 (IL-6) were (5.93±1.08) and (6.30±1.27) pg·mL-1, respectively; the levels of interleukin-10 (IL-10) were (6.21±1.37) and (6.62±1.49) pg·mL-1, respectively; and the levels of cyclooxygenase-2 (COX-2) were (9.46±2.66) and (10.26±2.02) ng·mL-1, respectively. There were statistical significant differences in the above indicators between treatment and control group (all P<0.05). The main adverse drug reactions in treatment group included dizziness, nausea and vomiting, and diarrhea, whereas dizziness and diarrhea occurred in control group. The overall incidence of adverse drug reactions was 4.85% (5 cases/103 cases) in treatment group and 2.06% (2 cases/97 cases) in control group, with no statistically significant difference between the two groups (P>0.05).

    Conclusion

    Bifidobacterium triple viable capsule in the treatment of type Ⅲ prostatitis can improve the pain symptom and depression, and regulate the levels of inflammatory factors, and it has good safety.

  • Huang ZHANG, Jia-wen YU, Hua-li ZHENG, Wei LIU
    Chinese Journal of Clinical Pharmacology. 2026, 42(5): 636-642.
    Objective

    To observe the clinical efficacy and safety of programmed death-1 (PD-1) inhibitors (tislelizumab injection or sintilimab injection) combined with the capecitabine tablet and oxaliplatin for injection regimen (XELOX) as first-line treatment in patients with advanced gastric signet-ring cell carcinoma (SRCC)

    Methods

    Patients with SRCC were enrolled and divided into control group and treatment group using a random number table. The control group received the XELOX regimen, 130 mg·m-2 intravenous oxaliplatin for injection on day 1, and oral 1 000 mg·m-2 capecitabine tablets twice daily from days 1 to 14, repeated every 21 days. The treatment group received an intravenous infusion of tislelizumab injection or sintilimab injection 200 mg per dose prior to the XELOX regimen, also administered every 21 days. Both groups were treated for 6 cycles. Clinical efficacy, tumor markers, immune function, clinical scores, safety and long-term prognosis were compared between the two groups.

    Results

    A total of 82 patients were included, with 41 cases in each group. The levels of carcinoembryonic antigen (CEA) in treatment and control group were (6.46±1.03) and (7.00±0.94) ng·mL-1, respectively; the levels of carbohydrate antigen 19-9 (CA19-9) were (18.62±3.36) and (20.58±3.52) U·mL-1, respectively; vascular endothelial growth factor (VEGF) were (33.57±5.56) and (36.15±5.03) ng·mL-1, respectively; CD3+ T cells were (62.31±5.71)% and (59.50±6.10)%, respectively; CD4+ T cells were (47.56±5.93)% and (44.91±4.84)%, respectively; European organisation for research and treatment of cancer quality of life questionnaire core 30 (QLQ-C30) score were (60.15±11.01) and (55.02±9.46) points, respectively; and revised piper fatigue scale (RPFS) score were (5.05±0.89) and (5.49±0.84) points, respectively; the levels of CA72-4 were (34.07±3.74) and (36.23±3.01) U·mL-1, respectively; the CD4+/CD8+ ratios were 1.99±0.35 and 1.75±0.37, respectively; the differences of above indicators between two groups were all statistically significant (P<0.05, P<0.01). Adverse drug reactions in both groups were gradeⅠorⅡand resolved after drug discontinuation. The incidence of adrenal dysfunction in the treatment group was 14.63% (6 cases/41 cases), which was significantly higher than that in the control group (0%) (P<0.05). The median survival time was 38 months in the treatment group and 28 months in the control group (P<0.05).

    Conclusion

    PD-1 inhibitors (tislelizumab or sintilimab injection) combined with the XELOX regimen as first-line therapy can enhance the efficacy in patients with advanced SRCC, significantly improve quality of life and long-term survival benefits, and exhibit a favorable safety profile. This therapeutic advantage may be attributed to the regimen’s effect on downregulating tumor markers and improving immune function.

  • Zhao-yang LI, En-gang WU, Feng WANG, Wei LI, Sheng-jun DONG, Kai-qiang YANG, Ning GAI
    Chinese Journal of Clinical Pharmacology. 2026, 42(5): 650-656.
    Objective

    To investigate the ameliorative effects of curculigoside on rats with aortic dissection by the inhibition of the reactive oxygen species /NOD-like receptor thermal protein domain associated protein 3 (ROS/NLRP3) pathway.

    Methods

    Rats were randomly divided into control group, model group, low-dose experimental group (50 mg·kg-1 curculigoside), high-dose experimental group (100 mg·kg-1 curculigoside) and combination group (100 mg·kg-1 curculigoside and 1.75 mg·mL-1 trimethylamine N-oxide), with 12 rats in each group. The rat model of aortic dissection was established by intragastric administration of 0.1 g·kg-1 β-aminopropionitrile (BAPN). Cardiac blood was collected, and the levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) were determined by enzyme-linked immunosorbent assay (ELISA). hematoxylin-eosin (HE) staining and Van Gieson staining were used to evaluate histopathological changes and the degree of elastic fiber rupture. Reactive oxygen species (ROS) levels were detected using 2′,7′-dichlorodihydrofluorescein diacetate (DCFH-DA) staining. The mRNA expression levels of matrix metalloproteinase 9 (MMP-9) and matrix metalloproteinase 2 (MMP-2) in aortic tissues were measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR). The protein expression levels of apoptosis-associated speck-like protein containing a CARD (ASC), NLR family pyrin domain-containing 3 (NLRP3) and caspase-1 in aortic tissues were detected by Western blotting.

    Results

    The IL-6 levels in the low-dose experimental group, high-dose experimental group, control group, model group and combination group were (49.06±4.98), (37.18±3.81), (35.62±3.63), (72.34±7.33) and (50.03±5.08) pg·mL-1, respectively; the TNF-α levels were (25.63±2.64), (16.35±1.71), (15.31±1.62), (42.06±4.23) and (26.15±2.64) pg·mL-1, respectively; the degrees of elastic fiber rupture were 2.01±0.22, 0.85±0.09, 0±0, 3.22±0.34 and 1.85±0.19, respectively; the ROS levels were 358.62±36.64, 203.11±20.15, 186.34±19.11, 588.64±60.03 and 361.24±37.24, respectively; the relative mRNA expression levels of MMP-9 were 1.67±0.18, 1.15±0.12, 1.02±0.11, 2.45±0.26 and 1.72±0.19, respectively; the relative mRNA expression levels of MMP-2 were 1.88±0.19, 1.24±0.14, 0.98±0.10, 2.85±0.30 and 1.91±0.20, respectively; the relative protein expression levels of Caspase-1 were 0.85±0.09, 0.55±0.06, 0.44±0.05, 1.24±0.13 and 0.88±0.10, respectively; the relative protein expression levels of ASC were 0.97±0.10, 0.64±0.08, 0.55±0.06, 1.48±0.16 and 0.89±0.09, respectively; and the relative protein expression levels of NLRP3 were 0.64±0.08, 0.35±0.05, 0.25±0.03, 1.02±0.11 and 0.72±0.09, respectively. Compared with the control group, the above indicators in the model group were significantly different (all P<0.05); compared with the model group, the above indicators in the high-dose experimental group were significantly different (all P<0.05); and compared with the high-dose experimental group, the above indicators in the combination group were significantly different (all P<0.05).

    Conclusion

    Curculigoside can effectively ameliorate BAPN-induced aortic injury in rats. Its protective mechanism against the development of aortic dissection may be associated with the inhibition of the ROS/NLRP3 signaling pathway.