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  • Jing SUN, Chang MENG, Yue ZHAO, Ying BAI, Shu-fang WANG, Guo-bin MIAO
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2667-2673.
    Objective

    The safety and efficacy of tranexamic acid in the perioperative period of burn patients remain controversial. This study aimed to investigate the safety and efficacy of tranexamic acid in perioperative burn patients.

    Methods

    A systematic search was conducted in Pubmed, Embase, Cochrane Library, China national know-ledge infrastructure (CNKI), Wanfang, and other databases up to March 1, 2025, for studies on the use of tranexamic acid in perioperative burn care. The primary outcomes included total perioperative blood loss, perioperative blood transfusion events, operative time, all-cause mortality, and incidence of adverse events. Meta-analysis was performed using RevMan 5.4.1, with risk of bias assessed using Cochrane’s ROB 2 tool and Robins-1 tool.

    Results

    Seven studies were included, comprising a total of 465 cases (218 in the tranexamic acid intervention group and 247 in the control group). The findings demonstrated that the total perioperative blood loss in the tranexamic acid group was significantly lower than in the control group [MD=-165.01, 95% confidence interval (CI) (-210.13 to -119.89), P<0.001]. Additionally, tranexamic acid reduced operative time [MD=-8.32, 95% CI (-14.55 to -2.09), P=0.009] and perioperative blood transfusion events (OR=0.26, 95% CI 0.15-0.44, P<0.001), without increasing all-cause mortality (OR=0.67, 95% CI 0.33 to 1.36, P=0.27).

    Conclusion

    Tranexamic acid is effective in reducing total perioperative blood loss, shortening operative time, and decreasing the risk of perioperative blood transfusion events in burn patients, without increasing all-cause mortality. Thus, tranexamic acid can serve as a valuable adjunct in perioperative management for burn patients.

  • Yan-qiu ZHU, Jun YANG, Wen-jun XU, Jin DUAN, Min JIA, Ying-min MA, Ping DU
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2661-2666.
    Objective

    To explore the impact of necrotic apoptosis-related long non-coding RNA (lncRNA) on the prognosis of hepatocellular carcinoma (HCC) in high-risk populations.

    Methods

    LncRNAs were identified by co-expression analysis of immune genes with gene expression and clinical data from the cancer genome atlas program (TCGA) database. A risk model was established through univariate and multivariate cox proportional hazards regression model (Cox), as well as Lasso regression analysis. Patients were screened from TCGA database and divided into high-risk group and low-risk group. Combined with necrotic apoptosis-related lncRNA features, a highly predictive nomogram was created.

    Results

    By analyzing data from the TCGA, a total of five lncRNAs (TMCC1-AS1, AC026412.3, AC026356.1, AC100872.2, and FOXD2-AS1) were identified as potential biomarkers. Nomogram was created, and its predictive efficiency was assessed using a calibration curve. Receiver operating characteristic (ROC) curve analysis showed that the area under curve (AUC) for predicting 1-year, 3-year, and 5-year survival rate were 0.781, 0.663, and 0.686, respectively (P<0.001).

    Conclusion

    Risk model constructed based on five necrotic apoptosis-related lncRNAs may predict prognosis in HCC patients.

  • Xiao-qun WANG, Wen-jing NI, Guang-wei ZHOU, Man-he ZHANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2611-2617.
    Objective

    To observe the effects and safety of different doses of alfentanil injection on hyperalgesia after continuous infusion of remifentanil injection in patients undergoing laparoscopic cholecystectomy.

    Method

    The patients scheduled to undergo laparoscopic cholecystectomy were divided into group A, group B, group C and group D. Ten minutes before the end of the surgery, groups A, B and C were intravenously injected with alfentanil at doses of 5, 15 and 25 μg·kg-1, respectively, while group D was injected with 0.9% NaCl. The hemodynamics indices [before anesthesia induction (T0), 5 minutes after induction (T1), during intubation (T2), at skin incision (T3), during extubation (T4), 10 minutes after extubation (T5)], quality of awakening, analgesia and sedation scores, incidence of postoperative hyperalgesia, inflammatory factors and safety were compared among the 4 groups.

    Results

    A total of 42 patients in each group were included in the statistical analysis. At T4, mean arterial pressure (MAP) values in groups A, B, C and D were (92.81±10.31), (87.50±10.33), (85.60±9.69) and (98.48±7.07) mmHg, respectively; heart rate (HR) values were (87.36±9.25), (81.76±9.35), (80.24±9.38) and (92.83±9.73) beat·min-1, respectively; at T5, MAP values were (95.40±8.63), (90.19±8.79), (89.71±8.86) and (99.48±8.72) mmHg, respectively; HR values were (92.31±8.56), (87.55±8.84), (86.24±8.64) and (97.33±8.51) beat·min-1, respectively; extubation time were (9.07±1.02), (9.38±1.25), (11.48±1.58) and (10.74±1.38) min; spontaneous breathing recovery time were (6.52±1.27), (6.86±1.28), (8.38±1.53) and (7.29±1.13) min; and PACU stay time were (22.64±4.57), (23.69±4.25), (32.95±4.62) and (27.26±4.98) min for groups A, B, C, and D, respectively; the incidence of hyperalgesia at 2 h postoperation were 4.76% (2 cases/42 cases), 2.38% (1 cases/42 cases), 0 and 21.43% (9 cases/42 cases), and at 24 h postoperation were 9.52% (4 cases/42 cases), 4.76% (2 cases/42 cases), 0 and 23.81% (10 cases/42 cases) in groups A, B, C, and D, respectively. Differences between group D and the other three groups were statistically significant (all P<0.05). There were no obvious adverse drug reactions in groups A and D. Adverse drug reactions in group B included nausea and vomiting, and adverse drug reactions in group C included respiratory depression. The total adverse drug reactions in groups A, B, C, and D were 0% (0 cases/42 cases), 2.38% (1 case/42 cases), 4.76% (2 cases/42 cases), and 0% (0 cases/42 cases), respectively, and there were no statistically significant differences (all P>0.05).

    Conclusion

    Compared with low dose alfentanil injection, high dose alfentanil injection applied in cholecystectomy can reduce hyperalgesia, effectively relieve pain, and alleviate inflammatory response, but the effect on improving the recovery quality of patients is not obvious.

  • Xun-ru ZHANG, Hong-zhuan LI, Fei WANG, Zong-yang CHEN, Jia-qi LIANG, Li-peng WEN, Zhong-feng LI
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2685-2691.

    Osteoarthritis, a degenerative bone disease commonly seen in the elderly, is particularly prevalent in weight-bearing joints such as the knee. Its etiology is multifactorial and characterized by pathological changes in the joint structure, including destruction and degeneration of articular cartilage, inflammatory response and formation of bone capillaries. Up to now, clinical treatment for osteoarthritis is mainly symptomatic treatment and pain relief, and there is no exact therapy that can reverse the pathological process of cartilage damage in osteoarthritis. In recent years, domestic and foreign scholars have found that mitochondria, as important organelles of chondrocytes, plays an important role in the process of cell metabolism, proliferation and apoptosis. It is also pointed out that mitochondrial autophagy imbalance is an important factor leading to cartilage damage in joints. Meanwhile, several basic experiments have shown that Chinese medicine exhibits the potential to protect cartilage by targeting the regulation of mitochondrial autophagy, thus showing positive results in the prevention and treatment of osteoarthritis. However, studies on this area have not been systematically elaborated. In view of this, the authors will systematically elaborate on the effects of mitochondrial autophagy on the development of osteoarthritis and the role of TCM in interfering with mitochondrial autophagy in the treatment of osteoarthritis, with the aim of providing new ideas and methods for the development of new medicines and therapeutic strategies for the treatment of osteoarthritis with TCM.

  • Ping HAN, Rui-chao CHU, Yan ZHANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2624-2629.
    Objective

    To observe clinical curative effect and safety of propofol emulsion injection combined with sufentanil citrate injection for intravenous anesthesia in children undergoing laparoscopic repair of oblique inguinal hernia.

    Methods

    According to historical medication regimens, children undergoing laparoscopic repair of oblique inguinal hernia were divided into treatment group and control group. The control group was given intravenous pumping of propofol emulsion injection 4-10 mg·kg-1·h-1 and fentanyl citrate injection 3 μg·kg-1·h-1 for anesthesia maintenance, while treatment group was given intravenous pumping of propofol emulsion injection 4-10 mg·kg-1·h-1 and sufentanil citrate injection 0.3 μg·kg-1·h-1 for anesthesia maintenance. The hemodynamic indexes, emergence agitation, awakening quality, pain and postoperative analgesics use were compared between the two groups at different time points, and safety evaluation was performed.

    Results

    According to electronic medical record, 427 children with oblique inguinal hernia were enrolled between June 2021 and 2024. Finally, 160 cases meeting the inclusion and exclusion criteria were included for grouping analysis, including 76 cases in control group and 84 cases in treatment group. Immediately after skin incision (T1), heart rate (HR) in treatment group and control group were (92.67±5.06) and (97.53±4.97) time·min-1, and mean arterial pressure (MAP) were (98.63±5.82) and (101.31±5.49) mmHg, respectively. At 5 min after the start of surgery (T2), HR in treatment group and control group were (89.35±5.22) and (94.21±5.36) time·min-1, and MAP were (96.97±5.13) and (99.29±4.75) mmHg, respectively. After the surgery (T3), HR in treatment group and control group were (87.41±4.89) and (89.82±4.61) time·min-1, and MAP were (93.82±5.67) and (96.71±5.03) mmHg, respectively. The incidences of emergence agitation in treatment group and control group were 3.57% (3 cases/84 cases) and 11.84% (9 cases/76 cases), awakening time were (8.21±1.76) and (10.45±2.59) min, recovery time of spontaneous respiration were (6.29±1.40) and (8.63±2.02) min, and extubation time were (12.43±2.51) and (15.87±3.08) min, respectively; immediately after awakening, scores of the face, legs, activity, cry, consolability behavioral tool (FLACC) in treatment group and control group were (2.08±0.59) and (2.43±0.65) points; at 1 h after awakening, FLACC scores were (1.75±0.47) and (2.12±0.61) points; at 6 h after awakening, FLACC scores were (1.42±0.41) and (1.73±0.49); at 12 h after awakening, FLACC scores were (1.28±0.36) and (1.56±0.43) points, and differences in the above indexes between the two groups were statistically significant (all P<0.05). The total dosages of postoperative analgesics in treatment group and control group were (33.51±3.21) and (41.98±3.94) mL, and compression frequency of analgesic pump was (1.55±0.42) and (2.89±0.75) times, the differences were statistically significant (all P<0.05). The adverse drug reactions were as follows: treatment group: nausea, hypotension, vomiting, dizziness; control group: nausea, hypotension, vomiting, dizziness. There was no significant difference in total incidence of adverse drug reactions between treatment group and control group [10.71% (9 cases/84 cases) vs. 9.21% (7 cases/76 cases), (P>0.05)].

    Conclusion

    Compared with propofol emulsion injection combined with fentanyl citrate injection, propofol emulsion injection combined with sufentanil citrate injection for intravenous anesthesia is beneficial to maintain hemodynamic stability, improve emergence agitation and awakening quality, relieve postoperative pain and reduce postoperative use of analgesics in children undergoing laparoscopic repair of oblique inguinal hernia, which has good safety.

  • De-jun SHU, Yu-guang SHEN, Ji-yang TANG, Wei-fu ZHOU, Xun LU, Yong MEI
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2605-2610.
    Objective

    To observe the clinical efficacy and safety of icotinib in the treatment of patients with recurrent mediastinal squamous cell carcinoma.

    Methods

    Patients with recurrent mediastinal squamous cell carcinoma were randomly divided into control group and treatment group using a random number table. Control group received docetaxel injection 75 mg·m-2, intravenous infusion, once every 3 weeks for 4 cycles; treatment group received icotinib 150 mg, orally, 3 times daily for 12 consecutive weeks. The clinical efficacy, disease control rate, progression-free survival, quality of life scores, physiological laboratory indicators and the incidence of adverse drug reactions were compared between the two groups.

    Results

    A total of 105 patients were enrolled, 3 cases were excluded during the trial, leaving 52 participants in treatment group and 50 in control group. After treatment, the objective response rates (ORR) for treatment group and control group were 42.31% (22 cases /52 cases) and 32.00% (16 cases /50 cases); the disease control rates (DCR) were 76.92% (40 cases/52 cases) and 60.00% (30 cases/50 cases); the median progression-free survival (PFS) were 5.60 and 4.20 months; the median overall survival (OS) were 16.90 and 10.50 months; the overall health status were (72.61±13.96) and (63.62±16.94) points, respectively; the functional scale scores were (80.19±15.73) and (68.39±14.55) points, respectively; the symptom scale scores were (31.41±12.61) and (41.81±10.57) points, respectively; white blood cell count (WBC) were (2.31±1.50) and (4.45±1.00)×109 cell·L-1 ; neutrophil count (NEU) were (3.70±1.38) and (1.96±0.95)×109 cell·L-1; hemoglobin (Hb) were (119.39±17.40) and (109.98±14.04) g·L-1; platelet count (PLT) were (217.68±50.33) and (164.93±56.01)×109 cell·L-1. Compared with control group, the above indexes in treatment group all had significant differences (all P<0.05). The main adverse drug reactions in treatment group were rash, diarrhea and elevated transaminase; in control group were bone marrow suppression, alopecia, nausea and vomiting . There was no significant difference in the total incidence of adverse drug reactions between the two groups (82.69% vs. 90.00%, P>0.05). However, the incidence of grade 3-4 adverse drug reactions in treatment group was significantly lower than that in control group (11.54% vs. 30.00%, P<0.05).

    Conclusion

    Icotinib tablet is more effective than docetaxel injection in treating recurrent mediastinal squamous cell carcinoma, with less hematological toxicity, lower incidence of severe adverse reactions, and better safety profile.

  • Yun LI, Bo ZHENG, Lan-qing CUI, Xiu-zhen ZHANG, Yun-jian HU, Yu-fen JIN, Shi-yang PAN, Wei GUO, Feng ZHAO, Yun-song YU, Xuan CAI, Wen-en LIU, De-hua LIU, Ying FEI, Jia-yun LIU, Feng-yan PEI, Ling MENG, Ping JI, Jin TANG, Lei ZHU, Kai-su PAN, He-ping XU, Jian-dong ZHANG, Feng XUE, Shan WANG, Yao-yao LIU, Wei ZHONG
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2567-2587.
    Objective

    To investigate the gram-negative bacteria resistance in nationwide tietiary hospitals, understand the trend of antimicrobial resistance and provide scientific data for the rational use of antibiotis.

    Method

    All the clinical isolates were collected from 18 hospitals and the minimal inhibitory concentrations (MICs) were tested using agar/broth dilution method recommended by Clinical and Laboratory Standards Institute (CLSI) in central laboratory.

    Results

    A total of 4 681 pathogenic isolates from 18 tertiary hospitals in 18 cities nationwide over the period from July 2023 to June 2024 were studied. Based on the MIC results, Escherichia coli and Klebsiella pneumoniae showed extended spectrum β-lactamase (ESBLs) phenotype rates of 50.7% and 20.7%, respectively, ESBLs phenotype rate keeps going down. The ratio of carbapenems resistance Klebsiella pneumoniae (CRKP) was 35.4%, increased by 10 percentage points compared with the previous monitoring. Carbapenems, β-lactam combination agents and amikacin displayed desirable antibacterial activity against Enterobacterales, susceptibal rates were above 78%. In addition, tigacycline, eravacycline, colistin maintained good antibacterial activity against their respective effective bacteria/species, and the bacterial sensitivity rates by more than 90%. Resistance rates of Pseudomonas aeruginosa and Acinetobacter baumannnii to imipennnem were 32.7% and 70.7% and multidrug-resistant (MDR) detection rates were 43.3% and 78.3%, Extensively drug-resistant (MDR) were 17.0% and 71.0%, respectively. Comparison of drug resistance rates from different wards, ages and specimen sources indicated that the proportion of resistance in Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter baumannii isolated from intensive care unit (ICU) were significantly higher than non-ICU. Resistance rates of Pseudomonas aeruginosa isolated from children were significantly lower than that in adults and the elderly. However, the detection rate of ESBLs phenotypes in Klebsiella pneumoniae in children was 57.1%, significantly higher than that in adults (16.3%) and the elderly (19.8%). In addition, the strains of Haemophilus influenzae from children had a higher resistance rates to cephalosporins, macrolides, and clindamycin than those in adults and the elderly. Comparisons of different specimen sources showed that the resistance rates of Acinetobacter baumannii isolated from urine specimens were significantly lower than that from other sources. No statistical differences were observed among other major bacterial species in different specimens, while the resistance rates of Pseudomonas aeruginosa in sputum specimens and Escherichia coli in source drainage fluids were slightly higher than those from other sources.

    Conclusion

    The detection rates of ESBLs phenotypes in Escherichia coli and Klebsiella pneumoniae have continued to decline, while the detection rates of CRKP and ampicillin-resistant Haemophilus influenzae have shown an upward trend, which requires continuous attention.

  • Xiang-xiang XU, Feng-qiang GUO, Yan-ling YANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2618-2623.
    Objective

    To compare and analyze the application effects of remifentanil tosylate injection and propofol injection in painless endoscopic retrograde cholangiopancreatography (ERCP) in elderly patients.

    Methods

    A total of 106 elderly patients who underwent painless ERCP for treatment were included in this study. After excluding 4 patients according to the inclusion criteria, 102 patients were finally included. They were divided into two groups based on the medication used: the remimazolam group and the propofol group, with 51 patients in each group. Both groups of patients received general intravenous anesthesia. The remimazolam group was anesthetized with remimazolam mesylate combined with sufentanil, while the propofol group was anesthetized with propofol combined with sufentanil. Compared the anesthesia induction time, induction success rate, intraoperative hemodynamics, anesthesia recovery time, hemodynamics, stress response indicators between two groups of patients, and the safty was comparied.

    Results

    The anesthesia induction time of the remimazolam group was (5.12±1.23) min, which was significantly longer than that of the propofol group (3.39±0.92) min. The success rate of the first induction was 52.94%, which was significantly lower than that of the propofol group 80.00% (all P<0.05). The eye-opening time of the remimazolam group and the propofol group were (4.96±1.58) and (8.00±2.03)min, respectively; the time for consciousness recovery were (5.92±1.64) and (9.10±2.59)min, respectively; the tracheal extubation time were (10.08±2.87) and (13.06±3.12) minutes, respectively; the retention time in the recovery room were (21.22±5.18) and (26.35±5.83) min, respectively. The eye opening, consciousness recovery, tracheal extubation and retention time in the recovery room in the remimazolam group were all significantly shorter than those in the propofol group (all P<0.05). After the examination, the VAS scores of the remimazolam group and the propofol group were (2.61±0.69) and (3.14±0.81) points, respectively; the VAS score of the remimazolam group was lower than that of the propofol group (P<0.05). At 24 h after the operation, the levels of epinephrine (E) in the remimazolam group and the propofol group were (42.11±5.93) and (47.12±6.01) ng·mL-1, respectively; the levels of norepinephrine (NE) were (67.28±7.84) and (72.46±8.10) ng·mL-1, respectively; the cortisol (COR) levels were (105.43±11.25) and (111.23±12.34) ng·mL-1, respectively. The E, NE and COR in the remimazolam group were all significantly lower than those in the propofol group (all P<0.05). The incidence of adverse drug reactions in the remimazolam group and the propofol group were 9.80% and 27.45%, respectively. The incidence of adverse drug reactions in the remimazolam group was lower than that in the propofol group (P<0.05).

    Conclusion

    Compared with propofol injection, the induction time of remifentanil tosylate injection for painless ERCP diagnosis and treatment in elderly patients is significantly longer than propofol injection, but the circulation after induction and during surgery is smoother, the stress response is lower, the recovery is rapid, and there are no serious adverse reactions. It can be clinically promoted and applied.

  • Rong GAO, Ya-zhong MA, Wei-hong ZHANG, Hai-long YUAN
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2650-2654.
    Objective

    To evaluate the bioequivalence of clindamycin hydrochloride capsules test formulation and reference formulation in healthy subjects under fasting and postprandial conditions.

    Methods

    A randomized, open-label, single-dose, two-cycle crossover study was used in this study. A single dose of clindamycin hydrochloride capsules was administered in fasting and postprandial conditions, and the main pharmacokinetic parameters of clindamycin were determined by liquid chromatography tandem mass spectrometry to evaluate the bioequivalence of the two preparations.

    Results

    Twenty- four healthy subjects were involved in the fasting and fed groups, respectively. The main pharmacokinetics (PK) parameters of the test formulation and reference formulation in the fasting group: Cmax were (2 174.17±616.64) and (2 288.75±678.73) ng·mL-1, AUC0-t were (8 080.29±3 707.51) and (8 496.10±4 801.26) h·ng·mL-1, AUC0-∞ were (8 333.89±3 838.97) and (8 790.21±4 987.28) h·ng·mL-1. The ratio of geometric mean and its 90% confidence interval were 95.27% (89.93%-100.93%), 97.75% (90.39%-105.70%), and 97.51% (90.13%-105.50%). The main PK parameters of the test formulation and reference formulation in the fed group: Cmax were (1 860.00±349.00) and (2 069.04±504.25) ng·mL-1, AUC0-t were (7 829.93±1431.81) and (8 317.23±2 267.65) h·ng·mL-1, AUC0-∞ were (8 053.74±1 486.71) and (8 543.98±2 328.35) h·ng·mL-1. The ratio of geometric mean and its 90% confidence interval were 91.56% (82.23%-101.95%), 96.41% (88.27%~105.31%), and 96.47% (88.14%~105.58%). The 90% confidence intervals of the geometric mean ratios of the main PK parameters of the test preparation and reference preparation for clindamycin hydrochloride capsules in the fasting group and fed group were all within 80.00% to 125.00%. The incidence of adverse events for the test and reference preparations in the fasting group were 25.00% and 20.80%, respectively, while in the postprandial group, they were 25.00% and 33.30%, respectively.

    Conclusion

    In the fasting and postprandial states, clindamycin hydrochloride capsules are bioequivalent to the original reference preparation.

  • Ming-li HENG, Feng-yu SUN, Chen-bo ZHANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(18): 2697-2700.

    The purpose of this article is to discuss the general statistical considerations of confirmatory clinical trial design of antiviral drugs for uncomplicated influenza patients, including estimands, sample size, bias control measures and statistical analysis methods, with reference to the Food and Drug Administration (FDA) biostatistics review report on baloxavir marboxil, the guidance of clinical trial technology for influenza treatment and prevention drugs, ICH E9R1 and statistical guidances issued by National Medical Products Administration (NMPA), in order to provide reference for clinical trial design of antiviral drugs in uncomplicated influenza patients.