首页|润燥止痒胶囊与氯雷他定片所致药物性肝损伤比较的真实世界队列研究

润燥止痒胶囊与氯雷他定片所致药物性肝损伤比较的真实世界队列研究

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目的 比较润燥止痒胶囊与氯雷他定片所致药物性肝损伤(DILI)的风险差异。方法 基于药品安全性主动监测获取的电子病历数据,采用回顾性队列研究,提取2004-2021年口服润燥止痒胶囊或氯雷他定片患者的临床资料。按1∶1倾向性评分均衡2组的混杂因素后,采用logistic回归模型分析2组人群DILI的发生风险。同时对匹配前及逆概率加权法后的数据进行敏感性分析。结果 共纳入31 636例患者,其中口服润燥止痒胶囊的患者26 840例。匹配后2组各4 072例,润燥止痒胶囊组发生DILI的风险明显低于氯雷他定片组(0。12%vs。0。83%),OR=0。15[95%CI(0。06,0。38)]。匹配前及逆概率加权后,润燥止痒胶囊组DILI发生率仍低于氯雷他定片组,差异均有统计学意义(P<0。001)。结论 润燥止痒胶囊在肝损伤安全性方面优于氯雷他定片。科学评价并理性对待何首乌及其制剂的肝毒性对于保障用药安全和健康至关重要。
Comparison of Runzao Zhiyang capsules and loratadine tablets in drug-induced liver injury:a real-world cohort study
Objective To compare the difference in risk of drug-induced liver injury(DILI)between Runzao Zhiyang capsules and loratadine tablets.Methods Based on electronic medical records obtained through active drug safety monitoring in China,a retrospective cohort study was conducted to collect clinical data of patients who took oral Runzao Zhiyang capsules or loratadine tablets between January 1,2004,and December 31,2021.After balancing the confounding factors with a 1∶1 propensity score,the logistic regression model was used to analyze the risk of DILI between the two groups.Additionally,the sensitivity analysis of the data before matching and after inverse probability weighting method was conducted.Results A total of 31 636 patients were included,with 26 840 patients taking Runzao Zhiyang capsules orally.After matching there were 4 072 patients in each group,the risk of DILI in the Runzao Zhiyang capsules group was significantly lower than in the loratadine tablets group(0.12%vs.0.83%),OR=0.15(95%CI 0.06 to 0.38).Before matching and after inverse probability weighting,the incidence of DILI in the Runzao Zhiyang capsules group was still lower than that in the loratadine tablets group,and the difference was statistically significant(P<0.001).Conclusion Runzao Zhiyang capsules have a better safety profile in terms of liver injury compared to the loratadine tablets.The hepatotoxicity of Polygonum multiflorum and its preparations should be scientifically evaluated and rationally treated to ensure medication safety and health.

Runzao Zhiyang capsulesLoratadine tabletsDrug-induced liver injuryReal-world studyRetrospective cohort study

龙子临、赵厚宇、郑泳祺、王连心、孙凤

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北京大学公共卫生学院流行病与卫生统计学系/重大疾病流行病学教育部重点实验室(北京大学)(北京1000191)

中国中医科学院中医临床基础医学研究所(北京 100700)

润燥止痒胶囊 氯雷他定片 药物性肝损伤 真实世界研究 回顾性队列研究

国家自然科学基金面上项目中国毒理学会临床毒理专项(2022)中国药品监管科学行动计划重点项目(第二批)

81973982CST2022CT102[2021]37-10

2024

药物流行病学杂志
中国药学会 武汉医药(集团)股份有限公司

药物流行病学杂志

CSTPCD
影响因子:0.746
ISSN:1005-0698
年,卷(期):2024.33(3)