富马酸替诺福韦二吡呋酯片安全性的真实世界研究

中国药物评价 ›› 2022, Vol. 39 ›› Issue (4): 285-290.

富马酸替诺福韦二吡呋酯片安全性的真实世界研究

丁丽1，史国琴2，滕月鹏2，万红2，李彩东2，潘新波1，赵丽娟1，王亚亚2*

1. 兰州市第二人民医院肝病研究所，甘肃兰州 730046； 2. 兰州市第二人民医院，甘肃兰州 730046

收稿日期:2022-07-05 修回日期:2022-06-17 出版日期:2022-08-28 发布日期:2022-10-08
基金资助:
兰州市人才创新创业基金资助项目（项目名称：基于中国医院药物警戒系统的慢乙肝治疗中ADR相关因素及用药优化研究；项目编号：2018-RC-46）；兰州市科技发展指导性计划项目（项目名称：PDCA循环理论在合理用药点评中的应用及评价研究；项目编号：2022-ZD-16）

Safety Evaluation of Tenofovir Disoproxil Fumarate in the Real-world Clinical Practice

1. Liver Disease Research Institute， The Second People′s Hospital of Lanzhou，Gansu Lanzhou 730046, China; 2. The Second People′s Hospital of Lanzhou， Lanzhou 730046， China

Received:2022-07-05 Revised:2022-06-17 Online:2022-08-28 Published:2022-10-08

摘要/Abstract

摘要： 目的：分析真实世界中使用富马酸替诺福韦二吡呋酯片（TDF）原研药和仿制药致肾功能异常的情况，探讨使用TDF后出现肾功能异常的相关影响因素。方法：基于中国医院药物警戒系统（CHPS），收集2019年1月至2021年12月我院使用TDF原研药和仿制药的住院患者信息，根据肾损伤标准设置检索条件，筛选出TDF致肾损伤疑似病例，临床药师逐一判定后确认阳性病例，计算原研药和仿制药肾损伤发生率；采用Logistic回归分析TDF原研药致肾损伤的相关因素。结果：TDF原研药和仿制药致肾损伤发生率无统计学差异（7.36% vs 4.53%，P=0.056）；多因素Logistic回归显示，低血磷水平、疾病进展为肝硬化失代偿期、合并消化道出血、联用恩替卡韦具有统计学差异（P<0.05），上述变量可能是使用富马酸替诺福韦二吡呋酯片后出现肾功能异常的相关因素。结论：通过分析真实世界中使用TDF致肾功能异常患者的临床特征，当临床使用TDF与上述因素同时存在时，应高度警惕肾功能异常的发生，进而早期发现、有效规避高危患者肾损伤不良反应的发生。

关键词: font-size:medium, ">富马酸替诺福韦二吡呋酯片；肾损伤；中国医院药物警戒系统；真实世界研究

Abstract: Objective：To analyze the clinical characteristics of patients with renal dysfunctions induced by tenofovir disoproxil fumarate (TDF) in the real world，and to explore the relavant risk factors for renal dysfunction caused by tenofovir disoproxil fumarate. Methods：The search criteria were set according to kidney injury criteria and suspected kidney injury cases were screened preliminary from inpatients who used original and generic TDF from January 2019 to December 2021 in our hospital by CHPS， the incidence and characteristics of kidney injury related to original and generic TDF were confirmed by clinical pharmacists， respectively， and then compare the incidence of TDF-related kidney injury between the original and generic group. Logistic regression analysis was utilized for screening related factors for the occurrence of original TDF-related kidney injury. Results：Differences in kidney injury rate between the generic and original TDF were not statistically significant (7.36% vs 4.53%， P=0.056). Multivariate Logistic regression analysis indicated that significant difference existed in hypophosphatemia， decompensated cirrhosis， gastrointestinal bleeding and combined entecavir(P<0.05)， these variables may be related to renal dysfunctions after TDF. Conclusion：Through the analysis of the clinical characteristics of patients with abnormal renal functions caused by TDF in the real world，when the clinical use of TDF and the above-mentioned factors exist at the same time，it is necessary to strengthen observation to prevent potential abnormal renal functions，so as to ensure the safety of medication，and then identify earlier and avoid effectively adverse effects for high-risk patients.

Key words: Tenofovir disoproxil fumarate, Drug-induced kidney injury, China hospital pharmacovigilance system, Real-world study

中图分类号:

丁丽, 史国琴, 滕月鹏, 万红, 李彩东, 潘新波, 赵丽娟, 王亚亚. 富马酸替诺福韦二吡呋酯片安全性的真实世界研究[J]. 中国药物评价, 2022, 39(4): 285-290.

DING Li, SHI Guo-qin, TENG Yue-peng, WAN Hong, LI Cai-dong, PAN Xin-bo, ZHAO Li-juan, WANG Ya-ya. Safety Evaluation of Tenofovir Disoproxil Fumarate in the Real-world Clinical Practice[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2022, 39(4): 285-290.

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