基于自发呈报系统的异烟肼与解热镇痛药联用的肝损害风险对比  

Comparison of the risk of liver injury caused by isoniazid combined with antipyretic analgesics based on the spontaneous reporting system

作　　者：戴志莲 朱立勤[3] 岳志华[4] 周畅[2] DAI Zhi-lian;ZHU Li-qin;YUE Zhi-hua;ZHOU Chang(The First Central Clinical College,Tianjin Medical University,Tianjin 300192,China;Department of Pharmacy,Tianjin Haihe Hospital,Tianjin 300350,China;Department of Pharmacy,Tianjin First Central Hospital,Tianjin 300192,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]天津医科大学一中心临床学院,天津300192 [2]天津市海河医院药剂科,天津300350 [3]天津市第一中心医院药剂科,天津300192 [4]国家药典委员会,北京100061

出　　处：《天津医科大学学报》2020年第6期560-562,共3页Journal of Tianjin Medical University

摘　　要：目的:比较异烟肼(INH)分别与两种解热镇痛药联用发生肝损害的风险,为临床用药提供参考。方法:选取美国不良反应自发呈报系统数据,研究病例被设置为两个观察组[INH联合洛索洛芬(LOX)和INH联合对乙酰氨基酚(APAP)]以及对照组(单用INH)。观察组和对照组通过报告比值比(ROR)法进行比较,同时应用比值比(OR)评价各组发生肝损害风险。结果:本研究共纳入17 930例事件报告,组间发生肝损害风险差异有统计学意义(P<0.001)。经过年龄、性别和报告年份校正后,与单用INH相比,INH联合LOX发生肝损害OR值为28.057(95%CI:22.783~34.553),联合APAP的OR值为92.551(95%CI:74.283~115.312)。年龄的OR值为0.988(95%CI:0.986~0.991);女性的OR值是0.714(95%CI:0.647~0.789)。结论:INH联合LOX肝损害发生风险低于INH联合APAP;女性和年长者发生肝损害风险可能更低。Objective: To compare the risk of liver injury caused by the combination of isoniazid(INH)and two kinds of antipyretic analgesics,respectively,and to provide references for clinical medication. Methods: The data was selected from the spontaneous reporting system for adverse reactions in the United States. The research cases were divided into two observation groups[the combination of INH and loxoprofen(LOX)and the combination of INH and acetaminophen(APAP)] and a control group(only INH). The two observation groups were compared with the control group by applying reporting odds ratios(ROR).The OR was adopted to evaluate the risk of liver injury in every group. Results: In total,17 930 reports were included in the study. In terms of the risk of liver injury among groups,there existed statistically significant differences(P<0.001).After adjusting age,gender and reporting years,compared with INH alone,the OR of liver injury caused by the combination of INH and LOX was 28.057(95%CI:22.783-34.553),the OR of the combination of INH and APAP was92.551(95%CI:74.283-115.312). The OR of age was 0.988(95%CI:0.986-0.991),the OR of female was 0.714(95%CI:0.647-0.789).Conclusion: The combination of INH and LOX has a lower risk of liver injury than the combination of INH and APAP. Female and the elderly have a lower risk of liver injury.

关 键 词：异烟肼 对乙酰氨基酚 洛索洛芬 肝损害 

分 类 号：R971+.1[医药卫生—药品]