兰索拉唑药物不良反应的Meta分析  

Meta-analysis of adverse drug reactions induced by lansoprazole

作　　者：李岩峰[1] 王楠[1] 李广鉴[1] 闫宇青[2] 李闻新 LI Yanfeng;WANG Nan;LI Guangjian;YAN Yuqing;LI Wenxin(Kailuan General Hospital,Tangshan 063000,China;The Second Hospital of Tangshan,Tangshan 063000,China)

机构地区：[1]开滦总医院,河北唐山063000 [2]唐山市第二医院,河北唐山063000

出　　处：《药物评价研究》2023年第4期866-877,共12页Drug Evaluation Research

基　　金：河北省医学科学研究重点课题计划(20211115)。

摘　　要：目的系统评价兰索拉唑临床应用中的药物不良反应(ADR)。方法计算机检索PubMed、Embase、Cochrane Library、中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)和中国生物医学文献数据库(CBM),检索时限均为建库起至2022年9月1日,收集兰索拉唑在临床应用中ADR的随机对照试验(RCT),采用RevMan 5.4统计软件进行Meta分析。结果共纳入23项RCTs,共计10980例患者。Meta分析结果显示,在ADR总体发生情况[OR=0.79,95%CI(0.69,0.90),P=0.0004]和胃肠道系统损害[OR=0.44,95%CI(0.32,0.62),P<0.00001]中,试验组ADR发生率低于对照组,差异有统计学意义。在中枢及外周神经系统损害[OR=0.80,95%CI(0.54,1.18),P=0.27]、呼吸系统损害[OR=1.67,95%CI(0.67,4.15),P=0.27]、皮肤及其附件损害[OR=1.24,95%CI(0.33,4.69),P=0.75]中,试验组ADR发生率与对照组的差异无统计学意义。15 mg·d^(−1)亚组的ADR发生率低于对照组[OR=0.66,95%CI(0.44,0.99),P=0.04],30 mg·d^(−1)亚组[OR=0.89,95%CI(0.76,1.05),P=0.16]和60 mg·d^(−1)亚组[OR=0.76,95%CI(0.37,1.56),P=0.46]的ADR发生率与对照组差异无统计学意义;疗程≤30 d亚组[OR=0.60,95%CI(0.46,0.77),P<0.0001]ADR发生率低于对照组,疗程>30 d亚组[OR=0.87,95%CI(0.75,1.01),P=0.07]ADR发生率与对照组差异无统计学意义;消化性溃疡亚组[OR=0.71,95%CI(0.56,0.92),P=0.008]ADR发生率低于对照组,胃食管返流病亚组[OR=0.93,95%CI(0.78,1.10),P=0.39]ADR发生率与对照组差异无统计学意义。结论兰索拉唑安全性良好,患者的给药剂量为30 mg·d^(−1)和60 mg·d^(−1)、疗程>30 d、临床诊断为胃食管返流病,其ADR发生率明显增加。Objective To systematically evaluate the adverse drug reactions(ADR)of lansoprazole in clinical application.Methods Databases such as PubMed,Embase,Cochrane Library,CNKI,Wanfang Data and CBM were searched by computer from foundation to September 1,2022.Collect randomized controlled trials of ADR of lansoprazole in clinical application.Meta-analysis was conducted by RevMan 5.4 software.Results A total of 23 RCTs were included,involving 10980 patients.Results of Metaanalysis showed that in the overall incidence of ADR[OR=0.79,95%CI(0.69,0.90),P=0.00004]and gastrointestinal system damage[OR=0.44,95%CI(0.32,0.62),P<0.00001],the incidence of ADR in the test group was lower than that in the control group,with a statistically significant difference.In the central and peripheral nervous system damage[OR=0.80,95%CI(0.54,1.18),P=0.27],respiratory system damage[OR=1.67,95%CI(0.67,4.15),P=0.27],skin and its accessories damage[OR=1.24,95%CI(0.33,4.69),P=0.75],the incidence of ADR in the test group was not significantly different from that in the control group.The subgroup analysis was carried out according to different dosage.The results showed that the incidence of ADR in the test group was lower than that in the control group in the 15 mg·d^(−1) subgroup,with a statistically significant difference[OR=0.66,95%CI(0.44,0.99),P=0.04];In the 30 mg·d^(−1) subgroup[OR=0.89,95%CI(0.76,1.05),P=0.16]and the 60 mg·d^(−1) subgroup[OR=0.76,95%CI(0.37,1.56),P=0.46],there was no significant difference in the incidence of ADR between the test group and the control group.The subgroup analysis was carried out according to different courses of treatment.The results showed that the incidence of ADR in the test group was lower than that in the control group in the subgroup of treatment≤30 days[OR=0.60,95%CI(0.46,0.77),P<0.0001],and the difference was statistically significant;There was no significant difference in the incidence of ADR between the experimental group and the control group in the subgroup of treatment course>30 days[OR=

关 键 词：兰索拉唑 不良反应 随机对照试验 META分析 胃食管返流病 

分 类 号：R975[医药卫生—药品]