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、CochraneLibrary、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10 980 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＝0.000 4］和胃肠道系统损害［OR＝0.44，95%CI（0.32，0.62），P＜0.000 01］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＜0.000 1］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 10 980 patients. Results of Metaanalysis showed that in the overall incidence of ADR [OR=0.79, 95%CI (0.69, 0.90), P＝0.000 04] and gastrointestinal system damage [OR=0.44, 95%CI (0.32, 0.62), P＜0.000 01], 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＜0.000 1], 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=0.87, 95%CI (0.75, 1.01), P＝0.07]. The subgroup analysis was carried out according to different clinical diagnoses. The results showed that the incidence of ADR in the experimental group was lower than that in the control group in the peptic ulcer subgroup [OR=0.71, 95%CI (0.56, 0.92), P＝0.008], 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 gastroesophageal reflux disease subgroup [OR=0.93, 95%CI (0.78, 1.10), P＝0.39]. Conclusions Lansoprazole is safe. When the dosage was 30 mg·d^-1 and 60 mg·d^-1, the course of treatment was＞30 days, and the clinical diagnosis was gastroesophageal reflux disease, its ADR was significantly increased.

R975

河北省医学科学研究重点课题计划（20211115）