目的 系統(tǒng)評價蘭索拉唑臨床應(yīng)用中的藥物不良反應(yīng)（ADR）。方法 計算機檢索 PubMed、Embase、CochraneLibrary、中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫（Wanfang Data）和中國生物醫(yī)學(xué)文獻數(shù)據(jù)庫（CBM），檢索時限均為建庫起至 2022年 9月 1日，收集蘭索拉唑在臨床應(yīng)用中 ADR的隨機對照試驗（RCT），采用 RevMan 5.4統(tǒng)計軟件進行Meta分析。結(jié)果 共納入23項 RCTs，共計10 980 例患者。Meta分析結(jié)果顯示，在ADR 總體發(fā)生情況［OR＝0.79，95%CI（0.69，0.90），P＝0.000 4］和胃腸道系統(tǒng)損害［OR＝0.44，95%CI（0.32，0.62），P＜0.000 01］中，試驗組ADR發(fā)生率低于對照組，差異有統(tǒng)計學(xué)意義。在中樞及外周神經(jīng)系統(tǒng)損害［OR＝0.80，95%CI（0.54，1.18），P＝0.27］、呼吸系統(tǒng)損害［OR＝1.67，95%CI（0.67，4.15），P＝0.27］、皮膚及其附件損害［OR＝1.24，95%CI（0.33，4.69），P＝0.75］中，試驗組ADR發(fā)生率與對照組的差異無統(tǒng)計學(xué)意義。15 mg·d^-1亞組的ADR發(fā)生率低于對照組［OR＝0.66，95%CI（0.44，0.99），P＝0.04］，30 mg·d^-1 亞組［OR=0.89，95%CI（0.76，1.05），P＝0.16］和60 mg·d^-1 亞組 ［OR=0.76，95%CI（0.37，1.56），P＝0.46］的 ADR 發(fā)生率與對照組差異無統(tǒng)計學(xué)意義；療程≤30 d亞組［OR＝0.60，95%CI（0.46，0.77），P＜0.000 1］ADR發(fā)生率低于對照組，療程＞30 d亞組［OR＝0.87，95%CI（0.75，1.01），P＝0.07］ADR發(fā)生率與對照組差異無統(tǒng)計學(xué)意義；消化性潰瘍亞組［OR＝0.71，95%CI（0.56，0.92），P＝0.008］ADR發(fā)生率低于對照組，胃食管返流病亞組［OR＝0.93，95%CI（0.78，1.10），P＝0.39］ADR發(fā)生率與對照組差異無統(tǒng)計學(xué)意義。結(jié)論 蘭索拉唑安全性良好，患者的給藥劑量為30 mg·d^-1和60 mg·d^-1、療程＞30 d、臨床診斷為胃食管返流病，其ADR發(fā)生率明顯增加。

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

河北省醫(yī)學(xué)科學(xué)研究重點課題計劃（20211115）