目的 对坤泰胶囊致不良反应（ADR）的文献进行调研，为临床合理用药提供参考。方法 检索中国学术期刊（网络版）、万方数字化期刊全文库、中文科技期刊全文数据库（维普）及PubMed等数据库，收集报道坤泰胶囊致不良反应的文献进行统计和分析。结果 共筛选出56篇文献，涉及病例2 140例，其中ADR病例232例；ADR病例年龄集中在46~55岁；用药2 d内出现ADR的例数最多；原患疾病为更年期综合征者最多（153例，65.95%）；报道的ADR病例主要为单独使用坤泰胶囊产生的，且单用药156例（67.24%），联合用药76例（32.76%）；ADR累及器官或系统主要为消化系统（256例次，42.95%），主要临床表现有胃肠道不适、腹胀、恶心、呕吐，且未见严重ADR发生；大部分发生ADR的患者未做任何处理，部分产生ADR的患者主要处理方法为饭后服药或停药处理，且处理后均好转。结论 目前未发现坤泰胶囊致严重的ADR，但仍需分析已经报道的ADR产生原因，挖掘潜在的用药风险，进一步加强对其ADR的监测，探索行之有效的应对措施。

Objective To investigate the literature of adverse reactions (ADR) induced by Kuntai Capsules, so as to provide references for rational use of drugs.Methods Chinese Academic Journal (online), Wangfang Database, Chinese Science and Technology Journal Full-text Database (VIP), and PubMed databases were retrieved, and the documents of ADR induced by Kuntai Capsules were analyzed and discussed. Results A total of 56 literatures with 2 140 cases were retrieved, including 232 cases of ADR. The ages of patients with ADR were mainly 46 — 55 years old. The most cases occured in the medication in 2 d. The primary disease was mainly menopausal syndrome (153 cases, 65.95%). The reported ADR cases were mainly produced by using Kuntai Capsules alone (156 cases, 67.24%), and other cases were combined with other drugs (76 cases, 32.76%). ADR induced by Kuntai Capsules mainly occured in digestive system (256 cases, 42.95%). The main clinical manifestations were gastrointestinal discomfort, bloating, nausea, and vomiting. And there was no serious ADR. Most ADR patients did not need treatment, and some patients with ADR had main treatment for taking drugs after meals or stopping treatment, and recovered after treatment. Conclusion At present, no serious ADR is found in Kuntai Capsules. The cause of reported ADR should be analyzed to tap the potential risk of medication, and the monitoring of ADR should be strengthened to explore effective countermeasures.