目的 對坤泰膠囊致不良反應(yīng)（ADR）的文獻(xiàn)進(jìn)行調(diào)研，為臨床合理用藥提供參考。方法 檢索中國學(xué)術(shù)期刊（網(wǎng)絡(luò)版）、萬方數(shù)字化期刊全文庫、中文科技期刊全文數(shù)據(jù)庫（維普）及PubMed等數(shù)據(jù)庫，收集報(bào)道坤泰膠囊致不良反應(yīng)的文獻(xiàn)進(jìn)行統(tǒng)計(jì)和分析。結(jié)果 共篩選出56篇文獻(xiàn)，涉及病例2 140例，其中ADR病例232例；ADR病例年齡集中在46~55歲；用藥2 d內(nèi)出現(xiàn)ADR的例數(shù)最多；原患疾病為更年期綜合征者最多（153例，65.95%）；報(bào)道的ADR病例主要為單獨(dú)使用坤泰膠囊產(chǎn)生的，且單用藥156例（67.24%），聯(lián)合用藥76例（32.76%）；ADR累及器官或系統(tǒng)主要為消化系統(tǒng)（256例次，42.95%），主要臨床表現(xiàn)有胃腸道不適、腹脹、惡心、嘔吐，且未見嚴(yán)重ADR發(fā)生；大部分發(fā)生ADR的患者未做任何處理，部分產(chǎn)生ADR的患者主要處理方法為飯后服藥或停藥處理，且處理后均好轉(zhuǎn)。結(jié)論 目前未發(fā)現(xiàn)坤泰膠囊致嚴(yán)重的ADR，但仍需分析已經(jīng)報(bào)道的ADR產(chǎn)生原因，挖掘潛在的用藥風(fēng)險(xiǎn)，進(jìn)一步加強(qiáng)對其ADR的監(jiān)測，探索行之有效的應(yīng)對措施。

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.