Abstract: Background　The status of dapagliflozin in guidelines at home and abroad has been gradually improved.There have been reports of adverse drug reactions （ADRs） of dapagliflozin abroad in recent years，but there is no corresponding case report due to its short time to market in China，and the insufficiency of a large sample of clinical data is difficult to confirm the safety of dapagliflozin.Therefore，the monitoring and analysis of ADRs of dapagliflozin is particularly important.Objective　To analyze the occurrence patterns and characteristics of ADRs induced by dapagliflozin，so as to provide references for the rational use of this drug in clinical practices.Methods　The case reports of ADRs caused by dapagliflozin in databases such as the CNKI，Wanfang Data，CQVIP，Medline，PubMed and Springer from November 2012 to March 2020 were retrieved.We extracted and analyzed the literature information，including gender，age，combined underlying diseases，drug combination，time of ADRs，clinical manifestations and involved systems/organs of ADRs，treatment and prognosis of ADRs，and drug re-exposure.Then the statistical description and analysis was performed.Results　A total of 15 articles were collected，of which 15 patients were found to have ADRs after the application of dapagliflozin，including 9（60.0%） males and 6（40.0%） females，and 10（66.7%） patients were over 50 years old，and 11（73.3%） patients were with underlying diseases.Ten（66.7%） patients had ADRs within 6 months of taking dapagliflozin，including 5（50.0%） cases with diabetic ketoacidosis（DKA）.Patients with ADRs showed 8（53.3%） cases of endocrine system-related diseases including 7（87.5%） cases with DKA and 1（12.5%） case with hyperkalemia，4（26.7%） cases of abnormal urogenital system，1（6.7%） case of hepatobiliary system damage，1（6.7%） case of digestive system damage，and 1（6.7%） case of motor system damage.The symptoms were improved and patients were recovered after drug withdrawal and symptomatic treatment such as anti-infection，rehydration，and surgery.Three（20.0%） patients continued to use dapagliflozin，and the rest did not use dapagliflozin again.Conclusion　The adverse reactions caused by dapagliflozin are more common in men，mainly involving the endocrine system and urogenital system，but new ADRs may also occur.Most of the symptoms are improved or patients are recovered after drug withdrawal and symptomatic treatment such as anti-infection，rehydration，and surgery.

Key words: Dapagliflozin, Sodium glucose transporter 2, Adverse drug reaction, Literature analysis

摘要： 背景　达格列净在国内外指南中的地位逐步提升，近年来，国外陆续出现达格列净导致患者不良反应的报道，但我国由于上市时间短，没有相应个案报道，同时缺乏大样本的临床数据证实其安全性，因此，对其不良反应的监测及分析尤为重要。目的　分析达格列净致不良反应的发生规律和特点，为临床合理用药提供依据。方法　检索2012年11月—2020年3月中国知网（CNKI）、万方数据知识服务平台、维普网、Medline、PubMed和Springer数据库中达格列净致不良反应的个案报道，提取文献资料，包括性别、年龄、合并基础疾病、合并用药、不良反应发生时间、不良反应临床表现及累及的系统/器官、不良反应的治疗与预后、药物再暴露情况，进行统计描述和分析。结果　最终纳入文献共计15篇，共15例患者应用达格列净后发生不良反应，其中男9例（60.0%）、女6例（40.0%），50岁以上发生不良反应的患者10例（66.7%），合并基础疾病11例（73.3%）；服用达格列净6个月内发生不良反应患者10例（66.7%），其中糖尿病酮症酸中毒（DKA）5例（50.0%）。发生不良反应患者表现为内分泌系统相关疾病8例（53.3%），其中DKA 7例（87.5%）、高钾血症1例（12.5%）；泌尿生殖系统异常4例（26.7%）；肝胆、消化、运动系统损害各1例（均为6.7%）。患者经停药及抗感染、补液、手术等对症治疗处理后症状均好转或痊愈。3例（20.0%）患者继续使用达格列净，其余均未再次使用达格列净。结论　达格列净所致的不良反应男性发生较多，且不良反应主要涉及内分泌系统、泌尿生殖系统，但也可能出现新的不良反应，大部分患者经停药及抗感染、补液、手术等对症治疗后症状好转或痊愈。

关键词: 达格列净, 钠葡萄糖协同转运蛋白2, 不良反应, 文献分析