摘要
目的系统评价达格列净治疗2型糖尿病的远期用药不良反应。方法检索相关国内外数据库,检索时间由建库截至2018年7月,纳入达格列净与安慰剂治疗2型糖尿病的RCT研究,应用RevMan5.3软件进行meta分析。结果共纳入9项RCT研究4632例患者。试验组使用的药物包括2.5、5、10mg的达格列净,对照组使用的药物为安慰剂。Meta分析结果显示,达格列净总体不良反应、严重不良反应发生率、低血糖和死亡事件发生率与对照组比较差异无显著性(P>0.05)。服用2.5mg和5mg达格列净组在肾功能下降和泌尿系感染方面与对照组比较差异无显著性(P>0.05),而服用10mg达格列净的患者肾功能下降和泌尿系感染发生率较对照组明显升高,差异有显著性(P<0.05)。3种不同剂量的达格列净均会使生殖器感染发生率明显升高(P<0.05)。结论长期服用达格列净不显著增加2型糖尿病患者总体不良反应发生率,但大剂量的达格列净可能增加泌尿系感染和肾脏损伤的风险,且不同剂量的达格列净均可增加生殖器感染的风险。建议患者在长期服用达格列净时应权衡利弊。
Objective To systematically evaluate the long-term adverse events of dapagliflozin in the treatment of type 2 diabetes mellitus.Method The related literatures in domestic and foreign databases were se arched from the beginning of the databases to July, 2018. The randomized controlled trials comparing dapagliflozin and placebo in type 2 diabetes mellitus were searched. Meta-analysis was conducted using RevMan 5.3 software. Result A total of 9 RCTs involving 4632 patients were included. The drugs used in the test group were dapagliflozin of 2.5 mg, 5 mg or 10 mg dosage, while the drugs used in the control group were placebo. The results of Meta-analysis showed that there were no significant differences in the incidence of overall adverse events, severe adverse events, hypoglycemia and mortality between the dapagliflozin group and the placebo group. There was no significant increase in renal function decline and urinary tract infections after taking 2.5 mg or 5 mg of dapagliflozin compared with placebo, while the incidence of renal function decline and urinary tract infections was significantly higher in patients taking 10 mg of dapagliflozin. Three different doses of dapagliflozin could significantly increase the incidence of genital infection. Conclusion Long-term use of dapagliflozin will not significantly increase the overall incidence of adverse events in patients with type 2 diabetes. But high doses of dapagliflozin may increase the risk of urinary tract infections and renal function decline, and various doses of dapagliflozin may increase the risk of genital infections. It is suggested that the risk assessment should be done before long-term medication for the benefit of patients.
作者
简伟明
蔡红芳
戴建立
张明浩
吴利平
张华
JIAN Wei-ming;CAI Hong-fang;DAI Jian-li;ZHANG Ming-hao;WU Li-ping;ZHANG Huai(Department of Geriatrics, First Affiliated Hospital of The Air Force Military Medical University, Shaanxi Xi 'an 710032, China;Blood Purification Centre, Zhejiang Taizhou Hospital, Zhejiang Taizhou 317000, China;Department of Emergency, Second Affiliated Hospital of Air Force Military Medical University, Shaanxi Xi 'an 710032, China)
出处
《中国医刊》
CAS
2019年第4期428-434,共7页
Chinese Journal of Medicine
基金
国家自然科学基金项目(81370928)
陕西省社会发展科技攻关项目(2015SF095)
