Empagliflozin治疗2型糖尿病达到HbA1c<7.0%的有效性及安全性评价  

Systematic review of efficacy and safety of empagliflozin treatment for achieving HbA1c<7.0% in type 2 diabetic patients

作　　者：王艳立[1] 张林[2] 刘芳[2] 胡茂清[2] 

机构地区：[1]成都中医药大学,成都610075 [2]成都中医药大学第三附属医院/四川省糖尿病防治中心糖尿病科,成都610075

出　　处：《重庆医学》2016年第34期4820-4825,4829,共7页Chongqing medicine

基　　金：成都中医药大学针灸推拿学院/第三附属医院科研创新基金(2015ZTYH03)

摘　　要：目的系统评价钠葡萄糖协同转运蛋白2(SGLT2)抑制剂empagliflozin治疗2型糖尿病(T2DM)达到HbA1c<7.0%的有效性与安全性。方法计算机检索Pubmed、Cochrane Library、EMbase,CBM和CNKI数据库发表empagliflozin的文献,检索时限均为建库至2015年10月,筛选合格随机对照试验(RCT)。根据Cochrane系统评价手册5.1评估纳入研究偏倚风险,采用RevMan 5.3软件进行统计分析。结果纳入8篇RCT,共4 728例研究对象。结果显示:empagliflozin使HbA1c<7.0%的达标率高于安慰剂(10mg RR=2.68,95%CI:2.06~3.47,P<0.05;25mg RR=3.25,95%CI:2.49~4.25,P<0.05),且不增加低血糖风险(10mg RR=1.04,95%CI:0.89~1.21,P>0.05;25mg RR=1.06,95%CI:0.91~1.23,P>0.05),同时能降低体质量(10mg WMD=-1.75,95%CI:-1.96^-1.55,P<0.05;25 mg WMD=-1.95,95%CI:-2.16^-1.74,P<0.05),收缩压和舒张压及改善空腹血糖;但增加了生殖道感染风险,在发生泌尿道感染和严重不良事件方面差异无统计学意义,且对T2DM患者肾功能无影响及不增加全因死亡率。结论 Empagliflozin能够有效地使T2DM患者达到HbA1c<7.0%,另有减轻体质量和降压的临床获益,且安全性好。Objective To assess the efficacy for reaching the target of HbA1c〈7.0% and safety of empagliflozin,a sodium glucose cotransporter 2 （SGLT2） inhibitor in type 2 diabetic patients. Methods We searched Pubmed,Cochrane Library,EMbase, CBM and CNKI databases from establishment to October 2015 to identify randomized controlled trials （RCTs） of empagliflozin. We assessed the risk of bias of the included RCTs according to the Coehrane Handbook for Systematic Reviews of Interventions Version 5.1. The RevMan 5. 3 software was used for meta-analysis. Results 8 RCTs were included, 4728 participants. Meta analysis showed that, compared with placebo, empagliflozin had a higher control rate of HbA1c〈 7.0 % （10 mg RR = 2.68,95 % CI 2.06- 3.47, P〈0.05 ; 25 mg RR = 3.25,95% CI 2.49= 4.25, P〈0.05）, did not increase the risk of hypoglycemia（10 mg RR = 1.04,95 CI 0.89-1.21,P〉0.05;25 mg RR=1. 06,95%CI 0. 91-1.23,P〉0.05）,and can reduce the body weight（10 mg WMD= -1.75,95%CI -1.96- -1.55,P〈0.05;25 mg WMD=-1. 95,95%CI-2.16- -1.74,P〈0.05） ,systolic blood pressure,diastolic blood pressure and improve the fasting plasma glucose;however, it increased the risk of genital infection, there were no statistically significant differences in the occurrence of urinary tract infection as well as serious adverse events, and had no effect on renal function in type 2 diabetic patients,no increase in all-cause mortality. Conclusion Empagliflozin,compared with placebo,can effectively achieve the HbAlc target〈7.0% in type 2 diabetic patients,it also has the benefits of weight loss and reducing blood pressure,besides,the safety is good. But we still need more multi-center and long-term randomized controlled studies for providing empagliflozin more reliable evidences of the efficacy and safety.

关 键 词：糖尿病 2型 协同转运子 泌尿道感染 empagliflozin 系统评价 HBA1C 

分 类 号：R587.1[医药卫生—内分泌]