Abstract：OBJECTIVE To systematically evaluate the safety of ertugliflozin as a monotherapy for the treatment of type Ⅱ diabetes. METHODS The randomized controlled trials(RCTs) of ertugliflozin for type Ⅱ diabetes were searched in the clinical trial registries and the related databases, such as CNKI, WANFANG, The Cochrane Library, Embase and Clinical Trials. The literatures were screened according to inclusion and exclusion criterias.After the data extraction and assessing the quality of included studies with Cochrane Handbook 5.3.3, Meta-analysis was conducted with RevMan5.3 software and the sensitivity of outcomes were analyzed by the Stata14.0. RESULTS The six individual randomized controlled trials were eligible. The 4 078 patients were enrolled. There are some results of Meta-analysis. At 26 weeks, compared to the control subjects, the risk of genital mycotic infection(GMI) in ertugliflozin group was higher(RR=6.25, 95%CI: 2.98-6.61, P<0.000 01).The risk of female patients with GMI was higher compared to that of male (RR=2.28,95%CI:1.55-3.36,P<0.000 1). At 52 weeks, compared to the control subjects, the risk of GMI in ertugliflozin group was higher (RR=4.44, 95% CI: 2.98-6.61, P<0.000 01). The risk of female patients with GMI was higher compared to that of male patients in the subgroup 15 mg ( RR=2.89, 95% CI:1.67-5.00, P=0.000 2). At 52 weeks,compared to the control group, the risk of urinary tract infection, symptomatic hypoglycaemia, hypovolaemia, estimated glomerular filtration(ΔeGFR)and the number of patients who sede crease from baseline >30% in eGFR were no significant difference. There were no significant difference between 5 and 15 mg group on the safety indicators at 52 weeks. CONCLUSION Ertugliflozin could cause GMI regularly. And the risk of female patients with GMI was higher than male. Meanwhile, it was easy to reduce eGFR, but most of them were reversible.Ertugliflozin was safe in urinary tract infection, symptomatic hypoglycaemia and hypovolaemia. However, there is no obvious difference in the safety of different dosage groups.
倪倩, 李婷, 裴艺芳, 谭玲. 埃格列净单药治疗2型糖尿病安全性的Meta分析[J]. 中国药学杂志, 2019, 54(15): 1268-1275.
NI Qian, LI Ting,PEI Yi-fang,TAN Ling. Safety of Ertugliflozin as a Monotherapy for the Treatment of Type Ⅱ Diabetes: a Meta-Analysis. Chinese Pharmaceutical Journal, 2019, 54(15): 1268-1275.
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2019, Vol. 54 
