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作 者:孔文强 文露 张春燕[3] 杜彪 KONG Wenqiang1, WEN Lu2, ZHANG Chunyan3, DU Biao1,4(1School of Pharmacy, Southwest Medical University, Luzhou, Sichuan Province, 646000; 2Department of Pharmacy, Siehuan Provincial People's Hospital, Chengdu, Siehuan Province, 610072; 3School of Pharnaaey, North Sichuan Medical Collage, Nanchong, Sichuan Province, 637000; 4Department of Pharmacy, Chongqing Three Gorges Central Hospital, Wanzhou, Chongqing, 404000, China)
机构地区:[1]西南医科大学药学院,四川泸州646000 [2]四川省人民医院药学部,成都610072 [3]川北医学院药学院,四川南充637000 [4]重庆三峡中心医院药学部,重庆万州4040004
出 处:《第三军医大学学报》2018年第19期1792-1804,共13页Journal of Third Military Medical University
基 金:重庆市社会事业与民生保障科技创新专项(CSTC2015shmszx120073;CSTC2017shmsA130105);重庆市万州区科技计划基金资助项目(201403055)~~
摘 要:目的采用Meta分析研究评价卡格列净、恩格列净、达格列净治疗2型糖尿病患者的安全性。方法检索PubMed、CENTRAL、Embase数据库,检索时限从建库到2018年1月,纳入有关RCT文献,传统Meta分析和网状Meta分析用STATA14完成。结果共纳入34篇文献,含21 216名患者的35项RCT。Meta分析结果显示,卡格列净、恩格列净、达格列净与安慰剂和阳性药物相比:①均不会增加因不良反应退出人数,差异无统计学意义(P>0.05);②能够显著增加生殖器感染的人数,且女性感染人数要明显多于男性,差异均有统计学意义(P <0.05);③仅达格列净可轻微增加尿路感染人数[OR=1.26,95%CI(1.02~1.55),P=0. 039]。④卡格列净与恩格列净[OR=1. 53,95%CI(1. 02~2.30)P <0.05]、安慰剂[OR=1.74,95%CI(1.32~2.30)P <0.05]相比,明显增加了低血糖发生人数。⑤恩格列净和达格列净与DPP-4抑制剂、GLP-1激动剂、二甲双胍、安慰剂相比,低血糖发生人数差异无统计学意义(P>0.05)。结论卡格列净、恩格列净、达格列净治疗2型糖尿病,仅增加生殖器感染人数,有较好的耐受性和安全性;3种药物中恩格列净耐受性和安全性可能最好。ObjectiveTo evaluate the safety of canagliflozin, empagliflozin and dapagliflozin in treatment of type 2 diabetes mellitus (T2DM) by network meta-analysis. MethodsThe databases including PubMed, Embase,and CENTRAL from inception to January 2018 were searched for eligible randomized controlled trials (RCTs) evaluating the SGLT2 inhibitors in T2DM patients. Conventional meta-analysis and network metaanalysis were performed by STATA14. ResultsA total of 34 studies, including 35 RCTs, involving 21 216 patients were collected. Meta-analysis showed that when compared with placebo and positive agents: ① the 3 drugs didn’t increase the number of patients who required discontinuation due to adverse events (P〉0.05); ② they significantly increased the number of genital infections, especially in women, with significant differences (P〈0.05). ③ Only dapagliflozin slightly raised the number of urinary tract infections (UTIs) (OR=1.26, 95%CI: 1.02-1.55, P=0.039); ④ Compared with empagliflozin (OR=1.53, 95%CI: 1.02-2.30, P〈0.05) and placebo (OR=1.74, 95%CI: 1.32-2.30, P〈0.05), canagliflozin slightly increased the incidence of hypoglycemia; ⑤ Empagliflozin and dapagliflozin didn’t increase the incidence of hypoglycemia,when compared with DPP-4 inhibitors, GLP-1 agonists, metformin and placebo (P〉0.05). ConclusionCanagliflozin, empagliflozin and dapagliflozin show better tolerance and safety, though increasing the risk of genital infections in treatment of T2DM. Among them, empagliflozin may be the best in tolerance and durability.
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