摘要
目的:系统评价达格列净联合胰岛素治疗2型糖尿病的有效性与安全性。方法:计算机检索PubMed、Em-base Cochrane图书馆、Clinical Trails.中国知网(CNKI)、中国维普期刊全文数据库(VIP)及万方数据库中达格列净联合胰岛素与安慰剂联合胰岛素比较治疗2型糖尿病随机对照试验(RCT),检索时间为从建库起至2018年10月,对纳人研究进行质量评价和Meta分析。结果:共纳人4项RCT,共计1332例患者。疗效分析结果显示.达格列净联合胰岛素治疗组能显著降低糖化血红蛋白水平[MD=-0.63,95%CI(-0.92,-0.35),P<0.01],显著降低体质量水平[MD=-1.94,95%CI(-2.76,-1.12),P<0.01],显著降低胰岛素日剂量[MD=-4.04,95%CI(-7.05,-1.02),P<0.01],显著降低空腹血糖水平[MD=-24.89,95%CI(-36.81,-12.97),P<0.01],两组间差别均具有统计学意义。安全性方面,达格列净联合胰岛素组患者严重低血糖发生率与安慰剂联合胰岛素组相似,差异无统计学意义[RR=1.03,95%CI(0.30,3.57),P>0.05];达格列净联合胰岛素组泌尿道感染发生率高于安慰剂联合胰岛素组[RR=1.70,95%CI(1.02,2.83),P=0.04],达格列净联合胰岛素组生殖道感染发生率高于安慰剂联合胰岛素组[RR=3.61,95%CI(1.76,7.38),P<0.01],其差异均具有统计学意义。结论:达格列净联合胰岛素治疗能有效降低2型糖尿病患者的糖化血红蛋白.体质量、胰岛素日剂量及空腹血糖,且不增加严重低血糖的发生率,但增加了泌尿道感染和生殖道感染的发生率。受纳人研究质量和数量限制,上述结论有待更多高质量的RCT来验证。
Objective;To systematically review the fficacy and safety of dapagliflozin plus insulin therapy in the treatment of type 2 diabetes mellitus.Methods:Dapalifloin and insulin were selected as key words.PubMed,Embase,Cochrane library,Clini-cal Trails,CNKI,VIP and WanFang Data were searched from inception to Oct 2018.All randomized control trail(RCTs)of dapa-gliflozin plus insulin therapy in patients with type 2 diabetes were selected.Results:Our meta-analysis included four eligible placebo-controlled trials involving 1332 patients.Compared with the combination of placebo and insulin,dapagliflozin and insulin treatment were significantly associated with a mean reduction in HbAlc of-0.63%,body weight of-1.94 kg,total daily dose of insulin(TDDI)of-4.04 IU,and fasting plasma glucose(FPG)of-24.89 mg/dL,but an increased risk of urinary tract infections by 70%and genital infections by 261%,No significant incrase was observed in risk of serious hypoglycaemia events(RR,1.03).Conclusion:The combination therapy of dapaliflozin and insulin ffectively decreased the HbAlc,body weight,TDDI and FPG levels in patients with type 2 diabetes without increasing the incidence of severe hypoglycemia,but it can increase the risk of urinary and genital tract infection.Further studies are needed to establish optimal cornbination type and dose.
作者
李蒙
杨晨
蓝高爽
禹洁
李正翔
袁恒杰
Li Meng;Yang Chen;Lan Gaoshuang;Yu Jie;Li Zhengxiang;Yuan Hengjie(Tianjin Medical University General Hospital,Tianjin 300052)
出处
《天津药学》
2019年第6期34-38,52,共6页
Tianjin Pharmacy
