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目的对西格列汀治疗2型糖尿病的疗效和安全性进行评价。方法以“sitagliptin”为关键词检索PubMed、Embase及Cochrane Library,以“西格列汀”为关键词检索万方数据库,收集以糖化血红蛋白<7%和不良反应发生率为研究终点的西格列汀治疗2型糖尿病的随机对照试验(RCT),对符合纳入标准的RCT进行质量评价,提取相关资料并应用RevMan 5.2软件进行统计分析,计算比值比(OR)和95%置信区间(CI)。结果共25个RCT入选。Meta分析显示,西格列汀糖化血红蛋白<7%达标率优于安慰剂(OR=3.02,95%CI为2.48~3.67,P=0.00),逊于噻唑烷二酮类药物(OR=0.60,95%CI为0.41-0.88,P=0.01),类似于二甲双胍(OR=0.78,95%CI为0.51~1.19,P=0.25)、胰高血糖素样肽1(GLP-1)受体激动剂(OR=0.53,95%GI为0.15~1.92,P=0.34)和磺酰脲类药物(OR=0.93,95%CI为0.58~1.48,P=0.76);不良反应发生率类似于安慰剂(OR=1.11,95%CI为0.89~1.39,P=0.33),低于二甲双胍(OR=0.42,95%CI为0.32~0.55,P=0.00)、噻唑烷二酮类药物(OR=0.65,95%CI为0.45~0.94,P=0.02)、GLP-1受体激动剂(OR=0.45,95%CI为0.24~0.83,P=0.01)、磺酰脲类药物(OR=0.38,95%CI为0.32~0.47,P=0.00)。结论西格列汀治疗2型糖尿病可有效降低患者糖化血红蛋白水平,不良反应发生率低于其他降糖药。
Objective To evaluate the efficacy and safety of sitagliptin in type 2 diabetes mellitus. Methods PubMed, Embase and Cochrane Library were searched with “sitagliptin” as the key word, and Wanfang database was searched using the keywords “sitagliptin”. The data were collected with the incidence of HbA1c <7% and the incidence of adverse reactions (RCT) of sitagliptin in treatment of type 2 diabetes mellitus (T2DM). The quality of RCTs complying with the inclusion criteria was evaluated and relevant data were extracted and analyzed by using RevMan 5.2 software to calculate the odds ratio (OR) and 95% confidence interval (CI). Results A total of 25 RCTs were selected. Meta-analysis showed that sitagliptin HbA1 was better than placebo (OR = 3.02, 95% CI 2.48-3.67, P = 0.00), lower than thiazolidinediones (OR = 0.60, 95% CI 0.41-0.88, P = 0.01), similar to metformin (OR = 0.78, 95% CI 0.51-1.19, P = 0.25), glucagon- like peptide 1 (GLP- 1) receptor agonist (OR = 0.53, 95% GI, 0.15 to 1.92, P = 0.34) and sulfonylureas (OR = 0.93, 95% CI 0.58-1.48, P = 0.76). The incidence of adverse reactions was similar to placebo OR = 1.11, 95% CI 0.89-1.39, P = 0.33), lower than metformin (OR = 0.42, 95% CI 0.32-0.55, P = 0.00) (OR = 0.45, 95% CI 0.24-0.83, P = 0.01), sulfonylureas (OR = 0.38, 95% CI 0.45-0.94, P = 0.02) and GLP-1 receptor agonists 0.32 ~ 0.47, P = 0.00). Conclusion Sitagliptin treatment of type 2 diabetes patients can reduce the level of glycosylated hemoglobin, the incidence of adverse reactions than other hypoglycemic agents.