摘要
目的系统评价维格列汀与安慰剂比较治疗2型糖尿病的疗效和安全性。方法计算机检索Cochrane图书馆(2010年第2期)、PubMed(1978～2010.9),EMbas(e1974～2010.9)、CNK(I1978～2010.9)、VIP(1989～2010.9)和CBM(1978～2010.9)数据库,搜集维格列汀与安慰剂比较治疗2型糖尿病的随机对照试验(RCT)。由两位研究者根据纳入与排除标准筛选试验、提取资料并根据Cochrane系统评价员手册进行质量评价后,采用RevMan 5.0软件进行Meta分析。结果共纳入13个RCT,Meta分析结果显示:单药治疗时,维格列汀降低患者糖化血红蛋白(HbA1c)的疗效优于安慰剂[MD=–0.76,95%C(I–0.94,–0.58),P<0.00001],但在控制体重方面不及安慰剂[MD=0.68,95%CI(0.29,1.07),P=0.0006],不良反应及低血糖的发生率与安慰剂相似[OR=1.00,95%CI(0.83,1.21),P=0.98;OR=1.03,95%CI(0.65,1.65),P=0.89]。联合其他口服降糖药或胰岛素治疗时,维格列汀在改善患者HbA1c水平方面优于安慰剂组[MD=–0.76,95%CI(–0.94,–0.58),P<0.00001],而在控制患者体重、减少不良反应及低血糖发生率方面,两组差异无统计学意义[MD=0.40,95%CI(–0.25,1.05),P=0.23;OR=0.95,95%CI(0.76,1.18),P=0.62;OR=1.11,95%CI(0.49,2.53),P=0.80]。结论维格列汀可以有效控制2型糖尿病患者血糖,且安全性较好。但远期结果有待高质量大样本长期随访的临床研究予以验证。
Objective To evaluate the efficacy and safety of vildagliptin vs.placebo for patients with type 2 diabe-tes.Methods e following databases as e Cochrane Library（Issue 2,2010）,PubMed（1978 to September,2010）,EM-base（1974 to September,2010）,CNKI（1978 to September,2010）,VIP（1989 to September,2010） and CBM（1978 to Sep-tember,2010） were searched to collect the randomized controlled trials（RCTs） of vildagliptin vs.placebo in treating type 2 diabetes.Two reviewers screened the trials according to the inclusion and exclusion criteria,Thextracted the data,assessed the quality in accordance with the Cochrane Collaboration,and conducted meta-analyses with RevMan 5.0 so ware.Re-sults A total of 13 studies were included.The results of meta-analyses showed that the vildagliptin given as monotherapy led to greater reduction in HbA1c compared with the placebo（MD= –0.76,95%CI –0.94 to –0.58,P0.00001）,but it was inferior to the placebo in losing weight（MD=0.68,95%CI 0.29 to 1.07,P=0.0006）.When the vildagliptin was given as monotherapy,there was no statistical difference in the incidence of overall adverse events（AEs）（OR=1.00,95%CI 0.83 to 1.21,P=0.98） and hypoglycaemia（OR=1.03,95%CI 0.65 to 1.65,P=0.89）.When the vildagliptin was combined with other oral antihyperglycemic drugs or insulin,it produced greater reduction in level of HbA1c（MD= –0.76,95%CI –0.94 to –0.58,P0.00001）,and there was no statistically signi cant difference between vildagliptin and placebo in weight loss（MD=0.40,95%CI –0.25 to 1.05,P=0.23）,AEs（OR=0.95,95%CI 0.76 to 1.18,P=0.62） and hypoglycaemia（OR=1.11,95%CI 0.49 to 2.53,P=0.80）.Conclusion e vildagliptin treatment for type 2 diabetes is effective and safe.A long-term study in large scale with high quality is required to confirm its long-term outcomes.
出处
《中国循证医学杂志》
CSCD
2011年第9期1070-1077,共8页
Chinese Journal of Evidence-based Medicine
