艾塞那肽治疗2型糖尿病的卫生技术评估

Exenatide in the treatment of type 2 diabetes: a health technology assessment

目的:评价艾塞那肽临床使用的有效性、安全性和经济性,为临床治疗和决策者提供循证依据。方法:系统检索Pub Med,EMbase,Cochrane Library,CNKI和万方等数据库,由2名评价者独立根据纳入和排除标准筛选艾塞那肽的随机临床试验(RCTs)研究和经济学研究,评价质量和提取数据。对结果进行定性分析或荟萃分析。结果:从5 828篇文献中筛选出RCT研究26篇,经济学研究11篇。在成年2型糖尿病患者中,与口服降糖药相比,艾塞那肽显著降低Hb A1c[WMD-1.04%,95%CI(-1.26^-0.81),P<0.000 01],与胰岛素相比对血糖的影响无显著差异。与口服降糖药[WMD-1.27 kg,95%CI(-1.60to-0.94),P<0.000 01]和胰岛素[WMD-4.59 kg,95%CI(-5.41^-3.76),P<0.000 01]相比,艾塞那肽可显著减轻体重,降低低血糖发生率,但会增加恶心、呕吐、腹泻的发生率。艾塞那肽联用甘精胰岛素可延长患者的质量调整生命年(QALY),并具有成本效果。结论:艾塞那肽治疗2型糖尿病具有良好的有效性、安全性,在我国具有较好的经济性。

Objective： To evaluate the effectiveness,safety and economy of the clinical use of exenatide,providing evidence for physicians and decision makers. Methods： Pub Med,EMbase,Cochrane Library and CNKI were systematically searched. Two reviewers independently identified RCTs and cost-effectiveness studies according to the inclusion criteria,extracted data and assessed quality of included studies. Qualitative analysis and metaanalysis were performed. Results： Among 5 828 screened articles,26 RCTs and 11 cost-effectiveness analysis were included. In type 2 diabetes patients,HAb1 c level was significantly reduced in exenatide group than in OADs（oral anti-diabetic drug） group [WMD-1. 04%,95% CI（-1. 26 to-0. 81）,P〈0. 000 01],while there was no effect compared with insulin group. Exenatide could reduce body weight [OADs： WMD-1. 27 kg,95% CI（-1. 60 --0. 94）,P〈0. 000 01; insulin： WMD-4. 59 kg,95% CI（-5. 41 --3. 76）,P〈0. 000 01]and also reduced the risk of hypoglycemia,but at the same time increased the risks of nausea,vomit and diarrhea when compared with OADs or insulin. Exenatide cotreatment with insulin glargine could improve patients ＇ QALYs andhave cost effective. Conclusion： Exenatide was an efficacious and safe choice for type 2 diabetes treatment and is a cost-effectiveness option.