中国2型糖尿病患者中的安慰剂效应

Placebo effect of the hypoglycemic drugs in Chinese type 2 diabetic patients

目的 系统评价在中国2型糖尿病患者群中的安慰剂效应.方法 在MEDLINE、EMBASE、CENTRAL等数据库中进行文献检索并设定入选研究标准,即在中国2型糖尿病患者中进行的临床双肓随机对照研究;患者年龄≥18岁;研究随访时间≥12周并以糖化血红蛋白（HbA1c）或空腹血糖为疗效判定标准.文献检索截止时间2013年12月.使用Cochrane协作网的RevMan5.2软件进行数据Meta分析.连续变量用加权均数差值（WMD）来表示.结果 共14项研究纳入本Meta分析.在HbA1c方面,较基线水平变化的WMD为-0.33％,95％可信区间（CI）为-0.41％～-0.25％（P＜0.05）;在空腹血糖方面,较基线水平变化的WMD为-0.04 mmol/L,95％CI为-0.40～ 0.32 mmol/L（P＞0.05）;在餐后血糖方面,较基线水平变化的WMD为-0.32 mmol/L,95％CI为-0.87～ 0.22 mmol/L（P＞0.05）;在体重方面,较基线水平变化的WMD为-0.44 kg,95％CI为-0.94～ 0.05 kg（P＞0.05）.回归分析显示,基线体质指数与HbA1c的变化值呈负相关（β=-0.477,95％CI：-0.926 ～-0.029,P=0.04）.结论 中国2型糖尿病患者中,安慰剂对HbA1c降低均值为0.33％,具有统计学意义;但对空腹血糖、餐后血糖及体重方面,安慰剂降低均值均无统计学意义.

Objective To evaluate the placebo effect of hypoglycemic treatment in Chinese type 2 diabetes patients.Methods The MEDLINE,EMBASE,CENTRAL databases were searched and qualified studies were included.All the studies were double blind,placebo-controlled randomized trials in Chinese type 2 diabetes patients; patients age≥18 years; duration of follow-up study ≥12 weeks with the efficacy evaluated by changes in glycated hemoglobin A1c （HbA1c）or fasting plasma glucose （FPG）from baseline in groups.References were collected until Dec.2013.All statistical analyses were performed with the Review Manager statistical software package （Version 5.1）.The Meta-analysis was performed by computing the weighted mean difference （WMD）for change from baseline to study endpoint.Results Totally 14 qualified studies were included.In terms of HbA1c change,treatment with placebo led to a significant HbA1c reduction from baseline（WMD,-0.33% ; 95%CI：-0.41% to-0.25%）.In terms of FPG,treatment with placebo led to a non-significant reduction from baseline （WMD,-0.04 mmol/L; 95% CI：-0.40 to 0.32 mmol/L）.In terms of postprandial glucose（PPG）,treatment with placebo led to a non-significant change from baseline （WMD,-0.32 mmol/L; 95% CI：-0.87 to 0.22 mmol/L）.Moreover,treatment with placebo led to a non-significant weight change from baseline（WMD,-0.44 kg;95%CI：-0.94 to 0.05 kg）.Conclusion This Meta-analysis provided comprehensive clinical evidence on the placebo effect of hypoglycemic treatment in Chinese type 2 diabetes patients.Treatment with placebo led to a significant HbA1c reduction from baseline of 0.33%,but non-significant FPG,PPG or weight reduction from baseline.