益气养阴活血法对2型糖尿病前期疗效和安全性的系统评价

Effectiveness and safety of Tonifying Qi,nourishing Yin and activating blood method on pre-diabetes: a systematic review

目的评价益气养阴活血法联合生活方式干预治疗2型糖尿病前期的疗效和安全性。方法检索中国生物医学文献数据库(CBMDisc)、《中国医学学术会议论文数据库》(CMAC)、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、万方数据库、Pub Med、EMbase、Web of Science,检索时限截至2013年12月。纳入益气养阴活血法联合生活方式干预治疗2型糖尿病前期的随机对照试验(RCT)。由2位研究人员根据纳入与排除标准独立进行文献筛选、数据提取、质量评价并交叉核对结果,采用Rev Man 5.1软件进行Meta分析。结果共纳入17个RCT,共1497例2型糖尿病前期患者。Meta分析显示:益气养阴活血法为主的中药复方加用生活方式干预与对照组比较,糖尿病的发生率降低,糖调节受损恢复正常率较高,对空腹血糖、餐后2 h血糖的影响其差异有统计学意义,对糖化血红蛋白的影响其差异没有统计学意义。但因纳入文章研究设计质量不高,故不能有力证明益气养阴活血法组优于对照组,只能说明对于糖尿病前期的治疗益气养阴活血法可能优于对照组。有3个研究报道了不良事件,未见严重不良事件的报道。结论基于当前临床证据,糖尿病前期的治疗益气养阴活血法可能优于对照组,但尚需设计严格的临床研究进一步验证。

Objective To assess the effectiveness and safety of Tonifying Qi,nourishing Yin and activating blood method on pre-diabetes. Methods The relevant data from the founding time to December 2013 in CBMDisc,CMAC,CNKI,VIP,Wan Fang Data,Pub Med,EMbase,Web of Science were retrieved by computer and was adopted in this randomized controlled trials about the Tonifying Qi,nourishing Yin and activating blood method combination life intervene in the treatment of pre-diabetes. After two reviewers had independently screened the documents,extracted data and evaluated the quality of included trials,the Cochrane Collaboration's software Rev Man 5. 1 was used for meta-analysis. Results A total of 17 studies involving 1497 patients were included. The results of meta analysis suggested that,compared with the control group,combination with the Tonifying Qi,nourishing Yin and activating blood method could reduce the incidence of diabetes,increase the incidence of impaired glucose return to normal. There were statistical differences in fasting blood-glucose and 2-hour post-meal blood glucose between two groups,and was not statistical differences on effects of glycosylated hemoglobin. The results suggest that the effectiveness of Tonifying Qi,nourishing Yin and activating blood method on pre-diabetes may be superior to the control group due to low qualit of inclusion trials. There were three studies reported adverse events and no serious adverse event was reported. Conclusion Based on current clinical evidence,the clinical effects of Tonifying Qi,nourishing Yin and activating blood method is better than the control group. However,more double-blind multi-center RCTs with high quality,large sample are required for further verification.