摘要
目的:系统评价目前参芪降糖颗粒治疗2型糖尿病气阴两虚证患者的疗效和安全性。方法:计算机检索Cochrane Library、Pub Med、WHO ICTRP、CNKI、VIP、CBM、Wanfang Data和中国优秀硕士、博士学位毕业论文数据库的文献,检索时限均为从建库至2014年11月11日,由两名研究者按照纳入和排除标准独立进行文献筛选、资料提取、质量评价并交叉核对后,采用RevMan5.2软件进行Meta分析。结果:共纳入8个随机对照试验,合计772例。各纳入研究的方法学质量总体中等。Meta分析结果显示:(1)有效率指标:共纳入的6个研究,实验组(联合组、单用组)治疗2型糖尿病气阴两虚证患者效果优于对照组,差异有统计学意义,分别为[OR=4.52,95%CI(2.44,8.37),P<0.000 01]、[OR=5.60,95%CI(2.33,13.45),P<0.000 01〗。(2)空腹血糖(FBG):共纳入的6个研究,实验组(联合组、单用组)降低2型糖尿病气阴两虚证患者FBG的疗效优于对照组,差异有统计学意义,分别为[MD=-2.29,95%CI(-2.67,-1.91)]、[MD=-1.97,95%CI(-2.80,-1.15)]。(3)餐后2小时血糖(2h PBG):共纳入的6个研究,实验组(联合组、单用组)降低2型糖尿病气阴两虚证患者2h PBG的疗效优于对照组,差异有统计学意义,分别为[MD=-2.21,95%CI(-2.69,-1.74)]、[MD=-1.46,95%CI(-2.32,-0.60)]。(4)不良反应:2个研究治疗组出现1例低血糖反应,对照组8例,两组比较有显著性差异(P<0.05);1个研究治疗组出现了2例低血糖反应,对照组16例,两组比较有显著性差异(P<0.05);1个研究治疗组在用药期间3例出现轻度腹泻。结论:参芪降糖颗粒对2型糖尿病气阴两虚证患者疗效确切,且不良反应少,值得临床应用。然而目前参芪降糖颗粒治疗2型糖尿病气阴两虚证临床研究的方法学和报告质量尚低,因此有必要进行大样本、多中心、随机、双盲的对照试验,以进一步证实其临床上的疗效和安全性。
Objective： To systematically review the effect and safety of the current system of Shenqi Jiangtang Granule for 2 Diabetes Mellitus of Qi- yin Deficiency. Methods： Such database as Cochrane Library,Pub Med,CBM,Wan Fang Data,CNKI and VIP were electronically searched from inception to November 11 st,2014. Result： 8 randomized controlled trials（RCTs） about 772 cases are included in this article,the quality of each study was generally medium. The results of Meta analysis show that：（1） The total effective rate： 6 randomized controlled trials are included,the total effective rate of treatment groups（ joint group,group） is higher than the control groups for 2 Diabetes Mellitus of Qi- yin deficiency,difference is statistically significant,just as follows： [OR = 4. 52,95% CI（ 2. 44,8. 37）,P 0. 000 01],[OR = 5. 60,95% CI（ 2. 33,13. 45）,P 0. 000 01〗;（ 2） Fasting blood glucose（ FBG） ： 6 randomized controlled trials are included,the total curative effect of treatment groups about reducing FBG is better than the control groups,difference is statistically significant,just as follows： [MD =- 2. 29,95% CI（- 2. 67,- 1. 91） ],[MD =- 1. 97,95% CI（- 2. 80,- 1. 15） ];（ 3） 2h Postprandial blood glucose（ PBG） ： 6 randomized controlled trials are included,the total curative effect of treatment groups about reducing2 h PBG is better than the control groups,difference is statistically significant,just as follows： [MD =- 2. 21,95% CI（- 2. 69,-1. 74） ],[MD =- 1. 46,95% CI（- 2. 32,- 0. 60） ];（ 4） There is 1 hypoglycemia reaction occurrenced in treatment group of one RCT,while 8 cases develope hypoglycemia reaction in control group,there is significant difference between the two groups（P〈0. 05）;there are 2 hypoglycemia reactions occurrenced in treatment group of another RCT,while 16 cases develope hypoglycemia reaction in control group,there is significant difference between the two groups（P〈0. 05）; there are 3 cases about mild diarrhea in treatment group of one RCT during the period of medication. Conclusion Shenqi Jiangtang Granule is effective and safe for 2 Diabetes Mellitus of Qi-yin Deficiency,which is recommended in clinical application. However,the current clinical studies on Shenqi Jiangtang Granule for 2Diabetes Mellitus of Qi- yin Deficiency are low in methodology and reporting quality,so it is necessary to design multicenter,strictly randomized and double- blind randomized control trials with large samples,to further confirm the clinical curative effect and safety.
出处
《江西中医药大学学报》
2015年第4期35-40,共6页
Journal of Jiangxi University of Chinese Medicine
基金
江西中医药大学校级课题(2013ZR0061
2013jzyl-4)
