半夏泻心汤治疗糖尿病胃轻瘫随机对照试验的Meta分析

Banxia Xiexin decoction for the treatment of diabetic gastroparesis: a meta-analysis of randomized clinical trials

[目的]系统评价半夏泻心汤治疗糖尿病胃轻瘫的临床疗效及安全性。[方法]计算机及手工检索2000年1月1日~2018年4月1日在Pubmed、Embase、Cochrane Library、SinoMed、CNKI、VIP及万方等数据库发表的以半夏泻心汤为主方的各种中药制剂治疗糖尿病胃轻瘫的随机对照试验(Randomized controlled trial,RCT),使用Cochrane协作网推荐的RCT的偏倚风险表(risk of bias table)对纳入的研究偏倚风险进行评价,应用Rev Man 5.3软件进行Meta分析。[结果]共纳入24个RCT研究,1801例患者。Meta分析结果显示,半夏泻心方组与西药组相比,临床总有效率更高,差异有统计学意义[RR=1.25,95%CI(1.19,1.32),P<0.00001];血清生化水平改善更明显,包括空腹血糖[WMD=-1.68,95%CI(-2.48,-0.88),P<0.0001]、餐后2h血糖[WMD=-1.46,95%CI(-2.06,-0.85),P<0.00001]、胃动素[WMD=-73.26,95%CI(-94.29,-52.22),P<0.00001];影像学改善更明显,其中胃排空率[WMD=6.66,95%CI(3.60,9.72),P<0.0001];复发率显著降低[RR=0.64,95%CI(0.44,0.94),P=0.02];现有证据表明2者不良反应发生率差异无统计学意义[OR=0.71,95%CI(0.29,1.77),P=0.46]。[结论]半夏泻心方组治疗糖尿病胃轻瘫临床疗效明显高于西药组,并具有较低的复发率,但不良反应发生率方面2者未见明显差异。鉴于纳入的试验质量较低且存在偏倚的可能,仍需进一步开展多中心、大样本、高质量、双盲的RCT研究进行进一步验证。

[Objective]To systematically evaluate the clinical efficacy and safety of Banxia Xiexin decoction for treating diabetic gastroparesis.[Methods]We searched datebases including CNKI,VIP,Wanfang,SinoMed,and Pubmed,Embase,Cochrane Library from January 01,2000 to April 30,2000 for randomized controlled trials（RCTs）,use the Cochrane recommended bias risk assessment method to evaluate the bias risk,and using Rev Man 5.3 software for meta-analysis.[Results]24 RCTs were included and 1801 patients were enrolled.Meta-analysis showed that Banxia Xiexin decoction in the treatment combined with Western medicine,higher clinical effective rate,which showed statistic significance [RR=1.25,95%CI（1.19,1.32）,P0.00001];the improvement of serum biochemical level was more evident,including fasting blood-glucose[WMD=-1.68,95%CI（-2.48,-0.88）,P0.0001],2 hpostprandial blood glucose[WMD=-1.46,95%CI（-2.06,-0.85）,P0.00001],Motilin[WMD =-73.26,95%CI（-94.29,-52.22）,P0.00001];Imaging improve more significantly,gastric emptying rate [WMD =6.66,95%CI（3.60,9.72）,P0.0001];significantly reduced recurrence rate [RR=0.64,95%CI（0.44,0.94）,P=0.02].Available evidence suggests that both the incidence of adverse reactions was no significant difference[OR=0.71,95%CI（0.29,1.77）,P=0.46].[Conclusion]Banxia Xiexin decoction was significantly higher clinical efficacy than western medicine in the treatment of diabetic gastroparesis,has a low recurrence rate.But the incidence of adverse reactions showed no significant difference between the two.Given the low quality in methodology and reports of included RCTs in this study,further multicenter,large-sample,high quality,double-blind RCT studies are needed for further validation.