白虎加人参汤治疗2型糖尿病有效性与安全性的Meta分析

Meta-analysis on the Therapeutic Effect and Safety of Baihu Renshen Decoction in the Treatment of Type 2 Diabetes Mellitus

目的评价白虎加人参汤治疗2型糖尿病的有效性和安全性。方法通过检索电子数据库中国知网、万方、维普、CBM、PubMed、EMBASE、Web of Science、Cochrane Library,筛选2000年1月—2020年12月发表的白虎加人参汤治疗2型糖尿病的随机对照试验,同时手工查询相关文献。采用Cochrane随机对照试验偏倚风险评估工具对文献进行偏倚风险评估。采用RevMan 5.4软件进行Meta分析。结果共纳入文献13篇,样本量1061例。Meta分析结果显示,白虎加人参汤可有效缓解2型糖尿病临床症状(P<0.00001);可显著降低空腹血糖(P<0.00001);可显著降低餐后2 h血糖(P<0.00001);可改善患者糖化血红蛋白(P=0.002)。亚组分析结果显示,白虎加人参汤对气阴两虚型糖尿病的降糖作用优于火热炽盛型。长疗程与短疗程的治疗效果差异无统计学意义。漏斗图显示可能存在发表偏倚。敏感性分析提示Meta分析结果较为稳定。2篇文献报告未见不良反应,其余文献未提及。结论白虎加人参汤可有效改善2型糖尿病患者临床症状,降低血糖,且对气阴两虚型糖尿病的降糖效果优于火热炽盛型。未来临床研究中,需注重糖尿病的中医证型,研究白虎加人参汤对不同证型糖尿病的治疗效果。由于白虎加人参汤的临床安全性研究较少,尚不能肯定其安全性,故未来临床试验仍需注重其安全性研究。

Objective To evaluate the therapeutic effect and safety of Baihu Renshen decoction in the treatment of type 2 diabetes mellitus.Methods The electronic databases of CNKI,Wanfang,VIP,CBM,PubMed,EMBASE,Web of Science,Cochrane Library were searched,the randomized controlled trials of Baihu Renshen decoction in the treatment of type 2 diabetes published from January 2000 to December 2020 were screened,and the related literatures were manually searched at the same time.The bias risk assessment tool of Cochrane randomized controlled trials was used to assess the risk of bias.RevMan 5.4 software was used for meta-analysis.Results A total of 13 articles were included,with a sample size of 1061 cases.Meta-analysis results showed that Baihu Renshen decoction could effectively alleviate the clinical symptoms of type 2 diabetes(P<0.00001).It can significantly reduce fasting blood glucose(P<0.00001).It can significantly reduce blood glucose 2 h after a meal(P<0.00001).It can improve patients glycated hemoglobin(P=0.002).The results of subgroup analysis showed that Baihu Renshen decoction had better hypoglycemic effect on qi and yin deficiency diabetes than that of heat pathogen.There was no significant difference between long course and short course of treatment.The funnel plot showed that there may be publication bias.Sensitivity analysis showed that the results of meta-analysis are relatively stable.There were no adverse reactions in the two literature reports,and the rest of the literature did not mention it.Conclusion Baihu Renshen decoction can effectively improve the clinical symptoms of type 2 diabetes patients,lower blood glucose,and the hypoglycemic effect of qi and yin deficiency diabetes is better than that of heat pathogen.In the future related clinical trials,it is necessary to focus on the traditional Chinese medicine syndromes of diabetes and study the therapeutic effect of Baihu Renshen decoction on diabetes with different syndromes.Since there are few studies on the clinical safety of Baihu Renshen decoction,its safety cannot be confirmed yet,and future clinical trials should pay attention to its safety.