葛根芩连汤联合西医常规治疗2型糖尿病的有效性研究

Study on the effectiveness of Gegen Qinlian Decoction combined with Western medicine in the conventional treatment of type 2 diabetes

关键词:  葛根芩连汤  2型糖尿病  Meta分析  系统评价  GRADE证据质量评价

Key words:  Gegen Qinlian Decoction  type 2 diabetes mellitus  Meta-analysis  systematic review  GRADE evidence quality assessment

摘要:

[目的] 系统评价葛根芩连汤治疗2型糖尿病的有效性和安全性。[方法] 系统地检索EMbase、PubMed、Cochrane Library、中国知网（CNKI）、维普网（VIP）、万方（WANFANG DATA）和中国生物医学文献数据库（CBM）七大数据库，检索时间从各数据库建库起至2023年6月，按照预先设定的筛选标准纳入葛根芩连汤治疗2型糖尿病的随机对照试验。使用Cochrane风险偏倚评估工具对文献质量进行评价，RevMan 5.4软件进行数据分析。[结果] 共检索到文献439篇，最终纳入33个研究，总样本量2 764例。Meta分析结果显示，葛根芩连汤联合西医常规治疗2型糖尿病的总有效率优于单用西医常规治疗[OR=0.24，95%CI（0.17，0.33），P<0.000 01]。与对照组比较，试验组在空腹血糖[MD=-1.27，95%CI（-1.57，-0.88），P<0.000 01]、餐后2 h血糖[MD=-1.43，95%CI（-1.78，-1.08），P<0.000 01]、糖化血红蛋白[MD=-0.97，95%CI（-1.30，-0.63），P<0.000 01]、总胆固醇[MD=-0.56，95%CI（-0.77，-0.35），P<0.000 01]、三酰甘油[MD=-0.29，95%CI（-0.43，-0.14），P=0.000 02]、低密度脂蛋白[MD=-0.43，95%CI（-0.53，-0.34），P<0.000 01]、身体质量指数[MD=-1.39，95%CI（-2.42，-0.35），P=0.009]等方面的降低效果及对高密度脂蛋白[MD=0.17，95%CI（0.03，0.30），P=0.01]的升高效果更优，且葛根芩连汤联合西医常规治疗会降低不良反应发生率[OR=0.40，95%CI（0.24，0.67），P=0.000 04]，但在空腹胰岛素指数方面试验组和对照组之间无统计学差异[MD=-1.50，95%CI（-4.12，1.11），P=0.26]。亚组分析显示，疗程在8周及以上，葛根芩连汤联合西医常规治疗在降低空腹血糖、餐后2 h血糖和糖化血红蛋白效果更优。敏感性分析及发表偏倚结果提示总有效率存在发表偏倚，但结果尚可靠。GRADE证据质量评价提示结局指标总体质量较低。[结论] 葛根芩连汤联合西医常规疗治疗2型糖尿病疗效显著，不良反应少。但由于纳入研究的样本量及方法学质量有限，该结论仍需更多高质量随机对照试验加以验证。

Abstract:

[Objective] To systematically evaluate the efficacy and safety of Gegen Qinlian Decoction in the treatment of type 2 diabetes. [Methods] Systematically search seven major databases：EMbase，PubMed，Cochrane Library，China National Knowledge Infrastructure（CNKI），VIP，WANFANG DATA and Chinese Biomedical Literature Database（CBM）. The retrieval time was from the establishment of each database to June 2023. According to the pre-set screening criteria，randomized controlled trials of Gegen Qinlian Decoction in the treatment of type 2 diabetes were included. The Cochrane risk of bias assessment tool was used to evaluate the quality of the literature，and RevMan 5.4 software was used for data analysis. [Results] A total of 439 literatures were retrieved，and 33 studies were finally included，with a total sample size of 2 764 cases. The results of Meta analysis showed that the total effective rate of Gegen Qinlian Decoction combined with conventional Western medicine in the treatment of type 2 diabetes was better than conventional Western medicine alone [OR=0.24，95%CI（0.17，0.33），P<0.000 01]. Compared with the control group，the fasting blood glucose of the experimental group [MD=-1.27，95%CI（-1.57，-0.88），P<0.000 01]，2-hour postprandial blood glucose [MD=-1.43，95%CI（-1.78，-1.08），P<0.000 01]，glycation hemoglobin [MD=-0.97，95%CI（-1.30，-0.63），P<0.000 01]，total cholesterol [MD=-0.56，95%CI（-0.77，-0.35），P<0.000 01]，triglycerides [MD=-0.29，95%CI（-0.43，-0.14），P=0.000 02]，low density lipoprotein [MD=-0.43，95%CI（-0.53，-0.34），P<0.000 01]，body mass index [MD=-1.39，95%CI（-2.42，-0.35），P=0.009] and other aspects of the reduction effect and the increasing effect of high-density lipoprotein [MD=0.17，95%CI（0.03，0.30），P=0.01] are better，and Gegen Qinlian decoction combined with conventional Western medicine treatment can reduce the incidence of adverse reactions [OR=0.40，95%CI（0.24，0.67），P=0.00004]，but in the fasting insulin index，there was no significant difference between the experimental group and the control group [MD=-1.50，95%CI（-4.12，1.11），P=0.26]. The subgroup analysis showed that Gegen Qinlian Decoction combined with routine western medicine had a better effect in reducing fasting blood sugar，2-hour postprandial blood sugar and glycosylated hemoglobin when the course of treatment was 8 weeks or more. The results of sensitivity analysis and publication bias suggested that there was publication bias in the total effective rate，but the results were still reliable. The GRADE assessment of the quality of evidence suggested that the overall quality of outcome indicators was low. [Conclusion] Gegen Qinlian Decoction combined with conventional treatment of Western medicine has significant efficacy in the treatment of type 2 diabetes mellitus，with less adverse reactions. However，due to the limited sample size and methodological quality of the included studies，more high-quality randomized controlled trials are needed to validate this conclusion.