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中药金芪降糖颗粒辅助治疗 2 型糖尿病的有效性:一项随机对照试验的系统评价和荟萃分析。

Effectiveness of traditional Chinese medicine Jinlida granules as an add-on therapy for type 2 diabetes: A system review and meta-analysis of randomized controlled trials.

机构信息

Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

J Diabetes. 2019 Jul;11(7):540-551. doi: 10.1111/1753-0407.12877. Epub 2018 Dec 25.

DOI:10.1111/1753-0407.12877
PMID:30430757
Abstract

BACKGROUND

Jinlida granules are a commonly prescribed oral medication in China used in combination with antidiabetic drugs to lower blood glucose. The aim of this study was to systematically identify and pool the findings of randomized controlled trials evaluating the effectiveness and safety of Jinlida granules as add-on therapy for glycemic control in type 2 diabetes (T2D).

METHODS

The China National Knowledge Infrastructure (CNKI), Wang Fang, PubMed, China biology medicine (CBM), and VIP Database for Chinese Technical Periodicals (VIP) databases were searched for papers regarding the effects of Jinlida granules in T2D published before 1 July 2018. A pooled analysis of extracted data was performed using random-effects models.

RESULTS

In all, data were retrieved for 15 studies including 1810 individuals. Decreases in HbA1c were greater in groups receiving Jinlida granules as add-on therapy compared with control groups (n = 1820; mean difference - 0.66; 95% confidence interval - 0.72, -0.60; P < 0.00001; I  = 38%). In addition, Jinlida granules reduced body mass index and had beneficial effects on homeostatic model assessment of β-cell function and homeostasis model assessment of insulin resistance. No obvious adverse events were reported.

CONCLUSIONS

Findings from this meta-analysis demonstrate additional benefits of Jinlida granules as an add-on therapy for T2D and that Jinlida granules are generally safe. Treatment with Jinlida granules provided clinically and statistically significant reductions in fasting plasma glucose, 2-hour post-load glucose, and HbA1c levels in patients with T2D. However, the findings should be interpreted with caution due to the small sample size and study limitations.

摘要

背景

金芪降糖颗粒是一种在中国广泛应用的口服药物,常与降糖药物联合使用以降低血糖。本研究旨在系统地检索和汇总金芪降糖颗粒作为 2 型糖尿病(T2D)辅助治疗药物的有效性和安全性的随机对照试验结果。

方法

检索中国知网(CNKI)、万方、PubMed、中国生物医学文献数据库(CBM)和维普中文科技期刊数据库(VIP),收集截至 2018 年 7 月 1 日有关金芪降糖颗粒治疗 T2D 的随机对照试验。采用随机效应模型对提取的数据进行汇总分析。

结果

共纳入 15 项研究,包括 1810 名患者。金芪降糖颗粒联合治疗组较对照组的糖化血红蛋白(HbA1c)水平下降更明显(n=1820;均数差值-0.66;95%置信区间-0.72,-0.60;P<0.00001;I²=38%)。此外,金芪降糖颗粒还降低了体重指数(BMI),对胰岛β细胞功能和胰岛素抵抗的稳态模型评估(HOMA-β 和 HOMA-IR)有改善作用。未观察到明显不良反应。

结论

本荟萃分析结果表明,金芪降糖颗粒作为 T2D 的辅助治疗药物具有额外获益,且总体安全性良好。金芪降糖颗粒治疗 T2D 可显著降低空腹血糖、餐后 2 小时血糖和 HbA1c 水平,具有显著的临床意义。但由于样本量小和研究局限性,该结论需谨慎解读。

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