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益气活血中药联合达格列净治疗2型糖尿病合并心力衰竭:基于随机对照试验的系统评价与Meta分析

Combination of Qi Benefiting and Blood Circulation Promoting Herbs with Dapagliflozin in the Treatment of Type 2 Diabetes Mellitus Combined with Heart Failure: A Systematic Evaluation and Meta-Analysis Based on a Randomized Controlled Trial.

作者信息

Liu Changxing, Guo Xinyi, Wang He, Zhou Yabin

机构信息

First Clinical School of Medicine, Heilongjiang University of Chinese Medicine, Harbin, China,

Clinical School of Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, China.

出版信息

Complement Med Res. 2024;31(6):551-566. doi: 10.1159/000541234. Epub 2024 Sep 18.

Abstract

INTRODUCTION

This systematic review examines the efficacy of a combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin in treating type 2 diabetes mellitus (T2DM) combined with heart failure (HF).

METHODS

Randomized controlled trials (RCTs) assessing the combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin for T2DM and CHF was conducted. The search, spanning from the database's establishment to June 2023, included seven databases: China Knowledge Network (CNKI), Wanfang Database, VIP Database, PubMed, Embase, Cochrane Library, and the Chinese Biomedical Literature Database. Two researchers screened and extracted data based on inclusion and exclusion criteria. The Cochrane Handbook version 5.1 guided the quality assessment of studies, and the meta-analysis was performed using RevMan 5.4 software.

RESULTS

Eleven articles, encompassing a sample size of 1,192 cases, were included. Meta-analysis results indicated that combining Qi benefiting and blood circulation promoting herbs with Dapagliflozin improved the clinical efficacy rate (OR = 4.35, 95% confidence interval [CI; 2.98, 6.35], p < 0.00001). It reduced blood glucose levels, evidenced by decreased fasting blood glucose (FBG) (mean difference [MD] = -1.19, 95% CI [-1.30, -1.09], p < 0.00001), 2-h postprandial blood glucose (2hPG) (MD = -1.95, 95% CI [-2.09, -1.80], p < 0.00001), and glycosylated hemoglobin (HbA1c) (MD = -1.40, 95% CI [-1.49, -1.31], p < 0.00001). Inflammatory factors also reduced, including C-reactive protein (CRP) (MD = -4.93, 95% CI [-5.38, -4.48], p < 0.00001), tumor necrosis factor (TNF-α) (MD = -2.91, 95% CI [-3.32, -2.49], p < 0.00001), and interleukin-6 (IL-6) (MD = -11.10, 95% CI [-12.43, -9.43], p < 0.00001). Additionally, left ventricular end-diastolic diameter (LVEDD) (standardized mean difference [SMD] = -1.25, 95% CI [-1.45, -1.05], p < 0.00001), left ventricular end-systolic diameter (LVESD) (SMD = -1.34, 95% CI [-1.51, -1.13], p < 0.00001), and improved left ventricular ejection fraction (LVEF) (SMD = 2.92, 95% CI [2.65, 3.19], p < 0.00001), 6-min walk test (6MWT) (MD = 35.59, 95% CI [29.72, 41.47], p < 0.00001), and Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores (MD = 35.59, 95% CI [29.72, 41.47], p < 0.00001) were observed. The incidence of adverse events also decreased (RR = 0.25, 95% CI [0.11, 0.56], p = 0.0007).

CONCLUSION

The combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin shows potential in treating patients with T2DM and HF, suggesting its use as adjunctive therapy in clinical practice. However, the limited number and quality of the included studies necessitate further high-quality research to confirm these findings.

摘要

介绍

本系统评价探讨益气活血中药联合达格列净治疗2型糖尿病(T2DM)合并心力衰竭(HF)的疗效。

方法

进行了评估益气活血中药联合达格列净治疗T2DM和CHF的随机对照试验(RCT)。检索范围从数据库建立至2023年6月,包括七个数据库:中国知网(CNKI)、万方数据库、维普数据库、PubMed、Embase、Cochrane图书馆和中国生物医学文献数据库。两名研究人员根据纳入和排除标准筛选并提取数据。采用Cochrane手册第5.1版指导研究的质量评估,并使用RevMan 5.4软件进行荟萃分析。

结果

纳入11篇文章,样本量为1192例。荟萃分析结果表明,益气活血中药联合达格列净可提高临床有效率(OR = 4.35,95%置信区间[CI;2.98,6.35],p < 0.00001)。它降低了血糖水平,空腹血糖(FBG)降低(平均差[MD] = -1.19,95% CI [-1.30,-1.09],p < 0.00001)、餐后2小时血糖(2hPG)(MD = -1.95,95% CI [-2.09,-1.80],p < 0.00001)和糖化血红蛋白(HbA1c)(MD = -1.40,95% CI [-1.49,-1.31],p < 0.00001)证明了这一点。炎症因子也有所降低,包括C反应蛋白(CRP)(MD = -4.93,95% CI [-5.38,-4.48],p < 0.00001)、肿瘤坏死因子(TNF-α)(MD = -2.91,95% CI [-3.32,-2.49],p < 0.00001)和白细胞介素-6(IL-6)(MD = -11.10,95% CI [-12.43,-9.43],p < 0.00001)。此外,观察到左心室舒张末期内径(LVEDD)(标准化平均差[SMD] = -1.25,95% CI [-1.45,-1.05],p < 0.00001)、左心室收缩末期内径(LVESD)(SMD = -1.34,95% CI [-1.51,-1.13],p < 0.00001)改善,左心室射血分数(LVEF)(SMD = 2.92,95% CI [2.65,3.19],p < 0.00001)、6分钟步行试验(6MWT)(MD = 35.59,95% CI [29.72,41.47],p < 0.00001)和明尼苏达心力衰竭生活问卷(MLHFQ)评分(MD = 35.59,95% CI [29.72,41.47],p < 0.00001)。不良事件的发生率也降低了(RR = 0.25,95% CI [0.11,0.56],p = 0.0007)。

结论

益气活血中药联合达格列净在治疗T2DM和HF患者方面显示出潜力,表明其可作为临床实践中的辅助治疗方法。然而,纳入研究的数量和质量有限,需要进一步的高质量研究来证实这些发现。

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