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基于银杏叶的中成药治疗高血压患者的疗效与安全性比较:一项随机临床试验的系统评价与网状Meta分析

Comparative efficacy and safety of ginkgo-based Chinese patent medicines in patients with hypertension: A systematic review and network meta-analysis of randomized clinical trials.

作者信息

Yi Yun-Hao, Zhang Guang-Heng, Lv Shi-Meng, Rong Yuan-Hang, Liu Hui, Teng Jing

机构信息

College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.

Department of First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan, China.

出版信息

Medicine (Baltimore). 2024 May 3;103(18):e37927. doi: 10.1097/MD.0000000000037927.

DOI:10.1097/MD.0000000000037927
PMID:38701296
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11062673/
Abstract

BACKGROUND

The efficacy and safety of different oral ginkgo-based Chinese patent medicines (CPMs) regimens for hypertension patients were analyzed based on the network meta-analysis of the frequency framework.

METHODS

We conducted a comprehensive search of PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database, and Chinese Biomedical Literature Database to gather data on randomized controlled trials (RCTs) evaluating the efficacy of 8 ginkgo biloba oral preparations for the treatment of hypertension. The trials included in the analysis were conducted from the inception of the databases up to September 2023. Methodological quality and risk of bias were assessed using the RoB 2.0 evaluation tool, and a reticulated meta-analysis was conducted using STATA MP 14 software. The RCTs included in this study were published studies and therefore did not require ethics committee review or patient consent.

RESULTS

We ultimately included 46 RCTs covering 8 CPMs including ginkgo biloba tablet (GBT), GB capsule (GBC), ginkgo biloba drop (GBD), ginkgo biloba ketone ester drop, Fufangyinxing capsule, fufangyinxingtongmai oral liquid, Yinxingmihuan oral liquid, Yindanxinanotong softgel capsule (YDXNT). GBD + CT demonstrated the highest effectiveness in reducing systolic blood pressure (surface under the cumulative ranking [SUCRA] = 78.7%) and improving total effective rate (SUCRA = 86.7%). GBC + CT exhibited the greatest efficacy in reducing diastolic blood pressure (SUCRA = 92.6%). GBT + CT was identified as the most effective in lowering total cholesterol (TC) (SUCRA = 100%). Additionally, YDXNT + CT demonstrated notable improvements in triglyceride levels (SUCRA = 92.2%), Nitric oxide (NO) (SUCRA = 93.9%), and ET-1 (SUCRA = 67.5%). In terms of safety, 14 studies reported the occurrence of adverse reactions with a high degree of clinical heterogeneity, which was only qualitatively analyzed in this study.

CONCLUSION SUBSECTIONS

We found that a combination of 8 ginkgo-based CPMs + CT was effective in hypertension compared with CT. The evidence showed that GBD + CT were the best in improving systolic blood pressure and total effective rate, GBC + CT improved diastolic blood pressure, GBT + CT were the most effective in improving TC, and YDXNT + CT was the most effective in improving TG, NO, and ET-1. Adverse effects were only analyzed qualitatively, and the number of adverse effects of CPMs treatment was relatively low compared to CT. In addition, the quality of the literature included in the study was low, and further validation through RCTs with larger sample sizes, higher quality, and more rigorously designed is needed.

摘要

背景

基于频率框架的网络荟萃分析,分析不同口服银杏叶中成药(CPMs)方案治疗高血压患者的疗效和安全性。

方法

全面检索PubMed、Cochrane图书馆、Embase、中国知网、万方、中国科技期刊数据库和中国生物医学文献数据库,收集评估8种银杏叶口服制剂治疗高血压疗效的随机对照试验(RCTs)数据。纳入分析的试验自数据库建立至2023年9月。使用RoB 2.0评估工具评估方法学质量和偏倚风险,并使用STATA MP 14软件进行网状荟萃分析。本研究纳入的RCTs为已发表研究,因此无需伦理委员会审查或患者同意。

结果

最终纳入46项RCTs,涵盖8种CPMs,包括银杏叶片(GBT)、GB胶囊(GBC)、银杏叶滴丸(GBD)、银杏叶酮酯滴丸、复方银杏胶囊、复方银杏通脉口服液、银杏蜜环口服液、银丹心脑通软胶囊(YDXNT)。GBD + CT在降低收缩压方面显示出最高疗效(累积排名曲线下面积[SUCRA]=78.7%)和提高总有效率(SUCRA = 86.7%)。GBC + CT在降低舒张压方面疗效最佳(SUCRA = 92.6%)。GBT + CT被确定为降低总胆固醇(TC)最有效的药物(SUCRA = 100%)。此外,YDXNT + CT在甘油三酯水平(SUCRA = 92.2%)、一氧化氮(NO)(SUCRA = 93.9%)和内皮素-1(SUCRA = 67.5%)方面有显著改善。在安全性方面,14项研究报告了不良反应的发生,临床异质性较高,本研究仅进行了定性分析。

结论

我们发现,与单用降压药(CT)相比,8种基于银杏叶的CPMs + CT联合用药治疗高血压有效。证据表明,GBD + CT在改善收缩压和总有效率方面最佳,GBC + CT改善舒张压,GBT + CT在改善TC方面最有效,YDXNT + CT在改善TG、NO和ET-1方面最有效。不良反应仅进行了定性分析,与CT相比,CPMs治疗的不良反应数量相对较少。此外,本研究纳入文献的质量较低,需要通过样本量更大、质量更高、设计更严谨的RCTs进一步验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c894/11062673/00991d713dc8/medi-103-e37927-g007.jpg
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