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11种单味中药口服制剂治疗不稳定型心绞痛的疗效与安全性:一项系统评价和网状Meta分析

Efficacy and safety of 11 oral preparations of single-source traditional Chinese medicines in the treatment of unstable angina pectoris: a systematic review and network meta-analysis.

作者信息

Li Xiuchong, Li Xiaohui, Zhu Xing, Xin Xin, Sheng Ran, Wang Te, Kan Junming, Huang Yongsheng

机构信息

College of Traditional Chinese Medicine, Changchun University of Chinese Medicine, Changchun, Jilin, China.

Heart Center, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China.

出版信息

Front Pharmacol. 2025 Jun 24;16:1582661. doi: 10.3389/fphar.2025.1582661. eCollection 2025.

DOI:10.3389/fphar.2025.1582661
PMID:40630122
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12235920/
Abstract

BACKGROUND

Unstable angina pectoris (UAP) is a cardiovascular disease with high morbidity and can cause serious cardiovascular complications. Oral preparations of single-source traditional Chinese medicines (SSTCM-OPs) are increasingly used as adjuncts to conventional treatments (CT) for UAP, providing complementary therapeutic advantages with favorable safety profiles. However, the comparative efficacy and safety of these SSTCM-OPs remain unclear. This network meta-analysis (NMA) evaluates the efficacy and safety of 11 approved SSTCM-OPs to guide clinical practice in UAP treatment.

METHODS

A comprehensive literature search was conducted across eight databases: China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang Database, China Biomedical Literature Database (CBM), Web of Science, PubMed, EMBASE, and the Cochrane Library. Only randomized controlled trials (RCTs) examining SSTCM-OPs combined with CT for UAP were included. The search covered publications up to 4 December 2024. Quality assessment was performed using RevMan 5.4.1, and certainty of evidence was evaluated with GRADEpro software 3.6.1. A frequentist random-effects model was employed for NMA. Statistical analysis was performed using Stata 18.0.

RESULTS

A total of 72 RCTs involving 11 SSTCM-OPs and 7,360 patients were included. The NMA results demonstrated that Maixuekang oral preparation combined with CT and Xinyue oral preparation combined with CT showed superiority in terms of angina efficacy; Xindakang oral preparation combined with CT and Yinxingtongzhi oral preparation combined with CT showed superiority in terms of Electrocardiogram (ECG) efficacy and had an advantage in reducing nitroglycerin dosages; Xindakang oral preparation combined with CT and Yinxingtongzhi oral preparation combined with CT showed superiority in reducing nitroglycerin dosages; Zhenyuan oral preparation combined with CT and Diaoxinxuekang oral preparation combined with CT showed superiority in reducing frequency of angina; Xinnaoshutong oral preparation combined with CT and Yinxingtongzhi oral preparation combined with CT showed superiority in reducing duration of angina; Xuezhikang oral preparation combined with CT showed superiority in improving TC, LDL-C, and HDL-C levels as well as reducing the occurrence of MACEs; Yinxingtongzhi oral preparation combined with CT showed superiority in improving TG and PV levels; Lastly, Xuesaitong oral preparation combined with CT and Yinxingye oral preparation showed superiority in reducing hs-CRP levels.

CONCLUSION

All 11 SSTCM-OPs combined with CT showed advantages over CT alone in treating UAP. Notably, Xinnaoshutong + CT did not significantly reduce angina frequency, but it was effective in other outcomes. These findings suggest incorporating traditional Chinese medicine into standardized treatment regimens may enhance UAP management.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42024618094.

摘要

背景

不稳定型心绞痛(UAP)是一种发病率较高的心血管疾病,可导致严重的心血管并发症。单味中药口服制剂(SSTCM-OPs)越来越多地被用作UAP常规治疗(CT)的辅助药物,具有互补的治疗优势且安全性良好。然而,这些SSTCM-OPs的相对疗效和安全性仍不明确。本网络荟萃分析(NMA)评估11种已获批的SSTCM-OPs的疗效和安全性,以指导UAP治疗的临床实践。

方法

对八个数据库进行了全面的文献检索:中国知网(CNKI)、维普中文科技期刊数据库(VIP)、万方数据库、中国生物医学文献数据库(CBM)、科学引文索引(Web of Science)、医学期刊数据库(PubMed)、荷兰医学文摘数据库(EMBASE)和考克兰图书馆。仅纳入了研究SSTCM-OPs联合CT治疗UAP的随机对照试验(RCT)。检索涵盖截至2024年12月4日的出版物。使用RevMan 5.4.1进行质量评估,并用GRADEpro软件3.6.1评估证据的确定性。NMA采用频率学派随机效应模型。使用Stata 18.0进行统计分析。

结果

共纳入72项涉及11种SSTCM-OPs和7360例患者的RCT。NMA结果表明,脉血康口服制剂联合CT和心悦口服制剂联合CT在心绞痛疗效方面表现出优越性;心可康口服制剂联合CT和银杏酮酯口服制剂联合CT在心电图(ECG)疗效方面表现出优越性,且在减少硝酸甘油用量方面具有优势;心可康口服制剂联合CT和银杏酮酯口服制剂联合CT在减少硝酸甘油用量方面表现出优越性;振源口服制剂联合CT和调脂活血康口服制剂联合CT在减少心绞痛发作频率方面表现出优越性;心脑舒通口服制剂联合CT和银杏酮酯口服制剂联合CT在缩短心绞痛持续时间方面表现出优越性;血脂康口服制剂联合CT在改善总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)和高密度脂蛋白胆固醇(HDL-C)水平以及减少主要不良心血管事件(MACEs)发生方面表现出优越性;银杏酮酯口服制剂联合CT在改善甘油三酯(TG)和血浆黏度(PV)水平方面表现出优越性;最后,血塞通口服制剂联合CT和银杏叶制剂在降低超敏C反应蛋白(hs-CRP)水平方面表现出优越性。

结论

所有11种SSTCM-OPs联合CT治疗UAP均显示出优于单纯CT的优势。值得注意的是,心脑舒通+CT并未显著降低心绞痛发作频率,但在其他结局方面有效。这些发现表明,将中药纳入标准化治疗方案可能会加强UAP的管理。

系统评价注册

https://www.crd.york.ac.uk/PROSPERO/,标识符CRD420246******。 (注:原文中CRD42024618094中间部分未给出具体数字,这里用******代替)

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