苏笑九心丸治疗对长效硝酸酯类药物不良反应不耐受的慢性冠脉综合征的有效性和安全性:一项多中心、随机、双盲、安慰剂对照研究。

IF 3.3 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
Yuanlong Hu, Yifei Wang, Shiqin Wang, Xirong Cui, Yong Feng, Zhengguang Li, Kegang Ji, Jianming Wang, Chenghua Sun, Yan Tang, Yunlun Li
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引用次数: 0

摘要

研究背景本研究旨在探讨对长效硝酸酯类药物不良反应不耐受的慢性冠脉综合征(CCS)患者在常规治疗基础上辅助服用复方九心丸(SJPs)的短期效果和安全性:这是一项多中心、随机、双盲、安慰剂对照试验。共有来自中国八个临床研究中心的174名CCS患者参与了修改后的意向治疗分析。试验招募了不耐受长效硝酸酯类药物不良反应的 CCS 患者,并将其随机分配到 SJPs 或安慰剂组,疗程为 4 周:与安慰剂组相比,4周后SJPs组的疗效显著提高(OR = 2.43,95% CI = 1.32 至 4.47,P = 0.004)。此外,与有饮酒史者相比,无饮酒史者的SAQ总分改善幅度更大:结论:对于对长效硝酸酯类药物不耐受的CCS患者,辅助SJPs可提高短期常规抗心绞痛治疗的效果,且在应用过程中无明显不良反应:试验注册:中国临床试验注册平台,ChiCTR2100050066。注册时间:2021年8月16日,https://www.chictr.org.cn/showproj.html?proj=131470 。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and Safety of Suxiao Jiuxin Pills in the Treatment of Chronic Coronary Syndrome with Intolerance to Adverse Effects of Long-acting Nitrates: A Multicenter, Randomized, Double-blind, Placebo-controlled Study.

Background: This study aims to investigate the short-term effects and safety of adjunct Suxiao Jiuxin Pills (SJPs) on conventional therapy in chronic coronary syndrome (CCS) patients who are intolerant to the adverse effects of long-acting nitrates.

Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial. A total of 174 CCS participants from eight clinical study centers in China were included in the modified intention-to-treat analyses. Participants with CCS and intolerance to the adverse effects of long-acting nitrates were recruited and randomized to either the SJPs or the placebo group for a duration of 4 weeks.

Results: Compared to the placebo group, the SJPs group showed a significant improvement in the efficacy rate after 4 weeks (OR = 2.43, 95% CI = 1.32 to 4.47, P = 0.004). Besides, individuals without a history of alcohol consumption showed a greater improvement in the SAQ summary score compared to those with a history of alcohol consumption.

Conclusion: Adjunctive SJPs enhance the effectiveness of short-term conventional anti-angina treatment for patients with CCS who experience intolerance to long-acting nitrates, without significant adverse effects during application.

Trial registration: Chinese Clinical Trials Registry Platform, ChiCTR2100050066. Registered 16 August 2021, https://www.chictr.org.cn/showproj.html?proj=131470 .

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来源期刊
BMC Complementary Medicine and Therapies
BMC Complementary Medicine and Therapies INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
6.10
自引率
2.60%
发文量
300
审稿时长
19 weeks
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