速效救心丸治疗稳定性心绞痛的疗效和安全性评价：一项随机、双盲、安慰剂对照、多中心临床试验。

Evaluation of the efficacy and safety of Suxiao Jiuxin Pill in the treatment of stable angina: A randomized, double-blind, placebo-controlled, multi-center clinical trial.

机构信息

Cardiovascular Department, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China; Cardiovascular Research Institute of Traditional Chinese Medicine, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.

Cardiovascular Disease Drug Research Committee, China Association of Traditional Chinese Medicine, China.

出版信息

J Ethnopharmacol. 2024 Jan 10;318(Pt A):116959. doi: 10.1016/j.jep.2023.116959. Epub 2023 Jul 23.

DOI:10.1016/j.jep.2023.116959

PMID:37487965

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

The Suxiao Jiuxin Pill (SJP) has been used for treating chronic stable angina (SA) for more than 40 years in China. SJP is composed of two Chinese herbs and has the effect of activating blood and promoting qi, according to traditional Chinese medicine (TCM) theory.

AIM OF THE STUDY

The study aims to determine the effects of adjunct SJP on conventional therapy in patients with SA which provides a complementary choice and its evidence for clinical medication for treating SA.

MATERIALS AND METHODS

Participants with SA were recruited and randomized 1:1 to either the SJP group or the control group for 24 weeks. Both groups received conventional treatment according to local tertiary hospital protocols, and the participants received additional SJP (composed of Ligusticum wallichii and Borneol) or placebo in treatment and control groups respectively. The primary outcome was the curative efficacy rate at week 4. Secondary outcomes are the curative efficacy rate, the total score of angina pectoris symptoms, CCS Angina Classification improvement, Seattle Angina Questionnaire (SAQ) score, TCM syndrome scores (TCMSS), and the curative efficacy rate of TCMSS. Adverse events and adverse drug reactions were observed and recorded for safety analysis.

RESULTS

A total of 324 participants with SA from 13 hospitals in China were enrolled in this trial. Compared with the control group, the curative efficacy rate of SA, the curative efficacy rate of TCMSS significantly increased, and the total score of angina pectoris symptoms and TCMSS significantly reduced in the SJP group at week 4, 12, and 24, accompanied by the statistically significant improvement in the curative efficacy rate based on CCS grade reduction (all P < 0.05). Furthermore, the SAQ score (physical limitation, angina stability, and treatment satisfaction) was evaluated as the quality of life significantly improved after treatment (P < 0.05). The medication compliance, concomitant medication, and rates of adverse events were similar between the two groups (P > 0.05).

CONCLUSION

The present prospective, multicenter, randomized, double-blind, placebo-controlled, clinical trial confirms that adjunct SJP to conventional treatment increased the curative efficacy and life quality of SA patients with no significant adverse drug reactions during the clinical application.

CLINICAL TRIAL REGISTRATION

(ID, ChiCTR1900021876, URL = http://www.chictr.org.cn/showproj.aspx?proj=34955).

摘要

民族药理学相关性

苏香救心丸（SJP）在中国已用于治疗慢性稳定性心绞痛（SA）超过 40 年。根据中医理论，SJP 由两种中药组成，具有活血行气的功效。

研究目的

本研究旨在确定 SJP 对 SA 患者常规治疗的辅助作用，为临床治疗 SA 提供补充选择及其证据。

材料与方法

招募 SA 患者并将其 1:1 随机分为 SJP 组或对照组，治疗 24 周。两组均根据当地三级医院的方案接受常规治疗，SJP 组（由川芎和冰片组成）或对照组分别接受额外的 SJP 或安慰剂治疗。主要结局为第 4 周的治愈率。次要结局为治愈率、心绞痛症状总评分、CCS 心绞痛分级改善、西雅图心绞痛问卷（SAQ）评分、中医证候评分（TCMSS）及 TCMSS 的治愈率。观察并记录不良反应和药物不良反应以进行安全性分析。

结果

本试验共纳入来自中国 13 家医院的 324 例 SA 患者。与对照组相比，SJP 组在第 4、12、24 周时 SA 的治愈率、TCMSS 的治愈率显著提高，心绞痛症状总评分和 TCMSS 显著降低，CCS 分级降低的治愈率也有统计学意义（均 P<0.05）。此外，SAQ 评分（身体限制、稳定性心绞痛和治疗满意度）评估为治疗后生活质量显著改善（P<0.05）。两组的药物依从性、伴随用药和不良反应发生率相似（P>0.05）。