舒血宁注射液治疗不稳定型心绞痛的疗效和安全性：一项多中心、随机、安慰剂对照试验

IF 6.7 1区医学 Q1 CHEMISTRY, MEDICINAL

Phytomedicine Pub Date : 2025-05-27 DOI:10.1016/j.phymed.2025.156916

Lintong Yu , Shiyi Tao , Qian Lin , Sheng Gao , Xitian Hu , Xiaoping Li , Xiaofeng Wang , Huijun Chen , Xianyou Ji , Qiufang Lian , Daoqun Jin , Jingyu Xu , Jun Feng , Yanling Qu , Deying An , Chunmei Qi , Ling Chen , Mingqi Zheng , Guiqiu Cao , Jing Liu , Helin Li

{"title":"舒血宁注射液治疗不稳定型心绞痛的疗效和安全性：一项多中心、随机、安慰剂对照试验","authors":"Lintong Yu , Shiyi Tao , Qian Lin , Sheng Gao , Xitian Hu , Xiaoping Li , Xiaofeng Wang , Huijun Chen , Xianyou Ji , Qiufang Lian , Daoqun Jin , Jingyu Xu , Jun Feng , Yanling Qu , Deying An , Chunmei Qi , Ling Chen , Mingqi Zheng , Guiqiu Cao , Jing Liu , Helin Li","doi":"10.1016/j.phymed.2025.156916","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>To determine the efficacy and safety of adjunct Shuxuening Injection (SXN) on conventional therapy in patients with unstable angina (UA) which provides a complementary choice and its evidence for clinical medication for treating UA.</div></div><div><h3>Methods</h3><div>In this multicenter, randomized, double-blind, placebo-controlled trial, 469 patients with UA from 25 hospitals in China who had an episode of angina within 48 hours were randomly assigned 3:1 to SXN and placebo group for 10 days in addition to conventional treatment. The primary outcome is the frequency of angina pectoris attacks after 10 days of intervention. The secondary outcomes are the frequency of angina pectoris attacks on day 30, the duration of angina pectoris symptoms, the visual analogue scale (VAS) score, total score of angina pectoris symptoms, the Global Registry of Acute Coronary Events (GRACE) score, total ischemia burden (TIB), and the level of high-sensitivity C-reactive protein (hs-CRP).</div></div><div><h3>Results</h3><div>A total of 469 participants from 25 hospitals in China were enrolled in this trial. After 10 days of treatment, the frequency and duration of angina pectoris attacks, VAS score, and total score of angina pectoris symptoms exhibited a significant improvement in the SXN group compared to the placebo group both on days 10 and 30 (all <em>P</em><0.05). The GRACE risk score classification, TIB, and hs-CRP levels in the SXN group showed no statistically significant decrease compared to the control group on day 10 (all <em>P</em>>0.05). The medication compliance, concomitant medication, and rates of adverse events were similar between the two groups (<em>P</em>>0.05).</div></div><div><h3>Conclusion</h3><div>In patients with UA, SXN added on conventional treatment reduced the frequency and duration of angina pectoris attacks, even after discontinuation of the intervention for 20 days.</div></div>","PeriodicalId":20212,"journal":{"name":"Phytomedicine","volume":"144 ","pages":"Article 156916"},"PeriodicalIF":6.7000,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of Shuxuening injection in patients with unstable angina: a multicenter, randomized, placebo-controlled trial\",\"authors\":\"Lintong Yu , Shiyi Tao , Qian Lin , Sheng Gao , Xitian Hu , Xiaoping Li , Xiaofeng Wang , Huijun Chen , Xianyou Ji , Qiufang Lian , Daoqun Jin , Jingyu Xu , Jun Feng , Yanling Qu , Deying An , Chunmei Qi , Ling Chen , Mingqi Zheng , Guiqiu Cao , Jing Liu , Helin Li\",\"doi\":\"10.1016/j.phymed.2025.156916\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>To determine the efficacy and safety of adjunct Shuxuening Injection (SXN) on conventional therapy in patients with unstable angina (UA) which provides a complementary choice and its evidence for clinical medication for treating UA.</div></div><div><h3>Methods</h3><div>In this multicenter, randomized, double-blind, placebo-controlled trial, 469 patients with UA from 25 hospitals in China who had an episode of angina within 48 hours were randomly assigned 3:1 to SXN and placebo group for 10 days in addition to conventional treatment. The primary outcome is the frequency of angina pectoris attacks after 10 days of intervention. The secondary outcomes are the frequency of angina pectoris attacks on day 30, the duration of angina pectoris symptoms, the visual analogue scale (VAS) score, total score of angina pectoris symptoms, the Global Registry of Acute Coronary Events (GRACE) score, total ischemia burden (TIB), and the level of high-sensitivity C-reactive protein (hs-CRP).</div></div><div><h3>Results</h3><div>A total of 469 participants from 25 hospitals in China were enrolled in this trial. After 10 days of treatment, the frequency and duration of angina pectoris attacks, VAS score, and total score of angina pectoris symptoms exhibited a significant improvement in the SXN group compared to the placebo group both on days 10 and 30 (all <em>P</em><0.05). The GRACE risk score classification, TIB, and hs-CRP levels in the SXN group showed no statistically significant decrease compared to the control group on day 10 (all <em>P</em>>0.05). The medication compliance, concomitant medication, and rates of adverse events were similar between the two groups (<em>P</em>>0.05).</div></div><div><h3>Conclusion</h3><div>In patients with UA, SXN added on conventional treatment reduced the frequency and duration of angina pectoris attacks, even after discontinuation of the intervention for 20 days.</div></div>\",\"PeriodicalId\":20212,\"journal\":{\"name\":\"Phytomedicine\",\"volume\":\"144 \",\"pages\":\"Article 156916\"},\"PeriodicalIF\":6.7000,\"publicationDate\":\"2025-05-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Phytomedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0944711325005549\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Phytomedicine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0944711325005549","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}

引用次数: 0

摘要

目的探讨舒血宁注射液对不稳定型心绞痛（UA）患者常规治疗的疗效和安全性，为临床治疗UA提供补充选择和用药依据。方法本研究为多中心、随机、双盲、安慰剂对照试验，选取国内25家医院469例48小时内发生心绞痛的UA患者，在常规治疗的基础上，以3:1的比例随机分为SXN组和安慰剂组，疗程10天。主要结果是干预10天后心绞痛发作的频率。次要结果为第30天心绞痛发作频率、心绞痛症状持续时间、视觉模拟评分（VAS）评分、心绞痛症状总分、急性冠状动脉事件全球登记（GRACE）评分、总缺血负荷（TIB）和高敏c反应蛋白（hs-CRP）水平。结果共纳入来自中国25家医院的469名受试者。治疗10天后，与安慰剂组相比，SXN组在第10天和第30天的心绞痛发作频率和持续时间、VAS评分和心绞痛症状总分均有显著改善（p < 0.05）。第10天，SXN组GRACE风险评分分级、TIB、hs-CRP水平较对照组下降无统计学意义（p < 0.05）。两组患者用药依从性、伴随用药及不良事件发生率比较，差异无统计学意义（P>0.05）。结论UA患者在常规治疗的基础上加用SXN可减少心绞痛发作的频率和持续时间，即使在停止干预20天后也是如此。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Efficacy and safety of Shuxuening injection in patients with unstable angina: a multicenter, randomized, placebo-controlled trial

Objective

To determine the efficacy and safety of adjunct Shuxuening Injection (SXN) on conventional therapy in patients with unstable angina (UA) which provides a complementary choice and its evidence for clinical medication for treating UA.

Methods

In this multicenter, randomized, double-blind, placebo-controlled trial, 469 patients with UA from 25 hospitals in China who had an episode of angina within 48 hours were randomly assigned 3:1 to SXN and placebo group for 10 days in addition to conventional treatment. The primary outcome is the frequency of angina pectoris attacks after 10 days of intervention. The secondary outcomes are the frequency of angina pectoris attacks on day 30, the duration of angina pectoris symptoms, the visual analogue scale (VAS) score, total score of angina pectoris symptoms, the Global Registry of Acute Coronary Events (GRACE) score, total ischemia burden (TIB), and the level of high-sensitivity C-reactive protein (hs-CRP).

Results

A total of 469 participants from 25 hospitals in China were enrolled in this trial. After 10 days of treatment, the frequency and duration of angina pectoris attacks, VAS score, and total score of angina pectoris symptoms exhibited a significant improvement in the SXN group compared to the placebo group both on days 10 and 30 (all P<0.05). The GRACE risk score classification, TIB, and hs-CRP levels in the SXN group showed no statistically significant decrease compared to the control group on day 10 (all P>0.05). The medication compliance, concomitant medication, and rates of adverse events were similar between the two groups (P>0.05).

Conclusion

In patients with UA, SXN added on conventional treatment reduced the frequency and duration of angina pectoris attacks, even after discontinuation of the intervention for 20 days.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Phytomedicine 医学-药学

CiteScore

10.30

自引率

5.10%

发文量

670

审稿时长

91 days

期刊介绍： Phytomedicine is a therapy-oriented journal that publishes innovative studies on the efficacy, safety, quality, and mechanisms of action of specified plant extracts, phytopharmaceuticals, and their isolated constituents. This includes clinical, pharmacological, pharmacokinetic, and toxicological studies of herbal medicinal products, preparations, and purified compounds with defined and consistent quality, ensuring reproducible pharmacological activity. Founded in 1994, Phytomedicine aims to focus and stimulate research in this field and establish internationally accepted scientific standards for pharmacological studies, proof of clinical efficacy, and safety of phytomedicines.