谷红注射液治疗不稳定性心绞痛的临床疗效和安全性研究  

Guhong injection in the treatment of unstable angina:A multicenter,randomized,double-blind,placebocontrolled clinical trial

作　　者：姜红菊[1] 王志军 传小文 毋会芃 李立鹏 王世喜 丁振江[7] 陈牧雷[8] JIANG Hong-ju;WANG Zhi-jun;CHUAN Xiao-wen;WU Hui-peng;LI Li-peng;WANG Shi-xi;DING Zhen-jiang;CHEN Mu-lei(Department of Cardiovascular Medicine,The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250001,China;Department of Cardiology,The Affiliated Hospital of North China University of Science and Technology,Tangshan 063000,China;General Practice Department,Xi’an Daxing Hospital,Xi’an 710016,China;Department of Cardiovascular Medicine,Jincheng University Hospital,Jincheng 048006,China;Department of Cardiovascular Medicine,Luoyang Third People’s Hospital,Luoyang 471002,China;Department of Cardiology,Zaozhuang Central Hospital of Shandong Guoxin Yiyang Group,Zaozhuang 277800,China;Department of Cardiology,Affiliated Hospital of Chengde Medical College,Chengde 067000,China;Department of Cardiovascular Medicine,Beijing Chao-yang Hospital,Capital Medical University,Beijing 100020,China)

机构地区：[1]山东中医药大学第二附属医院心血管内科,山东省济南市250001 [2]华北理工大学附属医院心内科 [3]西安大兴医院全科医学科 [4]晋城大医院心血管内科 [5]洛阳市第三人民医院心血管内科 [6]山东国欣颐养集团枣庄中心医院心内科 [7]承德医学院附属医院心脏内科 [8]首都医科大学附属北京朝阳医院心血管内科

出　　处：《中国心血管病研究》2024年第11期1021-1027,共7页Chinese Journal of Cardiovascular Research

基　　金：吉林省科技厅医药健康产业发展专项资金项目(20190003);吉林省科技厅医药健康产业发展专项资金项目(20200407007MH)。

摘　　要：目的 观察谷红注射液治疗不稳定性心绞痛患者的临床疗效和安全性。方法 本研究为一项多中心前瞻性研究,采用随机、双盲、平行对照的临床试验设计方法,纳入2021年08月05日至2024年04月16日就诊于20家医院的不稳定性心绞痛患者608例,随机分为试验组和对照组各304例。试验组给予谷红注射液,对照组给予安慰剂(0.9%Nacl溶液),两组疗程均为10 d。比较两组临床疗效、心绞痛发作次数和西雅图心绞痛量表(SAQ)评分,观察并记录治疗期间的不良反应。结果 治疗10 d后,试验组的心绞痛有效率优于对照组(93.62%比81.76%,P<0.001);2组心绞痛发作次数均较治疗前减少(P<0.05),其中以试验组的心绞痛发作次数减少更为明显(P<0.05);治疗28 d后,两组SAQ评分均有所升高,试验组SAQ评分较基线增加更多,差异有统计学意义(P<0.05)。两组的不良反应发生率差异无统计学意义(P>0.05)。综合不良反应、临床实验室检查、心电图和生命体征等安全性评价指标结果显示,两组的安全性相当。结论 谷红注射液具有疗效确切、安全可靠的优点,且能够提高临床顺应性,可有效改善不稳定性心绞痛患者的临床症状,提高生活质量,值得临床推广使用。Objective To observe the clinical efficacy and safety of Guhong injection in the treatment of patients with unstable angina. Methods This study was a multicenter prospective study using a randomized,double-blind, parallel-controlled clinical trial design method. 608 patients with unstable angina pectoris whovisited 20 hospitals from August 5, 2021 to April 16, 2024 were randomly divided into the experimental group andthe control group with 304 cases in each group. The experimental group was given Guhong injection, and thecontrol group was given placebo (0.9% Nacl solution);and the course of treatment in both groups was 10 days.The clinical efficacy, the number of angina pectoris attacks and the Seattle Angina Pectoris Scale (SAQ) scorewere compared between the two groups, and the adverse reactions during the treatment period were observed andrecorded. Results After 10 d of treatment, the angina rate of the experimental group was better than the controlgroup (93.62% vs. 81.76%, P<0.001);the number of angina pectoris attack in the two groups decreased comparedwith that before the treatment (P<0.05), and the decrease of angina attack in the experimental group was moresignificant (P<0.05);after 28 d of treatment, the SAQ score increased in both the groups;and the SAQ score in theexperimental group increased more from baseline, which was statistically significant (P<0.05). There was nosignificant difference in the incidence of adverse reactions between the two groups (P>0.05). Based on the resultsof comprehensive safety evaluation indicators such as adverse reactions, clinical laboratory tests,electrocardiogram and vital signs, the safety in the 2 groups was comparable. Conclusion Guhong injection hasthe advantages of definite curative effect, safety and reliability. It can improve clinical compliance, effectivelyimprove the clinical symptoms of patients with unstable angina pectoris, improve the quality of life, and is worthyof clinical promotion and use.

关 键 词：谷红注射液 不稳定性心绞痛 随机对照试验 西雅图心绞痛量表评分 

分 类 号：R541.7[医药卫生—心血管疾病]