Guhong injection in the treatment of unstable angina:A multicenter,randomized,double-blind,placebo-controlled clinical trial
JIANG Hong-ju
WANG Zhi-jun
CHUAN Xiao-wen
WU Hui-peng
LI Li-peng
WANG Shi-xi
DING Zhen-jiang
CHEN Mu-lei
Abstract：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 who visited 20 hospitals from August 5,2021 to April 16,2024 were randomly divided into the experimental group and the control group with 304 cases in each group.The experimental group was given Guhong injection,and the control 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)score were compared between the two groups,and the adverse reactions during the treatment period were observed and recorded.Results After 10 d of treatment,the angina rate of the experimental group was better than the control group(93.62％vs.81.76％,P＜0.001);the number of angina pectoris attack in the two groups decreased compared with that before the treatment(P＜0.05),and the decrease of angina attack in the experimental group was more significant(P＜0.05);after 28 d of treatment,the SAQ score increased in both the groups;and the SAQ score in the experimental group increased more from baseline,which was statistically significant(P＜0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P＞0.05).Based on the results of 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 has the advantages of definite curative effect,safety and reliability.It can improve clinical compliance,effectively improve the clinical symptoms of patients with unstable angina pectoris,improve the quality of life,and is worthy of clinical promotion and use.
Keywords：Guhong injectionUnstable angina pectorisRandomized controlled trialSeattle Angina Pectoris Scale score
Publication Date：2024-11-10
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：7( 1021-1027 )