谷红注射液治疗急性缺血性脑卒中的多中心、随机、双盲、安慰剂对照临床研究  

Clinical efficacy and safety of guhong injection in treatment of acute ischemic stroke:A multicenter,randomized,double⁃blind,placebo⁃controlled clinical trial

作　　者：夏健[1] 殷俊[1] 熊涛 狄政莉[3] 孙冰 王兵[5] 胡仁琳 龙泓宇 黄清[1] 肖波[1] XIA Jian;YIN Jun;XIONG Tao;DI Zhengli;SUN Bing;WANG Bing;HU Renlin;LONG Hongyu;HUANG Qing;XIAO Bo(Xiangya Hospital of Centre South University,Changsha,Hunan 410008,China;Wuhan Fifth Hospital,Wuhan,Hubei 430050,China;Xi'an Central Hospital,Xi'an,Shaanxi 710003,China;Luoyang Third People's Hospital,Luoyang,Heinan 471002,China;Huaian Hospital of Traditional Chinese Medicine,Huaian,Jiangsu 223001,China)

机构地区：[1]中南大学湘雅医院,湖南长沙410008 [2]武汉市第五医院,湖北武汉430050 [3]西安市中心医院,陕西西安710003 [4]洛阳市第三人民医院,河南洛阳471002 [5]淮安市中医院,江苏淮安223001

出　　处：《国际神经病学神经外科学杂志》2024年第4期1-7,共7页Journal of International Neurology and Neurosurgery

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急性缺血性脑卒中患者的临床疗效和安全性。方法该研究为一项多中心、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7月22日至2024年4月30日就诊于31家医院的急性缺血性脑卒中患者2000例。经筛选随机分组后,试验组纳入999例,对照组纳入1000例。试验组给予谷红注射液,对照组给予安慰剂(生理盐水),2组疗程均为10 d。比较2组患者发病90 d后的改良Rankin量表(mRS)相对于基线期的变化情况,评估经治疗后mRS评分≤2分的患者比例。观察并记录2组患者治疗期间出现的不良反应情况。结果发病90 d后,试验组mRS评分≤2分的患者比例[71.10%,710/999]高于对照组[65.10%,651/1000],差异有统计学意义(P<0.05)。在整个试验期间,试验组不良反应的发生率为0.70%,对照组不良反应的发生率为0.40%,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,试验组与对照组安全性相当。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,可有效改善急性缺血性脑卒中患者的临床症状,提高生活质量,值得临床推广使用。Objective To investigate the clinical efficacy and safety of guhong injection in the treatment of patients with acute ischemic stroke.Methods A multicenter prospective study was conducted with a randomized,double-blind,parallel-controlled clinical trial design.A total of 2000 patients with acute ischemic stroke who attended 31 hospitals from July 22,2021 to April 30,2024 were enrolled,and after screening and randomization,999 patients were enrolled in the experimental group and 1000 were enrolled in the control group.The patients in the experimental group were given Guhong injection,while those in the control group were given placebo(normal saline),and the course of treatment was 10 days for both groups.The two groups were compared in terms of the change in modified Rankin Scale(mRS)score on day 90 after disease onset,as well as the proportion of subjects with an mRS score of≤2 after treatment,and the adverse reactions during treatment were observed and recorded for both groups.Results On day 90 after disease onset,the experimental group had a significantly higher proportion of patients with an mRS score of≤2 than the control group[71.10%(710/999)vs 65.10%(651/1000),P<0.05].There was no significant difference in the incidence rate of adverse reactions between the experimental group and the control group during treatment(0.70%vs 0.40%,P>0.05).The experimental group showed comparable safety to the control group based on a comprehensive safety assessment of adverse reactions,clinical laboratory tests,electrocardiographic findings,and vital signs.Conclusions Guhong injection has the advantages of marked clinical efficacy and good safety and reliability and can effectively improve clinical compliance and the clinical symptoms and quality of life of patients with acute ischemic stroke,and therefore,it holds promise for clinical application.

关 键 词：急性缺血性脑卒中 谷红注射液 随机对照试验 Rankin量表评分 

分 类 号：R743.3[医药卫生—神经病学与精神病学]