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血塞通软胶囊治疗缺血性卒中有效性和安全性的随机双盲对照研究

A randomized double-blind controlled study on the effectiveness and safety of Xuesaitong soft capsule in the treatment of ischemic stroke
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摘要 目的分析血塞通软胶囊治疗缺血性卒中的有效性和安全性。方法抽取2019年4月至2021年3月临汾市中心医院收治的缺血性卒中患者124例,按随机数字表法分为观察组和对照组,每组62例。对照组给予血塞通软胶囊模拟剂联合阿司匹林肠溶片治疗,观察组给予血塞通软胶囊联合阿司匹林肠溶片治疗,两组均治疗3个月。比较两组治疗效果,治疗前后的凝血功能[凝血酶原时间(PT)、部分活化凝血酶活化时间(APTT)、纤维蛋白原(FIB)、D-二聚体(D-D)]、生活质量及神经功能[改良Barthel指数(mBI)、EuroQol健康指数量表(EQ5d)、美国国立卫生研究院卒中量表(NIHSS)]及治疗期间不良反应发生率。结果治疗3个月后,观察组总有效率(95.16%,59/62)高于对照组(83.87%,52/62),P<0.05。治疗3个月后,两组PT、APTT较治疗前延长,且观察组长于对照组(P<0.05);两组血浆FIB、D-D水平及EQ5d、NIHSS评分低于治疗前,且观察组低于对照组(P<0.05)。治疗3个月后,两组mBI评分均较治疗前升高,且观察组高于对照组(P<0.05)。治疗期间,观察组并发症发生率(1.61%,1/62)低于对照组(12.90%,8/62),P<0.05。结论血塞通软胶囊可改善缺血性卒中患者凝血功能,促进患者神经功能恢复,进而提高其生活质量,同时降低不良反应发生率,安全性高且疗效确切。 Objective To analyze the effectiveness and safety of Xuesaitong soft capsule in the treatment of ischemic stroke.Methods A total of 124 patients with ischemic stroke admitted to Linfen Central Hospital from April 2019 to March 2021 were selected,and they were divided into observation group and control group by random number table method,with 62 cases in each group.The control group was treated with Xuesaitong soft capsule simulant combined with aspirin enteric-coated tablets,while the observation group was treated with Xuesaitong soft capsule combined aspirin enteric-coated tablets.Both groups were treated for 3 months.The clinical efficacy,preoperative and postoperative blood coagulation function assessed by prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinogen(FIB)and D-dimer(D-D),quality of life and neurological function assessed by modified Barthel index(mBI),EuroQol Five Dimensions Questionnaire(EQ5d),and National Institutes of Health Stroke Scale(NIHSS),and incidence of adverse reactions during the treatment period were compared between the two groups.Results After 3 months of treatment,the total effective rate of the observation group(95.16%,59/62)was higher than that of the control group(83.87%,52/62),P<0.05.After 3 months of treatment,PT and APTT of the two groups were longer than that before treatment,and the indexes of the observation group were longer than those of the control group(P<0.05).After 3 months of treatment,the plasma FIB level,D-D levels,EQ5d score and NIHSS score of the two groups were lower than those before treatment,and those indexes of the observation group were lower than those of the control group(P<0.05).After 3 months of treatment,the mBI score of the two groups were higher than those before treatment,and score of the observation group was higher than that of the control group(P<0.05).During the treatment,the incidence of complications in the observation group(1.61%,1/62)was lower than that in the control group(12.90%,8/62),P<0.05.Conclusions Xuesaitong soft
作者 梁辉 李万英 Liang Hui;Li Wanying(Department of Neurology,Linfen Central Hospital,Linfen 041000,China)
出处 《中国实用医刊》 2022年第18期120-122,F0003,共4页 Chinese Journal of Practical Medicine
关键词 缺血性卒中 血塞通软胶囊 神经功能 生活质量 安全性 Ischemic stroke Xuesaitong soft capsule Nerve function Quality of life Safety
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