【摘要】 目的探讨脑脉利颗粒治疗急性前循环缺血性卒中的有效性及安全性。方法 2015年5月-2018年3月前瞻性入组13家研究中心神经内科收治的前循环急性缺血性卒中患者,随机分为治疗组和对照组,对照组给予常规药物治疗并加用脑脉利颗粒模拟剂治疗20 d,治疗组在常规药物治疗的基础上加用脑脉利颗粒(每次10 g,每天3次)口服,治疗20 d。治疗后30 d、60 d和90 d随访评估患者的NIHSS和Barthel指数(Barthel index,BI)评分,90 d随访评估mRS,以mRS≤2分为功能独立。比较两组上述治疗指标的差异,并比较两组90 d急性心脑血管事件(包括心肌梗死、缺血性卒中、TIA)和不良反应的发生率。结果研究共入组190例患者,排除脱落患者,共187例纳入最终统计分析,其中治疗组93例,对照组94例。治疗组90 dNIHSS评分低于对照组(2.54±2.16分vs 3.84±3.08分,P=0.006),60 d(86.08±17.24分vs 82.61±16.91分,P=0.031)及90 dBI评分(89.62±13.50分vs 83.78±17.08分,P=0.004)高于对照组;90 d治疗组和对照组分别有50例和42例完成mRS评分,治疗组功能独立率高于对照组(70.00%vs 45.24%,P=0.016)。研究期间,两组不良反应发生率及急性心脑血管事件发生率差异均无统计学意义。结论在常规药物治疗基础上加用脑脉利颗粒能有效减轻急性缺血性卒中患者的神经功能缺损与残障,改善日常生活能力,且治疗安全性良好。更多还原

【Abstract】 Objective To investigate the clinical efficacy and safety of Naomaili Granules in the treatment of acute anterior circulation ischemic stroke.Methods This study prospectively enrolled consecutive patients with acute anterior circulation ischemic stroke from thirteen centers in China from May 2015 to March 2018, and all the subjects were randomly assigned into treatment group and control group. Patients in treatment group were given routine treatment and Naomaili granules for 20 days, while patients in control group were given routine treatment and placebo for 20 days. NIHSS, Barthel index(BI) scores at 30 days, 60 days and 90 days after treatment, and 90-day m RS were evaluated. The functional independence was defined as a m RS score of 0 to 2. The differences of the above indexes between the two groups were compared, and the incidence of acute cardiovascular and cerebrovascular events(myocardial infarction, ischemic stroke and TIA) and adverse reactions within 90 days after treatment were compared between the two groups.Results A total of 190 patients were enrolled and 187 patients were included in the final statistical analysis, including 93 patients in treatment group and 94 patients in control group. The 90-day NIHSS score in treatment group were lower than that in control group(2.54±2.16 vs 3.84±3.08, P =0.006), and the 60-day and 90-day BI scores in treatment group were higher than that in control group(86.08±17.24 vs 82.61±16.91, P =0.031; 89.62±13.50 vs 83.78±17.08, P =0.004). A total of 50 patients in treatment group and 42 in control group received 90-day m RS evaluation, and the proportion of patients with m RS ≤2 in treatment group was higher than that in control group(70.00% vs 45.24%, P =0.016). There were no statistical differences in the incidence of adverse reactions, acute cardiovascular and cerebrovascular events between the two groups.Conclusions For patients with acute ischemic stroke, Naomaili granules could effectively reduce the patients’ neurological deficit and disability, improve their ability of daily living, and its safety is favorable.更多还原