丁苯酞软胶囊治疗急性缺血性脑卒中Ⅳ期大样本临床有效性及安全性研究

摘要

Objective:To observe the efficacy and safety of two different doses of dl-3-butylphthalide soft capsules in patients with acute ischemic stroke.Methods:1457 patients who were attacked by acute ischemic stroke within 72 hours and scored from 5 to 25 on National Institutes of Health Stroke Scale ( NIHSS) were enrolled in a multi-centered, open and random clinical research.The dl-3-butylphthalide capsules were assigned b.i.d.to 318 patients, and t.i.d.to 1147 patients.Results:Before the treatment, the NIHSS scores of the b.i.d.and t.i.d.groups were 9.19 ±3.13 and 9.01 ±3.51, respectively.11 and 21 days after the treatment, the scores of the two groups became to 5.58 ±3.32 (b.i.d.) and 5.59 ±3.77 (t.i.d.), and 3.55 ±3.05 (b.i.d.) and 3.48 ±3.39 (t.i.d.), respectively.While, the Bar-thelindices of the respective two groups were 47.38 ±23.12 and 46.78 ±23.98, 62.76 ±23.36 and 62.99 ±24.83, and 71.17 ±22.68 and 74.90 ±23.62, before, and 11 and 21 days after the treatment, respectively.The difference of the Barthel indices between the two groups at days 21 was significant (P=0.008).The effective rate of the b.i.d.group and t.i.d.groups were 77.9%and 78.0%, respectively.The adverse effect rates of the two groups were 4.82%and 6.35%, respectively ( no significance, P=0.350).The most common adverse effect was an increase in the alanine aminotransferase.Conclusion:Dl-3-butylphthalide soft capsules are effective and safe to treat acute is-chemic stroke, and the Barthel index of the t.i.d.group was better than that of the b.i.d.group at days 21.%目的：观察丁苯酞软胶囊对急性脑梗死患者的疗效及安全性。方法：采用多中心、开放和多中心、随机临床研究设计，共纳入1457例起病72h内，美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale， NIHSS）评分为5～25分的急性缺血性脑卒中患者，其中丁苯酞软胶囊2次／日给药组310例，3次／日给药组1147例。结果：2次／d给药组和3次／d给药组治疗前、治疗后第11天和第21天的NIHSS总评分分别为9.19±3.13、9.01±3.51，5.58±3.32、5.59±3.77和3.55±3.05、3.48±3.39；两组BarthelIndex（BI）分别为47.38±23.12、46.78±23.98，62.76±23.36、62.99±24.83和71.17±22.68、74.90±23.62，治疗后第21天BI两组比较差异有统计学意义（P＝0.008）。2次／d和3次／d给药组有效率分别为77.9％和78.0％；2次／d及3次／d给药组不良反应发生率分别为4.82％和6.35％，差异无统计学意义（ P＝0.350），两组最常见的不良事件均为血清氨基转移酶升高。结论：丁苯酞软胶囊用于治疗急性脑梗死安全有效，治疗第21天3次／d组BI优于2次／d组。