灯盏花素滴丸治疗中风后遗症的临床研究

Clinical Study of Breviscapine Dropping Pills in the Treatment of Apoplectic Sequela

目的:评价灯盏花素滴丸治疗中风后遗症的安全性和有效性。方法:将接受治疗的中风后遗证患者240例作为研究资料,采用随机、双盲双模拟、阳性药平行对照、多中心临床试验,试验组纳入180例,对照组纳入60例,评价两组治疗在访视第0天、第84天效果及不良反应发生情况。结果:主要疗效评价指标试验组神经功能缺损程度评分(NIHSS)与治疗前比较平均下降4. 7;日常生活自理能力Barthel指数治疗前后变化值为-21. 2,与对照组比较均明显改善(P <0. 000 1);试验组无不良反应发生,对照组不良反应发生率为1. 67%。结论:灯盏花素滴丸治疗瘀血阻络型中风后遗症安全、有效。

Objective: To evaluate the safety and efficacy of Breviscapine dripping pill in the treatment of apoplectic sequela.Methods: 240 patients with apoplexy sequelae who received treatment. The clinical trial was Randomized,double-blind,double-dummy,positive drug parallel control and multi-center. 180 patients in the test group and 60 patients in the control group. The effects and adverse reactions of the two groups on day 0 and day 84 of visit were evaluated. Results: Compared with pre-treatment,the NIHSS of the test group decreased by 4. 7 on average,and the Barthel index of daily living self-care ability changed by-21. 2 which was significantly higher than that of the control group( P < 0. 000 1). There were no adverse events in the test group,and the incidence of adverse events in the control group was 1. 67%. Conclusion: Breviscapine dropping pill is safe and effective in treating apoplectic sequela caused by blood stasis.