• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2019, Vol. 36 ›› Issue (6): 447-451.

• 药品评价-临床研究 • 上一篇    下一篇

灯盏花素滴丸治疗中风后遗症的临床研究

黄立武1,陈恬2, 梁建萍3, 冷辉林4,张永成5,赵岩6   

  1. 1. 广西中医药大学第一附属医院
    2. 江西省中西医结合医院
    3. 南昌大学第四附属医院
    4. 宜春市人民医院
    5. 井冈山大学附属医院
    6. 南昌弘益药业有限公司
  • 收稿日期:2020-01-19 出版日期:2019-12-28 发布日期:2020-01-21

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

  • Received:2020-01-19 Online:2019-12-28 Published:2020-01-21

摘要: 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。

Abstract: 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.

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