摘要
目的:评价超微粉碎工艺的通心络胶囊治疗中风病(气虚血瘀络阻型)的临床疗效和安全性。方法:采用随机、双盲、不同工艺不同剂量平行对照的非劣效性试验设计方法,选择病程在2周以上3个月以内、神经功能缺损评分为8～30分、总的生活能力评分在2～5级的中风病恢复期患者144例,其中试验组72例,对照组72例。试验组服用超微粉碎工艺的通心络胶囊,规格每粒0.26g,1次4粒,1日3次;对照组服用普通粉碎工艺的通心络胶囊,规格每粒0.38g,1次4粒,1日3次;疗程28d。结果:中风病综合疗效,试验组与对照组总有效率分别为91.3%和87.3%,两组比较差异无统计学意义。两组总有效率差值的95%可信区间下限为-4.57%,大于预设的非劣效性界值-15%,非劣效性检验合格。试验期间发生3例不良反应,其中试验组1例,对照组2例。结论:超微粉碎工艺的通心络胶囊对于气虚血瘀络阻型中风病患者疗效确切,与普通粉碎工艺的通心络胶囊疗效相当,且服用安全。
Objective： To evaluate the clinical efficacy and security of super crush-run tong xinluo capsule （SCTXLC） for apoplexy due to energy-deficiency and blood-stasis. Method：The randomised controlled double blind non-inferiority trial versus paroxefine, parallel contrast, different Kinds of Techniques and dosage , the clinical trial design was adopted, 144 patients with stroke of convalescent stage were selected by 2 group, which course of diseases was in 2 weekens to 3 months, neurological deficit scores was 8 to 30, grade of acaties of daily living scores was 2 to 5. the treatment group （ n = 72 ） received SCTXLC 0. 26 g （ a capsule） , 4 capsules at a time, three times a day, while that of the control group （ n = 72 ） received common crush-run tong xiuluo capsule （CCTXLC） 0. 38 g （a capsule） , 4 capsules at a time, three times a day, the therapeutic course for both groups was 28 d. Result： The synthesis total effective rates of the stroke in treatment group and control group were 91.3 % and 87.3% respectively, showing no significant difference. The Lower Bound Upper Bound of Asymptotic 95% Confidence Interval of the total effective rates difference is -4.57% , over the beforehand Lower Bound of 15% , non-inferiority trial versus paroxetine was eligible. The adverse reactions occurred was 1 patient in the treatment group and 2 patients in control group in clinical trial. Conclusion：SCTXLC has definite effect for apoplexy due to energy-deficiency and blood-stasis, the efficacy in the treated group was equal to that in the control group, and favourable satety for usage.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2007年第18期1928-1931,共4页
China Journal of Chinese Materia Medica
基金
国家"十五"科技攻关项目(2001BA701A06)
关键词
通心络胶囊
超微粉碎
中风病
非劣效性检验
临床研究
Tongxinluo capsule
super crush-run
stroke
noninferiority testing
clinical study
