脑塞通丸治疗中风恢复期有效性和安全性的临床研究

Clinical research of effectiveness and safety of naosaitong wan in treating ischemic stroke during recovery phase

目的评价脑塞通丸治疗中风恢复期(中经络,气虚血瘀证)安全性和有效性。方法采用分层区组随机、双盲双模拟、阳性平行对照、多中心试验设计方法。将符合中风恢复期(中经络,气虚血瘀证)诊断标准的受试者按3∶1比例随机分为试验组和对照组,试验组服用脑塞通丸,对照组服用偏瘫复原丸,疗程为8周。以美国国立卫生研究院脑卒中量表(NIHSS)评分、中医证候积分为主要指标,以日常生活活动能力量表(Barthel)指数评分、中医证候单项疗效为次要指标,并对其安全性进行评价。结果与基线比较试验组和对照组治疗8周后NIHSS评分均降低,Barthel指数评分均升高,组内比较差异均有统计学意义;治疗8周后相对基线NIHSS评分变化值,组间比较差异有统计学意义,试验组优于对照组;治疗8周后相对基线Barthel指数评分变化值,组间比较差异无统计学意义。中医证候疗效两组比较,差异均有统计学意义,试验组总有效率为87.42%,对照组总有效率为73.58%,试验组优于对照组。试验组与对照组的不良事件发生率组间差异无统计学意义,两组均无严重不良事件发生。结论脑塞通丸治疗中风恢复期(中经络,气虚血瘀证)疗效确切,安全性好。

Objective To assess the effectiveness and safety of NaoSaiTong Wan in treating apoplexy involving the channels and collaterals of ischemic stroke during recovery phase of blood stasis. Method This clinical trial adopts the design procedures which included stratified-block randomized, double-blind and double- modeling, masculine paraXleI comparison and multiple centers. The patients who have been made a definite diagnosis of apoplexy involving the chan- nels and collaterals of ischemic stroke in recovery phase of blood stasis due to deficient qi were divided into treatment and control groups with the proportion of 3：1. The patients of treatment group take NaoSaiTong IVan and the patients of control group take PianTanFuYuan Wan, the course of treatment was 8 weeks. The primary effective indexes include the scores of NIHSS and TCM symptoms. The Secondary effective indexes include the score of Barthel exponent. The safety assess is also performed. Results Compared with the baseline, the scores of NIHSS of the two groups decreased while the scores of Barthel exponent increased after treatment, the results were significantly different. Compared with the control group, the change score of NIHSS in treatment group was significantly different. The change score of Barthel exponent did not show significant difference between the two groups. The efficacy of TCM symptoms was significantly different between the two groups. The total effective rate was 87.42% ,the control group was 73.58% ,the treatment group was superior to the control group. The difference of the incidence rate of adverse events was not significant, no serious adverse event oc- cured during the treatment course. Conclusion NaoSaiTong IVan is an effective and safe drug in treating apoplexy in- volving the channels and collaterals of ischemic stroke in recovery phase of blood stasis due to deficient qi.