丹红注射液治疗中风（恢复期）瘀血闭阻证的临床研究

目的 评价丹红注射液治疗中风（恢复期）瘀血闭阻证（脑梗死）的临床有效性和安全性.方法 采用随机、阳性药平行对照、双盲、多中心的临床试验方法将260例中风（恢复期）瘀血闭阻证病人分为试验组（195例）与对照组（65例）.试验组给予丹红注射液治疗,对照组给予舒血宁注射液治疗,连续用药1个疗程（14 d）.观察两组中风病疗效、中医证候疗效、中国脑卒中量表（CSS）积分、中医证候积分、中风病积分、日常生活活动量表积分变化.结果 中风病疗效总有效率在试验组和对照组分别为90.3%和84.6%,中医证候疗效总有效率在试验组和对照组分别为77.4%和69.2%,两组各疗效指标比较差异均无统计学意义（P＆gt;0.05）,且两组均未发现明显的不良反应.结论 丹红注射液治疗中风（恢复期）瘀血闭阻证安全有效.

Clinical Observation on Danhong Injection in the Treatment of Stroke Recovering Period Patients with Syndrome of Blood-stasis and Impatency

Objective To access the clinical efficacy and safety of Danhong injection（DHI） in the treatment of stroke recovery pa- tients with syndrome of blood - stasis and impatency. Methods A randomized, positive drug parallel controlled,double- blind,multi- center clinical trial was conducted. Two hundreds and sixty patients with stroke recovery and syndrome of blood - stasis and impaten ey were randomly divided into two groups：Treatment group（n= 195） treated by DHI and control group（n= 65） treated by Shuxuen- ing injection for 14 days. The results of clinic trial were observed. The evaluating outcomes included the therapeutic effectiveness of stroke and traditional Chinese medicine （TCM） symptoms, improvement of scores of Chinese stroke scale （CSS）, scores of TCM symptoms,scores of stroke and scores of activities of daily living （ADL） scale. Results The effective rates of stroke are 90.3% in treatment group and 84.6 % in control group, the effective rates of TCM symptoms are 77.4 % in treatment group and 69.2% in con- trol group. There are non - statistical significance（P〉0.05）of the differences of indexes about therapeutic effectiveness and improve- ment of scores between the groups. Neither of the two groups has been found significant adverse reactions. Conclusion DHI is effica- cy and safety for treatment of stroke recovery patients with syndrome of blood - stasis and impatency.