目的 觀察注射用血塞通（凍干）治療腦梗死恢復(fù)期（瘀血阻滯證）的有效性和安全性。方法 采用區(qū)組隨機(jī)、盲法、陽性藥/安慰劑平行對照、多中心臨床研究的方法。本研究分四組：血塞通高劑量組（105例），給予注射用血塞通（凍干）靜脈滴注，400 mg/d；燈盞細(xì)辛組（36例），給予燈盞細(xì)辛注射液靜脈滴注，40 mL/d；安慰劑組（70例）給予0.9%氯化鈉注射液靜脈滴注，250 mL/d；血塞通低劑量組（71例），給予注射用血塞通（凍干）靜脈滴注，200 mg/d。4組患者療程均為15 d。分別觀察NIHSS量表評分、改良Rankin量表評分、中醫(yī)證候積分、Barthel指數(shù)等指標(biāo)的改善情況。結(jié)果 血塞通高劑量組在改善中醫(yī)證候積分及單項(xiàng)癥狀下肢不遂、口舌歪斜、舌強(qiáng)言謇或不語、偏身麻木、頭暈、口唇紫暗、肢體疼痛方面療效較對照藥燈盞細(xì)辛注射液有優(yōu)勢，兩組間比較差異均有統(tǒng)計學(xué)意義（P<0.008 3）；血塞通高劑量組在改善NIHSS評分、中醫(yī)證候積分和單項(xiàng)癥狀下肢不遂、舌強(qiáng)言謇或不語、偏身麻木、口唇紫暗方面療效好于血塞通低劑量組，兩組間比較差異均有統(tǒng)計學(xué)意義（P<0.008 3）。結(jié)論 注射用血塞通（凍干）治療腦梗死恢復(fù)期（瘀血阻滯證）療效確切，臨床使用安全。

Objective To evaluate the efficacy and safety of Xuesaitong Injection (lyophilization) in treatment of cerebral infarction recovery period (blood stasis syndrome). Methods The study was a block randomized, blinded, positive medicine/placebo parallel control, multi-center clinical research, controlled with Dengzhan Xixin Injection, placebo and low dosage of Xuesaitong Injection (lyophilization). The study was divided into four groups:there were 105 patients in high dosage of Xuesaitong Injection (lyophilization), and they were iv administered with Xuesaitong Injection (lyophilization), 400 mg/d. There were 36 patients in Dengzhan Xixin group, and they were iv administered with Dengzhan Xixin Injection, 40 mL/d. There were 70 patients in placebo control group, and they were iv administered with 0.9% sodium chloride injection, 250 mL/d. There were 71 patients in low dosage of Xuesaitong Injection (lyophilization), and they were iv administered with Xuesaitong Injection (lyophilization), 200 mg/d. The course of treatment was 15 d. The changes of NIHSS score, modified Rankin score, TCM syndrome integration, and Barthel index in four groups were compared. Results The high dosage of Xuesaitong Injection (lyophilization) group has advantages in Chinese medicine syndrome, found in the lower limb, askew mouth, tongue Jian strong words or not language, partial body numbness, dizziness, oral dark purple, limb pain than Dengzhan Xixin Injection, and there were differences between two groups (P<0.008 3). The high dosage of Xuesaitong Injection (lyophilization) group has advantages in NIHSS score improvement, Chinese medicine syndrome, found in the lower limb, tongue Jian strong words or not language, partial body numbness, oral dark purple than the low dosage Xuesaitong Injection (lyophilization), and and there were differences between two groups (P<0.008 3). Conclusion Xuesaitong Injection (lyophilization) shows defined efficacy and safety for the treatment of cerebral infarction recovery period (blood stasis syndrome) with clinical safety.