注射用血塞通（冻干）治疗脑梗死恢复期（瘀血阻滞证）的多中心临床研究

目的观察注射用血塞通(冻干)治疗脑梗死恢复期(瘀血阻滞证)的有效性和安全性。方法采用区组随机、盲法、阳性药/安慰剂平行对照、多中心临床研究的方法。本研究分四组:血塞通高剂量组(105例),给予注射用血塞通(冻干)静脉滴注,400 mg/d;灯盏细辛组(36例),给予灯盏细辛注射液静脉滴注,40 m L/d;安慰剂组(70例)给予0.9%氯化钠注射液静脉滴注,250 m L/d;血塞通低剂量组(71例),给予注射用血塞通(冻干)静脉滴注,200 mg/d。4组患者疗程均为15 d。分别观察NIHSS量表评分、改良Rankin量表评分、中医证候积分、Barthel指数等指标的改善情况。结果血塞通高剂量组在改善中医证候积分及单项症状下肢不遂、口舌歪斜、舌强言謇或不语、偏身麻木、头晕、口唇紫暗、肢体疼痛方面疗效较对照药灯盏细辛注射液有优势,两组间比较差异均有统计学意义(P0.008 3);血塞通高剂量组在改善NIHSS评分、中医证候积分和单项症状下肢不遂、舌强言謇或不语、偏身麻木、口唇紫暗方面疗效好于血塞通低剂量组,两组间比较差异均有统计学意义(P0.008 3)。结论注射用血塞通(冻干)治疗脑梗死恢复期(瘀血阻滞证)疗效确切,临床使用安全。

Multi-center clinical study of Xuesaitong Injection (lyophilization) in treatment of cerebral infarction recovery period (blood stasis syndrome)

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.