注射用红花黄色素治疗急性期脑梗死的临床研究

目的对注射用红花黄色素治疗急性期脑梗死瘀血阻络证的有效性和安全性进行评价。方法采用随机、盲法、带有基础治疗的安慰剂对照试验方法。将患者随机分为治疗组77例、对照组26例。两组均给予基础药物治疗:曲克芦丁注射液200mg,静脉滴注,1次/d。治疗组给予注射用红花黄色素80mg,静脉滴注,1次/d;对照组给予安慰剂。疗程均为14d。结果治疗7、14d两组中风病评分、神经功能缺损程度评分均有不同程度的降低,并随时间的推移更显著,两组内总评分的改善率均有统计学意义(P<0.01)。治疗前基线评分对疗效评价有影响,扣除了基线评分影响后,治疗7、14d两组间总评分改善率的差异仍有统计学意义(P<0.01)。两组不良事件发生率比较无统计学意义(P>0.05)。结论注射用红花黄色素用于治疗急性期脑梗死瘀血阻络证是安全、有效的,可以有效地改善患者的临床症状,明显提高患者的生活能力。

Treatment of cerebral infarction in acute stage with safflor yellow for injection

Objective To evaluate the efficacy and safety of safflor yellow for injection to cerebral infarction in acute stage. Method The placebo (random, blind and basic treatment) was used as the control experiment. The patients were randomly divided into the treatment group (n=77) and control group (n=26). Two groups were all treated with the basic medicines, i.e. troxerutin injection (200 mg) by intravenous drop once daily. Besides safflor yellow for injection (80 mg) was given to the treatment group by intravenous drop once daily and placebo was given to the control group. One treatment course was for 14 days. Result The scores of stroke and neurological impairment were decreased in two groups respectively 7 or 14 days after the treatment, and were more significant along with time. The improvement rates of the total scores in two groups had a statistic significance (P<0.01). Before the treatment the baseline score had an influence on the curative effect evaluation, while after the influence was subtracted the improvement rates of the total scores in two groups still had a statistic significance 7 or 14 days after the treatment (P<0.01). The comparison of bad events incidence in 2 groups had no statistic significance (P>0.05). Conclusion Safflor yellow for injection is safe and effective for treating cerebral infarction in acute stage. It can relieve the symptoms efficiently and improve living ability of the patients.