应用中风防治灵Ⅰ号、Ⅱ号干预脑梗死二级预防观察比较

Observation and Comparison of Zhongfeng Fangzhi Ling Granule 1,2 for the Secondary Prevention of Cerebral Infarction

目的:探讨中风防治灵Ⅰ号、Ⅱ号方在脑梗死二级预防中的作用,为脑梗死二级预防提供一种新的选择。方法:将160例脑梗死患者采用随机数字表法分为对照组80例和治疗组80例。对照组予基础治疗。治疗组在基础治疗的基础上,辨证属风火上扰、风痰火亢、痰热腑实、气虚血瘀、阴虚风动五个证型者加服中风防治灵Ⅰ号,属风痰瘀阻、痰湿蒙神两个证型者加服中风防治灵Ⅱ号。观察两组脑血管事件的发生率,平均随访1年。结果:最后153例完成试验,其中对照组75例,试验组78例。对照组各事件的累积发病率21.3%,脑梗死10.7%,短暂性脑缺血发作(TIA)9.3%,脑出血1.3%,总死亡率4.0%,因事件死亡率2.7%;试验组分别为总事件7.7%,脑梗死2.6%,短暂性脑缺血发作(TIA)3.9%,脑出血1.3%,总死亡率2.6%,因事件死亡率1.3%。两组对比,短暂性脑缺血发作(TIA)、脑出血、总死亡率、因事件死亡率均无统计学意义(P>0.05);而发生脑血管事件的累积发病率、脑梗死、缺血性脑血管事件的发生(包括脑梗死及TIA),对比两组资料,则显示出,差异有统计学意义(P<0.05)。结论:中风防治灵Ⅰ号、Ⅱ号能降低脑血管事件特别是脑缺血性事件的发生率,而不增加脑出血和死亡的风险,对脑梗死的二级预防作用明显,可广泛应用于临床。

Objective： To explore the effect of Zhongfeng Fangzhi Ling Granule 1, 2 for the secondary prevention of cerebral infarction. Method： 160 enrolled cases were randomly divided into the treatment group and the control group with 80 in each.The control group was given basic treatment, while the treatment group was treated based on the basic treatment. The cases with TCM syndromes wind-fire rising, excession of wind phlegm-fire, Qi Deficiency and Blood Stasis, Yin Deficiency and wind movement were treated with Zhongfeng Fangzhi Ling Granule 1; and Zhongfeng Fangzhi Ling Grangule 2 was given to the cases with TCM syndromes of Wind-phlegm Syndrome, phlegm-wetness with the coma type. The incidence rate of the two groups were observed and the cases were followed up for 1 year. Results： 153 subjects have finished the study（78 in the experimental group and 75 in the control group）. In test group the cumulative incidence rate was 21.3%（cerebral infraction10.7%, transient ischemic attack（TIA）9.3%,Cerebral Hemorrhage 1.3%）.The total mortality rate was 4.0%, death caused by cerebro-cardiovascular accidents was 2.7%; But in control group the cumulative incidence risk of each event was 7.69%（2.6%,3.9%,1.3%）,2.6%,1.28%. Between the two groups, there were no obviously statistical differences in transient ischemic attack（TIA）, cerebral hemorrhage, total mortality rate, death caused by cerebro-cardiovascular accidents（P〈0.05）; but there was statistical significance in cumulative incidence rate, cerebral infraction, ischemic cerebrovascular event（cerebral infraction and TIA）（P〉0.05）.Conclusion： Zhongfeng Fangzhi Ling Granule 1, 2 can reduce the incidence of cerebrovascular,especially ischemic cerebrovascular event without increasing the risk of cerebral hemorrhage and mortality rate. Therefore Zhongfeng Fangzhi Ling Granule 1, 2 have significant influence on the Secondary Prevention of cerebral infarction and can be widely applied.