桂枝茯苓丸加地龙干预脑内微小病变及预防脑梗死发病的临床研究

目的以脑内微小病变为脑梗死治未病的客观依据,研究中药干预脑内微小病变,进而预防脑梗死发病的效果,同时观察中药对脑梗死相关危险因子的影响。方法采用随机对照前瞻性试验方法,将300例经头颅核磁共振成像(MRI)检查确诊为脑内多发微小病变者随机分为中药组、阿司匹林组和阴性对照组,每组100例;中药组予桂枝茯苓丸加地龙粉剂,阿司匹林组予阿司匹林,治疗均以3个月为1个疗程,连续服药时间不少于6个月;阴性对照组不使用相关治疗药物。定期随访各组脑内微小病变、相关危险因子变化情况,以及脑梗死发病情况。结果中药组入组时与入组6个月时组内比较,收缩压、低密度脂蛋白差异有统计学意义(P<0.05);阿司匹林组、阴性对照组入组时与入组6个月时组内比较,收缩压差异有统计学意义(P<0.05)。入组6个月时组间比较,中药组与阿司匹林组低密度脂蛋白、总胆固醇和三酰甘油差异有统计学意义(P<0.05),中药组与阴性对照组低密度脂蛋白差异有统计学意义(P<0.05)。中药组、阿司匹林组、阴性对照组脑内微小病变总有效率分别为64.56%、48.19%、42.86%;组间脑内微小病变疗效比较,中药组与阿司匹林组、阴性对照组差异有统计学意义(P<0.05)。截至随访结束,中药组、阿司匹林组、阴性对照组脑梗死发病分别为2例、6例和9例;中药组与阴性对照组比较,脑梗死发病率差异有统计学意义(P<0.05)。结论桂枝茯苓丸加地龙可以治疗脑内微小病变,减少微小病变的数量,预防脑梗死发生,并可有效干预血管性危险因素。

Clinical study on "Guizhi Fuling Pill" with Lumbricus for microlesions in brain and cerebral infarction

Objective To research the effect of Chinese medicine on intervention of microlesions in brain,prevention of cerebral infarction and risk factors related to cerebral infarction.Methods Randomized prospective trial was applied.Three hundred cases with microlesions in brain were randomized into Chinese medicine group,aspirin group and negative control group,100 cases in each group.Chinese medicine group was treated by "Guizhi Fuling Pill" and Lumbricus;aspirin group was treated by aspirin,3 months as a course,for more than 6 consecutive months;negative control group was not treated by any medicine.The microlesions in brain,associated risk factors and cerebral infarction were observed by regular follow-up.Results There were significant differences in systolic pressure and LDL in Chinese medicine group between the beginning and 6 months(P<0.05);in aspirin group and negative control group,there was a significant difference in systolic pressure between the beginning and 6 months(P<0.05);in the 6 months,there were significant differences in LDL,CHOL and TG between Chinese medicine group and aspirin group(P<0.05),with a significant difference in LDL between Chinese medicine group and negative control group.The overall effective rate of microlesions was 64.56% in the Chinese medicine group,48.19% in aspirin group and 42.86% in negative control group;there was a significant difference in clinical efficacy of microlesions between Chinese medicine and the other two groups(P<0.05).At the end of follow-up,two cases in Chinese medicine developed cerebral infarction,6 cases in aspirin group and 9 cases in negative control group.There was a significant difference in morbidity of cerebral infarction between Chinese medicine group and negative control group(P<0.05).Conclusion Combined "Guizhi Fuling Pill" with Lumbricus can treat microlesions in brain,reduce the number of microlesions,prevent cerebral infarction and intervene the vascular risk factors effectively.