通脉胶囊治疗急性缺血性脑卒中临床观察

Clinical Observation on Tongmai Capsule in Treatment of Acutely Ischemic Stroke

目的 :通过随机、双盲、安慰剂对照的临床研究 ,观察通脉胶囊治疗风痰血瘀型急性缺血性脑卒中的临床疗效。方法 :将 10 0例急性缺血性脑卒中的患者随机分成 2组 ,各 5 0例 ,治疗组在静点胞二磷胆碱基础上 ,口服通脉胶囊 ,每日 3次 ,每次 5粒 ;对照组亦予静点胞二磷胆碱 ,同时口服安慰剂。 2组均 4周为 1个疗程 ,1个疗程后评定疗效。结果 :治疗组临床总有效率 (92 0 0 %)明显高于对照组 (82 0 0 %) ,2组比较有显著性差异 (χ2 =10 6 5 ,P<0 0 5 )。治疗组治疗后血液流变较治疗前和对照组治疗后明显下降 (P <0 0 5或P <0 0 1) ,总胆固醇和甘油三酯较治疗前亦明显下降 (P <0 0 1)。结论 :通脉胶囊治疗急性缺血性脑卒中疗效肯定 ,安全可靠 ,无不良反应 ,值得推广使用。

Objective:To observe the clinical curative effects of Tongmai Capsule(TMC) on acutely ischemic stroke(AIS)of wind-phlegm and blood stasis syndrome by randomized,double-blind,and placebo-controlled clinical trial.Methods:100 patients with AIS were randomly divided into two groups.The therapeutic group(n=50)based on treatment with citicoline infused intravenously was treated with TMC 5 tablets three times a day while the control group(n=50)based on treatment with citicoline infused intravenously was treated with placebo.Four weeks were one therapeutic course for both two groups.Results:In therapeutic group the clinical total effective rate(92.00%)was markedly higher than that(82.00%)in control group and in comparison between two groups the difference was significant(χ 2=10.65 P<0.05).Otherwise after therapy the decreases in parameters of blood rheology in therapeutic group were much more significant than those before therapy and those in control group(P<0.05 or P<0.01),meantime the decreases in total cholesterols and triglyceride were much more significant than those before therapy too(both P<0.01).Conclusions:The curative effects of TMC on treating AIS are confirmed.TMC is safe,reliable,and not side effective actions.It is worth to spread.