丁苯酞软胶囊联合氯吡格雷片治疗进展性脑梗死的临床研究

Clinical trial of butyl phthalide capsule combined with clopidogrel tablets in the treatment of progressive cerebral infarction

目的观察丁苯酞软胶囊联合氯吡格雷治疗进展性脑梗死的临床疗效及安全性。方法将78例进展性脑梗死患者随机分为对照组39例和试验组39例。对照组予以口服氯吡格雷首剂剂量300 mg,qd,以后每次剂量为75 mg,qd;试验组在对照组治疗的基础上,予以口服丁苯酞软胶囊每次200 mg,tid。2组患者均治疗28 d。比较2组患者的临床疗效和药物不良反应发生率,以及治疗前后的巴氏指数(BI)评定量表评分和欧洲卒中量表(ESS)评分、微小RNA-155、CD4^+CD25^+Treg变化情况。结果治疗后,试验组和对照组的总有效率分别为89.74%(35/39例)和66.67%(26/35例),差异有统计学意义(P<0.05)。治疗后,试验组与对照组的ESS评分分别为(82.54±4.78),(73.24±3.46)分;BI评分分别为(72.33±2.80),(61.10±2.94)分;微小RNA-155表达量分别为(0.63±0.03),(0.98±0.05);CD4^+CD25^+Treg细胞百分率分别为(1.55±0.44)%,(2.16±0.31)%,差异均有统计学意义(P<0.05)。试验组出现的药物不良反应主要有皮疹、腹部不适、恶心,对照组出现的药物不良反应主要有消化道出血、腹痛、便秘。试验组和对照组的药物不良反应发生率比较差异无统计学意义(10.26%vs 12.82%,P>0.05)。结论丁苯酞软胶囊联合氯吡格雷治疗进展性脑梗死的临床疗效确切,可保护患者的神经功能,有效地降低微RNA-155、CD4^+CD25^+Treg细胞的表达水平,且安全性较高。

Objective To observe the clinical efficacy and safety of butyl phthalide combined with clopidogrel in the treatment of progressive cerebral infarction.Methods Seventy-eight patients with progressive cerebral infarction were randomly divided into control group（n = 39） and treatment group（n = 39）.Control group was given the first dose of clopidogrel 300 mg qd,after each dose was 75 mg qd.Treatment group was received butyl phthalide 200 mg tid,on the basis of control group.Two groups were treated for 28 days.The clinical efficacy,incidence of adverse drug reactions,scores of Barth index（BI） rating scale and European stroke scale（ESS）,changes of microRNA-155 and CD4~＋CD25~＋Treg were compared between two groups.Results After treatment,the total effective rates in treatment and control groups were 89.74%（35/39） and 66.67%（26/35）,with significant difference（P 0.05）.After treatment,the main indexes in treatment and control groups werecompared：ESS were（82.54 ± 4.78）,（73.24 ± 3.46） point;BI were（72.33 ± 2.80）,（61.10 ± 2.94） point;the expression of microRNA-155 were（0.63 ± 0.03）,（0.98 ± 0.05）;the percentages of CD4~＋CD25~＋Treg were（1.55 ± 0.44） %,（2.16 ± 0.31） %,with significant difference（P 0.05）.Adverse drug reactions in treatment group were based on rash,abdominal discomfort and nausea,which were gastrointestinal bleeding,abdominal pain and constipation in control group.The incidences of adverse drug reactions were 10.26% and 12.82% in treatment and control groups without statistically significant difference（P 0.05）.Conclusion Butyl phthalide combined with clopidogrel have a definitive clinical efficacy and safety for the treatment of progressive cerebral infarction,which can reduce the expression levels of micro RNA-155 and CD4~＋CD25~＋Treg.