丁苯酞软胶囊治疗脑小血管病的临床研究

Clinical study of Butylphthalide Soft Capsules in treatment of cerebral small vessel disease

目的探讨丁苯酞软胶囊治疗脑小血管病的临床疗效。方法选取2016年3月—2018年2月在天津中医药大学第一附属医院就诊的脑小血管病患者100例,随机分为对照组(50例)和治疗组(50例)。对照组给予常规治疗,治疗组在此基础上口服丁苯酞软胶囊,2粒/次,3次/d,持续治疗2个月。观察两组患者临床疗效,同时比较治疗前后两组患者NIHSS、Fugl-Meyer量表、MBI评分,反应性充血指数(RHI)和内皮祖细胞(EPCs)数以及细胞因子水平。结果治疗后,对照组临床有效率为60.0%,显著低于治疗组的76.0%,两组比较差异具有统计学意义(P<0.01)。治疗后,两组NIHSS评分显著降低,FMA-UE、FMA-LE、MBI评分显著升高,同组治疗前后比较差异具有统计学意义(P<0.05、0.01);且治疗后治疗组上述评分均显著优于对照组,两组比较差异具有统计学意义(P<0.05、0.01)。两组RHI、EPCs均较治疗前明显升高,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗后治疗组RHI、EPCs明显高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者血清ET-1、v WF水平均显著降低,NO水平显著升高,同组治疗前后比较差异具有统计学意义(P<0.05、0.01);且治疗后治疗组上述血清细胞因子水平显著优于对照组,两组比较差异具有统计学意义(P<0.05、0.01)。结论丁苯酞软胶囊能显著改善脑小血管病患者的运动功能和生活自理能力,增加外周血EPCs数目、有效调节ET-1/NO平衡,具有一定的临床应用价值。

Objective To observe the clinical efficacy of butylphthalide in treatment of cerebral small vessel disease. Methods Patients with cerebral small vessel disease in First Teaching Hospital of Tianjin University of Traditional Chinese Medcine from March 2016 to February 2018 were randomly divided into control(50 cases) and treatment(50 cases) groups. Patients in the control group were given conventional treatment. Patients in the treatment group were po administered with Butylphthalide Soft Capsules on the basis of the control group, 2 grains/time, three times daily. Patients in two groups were treated for two months. After treatment, the clinical efficacy was evaluated, and NIH Stroke Scale(NIHSS), Fugl-Meyer Assessment(FMA), and Modified Barthel Index Score(MBI), reactive hyperemia index(RHI), endothelial progenitor cells(EPCs), and cytokine levels in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 60.0%, which was significantly lower than 76.0% in the treatment group, and there were differences between two groups(P < 0.01). After treatment, NIHSS scores in two groups were significantly decreased, but FMA-UE, FMA-LE, MBI scores in two groups were significantly increased, and the difference was statistically significant in the same group(P < 0.05, 0.01). And those scores in the treatment group were significantly better than those in the control group, with significant difference between two groups(P < 0.05, 0.01). RHI and EPCs in two groups were significantly increased, and the difference was statistically significant in the same group(P < 0.05). And RHI and EPCs in the treatment group were significantly higher than those in the control group, with significant difference between two groups(P < 0.05). After treatment, ET-1 and vWF levels in two groups were significantly decreased(P < 0.01),but NO level in two groups were significantly decreased(P < 0.05, 0.01), and the cytokine levels in the treatment group were significantly better than those in the control group, with significant difference between two groups(P < 0.05, 0.01). Conclusion Butylphthalide can significantly improve the motor function and daily living activities of patients with cerebral small vessel disease, and can increase the number of EPCs in peripheral blood and effectively regulate the balance of ET-1/NO, which has a certain clinical application value.