消栓通络颗粒治疗中风后遗症中的真实世界前瞻性研究

Real World Prospective Study of Xiaoshuan Tongluo Granules(消栓通络颗粒)for Stroke Sequela

目的 探讨消栓通络颗粒在中风后遗症中的应用效果。方法 选取2019年1月—2020年12月收治的95例中风后遗症患者,按随机数字表法随机分为对照组47例和观察组48例,对照组予常规治疗,观察组加服消栓通络颗粒,3个月为1个疗程。比较临床疗效,分别采用NIHSS、Brunnstrom和ADL量表评价神经功能缺损、肢体功能和日常生活能力,检测血流变指标(全血黏度、血浆黏度、红细胞比容)和氧化应激指标(MDA、SOD、GSH)。结果 观察组临床有效率为89.6%(43/48),高于对照组的70.2%(33/47)(P<0.05)。治疗后,两组NIHSS评分、全血黏度、血浆黏度、红细胞比容、血浆MDA水平显著降低,Brunnstrom和ADL评分、血浆SOD和GSH水平显著增加(P<0.05);组间相比,观察组NIHSS评分、全血黏度、血浆黏度、MDA水平低于对照组,Brunnstrom和ADL评分、SOD水平高于对照组,差异均有统计学意义(均P<0.05)。结论 真实世界中,消栓通络颗粒辅助治疗中风后遗症安全且有效,值得临床推广。

Objective To observe the application of Xiaoshuan Tongluo Granules(消栓通络颗粒)for patients with stroke sequela.Methods From January 2019 to December 2020,95 patients with stroke sequela were enrolled,and randomly divided into control group(47 cases)and study group(48 cases)according to the method of random number table.The control group received conventional treatment and the study group received Xiaoshuan Tongluo Granules additionally.The treatment course was 3 months.The clinical efficacy was compared.The Health Stroke Scale(NIHSS),Brunnstrom and activity of daily living scale(ADL)were used to assess the neurological function impairment,limb function and activity of daily living,respectively.Hemorheological parameters[whole blood viscosity,plasma viscosity and hematocrit(HCT)]and oxidative stress indexes[malondialdehyde(MDA),glutathione(GSH)and superoxide dismutase(SOD)]were determined.Results The total effective rate was 89.6%in the study group,which was higher than 70.2%of control group(P<0.05).After treatment,NIHSS score,whole blood viscosity,viscosity and the levels of HCT and MDA decreased,Brunnstrom and ADL score,plasma levels of SOD and GSH increased in both groups.The differences were statistically significant(P<0.05).The NIHSS score,whole blood viscosity,plasma viscosity and MDA of study group were lower than those of the control group and the difference was statistically significant(P<0.05).The Brunnstrom and ADL score and plasma levels of SOD of study group were higher than those of the control group and the difference was statistically significant(P<0.05).Conclusion Xiaoshuan Tongluo Granules are effective and safe for patients with stroke sequela in the real world study,and are worthy of widely clinical use.