出 处:《中国实验方剂学杂志》2017年第14期198-203,共6页Chinese Journal of Experimental Traditional Medical Formulae
基 金:河北省中医药管理局科研计划项目(2012031)
摘 要:目的:探讨消栓通络颗粒早期干预对缺血性中风(风痰瘀阻证)患者康复的疗效,及对炎症因子和神经因子的影响。方法:将160例患者按SAS软件生成的随机按数字表法分为对照组和观察组。两组均参照指南给予综合内科处理和康复措施。对照组给予针刺和推拿的中医康复措施,观察组在对照组基础加用消栓通络颗粒,12 g/次,3次/d,温开水冲服。两组疗程均为4周。分别于治疗前、治疗后7,14,28 d进行美国国立卫生院神经功能缺损(NIHSS)评分评价;采用功能独立性评定量表(FIM)评定日常生活活动能力,采用四肢简化Fugl-Meyer功能量表(FMA)评价肢体的功能活动,致残/病死情况采用Rankin修订量表(mRS)评价;检测治疗前后可溶性黏附分子-1(SICAM-1),高敏C反应蛋白(hs-CRP),白细胞介素-6(IL-6),肿瘤坏死因子-α(TNF-α),S100-β蛋白(S100-β),血管生成素(ANG-1)和内皮素-1(ET-1)水平。并进行安全性评价。结果:观察组疾病疗效总有效率为89.47%,优于对照组的77.03%(χ~2=4.182,P<0.05);经重复测量的方差分析,治疗后两组患者NIHSS评分均呈下降趋势(F_(对照)=7.026,F_(观察)=7.683,P<0.05),治疗后14 d和28 d观察组NIHSS评分均低于对照组(P<0.05,P<0.01);治疗后观察组FIM和Fugl-Meyer(上、下肢)评分及总分均高于对照组(P<0.01);治疗后观察组PRO量表症状、心理维度评分及总分均低于对照组(P<0.01);经秩和检验,观察组致残/病死情况轻于对照组(P<0.05);治疗后观察组血清SICAM-1,hs-CRP,IL-6和TNF-α水平均低于对照组(P<0.01);治疗后观察组血清S100-β,ANG-1和ET-1水平低于对照组(P<0.01)。结论:在综合治疗方案中,消栓通络颗粒能减轻致残程度和提高患者和临床疗效,并能抑制SICAM-1,hs-CRP,IL-6和TNF-α炎症因子表达,调节S100-β,ANG-1和ET-1因子,起到减轻炎症反应,保护神经细胞,促进神经功能康复的作用。Objective : To discuss the clinical efficacy of early intervention of Xiaoshuan Tongluo granules on ischemic stroke (wind phlegm stagnation syndrome ) and observe its effect on inflammatory factors and neurological factors. Method: One hundred and sixty patients were randomly divided into control group and observation group by random number table. The patients in both groups received comprehensive medical treatment measures and rehabilitation measures by referring to the guide. Patients in control group got acupuncture and Chinese medicine rehabilitation measures; based on the treatment in control group, the patients in observation group also received Xiaoshuan Tongluo granules, 12 g/time, 3 times/day. The treatment course was 4 weeks in both groups. Before treatment and at day 7, day 14 and day 28 after treatment, scores of neurological deficits in the US national institutes of health (NIHSS) were graded. Activities of daily living were evaluated by functionalindependence rating scale (FIM). Functional activities of the limbs were evaluated by Fugl-Meyer functional scale (FMA). Disability or death was evaluated by modified Rankin scale (mRS). Before and after treatment, levels of soluble adhesion molecules ( SICAM-1 ), high-sensitivity C-reactive protein ( hs-CRP), interleukin-6 ( IL-6), tumor necrosis factor-α (TNF-α), S100-β protein (S100-β), angiopoietin-1 (ANG-1) and endothelin-1 (ET-1) were detected, and safety evaluation was conducted. Result: The total effective rate for the disease was 89.47% in observation group, higher than 77.03% in control group (X2 = 4. 182, P 〈 0.05 ). By analysis of variance for repeated measures, scores of NIHSS were decreased after treatment in both groups (F control = 7. 026, Fabservation=7. 683, P 〈0.05) , and at the 14th and 28th days after treatment, NIHSS score in observation group was lower than that in control group (P 〈0.05 or P 〈0.01 ). Scores of FIM ( Upper limbs, lower limbs) and Fugl-Me
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