芪参通络增智汤对缺血性中风急性期患者认知障碍的干预研究

A study of Qishen Tongluo Zengzhi decoction for intervention of cognitive impairment in patients with acute phase of ischemic stroke

目的：观察芪参通增智络汤对缺血性中风急性期患者认知障碍的影响。方法采用前瞻性随机临床对照研究，选择山东中医药大学附属日照市中医医院神经内科、康复科收治的130例气虚血瘀兼痰湿停滞型缺血性中风急性期认知障碍患者，按随机数字表法分为治疗组和对照组，每组65例。两组均给予内科常规治疗，治疗组在常规治疗基础上加服芪参通络增智汤〔组成：黄芪30 g，太子参30 g，三七10 g，鸡血藤25 g，水蛭粉（冲服）3 g，地龙10 g，赤芍12 g，当归12 g，桃仁10 g，红花10 g，川牛膝12 g，漏芦10 g，泽泻6 g，石菖蒲9 g，远志9 g，香附10 g，豨莶草15 g〕每日1剂；对照组在常规治疗基础上静脉滴注奥拉西坦注射液4.0 g，每日1次。两组总疗程均为21 d。采用简易智力状态检查量表（MMSE）、蒙特利尔认知量表（MoCA）评分评定两组患者治疗前后的认知功能，记录P300波潜伏期、波幅。结果最终治疗组纳入62例，对照组纳入63例。两组治疗前MMSE评分、MoCA评分、P300波潜伏期和波幅比较差异均无统计学意义（均P＞0.05）。两组治疗后MMSE评分、MoCA评分和P300波幅均较治疗前升高，P300波潜伏期较治疗前缩短，且以治疗组变化更显著〔MMSE评分（分）：25.33±2.32比21.68±2.29，MoCA评分（分）：26.61±3.06比22.40±2.93，P300波潜伏期（ms）：349.62±20.01比371.87±19.63，P300波波幅（μV）：8.70±2.92比5.72±2.33，均P＜0.01〕。结论芪参通络增智汤能有效干预缺血性中风急性期患者的认知障碍，改善其认知功能。

ObjectiveTo observe the effect of Qishen Tongluo Zengzhi decoction on cognitive impairment in patients with acute phase of ischemic stroke.Methods A prospective randomized controlled trial was conducted, and 130 patients with acute phase of ischemic stroke and cognitive impairment accompanied by Qi deficiency and blood stasis and stagnationof phlegm-dampness syndrome admitted into the Neurology and Rehabilitation Departments of Rizhao Hospital of Traditional Chinese Medicine（TCM） Affiliated to Shandong University of TCM were randomly divided into treatment group and control group, 65 cases in each group. In the two groups, conventional internal treatment was given to all patients, and in the treatment group, additionally the Qishen Tongluo Zengzhi decoction was administered orally（composition： astragalus membranaceus 30 g, radix pseudostellariae 30 g, notoginseng 10 g,spatholobus stem 25 g, hirudo 3 g, pberetima 10 g, radix paeoniae rubra 12 g, Chinese angelica 12 g, peach kernel 10 g, carthamus tinctorious 10 g, achyranthes 12 g, radix rhapontici 10 g, rhizoma alismatis 6 g, Acorus gramineus Soland 9 g, polygala root 9 g, rhizoma cyperi 10 g, herba siegesbeckiae 15 g）,one dose a day. While in the control group, oxiracetam 4.0 g intravenous drip was given, once a day. The whole course was 21 days in both groups. Before and after treatment, the cognitive function of all the patients in two groups was assessed by Mini-Mental State Examination（MMSE）and Montreal Cognitive Assessment（MoCA） scores, and incubation period and amplitude of P300 wave were recorded.Results Finally 62 cases were in treatment group and 63 cases in control group. Before treatment, the comparisons of the MMSE score, MoCA score and P300 latent period and amplitude between the two groups had no statistically significant differences（allP〉0.05）. After treatment in the two groups, the MMSE score, MoCA score and P300 wave amplitude were elevated, P300 latency period was shortened compared with those before treatment, and the changes were more prominent in treatment group〔score of MMSE： 25.33±2.32 vs. 21.68±2.29, score of MoCA（score）： 26.61±3.06 vs. 22.40±2.93, P300 wave incubation period（ms）： 349.62±20.01 vs. 371.87±19.63, P300 wave amplitude（μV）： 8.70±2.92 vs. 5.72±2.33,allP〈0.01〕.ConclusionQishen Tongluo Zengzhi decoctioncan effectively intervene cognitive impairment in patients with acute phase of ischemic stroke, and improve their cognitive function.