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目的:观察缺血性中风恢复期痰瘀互结兼气虚证中西医综合治疗方案,借以提高中西医结合综合治疗方案干预本病证的疗效。方法:采用多中心、区组随机、盲法、平行对照试验,运用描述性统计方法,t检验,重复测量资料方差分析等统计方法对数据进行统计分析。结果:240例患者参与随机分配,1例随机号错误,试验组3例时间超窗,1例肌酐超标被排除出全分析数据集,符合方案数据集116例。对照组4例时间超窗,1例失访,1例不良事件排除出全分析数据集,符合方案数据集人数113例。试验组与对照组比较,0周一般资料具有可比性,量表基线相平,第4周缺血性中风恢复期痰瘀互结兼气虚证证候积分表总分试验组x珋±s为35.40±6.00,对照组x珋±s为37.56±7.23,差异有统计学意义P(0.015)<0.05。结论:中西医结合综合治疗方案能有效地改善缺血性中风病恢复期痰瘀互结兼气虚证患者的中医临床症状。
OBJECTIVE: To observe the integrated traditional and western medicine treatment of phlegm and blood stasis and Qi-deficiency syndrome in the period of recovery from ischemic stroke so as to improve the curative effect of integrated traditional Chinese and western medicine in treating this disease. Methods: The data were statistically analyzed by multicentre, block randomized, blinded, and parallel controlled trials using descriptive statistics, t-test, repeated measures ANOVA and other statistical methods. Results: Two hundred and forty-four patients were randomly assigned, one was randomized incorrectly, three patients in the test group were ultra-windows, and one case of excessive creatinine was excluded from the whole analysis dataset, which met the criteria of 116 cases. In the control group, 4 cases were ultra-windows, 1 case lost to follow-up, and 1 case was excluded from the total analysis dataset, which was in line with 113 cases. The experimental group compared with the control group, 0 week general information was comparable, the baseline was flat, the first 4 weeks of recovery of ischemic stroke, phlegm and blood stasis and qi deficiency syndrome syndrome score points test group x 珋 ± s 35.40 ± 6.00 in the control group, and x 珋 ± s in the control group was 37.56 ± 7.23, with a significant difference P (0.015) <0.05. Conclusion: The integrated traditional Chinese and Western medicine treatment can effectively improve the TCM symptoms of patients with phlegm, blood stasis and qi deficiency syndrome in the recovery period of ischemic stroke.