急性缺血中风阴类证综合治疗方案的初步研究

Preliminary Analysis of Comprehensive Therapeutic Regimen for Acute Ischemic Stroke Patients with Yin Series-syndromes

目的:观察中西医结合综合治疗方案治疗非溶栓指征急性缺血中风阴类证的临床疗效。方法:将87例患者随机分为2组,试验组在对症治疗基础上加用华佗再造丸、灯盏细辛注射液与中药汤剂治疗,对照组在对症治疗基础上加用胞二磷胆碱注射液与中药安慰剂治疗。观察美国国立卫生研究院卒中量表(NIHSS)评分、Barthel指数(BI)、修正的RANKIN标准(mRS)等级评分、中医症征积分等相关指标。结果:治疗后2组NIHSS评分基本恢复正常率、中医症征积分比较,差异均无显著性意义(P>0.05)。发病后90天随访,2组BI、mRS基本恢复正常率比较,差异均无显著性意义(P>0.05)。结论:尚未得出中西医结合综合治疗方案优于一般西医治疗方案的结论。应进一步扩大样本,加强各环节质控,减少失访和脱落病例,增加各种类型患者的纳入,以期客观评价中医药治疗急性缺血中风的优势和作用环节。

Objective: To observe the therapeutic effect of traditional Chinese medicine (TCM) combined with western medicine (WM) for acute ischemic stroke patients with Yin series-syndromes,which have no operation indications. Methods: Eighty-seven qualified patients were randomized into 2 groups: the treatment group was given symptomatic treatment combined with Huatuo Zaizao Pills,Dengzhan Xixin Injection and decoction of herbal medicine,and the control group was given symptomatic treatment combined with Citicoline Injection and placebo of herbal medicine. After treatment,the neurologic score evaluated by the National Institutes of Health Stroke Scale (NIHSS),Barthel index (BI),modified Rankin Scale (mRS) score,TCM score of stroke were observed. Results: After treatment,the difference of the rate for NIHSS score recovering to the normal and TCM score was insignificant between the two groups ( P > 0. 05 ). The results of follow-up 90 days after the onset showed that the activities of daily life and mRS score in the treatment group did not differ from those in the control group ( P > 0. 05 ).Conclusion: We can not obtain the result that TCM combined with WM has a better effect than routine western medicine for acute ischemic stroke patients with Yin series-syndromes. To give the objective evaluation of Chinese medicine for acute ischemic stroke,we should enlarge the sample size,strengthen the quality control of treatment course,decrease the number of dropped-out patients and the patients failing in follow-up,and increase the adoption of patients with various syndromes.