中西医结合综合方案对急性脑出血患者临床疗效及中医证候评分的影响--404例多中心临床试验

The effect of comprehensive protocol of integrated Chinese and western medicine on clinical curative effect and Chinese medicine symptom complex score of acute intracerebral hemorrhage patients with 404 cases of muificentre clinical trials

目的探讨中西医结合综合方案对于急性脑出血的临床疗效。方法采用多中心、单盲随机对照试验的设计方法,404例患者分别用中西医结合综合(试验组199例)和西医加中药安慰剂(对照组205例)治疗。在28 d、3个月分别进行神经功能缺损评分(nerve functional failure,NF)、愈显率的比较,在14、21、28 d进行中医证候评分的比较。结果与对照组相比,试验组在治疗后28 d及3个月后随访,NF评分的改善有显著性差异(P<0.05);28 d后愈显率无显著性差异(P>0.05),3个月后愈显率有显著性差异(P<0.01)。治疗后14、21 d试验组中医证候评分较对照组的改善有显著性差异(P<0.05),治疗后28 d,两组比较无差异(P>0.05)。结论中西医结合综合治疗能改善急性脑出血患者的NF评分、提高随访愈显率。

Objective To explore the effect and safety of a comprehensive protocol of integrated Chinese and western medicine （IC- WM） on treating acute intracerebral hemorrhage （AICH） with nerve functional failure （ NF）, good improvement rate, Chinese medicine symptom complex score as the evaluate indexes adopting yin and yang dialectics of method. Methods A multi-centers, single blinded, random and control clinical trail was adopted. 404 AICH patients were divided into the treatment group （199 cases） treated with ICWM protocol, and the control group （205 cases） treated with Western medicine plus placebo to compare NF and good improvement rate between two groups at the 28th day and the third month and to compare the Chinese medicine symptom complex score hetween two groups at the 14th, 21st and 28th day. Results There was significant difference in NF hetween two groups at the 28th day and 3rd month after treatment （ P 〈 0. 05） , hut there was no significant difference （P 〉0. 05） at the 28th day and there was significant difference （P 〈0. 01 ） at the 3rd month in good improvement rate between two groups. And the treatment group had better Chinese medicine symptom complex score than control group 14 and 21 days after treatment （ P 〈 0. 05 ）, hut there was no significant difference between two groups 28 days after treatment （ P 〉 0. 05）. Conclusions ICWM has better effect on NF, good improvement rate and Chinese medicine symptom complex score than western medicine plus placebo.