中风病急性期综合治疗的疗效评价指标探讨

目的:探索能反映中风病急性期中医药综合干预特色和优势的临床疗效评价指标体系。方法:采用多中心随机单盲对照试验,将纳入的急性高血压性脑出血患者随机分为试验组和对照组,试验组采用常规西医治疗及中医辨证疗法,对照组采用常规西医疗法及中药安慰剂进行干预。在入组治疗后第7、14、21、28天以及随访3个月后的5个时点分别进行指标评定。指标有中医证候指标(简称ZH)、格拉斯哥昏迷评定(Glasgowcoma standard,GCS)、神经功能缺损评分(nerve functional failure,NF)、生活能力状态(activity of daily living,ADL)、日常生活活动量表(Barther index,BI)、生存质量(quality of life index,QLI)和社会功能活动问卷(functional activities questionnaire,FAQ)。结果:共纳入404例患者,试验组199例,其中阳类证178例,阴类证21例,对照组205例,其中阳类证165例,阴类证40例。治疗3个月后,试验组愈显率(基本痊愈 显著进步)为86.5%,对照组为73.6%,两组比较差异有统计学意义(P<0.01)。指标的反应度表明GCS评分对病人的敏感性从第7天开始升高,至第14天、21天对全部病人敏感。NF的反应度在第14天、21天、28天对全部病人的敏感性较高。BI指数评分在第21天对轻度、中度病人敏感,随访3个月后对轻度病人敏感。QLI评分在第21天对轻度、中度病人及随访3个月后的轻度病人敏感。FAQ评分在第21天、随访3个月后对轻度病人敏感。ADL评分在第28天对所有病人及随访3个月后的轻度病人敏感。在第0~7天、14天、28天,ZH评分对全部病人的反应度均较好。主成分分析显示上述7个指标在发病时(第0~7天)、第21天及随访3个月后都能较好地反映中风病人的病情并评价出血中风病人的疗效,其中ZH评分和FAQ评分在第28天的贡献度更大。结论:对于出血中风急性期病人,所选择的7个指标(GCS、NF、BI、QLI、FAQ、ADL、ZH)均有较好的反应度,其中第21天的反应度最好。ZH评分会随病情波动,相对于其余指标更符合病情变化。

Effect evaluation for comprehensive treatment of acute stage of stroke

OBJECTIVE: To explore the clinical evaluation system reflecting the superiority and characteristics of comprehensive traditional Chinese medicine (TCM) therapy for acute stroke. METHODS: A randomized controlled trial with single blind in various therapeutic centers was applied on the patients with the acute stage of hemorrhagic stroke due to hypertension, who were allocated to the trial group and the control group. The trial group accepted the general Western medicine therapy and differential treatment of traditional Chinese medicine based on stage classification. Patients in the control group were treated with the general Western medicine and the placebo of traditional Chinese herbal medicine. The treatment effect was assessed at the 7th day, 14th day, 21st day, and 28th day of post-treatment and after 3-month follow-up. The clinical evaluation system included the syndromes of TCM (ZH), Glasgow coma standard (GCS), nerve functional failure (NF), activity of daily living (ADL), Barther index (BI), quality of life index (QLI) and functional activities questionnaire (FAQ). RESULTS: Four hundred and four patients with acute stroke were included. There were 178 cases with yang-syndrome and 21 cases with yin-syndrome in the trial group (n=199), and there were 165 cases with yang-syndrome and 40 cases with yin-syndrome in the control group (n=205). The rates of recovery and obvious improvement after 3-month treatment in the trial group and the control group were 86.5% and 73.6% respectively. There was significant difference between the two groups (P<0.01). The response sensitivity of the effect items indicated that the sensitivity of GCS began to increase from the 7th day and was high at the 14th day and the 21st day for all patients. The response sensitivity of the NF scale was high for all patients at the 14th day, the 21st day and the 28th day. The BI scale and the QLI scale were sensitive to the patients with light and middle stage of stroke at the 21st day, and were sensitive to the patients with light stage of stroke after 3-month follow-up. The FAQ scale was sensitive to the light stroke at the 21st day and after 3-month follow-up. The ADL scale was sensitive to all patients at the 28th day and the patients with light stage of stroke after 3-month follow-up. The ZH scale was sensitive to all patients from 0 to 7d, the 14th day, and the 28th day. The principle components analysis indicated these 7 items could reflect the condition of stroke from 0-7d, the 21st day and after 3-month follow-up, and could be used to evaluate the therapeutic effect of hemorrhagic stroke. ZH scale and FAQ scale were more sensitive than other effect items at the 28th day. CONCLUSION: The seven items (GCSbNFbBIbQLIbFAQbADLbZH) have high sensibility to all patients in the acute stage of hemorrhage stroke especially at the 21st day. The ZH score will change in accord with the condition of stroke, and is appropriate to reflect the condition of stroke. It is believed that the seven items can form the system of effect evaluation in different stages of stroke, and the ZH scale is a very important item.