目的：探讨三种不同中医症状赋分方法对中风恢复期中医证候疗效评价及单项中医症状改善情况的影响。方法：选取2006年1月至2006年12月在包括辽宁中医药大学附属医院等三家医院的药物临床试验机构专业科室就诊的符合该中药新药Ⅱ、Ⅲ期临床试验入选与排除标准的受试者393名的临床资料,采用双人双录入的方法将其症状积分资料按改良的赋分方法录入设计好的Epi-data2.0数据库,原赋分方法数据采用已录入完毕的临床试验资料数据库,并采用卡方检验、秩和检验等方法按中医证候疗效判定标准及单项症状疗效判定标准进行分析。结果：在总体疗效评价方面,试验组与对照组相比,原赋分方法与改良赋分方法1均无显著性差异（P=0.286,P=0.418）,而改良赋分方法2中却有显著性差异（P=0.037）;在单项症状疗效评价方面,半身不遂这一主症治疗后症状评分与基线症状评分差值的原赋分方法与改良赋分方法1中试验组和对照组相比具有显著性差异（P=0.0364）,改良赋分方法2中试验组和对照组相比无显著性差异（P=0.184）。结论：不同的症状赋分方法对中医证候疗效评价及对单项症状的疗效评价会有重大影响,有些赋分方法的改变会使试验组和对照组的比较,从具有显著性差异变成无显著性差异,或从无显著性差异变成有显著性差异,这些改变将直接关系到对中药新药疗效的评价。因此,科学地确定主症、次症的项目组合,确定主症、次症的赋分,以及主症、次症分值在症状总分中所占的比例,对中医证候疗效评价的研究,具有重大的推动作用。研究结果还显示,在中医症状赋分方法的研究中,不仅主症在症状总分中所占比例的合理性很重要,而且保证主症分值不能过高更为重要。

We investigated the relationships between syndrome evaluation and individual symptom improvement of stroke patients, using three different evaluation methods. In the study, 393 subjects were enrolled from January 2006 to December 2006 to attend phase Ⅱ and phase Ⅲ clinical trials, in line with selected and exclusion criteria of new medicine. Patients' clinical symptom score data were fed into Epidata2.0 database using double- double entry method, while the original evaluation data were recorded in the clinical trial database. Chi- square test and rank test were used for the purpose. Improved method 2 indicated a significant difference (P = 0.037) between the test group and the control group. In the context of individual symptoms, there was a significant difference (P = 0.0364) between the original and improved method 2 in main symptom score margins and baseline symptom score of the paraplegia, before and after the treatment. We have come to the following conclusions: different symptom evaluation and individual symptom evaluation methods are differed significantly in results. The differences will, thus, have a direct bearing on the evaluation of new Chinese medicines. In this context, the identification of portfolio and score of main symptoms and minor symptoms, and the symptoms' percentile in the percentage of the overall scores will improve syndrome evaluation in a significant manner.

辽宁省高等学校创新团队支持计划课题( 辽教发[2006]123 号) : 中药新药临床试验关键技术研究, 负责人: 杨关林。