中医证候主症、次症地位在中药临床试验中的体现

Status of Main Symptom and Minor Symptom of TCM Syndromes in Clinical Trial

目的：通过回顾3种不同疾病的中药新药临床试验中中医单项症状痊愈率,确定中医证候的主症、次症在总体疗效评价中的地位。方法：分别选取符合试验入选与排除标准的受试者临床资料,其中医证候赋分数据应用已录入完毕的临床试验数据库,通过计算入组时症状评分不为＂0＂而出组时症状评分为＂0＂的病例数,统计出单项症状痊愈率,用以评价各疾病中医主症、次症单项症状的疗效。结果：治疗胃溃疡、中风、慢性盆腔炎中药临床试验的中医症状的次症痊愈率优于主症痊愈率,其中治疗慢性盆腔炎的临床试验的次症痊愈率为55%～78%,而主症痊愈率为39%～41%;治疗中风的临床试验的次症痊愈率为37.2%～48.0%,而主症痊愈率在0.5%～33.6%;治疗胃溃疡的临床试验的次症痊愈率为80%～88%,而主症痊愈率为74%～80%。结论：中药临床试验中特定疾病中医证侯的主症多与该疾病的西医主要症状、体征一致,对于难以彻底根治的疾病,药物对于这些主症的改善就显得有限。而临床试验中中医证侯的次症出现了较高的痊愈率则反映了中药在改善临床症状方面的补充作用。临床试验当中除了关注中医证侯的主症改善情况,更应该注意观察药物治疗次症的疗效,这样才能寻找到真正体现中药新药治疗特色的靶点。

Objective ： To review the cure rate of individual symptoms in three different clinical trials of traditional Chi- nese medicine to determine the status of main symptom and minor symptom of TCM syndromes on the overall efficacy eval- uation in clinical trial. Methods： The subjects was chosen in accordance with inclusion and exclusion criteria of certain diseases, and their clinical data of symptom score was input to Epidata 2.0 database by double-double entry method ac- cording to the modified method of symptom recording, the original evaluation data had been recorded in the clinical trial database. The number of cases that the symptom scores was 0 when out of the group while above 0 before into the trial were counted to calculate the cure rate in order to evaluate the efficacy of the main symptoms and the minor symptoms of certain disease. Results：The cure rate of minor symptoms in the clinical trials of chronic pelvic inflammatory, stroke, gastric ulcer was better than that of the main symptoms ,for example the cure rate of minor symptoms in chronic pelvic inflammatory was 55% to 78% ,while the cure rate of main symptoms was 39% to 41% ; the cure rate of minor symptoms in stroke was 37.2% to 48.0% while that of the main symptoms was between 0.5% to 33.6% ; the cure rate of minor symptoms in gastric ulcer was 80% to 88% while that of the main symptoms was 74% to 80%. Conclusion： The judgment of the clinical symptoms should focus on the observation of the improvement of specific symptoms and main symptoms. The changes of specific symptoms are to determine the efficacy of the medicine; however,the changes of specific and main symptoms are to determine the efficacy of TCM symptoms. TCM syndromes should focus on the changes in main symptoms ,for the minor symptoms can not accurately reflect the treatment of the disease, so it may not truly reflect the clinical efficacy and characteristics of the traditional Chinese medicine.