基于多次临床试验的中医药疗效评价研究思路

多数研究报告所显示的中医药治疗疗效比西药低,不是中医药临床疗效的确切结果和最终结果,而是用西医思维利用现有临床疗效评价方法的结果。从一种治疗方法治疗后出现的有效与无效人群的差别之中找到规律才是中医辨证论治的重要体现。将从该差别中找到的与疗效相关的要素列入纳入和排除标准,再进行二次临床验证试验乃至多次临床试验,追求中医药治疗适应症的针对性是中医辨证论治临床疗效评价的主要方法。

Methodological thoughts on clinical efficacy evaluation with multiple clinical trials

Some clinical trials showed that the efficacy of traditional Chinese medicine was not good as the efficacy of western medicine even thoush clinical doctors have been using traditional medicine effectively. Such a result originated from improper application of western medical thoughts in routine clinical efficacy evaluation. To find differences from effective cases with non-effective cases and put the differences into the indication of next clinical trial would conform to the differentiation theory in traditional Chinese medicine. The differences, whether positively or negatively related to the efficacy, could be obtained from all information including symptom evaluation, tongue appearance, pulse feeling and biological parameters with non-linear and other statistical methods. More specific indication finding would be the key task for clinical efficacy evaluation via multiple clinical trials.