中药序贯疗法治疗外感发热临床试验设计

Traditional Chinese Medicine Clinical Trial Design of Sequential Therapy in the Treatment of Exogenous Fever

临床试验设计是临床试验中的关键环节之一。规范化的临床试验设计是完成临床试验的前提和基础。中药疗效的优势是通过整体调节来改善证候的失衡,提高患者的生存质量。中药的序贯疗法讲的是量效关系,它的研究不能脱离临床,离开证候、症状。应建立以临床疗效评价为中心,采用现代科学技术,临床与试验相结合,探索中药序贯意义。证候是中医诊断与疗效评价的核心所在,撇开证候的改善,完全用西医的指标体系评价中医的疗效,无异是本末倒置,不利于中医药的发展。因此文章通过对外感发热的临床试验设计来达到完成中药序贯疗法临床试验的成功。

Clinical trial design is one of the key links in clinical trials.Standardization of clinical trial design is the prerequisite and basis for completion of the clinical trial.Advantage is through the whole regulation to improve traditional Chinese medicine syndromes imbalance as well as the quality of life of patients.Sequential therapy of traditional Chinese medicine tells of the dose-effect relationship,it could not be isolated from clinical research,leaving syndrome manifestations and symptoms.The clinical evaluation for the centre should be established,using modern science and technology,combining clinical and experimental practice,exploring sequential therapy significance of traditional Chinese medicine.Syndrome manifestation is a diagnosis of traditional Chinese medicine and clinical evaluation of core,leaving aside the syndrome manifestations improved,completing evaluation of curative effect of traditional Chinese medicine with Western medicine index system,which would be putting the cart before,and it is not conducive to the development of Chinese medicine.Therefore this article completed the success of sequential therapy in the clinical trials of traditional Chinese medicine through external fever clinical trials design.