回顾性治疗结局研究设计及其在中医学领域的应用展望

Design of Retrospective Treatment Outcome Research and Its Application in Traditional Chinese Medicine

回顾性治疗结局(RTO)研究是一种通过回顾性问卷调查或访谈,对已经出现临床结局的某一特定人群在某一特定时期的暴露因素或接受的治疗措施进行资料收集,分析各暴露因素或治疗措施与疾病结局之间相关性的观察性研究。其可用于初步评估治疗措施对特定人群已出现的疾病结局的有效性和安全性,识别与疾病结局关联较强的治疗措施,从而为后续的前瞻性临床试验提供线索。系统介绍RTO的概念、起源与方法学设计要点,对比RTO与其他观察性研究的异同,分析RTO的应用现状与展望、优势与局限性。在此基础上提出,在中医药领域可采用RTO研究筛选治疗某疾病的不同组方/配伍比例/剂量/剂型/给药方式的中药,初步评价中医特色疗法治未病的效果,遴选新发突发传染病的不同治疗方案等,以期为RTO研究在中医药领域的应用提供方法学参考。

Retrospective treatment outcome(RTO)is a kind of observational study that retrospectively collects data about the exposure factors or the interventions over a period of time in certain people who have already had clinical outcomes through questionnaire survey or interview,and analyzes the correlation between exposure factors or interventions and disease outcomes.RTO can initially evaluate the effectiveness and safety of the interventions for the specific group of people,and identify the treatments with the highest association with disease outcomes,thereby providing clues and evidence for subsequent prospective clinical trials.This study systematically introduced the concept,origin and methodological items of RTO,compared the similarities and differences between RTO and other observational studies,described the application status and prospects,advantages and limitations of RTO.It is proposed that future applications of RTO in traditional Chinese medicine(TCM)include such as screening out the Chinese material medica with different prescriptions/compatibility/dosage/preparations/modes of administration,evaluating the effect of TCM-specific therapies when treating disease before it arises,selecting the varied treatment options for emergent and novel infectious diseases.All these provide methodological references for the application of RTO in conducting TCM researches.