中医药治疗艾滋病疗效评价指标体系构建的思考与实践

Establishment of an index system to evaluate the efficacy of traditional Chinese medicines in treating HIV/AIDS

目的探索建立中医药治疗艾滋病临床疗效评价的指标体系,为全面客观评价中医药的临床疗效提供依据。方法以能够反映临床治疗效果的指标为切入点,通过对现有文献证据的分析、临床医生和典型患者的访谈,经过收集基础指标、指标分类、专家论证等研究过程,探索建立用于评价治疗效果的指标体系。结果形成了5个方面的评价指标,依次为患者自我感受的症状、生存质量、医生关注的症状与体征、终点指标、生物学指标。针对不同的治疗方案,各类指标间可以有机结合使用。结论全面客观的临床评价指标体系,为中医药治疗艾滋病疗效的判定提供了统一的标准和应用工具。

Objective To establish an index system to evaluate effect of traditional Chinese medicine （TCM） in treating HIV/AIDS and provide evidence for evaluating clinical efficacy of TCM in a comprehensive and objective manner. Methods Indexes reflecting the clinical efficacy of HIV/AIDS therapy were employed as the basis of an index system by analyzing available data,interviewing with clinicians and typical patients and collecting basic parameters and parameter classification,as well as through peer review,Results An index system was established to cover the following five aspects：subjective symptoms of the patients,their quality of life,the symptoms and signs concerned by physicians,end points,and biological parameters. Different indexes could be applied in combination according to different therapeutic regimes. Conclusion The index system established in an objective and comprehensive way may serve as a standard and unified tool for evaluating clinical efficacy of HIV/AIDS therapy with traditional Chinese medicine.