治疗肌少症中药新药临床试验设计的关键问题

Key issues in clinical trial design of new traditional Chinese medicine for treating sarcopenia

肌少症是老龄化社会背景下的重大疾病,研发有效治疗新药是当前肌少症研究领域的热点问题,但是截至目前还没有公认有效的治疗药物。近年来中医药在肌少症治疗领域打下较好的基础,基于中医理论、临床人用经验及肌少症现代医学研究发掘有效中药复方、中药有效成分是极具潜力的方向。在综合国内外肌少症治疗研究指南基础上,就中药治疗肌少症的临床定位、诊断标准、目标人群选择、疗效评价、干预及随访周期、对照组选择、质量控制等方面展开讨论,以期提高并规范我国肌少症中药新药临床试验方案设计水平。

Sarcopenia is a major disease in the context of aging society. The research and development of effective new drugs is a hot issue in the field of sarcopenia, but up to now, there is no recognized effective drug for the treatment of sarcopenia. In recent years, Chinese medicine has accumulated a good foundation in the field of treatment of sarcopenia, based on the theory of traditional Chinese medicine, clinical human experience, and modern medical research on sarcopenia, it is a promising direction to explore effective traditional Chinese medicine compounds and effective ingredients. Based on comprehensive domestic and international guidelines for the treatment of sarcopenia, this article will discuss the clinical orientation, diagnostic criteria, target population selection, efficacy evaluation, intervention and follow-up period, control group selection and quality control of traditional Chinese medicine in the treatment of sarcopenia, to improve the level and standardization of clinical trial scheme design of new Chinese medicine for sarcopenia in China.