肌少癥是老齡化社會(huì)背景下的重大疾病，研發(fā)有效治療新藥是當(dāng)前肌少癥研究領(lǐng)域的熱點(diǎn)問題，但是截至目前還沒有公認(rèn)有效的治療藥物。近年來中醫(yī)藥在肌少癥治療領(lǐng)域打下較好的基礎(chǔ)，基于中醫(yī)理論、臨床人用經(jīng)驗(yàn)及肌少癥現(xiàn)代醫(yī)學(xué)研究發(fā)掘有效中藥復(fù)方、中藥有效成分是極具潛力的方向。在綜合國內(nèi)外肌少癥治療研究指南基礎(chǔ)上，就中藥治療肌少癥的臨床定位、診斷標(biāo)準(zhǔn)、目標(biāo)人群選擇、療效評(píng)價(jià)、干預(yù)及隨訪周期、對(duì)照組選擇、質(zhì)量控制等方面展開討論，以期提高并規(guī)范我國肌少癥中藥新藥臨床試驗(yàn)方案設(shè)計(jì)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.

R286.7;R969.4

上海市衛(wèi)健委臨床研究專項(xiàng)（201940063）；上海市“科技創(chuàng)新行動(dòng)計(jì)劃”生物醫(yī)藥科技支撐專項(xiàng)（20S21902100）；上海市慢性筋骨病臨床醫(yī)學(xué)研究中心項(xiàng)目（20MC1920600）；上海申康醫(yī)院發(fā)展中心“市級(jí)醫(yī)院醫(yī)企協(xié)同臨床試驗(yàn)管理項(xiàng)目”（20CR4003B）；中西醫(yī)結(jié)合-中成藥臨床評(píng)價(jià)平臺(tái)（A1-U21-205-0103）；上海市中醫(yī)藥三年行動(dòng)計(jì)劃［ZY（2021-2023）-0211］