由于方法學(xué)和中藥新藥臨床特點，中藥安慰劑在臨床研究使用較為廣泛。中藥安慰劑質(zhì)量和模擬效果，影響整個中藥新藥臨床研究的質(zhì)量和有效性評價的客觀性與準(zhǔn)確性。從中藥安慰劑制作的技術(shù)難度，與受試藥物相似性，客觀化、規(guī)范化模擬效果評價，服用依從性等方面探討目前中藥新藥臨床試驗中安慰劑的主要問題。在此基礎(chǔ)上，提出了加強(qiáng)安慰劑制作技術(shù)和可用原輔料研究；出臺安慰劑模擬效果評估指導(dǎo)原則，引導(dǎo)研發(fā)企業(yè)加強(qiáng)相關(guān)研究；增加客觀性評價指標(biāo)設(shè)置，提高臨床研究結(jié)果的可信度；根據(jù)不同研究階段、劑型和給藥方式，通過流程設(shè)計和管理，彌補(bǔ)中藥安慰劑模擬效果不佳等缺陷的建議和思考。

Due to the methodology and clinical characteristics of traditional Chinese medicine (TCM), TCM placebo is widely used in clinical research. The quality and simulation effect of TCM placebo affect the quality of the whole clinical research of new TCM and the objectivity and correctness of effectiveness evaluation. This article discusses the main problems of placebo in the clinical trials of new drug of TCM from the aspects of technical difficulty in the preparation of TCM placebo, similarity with the tested drug, objective and standardized simulation effect evaluation, medication compliance and so on. On this basis, it is proposed to strengthen the research on the preparation technology and available raw and auxiliary materials of placebo. Issue guidelines for placebo simulation effect evaluation to guide research and development enterprises to strengthen relevant research. Increase the setting of objective evaluation indexes and improve the reliability of clinical research results. Make up for the poor simulation effect of TCM placebo according to different research stages, dosage forms and administration methods with process design and management.

R944.5

國家自然科學(xué)基金資助項目(81403414);上海市"科技創(chuàng)新行動計劃"生物醫(yī)藥科技支撐專項(20S21902100、22S21900700);上海市慢性筋骨病臨床醫(yī)學(xué)研究中心項目(20MC1920600);上海市衛(wèi)計委"杏林新星"項目(ZYSNXD011-RC-XLXX-20130049);上海市衛(wèi)健委臨床研究專項(201940063);上海市教委資助項目(A1-U21-205-0103);上海申康醫(yī)院發(fā)展中心臨床三年行動計劃項目(SHDC2020CR1051B);上海市級醫(yī)院醫(yī)企協(xié)同臨床試驗管理項目(20CR4003B)