[關(guān)鍵詞]
[摘要]
安慰劑的制作成功與中醫(yī)藥臨床試驗(yàn)的整體質(zhì)量以及成功直接相關(guān),因此可靠的質(zhì)量評(píng)價(jià)標(biāo)準(zhǔn)可以為成功制備安慰劑提供更有力的證據(jù)。保障中藥安慰劑的正常制作以及進(jìn)行質(zhì)量評(píng)價(jià)對(duì)于保護(hù)患者和試驗(yàn)順利進(jìn)行至關(guān)重要。就不同劑型中藥安慰劑的制作(中藥湯劑、中藥顆粒、中藥丸劑安慰劑)、中藥安慰劑的質(zhì)量評(píng)價(jià)方法(人工打分法、電子仿生測(cè)評(píng)法),中藥安慰劑的臨床使用和注意問題等進(jìn)行綜述,以期為提高中藥安慰劑的制作工藝及評(píng)價(jià)方法提供一定的參考。
[Key word]
[Abstract]
The success of placebo preparation is directly related to the overall quality and success of traditional Chinese medicine clinical trials. Therefore, reliable quality evaluation criteria can provide a stronger argument for the successful preparation of placebo. It is very important for patients to ensure the normal preparation of Chinese medicine placebos and carry out corresponding quality evaluation. The preparation of Chinese medicine placebos with different dosage forms (Chinese medicine decoction, Chinese medicine particles, and Chinese medicine pill placebos) and quality evaluation methods of Chinese medicine placebos, including artificial scoring method, electronic bionic evaluation method, clinical use of Chinese medicine placebos, and problems needing attention, were reviewed, in order to provide some references for the preparation process and evaluation of clinical Chinese medicine placebos.
[中圖分類號(hào)]
R286;R969.3
[基金項(xiàng)目]
上海市中醫(yī)藥“三年行動(dòng)計(jì)劃”[ZY(2021-2023)-0211、ZY(2021-2023)-0601];上海市教委協(xié)同創(chuàng)新中心中西醫(yī)結(jié)合-中成藥臨床評(píng)價(jià)平臺(tái)(A1-U21-205-0103);上海市申康中心示范性研究型病房建設(shè)(SHDC2022CRW010);上海市申康中心醫(yī)企融合創(chuàng)新協(xié)同專項(xiàng)(SHDC2022CRT018);上海市慢性筋骨病臨床醫(yī)學(xué)研究中心項(xiàng)目(20MC1920600)