反安慰劑效應(yīng)對(duì)新藥臨床試驗(yàn)療效評(píng)估的影響與應(yīng)對(duì)建議
發(fā)布時(shí)間:2018-05-23 11:42
本文選題:新藥臨床試驗(yàn) + 安慰劑對(duì)照 ; 參考:《中華中醫(yī)藥雜志》2015年02期
【摘要】:對(duì)一項(xiàng)新藥臨床試驗(yàn)進(jìn)行回顧性研究發(fā)現(xiàn),知情同意導(dǎo)致反安慰劑效應(yīng),嚴(yán)重干擾療效評(píng)估;功能性指標(biāo)更易受反安慰劑效應(yīng)的干擾,而客觀指標(biāo)則較為穩(wěn)定。建議嚴(yán)格選擇應(yīng)用安慰劑的適應(yīng)癥、使用客觀指標(biāo)判定療效、采用基礎(chǔ)治療與加載試驗(yàn)、謹(jǐn)慎納入人格缺陷者、暫時(shí)隱瞞等應(yīng)對(duì)反安慰劑效應(yīng)。
[Abstract]:A retrospective study of a new drug clinical trial found that informed consent resulted in anti-placebo effect, which seriously interfered with the evaluation of efficacy; the functional index was more susceptible to anti-placebo effect, while the objective index was more stable. It is suggested that the indications of placebo should be strictly selected, objective indexes should be used to judge the curative effect, basic treatment and loading test should be adopted, personality defect should be carefully included, and temporary concealment should be used to deal with the antiplacebo effect.
【作者單位】: 商洛學(xué)院;商洛職業(yè)技術(shù)學(xué)院;陜西天方科技有限責(zé)任公司;陜西中醫(yī)學(xué)院;
【分類號(hào)】:R969.4
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