摘要
目的客观评价全营养配方临床试验中安慰剂的模拟效果,为特殊医学用途配方食品临床试验安慰剂的制备提供参考。方法运用人工打分法,由评判者独立从外形、颜色、气味和口味四个方面对试验产品的可能性,安慰剂与试验产品的相似性和一致性进行判断。结果试验产品组的猜测正确率和猜测错误率为40%和50%,安慰剂组的猜测正确率和错误率为10%和70%。与参比产品相比,试验产品和安慰剂外形、颜色、气味和口味方面的评分分别为(9.75±0.79)分比(6.63±3.73)分、(9.75±0.79)分比(7.25±3.99)分、(8.75±3.17)分比(8.50±3.16)分和(9.00±1.29)分比(7.75±2.99)分;同一评判者对不同产品在外形、颜色、气味和口味评价的一致性,分别为80%、80%、80%和90%。结论本案例的安慰剂制备较为成功,在颜色、气味、口味上与试验产品较为接近,但在外形上评分有一定差别。特殊医学用途配方食品临床试验可借鉴本案例进行安慰剂制备和评价。
Objective To evaluate the simulation effect of the placebo in a clinical trial of whole nutrition formula,and to inform the preparation of placebo in the clinical trial of foods for special medical purposes.Methods Evaluators assessed the appearance,color,smell,and taste,and made the distinction between the placebo and the experimental product independently.The similarity and consistency between the placebo and experimental product were also assessed using a manual scoring method.Results In the group assessing experimental product,40%evaluators made the correct judgment while 50%did not.In the group assessing placebo,10%evaluators made the correct judgment while 70%did not.Compared with the reference product,the experimental product and placebo were scored 9.75±0.79 vs.6.63±3.73 for appearance,9.75±0.79 vs.7.25±3.99 for color,8.75±3.17 vs.8.50±3.16 for smell,and 9.00±1.29 vs.7.75±2.99 for taste.The intra-evaluator consistency rate for the appearance,color,smell and taste of different products was 80%,80%,90%,and 90%,respectively.Conclusions The blinding effect of placebo was relatively satisfactory in the trial we assessed.The placebo was comparable with the experimental product in terms of color,smell,and taste,but not appearance.The approaches for preparing and evaluating placebo in this clinical trial could give some clues for similar trials involving foods for special medical purposes.
作者
苑杰
陈夏燕
李会娟
Yuan Jie;Chen Xiayan;Li Huijuan(Peking University Clinical Research Institute,Beijing 100191,China)
出处
《中华临床营养杂志》
CSCD
2023年第5期307-311,共5页
Chinese Journal of Clinical Nutrition
关键词
安慰剂
盲法
临床试验
模拟效果
评价
Placebo
Blinding
Clinical trial
Simulation effect
Evaluation
