生物等效性试验中受试者食用高脂餐的调查研究

Study on the investigation of high-fat meal in fed bioequivalence studies

目的评价餐后生物等效性试验中受试者食用高脂餐的情况,总结高脂餐食谱制订的考虑因素。方法对完成首都医科大学附属北京朝阳医院Ⅰ期临床试验研究室(以下简称"本中心")两周期、双交叉、餐后生物等效性试验的33例健康受试者的高脂餐食谱、就餐时间、进食量进行分析,对食用西式高脂餐的21例受试者进行就餐感受的问卷调查,调查内容包括食用高脂餐的感受、餐后饱腹感、餐后有无不适、对于中西式高脂餐的选择和对西式高脂餐中接受度不高的成分。结果本中心选择的中式、西式高脂餐对于受试者的进食量均无影响;57. 14%的受试者倾向于食用西式高脂餐,42. 86%的受试者倾向于食用中式高脂餐;西式高脂餐中接受度不高的成分主要有黄油(33. 33%)、纯牛奶(14. 29%)、沙拉酱(14. 29%)、美式培根(9. 52%)。结论本中心选择的中西式高脂餐基本满足试验需要。综合考虑指导原则要求、受试者就餐感受、避免接受度不高的食物成分等因素,制订更为合理的高脂餐食谱,从而提高临床试验质量。

Objective To evaluate the consumption of high-fat meals in fed bioequivalence studies,and to summarize the consideration factors for making the test meal. Methods Meal composition,eating time and food intake of 33 healthy subjects in the two-period,two-sequence crossover bioequivalence (BE) studies under fed conditions were researched. A questionnaire survey was conducted among 21 subjects who ate Western-style high-fat meal. The survey included the dining experience,postprandial fullness,postprandial discomfort,choice of Chinese-style and Western-style high-fat meals,and not high acceptance ingredients in Western-style high-fat meal. Results Both Chinese-style and Western-style high-fat meals had no effect on the intake of the healthy subjects. The results of the questionnaire showed that 57. 14% of the subjects preferred to eat Western-style high-fat meal,while 42. 86% of subjects preferred to eat Chinese-style high-fat meal. Not high acceptance ingredients in Western-style high-fat meal were butter (33. 33%),milk (14. 29%),salad dressing (14. 29%)and bacon (9. 52%). Conclusion Chinese-style and Western-style high-fat meals we used in the BE studies basically meet the requirements. In order to improve the quality of clinical trials,we should make a more reasonable diet of high-fat meals by considering the requirements of guidelines,the dining experience of the subjects and avoiding the food ingredients with not high acceptance.