Department of Medicine, University of Chicago, Chicago, IL, USA.
Clin Cancer Res. 2010 Sep 1;16(17):4446-51. doi: 10.1158/1078-0432.CCR-10-0663. Epub 2010 Aug 24.
Several recent oral oncology drugs were labeled for administration in fasted states despite the fact that food increases their bioavailability. Because this was inconsistent with the principles of oral drug delivery, we hypothesized that there were inconsistencies across therapeutic areas.
Oral agents approved by the U.S. Food and Drug Administration from January 2000 to May 2009 were included in our study. Comparison of the food labeling patterns between oncology and non-oncology drugs was made using Fisher's exact test.
Of the 99 drugs evaluated, 34 showed significant food effects on bioavailability. When food markedly enhanced bioavailability, eight out of nine non-oncology drugs were labeled "fed" to take advantage of the food-drug interaction, whereas all oncology drugs (n = 3) were labeled to be administered in "fasted" states (Fisher's exact test, P = 0.01).
Drug labeling patterns with respect to food-drug interactions observed with oncology drugs are in contradiction with fundamental pharmacologic principles, as exemplified in the labeling of non-oncology drugs. .
尽管食物会增加某些口服肿瘤药物的生物利用度，但最近有几种口服肿瘤药物仍被标注为可在禁食状态下给药。鉴于此与口服药物传递的原则相悖，我们假设在不同治疗领域中存在不一致的情况。
本研究纳入了 2000 年 1 月至 2009 年 5 月期间经美国食品和药物管理局批准的口服药物。采用 Fisher 确切检验比较肿瘤药物与非肿瘤药物的食物标签模式。
在所评估的 99 种药物中，有 34 种药物的生物利用度受到食物的显著影响。当食物明显增强生物利用度时，9 种非肿瘤药物中有 8 种被标注为“进食时”服用以利用药物-食物相互作用，而所有肿瘤药物（n=3）均被标注为在“禁食”状态下给药（Fisher 确切检验，P=0.01）。
与非肿瘤药物的标签相比，观察到的肿瘤药物与食物-药物相互作用的药物标签模式与基本药理学原理相矛盾。
