de la Rey N, Schall R, Luus H G, Meyer B H, Müller F O
FARMOVS Institute for Clinical Pharmacology and Drug Development, Department of Pharmacology, University of the Orange Free State, Bloemfontein, Republic of South Africa.
Int J Clin Pharmacol Ther Toxicol. 1993 Sep;31(9):435-9.
When certain drugs are taken concomitantly with an oral contraceptive, the efficacy of the contraceptive may be obtunded, and pregnancy may ensue. Since the function of oral contraceptives is to suppress ovulation, the risk of ovulation is an important parameter in clinical studies investigating interactions between drugs and oral contraceptives. The purpose of this paper is to compare a crossover design, and a new study design used for assessing a possible interaction between a drug and an oral contraceptive, and to discuss the statistical issues involved in the planning and evaluation of the results of such studies.
当某些药物与口服避孕药同时服用时，避孕药的功效可能会减弱，进而可能导致怀孕。由于口服避孕药的作用是抑制排卵，排卵风险是研究药物与口服避孕药之间相互作用的临床研究中的一个重要参数。本文的目的是比较一种交叉设计和一种用于评估药物与口服避孕药之间可能存在的相互作用的新研究设计，并讨论此类研究在规划和结果评估中涉及的统计学问题。
