Percival-Smith R K, Frohlich J, Jones W N, Abercrombie B A
Student Health Service, University of British Columbia, Vancouver, Canada.
Contraception. 1988 Jul;38(1):19-26. doi: 10.1016/0010-7824(88)90092-3.
This study was designed to determine whether mean values for lipids and lipoproteins changed during the 21 days on oral contraceptive (OC) preparations and during the seven days off the pills. The design allowed for comparison of the effects of Triphasil and Ortho 777 and for examining the consistency over two pill cycles. The mean values for total cholesterol, HDL-cholesterol, LDL-cholesterol and HDL3-subfraction were consistently lower on Day 20 when compared to Day 2 (p less than 0.05) for the two cycles and higher on Day 2 of Cycle II when compared to Day 20 of Cycle I. This fall-rise-fall pattern was consistent for cholesterol in 17 out of 28 of the women studied and these women were heavier (p less than 0.05), had a greater mean Quetelet Index (p less than 0.05) and had been using OCs for a shorter mean period of time (p less than 0.05). Consistently higher apolipoprotein A1 mean values were found on Day 20 of both cycles for Triphasil users compared to Ortho 777 users (p less than 0.02). This paper discusses the importance of these findings in relation to study design when measuring for differences between OC preparations and changes over time.
本研究旨在确定口服避孕药(OC)服用21天期间及停药7天期间血脂和脂蛋白的均值是否发生变化。该设计允许比较三相片和炔诺酮片的效果,并检验两个服药周期的一致性。两个周期中,与第2天相比,第20天总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白3亚组分的均值持续降低(p<0.05),而与周期I的第20天相比,周期II的第2天这些指标均值更高。在28名研究对象中,17名女性的胆固醇呈现这种先降后升再降的模式,这些女性体重更重(p<0.05),平均克托莱指数更高(p<0.05),且服用OC的平均时间更短(p<0.05)。与服用炔诺酮片的使用者相比,服用三相片的使用者在两个周期的第20天载脂蛋白A1均值持续更高(p<0.02)。本文讨论了这些研究结果在测量OC制剂之间差异及随时间变化时对于研究设计的重要性。