Kakis G, Powell M, Marshall A, Woutersz T B, Steiner G
Bay Centre for Birth Control, University of Toronto, Ontario, Canada.
Int J Fertil Menopausal Stud. 1994 Sep-Oct;39(5):283-91.
Oral contraceptive formulations can alter plasma lipid and lipoprotein levels; however, lower-dose triphasic tablets show only minimal metabolic effects during 6 or 12 cycles of use. Involvement of lipids in chronic cardiovascular conditions, plus long-term use of oral contraceptive tablets, prompted this first 24-cycle study of the effect of triphasic formulations on young women.
69 women assigned randomly to an ethinyl estradiol/levonorgestrel formulation (Triphasil) or an ethinyl estradiol/norethindrone formulation (Ortho 7/7/7) and 25 control women (no hormonal contraception) had blood sampled for lipids and lipoproteins pre-trial, and at 3- or 6-cycle intervals for 24 cycles.
At cycle 24, control women experienced no significant change from baseline in any variable except apolipoprotein B (apo B). Plasma apo B increased 42% (P < .01), reflecting the LDL apo B increase (42%, P < .01). Both combination formulations significantly increased apo B (plasma, VLDL, IDL and LDL); the increases ranged between 47% and 84%. Plasma apo A1 rose (15%, P < .001) in the Ortho 7/7/7 group only. Plasma and LDL triglycerides were increased significantly (P < .001) by the norethindrone product, 43% and 81%, respectively, and plasma and LDL cholesterol, 14% and 28%, respectively. Cholesterol decreased in all other subfractions, including HDL (11%, P < .01). HDL cholesterol decreased significantly in the Triphasil group (8%, P < .05); no other cholesterol subfractions changed significantly. All cycle-24 lipid and lipoprotein values remained well within respective normal ranges.
Although 2-year exposure to the triphasic oral contraceptive formulations changed the lipid risk factors for cardiovascular disease only within normal ranges, there remains potential for long-term health effects when compounded with other risk factors.
口服避孕药制剂可改变血浆脂质和脂蛋白水平；然而，低剂量三相片在使用6个或12个周期期间仅显示出最小的代谢影响。脂质与慢性心血管疾病的关联以及口服避孕药片的长期使用，促使开展了这项关于三相制剂对年轻女性影响的首次24周期研究。
69名随机分配至炔雌醇/左炔诺孕酮制剂（三相片）或炔雌醇/炔诺酮制剂（炔诺酮三相片）的女性以及25名对照女性（未使用激素避孕）在试验前以及每3个或6个周期进行一次血液采样，共采样24个周期，以检测脂质和脂蛋白水平。
在第24周期时，除载脂蛋白B（apo B）外，对照女性的任何变量与基线相比均无显著变化。血浆apo B升高了42%（P <.01），反映出低密度脂蛋白apo B升高（42%，P <.01）。两种复方制剂均显著增加了apo B（血浆、极低密度脂蛋白、中间密度脂蛋白和低密度脂蛋白）；增幅在47%至84%之间。仅炔诺酮三相片组的血浆apo A1升高（15%，P <.001）。炔诺酮产品使血浆和低密度脂蛋白甘油三酯显著升高（P <.001），分别升高了43%和81%，血浆和低密度脂蛋白胆固醇分别升高了14%和28%。所有其他亚组分的胆固醇均下降，包括高密度脂蛋白（11%，P <.01）。三相片组的高密度脂蛋白胆固醇显著下降（8%，P <.05）；其他胆固醇亚组分无显著变化。所有第24周期的脂质和脂蛋白值均仍在各自的正常范围内。
尽管两年接触三相口服避孕药制剂仅在正常范围内改变了心血管疾病的脂质风险因素，但与其他风险因素叠加时，仍存在长期健康影响的可能性。
