Greco Teri, Graham Cynthia A, Bancroft John, Tanner Amanda, Doll Helen A
Department of Medicine, Regenstrief Institute for Health Care, Indiana University School of Medicine, Indianapolis, IN 40202, USA.
Contraception. 2007 Jul;76(1):8-17. doi: 10.1016/j.contraception.2007.04.002. Epub 2007 May 23.
This study compared two oral contraceptives (OCs) with the same triphasic regimen of progestin (norgestimate 0.18, 0.215 and 0.25 mg) but differing doses of ethinyl estradiol (EE) - 25 and 35 microg EE - in their effects on androgens, mood and sexual interest in women starting on OCs.
Total testosterone (T), free testosterone (FT), sex-hormone-binding globulin (SHBG) and dehydroepiandrosterone sulphate (DHEA-S), together with measures of mood [Beck Depression Inventory (BDI)], sexual interest [Dyadic and Solitary subscales of the Sexual Desire Inventory (SDI)] and self-reported side effects were assessed before starting on the OC and again after 3 months of use.
Sixty women, all university students, were randomized to receive either the 25 microg EE (N/EE25) or the 35 microg EE (N/EE35) pill; 12 women discontinued, leaving 48 who completed the 3-month study. Their mean age was 19.7 years (18-30) and they were predominantly white and single. Both OCs produced reductions in mean T [N/EE35: from 1.33 to 0.60 nmol/L, p<.001; N/EE25: from 1.12 to 1.02 nmol/L; nonsignificant (NS)] and FT (N/EE35: from 41.3 to 4.4 pmol/L, p<.001; N/EE25: from 25.4 to 7.9 pmol/L, p<.01), but the reduction in both T and FT was significantly greater with the higher EE dose (N/EE35) (p=.05 and p=.03, respectively). DHEA-S was also reduced with both formulations (N/EE35: from 7.26 to 5.22 micromol/L); N/EE25: from 7.50 to 5.39 micromol/L), although the reduction was only significant in the N/EE35 group (p<.02). Considerable variability in changes in mood was evident with both OCs, with some women showing predominantly negative effects (10 in N/EE35, 5 in N/EE25); others, positive effects (9 in N/EE35, 17 in N/EE25) and some, no change (four in each group). Women using N/EE25 were significantly more likely to show improvement in premenstrual mood than those in the N/EE35 group (p<.02), although there was no correlation between changes in BDI and FT or DHEA-S. Sexual interest scores did not change significantly from baseline to posttreatment with either OC (N/EE35: dyadic, from 40.5 to 39.6, NS; solitary, from 5.9 to 6.4, NS; N/EE25: dyadic, from 36.7 to 37.0, NS; solitary, from 5.0 to 4.2, NS).
The lower EE pill reduced FT less and was associated with greater improvement in premenstrual mood. A causal relation between these two effects is uncertain.
本研究比较了两种口服避孕药(OCs),它们具有相同的孕激素三相方案(诺孕酯0.18、0.215和0.25mg),但炔雌醇(EE)剂量不同(25和35μg EE),观察其对开始服用OCs的女性雄激素、情绪和性兴趣的影响。
在开始服用OC之前及使用3个月后,评估总睾酮(T)、游离睾酮(FT)、性激素结合球蛋白(SHBG)和硫酸脱氢表雄酮(DHEA-S),同时测量情绪指标[贝克抑郁量表(BDI)]、性兴趣[性欲量表(SDI)的二元和单独分量表]以及自我报告的副作用。
60名女性,均为大学生,随机分为接受25μg EE(N/EE25)或35μg EE(N/EE35)避孕药组;12名女性退出,48名完成了3个月的研究。她们的平均年龄为19.7岁(18 - 30岁),主要为白人且单身。两种OCs均使平均T降低(N/EE35:从1.33降至0.60nmol/L,p <.001;N/EE25:从1.12降至1.02nmol/L;无统计学意义(NS))以及FT降低(N/EE35:从41.3降至4.4pmol/L,p <.001;N/EE25:从25.4降至7.9pmol/L,p <.01),但EE剂量较高的N/EE35组T和FT的降低幅度显著更大(分别为p =.05和p =.03)。两种制剂均使DHEA-S降低(N/EE35:从7.26降至5.22μmol/L;N/EE25:从7.50降至5.39μmol/L),尽管仅N/EE35组的降低具有统计学意义(p <.02)。两种OCs在情绪变化方面均存在相当大差异,一些女性主要表现为负面影响(N/EE35组10名,N/EE25组5名);另一些表现为正面影响(N/EE35组9名,N/EE25组17名),还有一些无变化(每组4名)。使用N/EE25的女性经前情绪改善的可能性显著高于N/EE35组(p <.02),尽管BDI变化与FT或DHEA-S之间无相关性。两种OCs治疗后性兴趣得分与基线相比均无显著变化(N/EE35:二元,从40.5降至39.6,NS;单独,从5.9降至6.4,NS;N/EE25:二元,从36.7降至37.0,NS;单独,从5.0降至4.2,NS)。
较低剂量EE的避孕药对FT的降低作用较小,且与经前情绪的更大改善相关。这两种效应之间的因果关系尚不确定。