• 【两种低剂量口服避孕药的12个月比较临床研究,其中含有20微克乙炔雌二醇/75微克孕二烯酮和20微克乙炔雌二醇/150微克去氧孕烯,关于功效,周期控制】 复制标题 收藏 收藏
    DOI:10.1016/0010-7824(95)00191-c 复制DOI
    作者列表:Endrikat J,Jaques MA,Mayerhofer M,Pelissier C,Müller U,Düsterberg B
    BACKGROUND & AIMS: The aim of this study was to compare contraceptive reliability, cycle control and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol and 75 micrograms gestodene, with a reference preparation containing the same dose of estrogen combined with 150 micrograms desogestrel. This article presents interim data from centers in France and Austria, involving a total of 479 women and 4,991 cycles. Contraceptive reliability was good with both preparations. Two pregnancies occurred in the gestodene group, but neither were due to method failure. In the desogestrel group there were also two pregnancies, of which one was due to method failure. With respect to cycle control, there is a trend towards a lower incidence of intermenstrual bleeding in the gestodene group. The incidence of spotting (scanty bleeding) during the important first three cycles was 3.5% lower in the gestodene group, and over the first six cycles, it was 7.6% lower. Amenorrhea was similar in both groups, but the incidence of dysmenorrhea was significantly lower in the gestodene group (p=0.001). Adverse events were similar in both groups, with headache, breast tension and nausea the most frequently reported symptoms. Body weight remained relatively constant during treatment in both groups, and no hypertension was reported for any woman during the course of the study. In each treatment group, 19 women discontinued because of adverse events. It is concluded that both preparation are reliable and well tolerated oral contraceptives are reliable and well tolerated oral contraceptives; however, there is a more favourable effect on dysmenorrhea by the gestodene formulation.

    背景与目标: 这项研究的目的是比较含有20微克乙炔雌二醇和75微克孕二烯酮的口服避孕药与含有相同剂量雌激素和150微克去氧孕烯的参考制剂的避孕可靠性,周期控制和耐受性。本文介绍了来自法国和奥地利中心的中期数据,涉及总共479个妇女和4,991个周期。两种制剂的避孕可靠性都很好。孕二烯酮组发生了两次怀孕,但都不是由于方法失败所致。在去氧孕烯组中,也有两次怀孕,其中一次是由于方法失败。在周期控制方面,孕酮组有降低月经间出血发生率的趋势。在重要的前三个周期中,孕多芬组的斑点 (少量出血) 发生率3.5% 较低,而在前六个周期中,其发生率7.6% 较低。两组的闭经相似,但孕二烯酮组的痛经发生率明显较低 (p = 0.001)。两组的不良事件相似,头痛,乳房紧张和恶心是最常报告的症状。两组在治疗期间体重保持相对恒定,在研究过程中没有任何女性的高血压报告。在每个治疗组中,有19名妇女因不良事件而停药。结论是,两种制剂都可靠且耐受性良好的口服避孕药是可靠且耐受性良好的口服避孕药; 但是,孕二烯酮制剂对痛经有更有利的作用。
  • 【使用乙炔雌二醇和去氧孕烯对两种避孕方案的激素抑制进行评估。】 复制标题 收藏 收藏
    DOI:10.1007/s00404-012-2545-6 复制DOI
    作者列表:Gassen DT,Herter LD,Chagas JK,Schmid H
    BACKGROUND & AIMS: PURPOSE:Because of the lack of data on hormone levels in the hormone-free interval of the contraceptive regimens with desogestrel and ethynil estradiol, the objective of this study was to compare hormonal levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and inhibin B using two contraceptive regimens with those steroids. METHODS:Prospective and randomized study with 21 patients. Eleven patients received a 21/7 regimen (group 1) and ten patients received a 21/2 placebo/5 ethinyl estradiol 10 μg regimen (group 2). RESULTS:We found a significant increase in FSH and LH levels in both groups. There was a significant reduction of inhibin B in the 21/2/5 regimen. No difference in estradiol levels was found. CONCLUSIONS:Steroids withdrawal in the hormone-free interval causes reduced inhibition of the HPO axis. The significant decrease in inhibin B levels of group 2 suggests better suppression of the HPO axis in the 21/2/5 regimen.
    背景与目标:
  • 【去氧孕烯加睾丸激素可有效抑制精子发生,但也会导致适度的体重增加和高密度脂蛋白抑制。】 复制标题 收藏 收藏
    DOI:10.1016/s0015-0282(00)01490-4 复制DOI
    作者列表:Anawalt BD,Herbst KL,Matsumoto AM,Mulders TM,Coelingh-Bennink HJ,Bremner WJ
    BACKGROUND & AIMS: OBJECTIVE:To test the hypothesis that oral desogestrel (DSG) plus testosterone would uniformly and rapidly suppress sperm concentrations in young men as effectively as levonorgestrel (LNG) plus testosterone and cause less high-density lipoprotein (HDL) suppression and weight gain. DESIGN:Single-blind, randomized trial. SETTING:VA Puget Sound and University of Washington, Seattle, Washington. PATIENT(S):Twenty-four healthy young men, aged 20-49. INTERVENTION(S):Subjects were randomized to three groups of men who were administered 6 months of therapy with oral DSG plus im testosterone enanthate: 150 microg of DSG plus 50 mg of testosterone (DSG 150-T 50), 150 microg of DSG plus 100 mg of testosterone (DSG 150-T 100) or 300 microg of DSG plus 100 mg of testosterone (DSG 300-T 100). We compared these three groups to two groups of historical controls of 100 mg of im testosterone alone or 150 microg of oral LNG plus 100 mg of im testosterone (LNG 125-T 100 group) enrolled in similar studies. MAIN OUTCOME MEASURE(S):Suppression of sperm counts to severe oligoazoospermia (sperm counts <1 x 10(6)/mL) and azoospermia, weight gain, and serum high-density cholesterol (HDL) suppression. RESULT(S):Azoospermia was achieved in all eight men receiving DSG 150-T 100 and seven of the eight men in the DSG 300-T 100 group. DSG 150 or 300 plus T 100 suppressed spermatogenesis as effectively as LNG 125-T 100 and more effectively than DSG 50-T 100 or testosterone alone. All groups tended to gain weight compared with their baseline, but the weight gain was greatest (and statistically significant) in the DSG 150-T 100, DSG 300-T 100, and LNG 125-T 100 groups. Serum HDL levels were modestly suppressed in all groups, and this effect was greatest in the DSG 300-T 100 and LNG 125-T 100 groups. CONCLUSION(S):The combination of DSG plus testosterone is a very effective regimen for suppression of spermatogenesis and has acceptably low side effects.
    背景与目标:
  • 【含有3 mg微粉化17β-雌二醇和0.150 mg去氧孕烯的口服避孕药的药效学作用持续21天,然后仅0.030 mg去氧孕烯持续7天。】 复制标题 收藏 收藏
    DOI:10.1016/s0010-7824(96)00201-6 复制DOI
    作者列表:Csemiczky G,Dieben T,Coeling Bennink HJ,Landgren BM
    BACKGROUND & AIMS: :During oral treatment with 3 mg micronized 17 beta-estradiol and 0.150 mg desogestrel for 21 days followed by 0.030 mg (A) desogestrel (15 women) or placebo (B) (14 women) for 7 days, ovarian function, bleeding pattern and estradiol levels were evaluated. The study was performed in a group-comparative, double-blind fashion. During a pre-treatment control cycle, using ultrasound scan, follicular diameter was measured on cycle days 10-16 and endometrial thickness on one of cycle days 22-26. Estradiol was measured at the time of ultrasound scan and progesterone three times in the luteal phase. During three treatment cycles, follicular diameter and endometrial thickness were monitored three times weekly and at the same time, estradiol and progesterone were measured. Treatment resulted in anovulation in all women. Maximum and mean estradiol levels were approximately 900 pmol/l and 550 pmol/l during treatment, respectively, and approximately 200 pmol/l during the estradiol-free weeks in both groups. Ten women showed ovarian activity (follicle size > or = 15 mm) during treatment, seven in group A and three in group B. Endometrial thickness decreased approximately 3 mm during treatment in both groups. The incidence of breakthrough bleeding and spotting was higher in group A when compared to group B. The study indicates that the combination of 3.0 mg micronized estradiol and 0.150 mg desogestrel is an effective and safe contraceptive, offering an acceptable cycle control. The addition of a low dose of desogestrel during the pill-free period did not further suppress ovarian activity nor improve the bleeding pattern. The results of this study should be interpreted with great care, since the number of women studied is relatively small. :Although natural estrogens have the potential to eliminate the adverse hemostatic effects associated with high-dose synthetic estrogen, such regimens have been associated with a high incidence of irregular bleeding and difficulties maintaining sufficient circulating estradiol levels for at least 24 hours. To identify strategies for improving this bleeding pattern, 36 women were randomly allocated to receive either 3 mg of desogestrel during the 7-day pill-free interval (group A) or a placebo (group B); for the 21 preceding days, women in both groups were treated with 3 mg of micronized 17 beta-estradiol and 0.150 mg of desogestrel. Ovulation was inhibited in all women in all three treatment cycles monitored. Mean estradiol levels were 550 pmol/l during treatment and 200 pmol/l during the estradiol-free period in both groups. Seven women from group A and three from group B showed ovarian activity (follicle size equal to or greater than 15 mm). Two women, both from group A, developed asymptomatic ovarian cysts with a diameter of 30 mm or greater. Women in both groups showed a decrease in endometrial thickness of approximately 3 mm. Breakthrough bleeding occurred in 30 (34.5%) of the 87 cycles available for analysis; the addition of desogestrel in the pill-free period had no effect on the bleeding pattern. Although these findings suggest that the addition of desogestrel to the pill-free interval neither improves the bleeding pattern nor further suppresses ovarian activity, the number of subjects was too small to permit final conclusions.
    背景与目标:
  • 【含去氧孕烯口服避孕药的长间隔治疗方案。】 复制标题 收藏 收藏
    DOI:10.1016/0010-7824(93)80141-h 复制DOI
    作者列表:Cachrimanidou AC,Hellberg D,Nilsson S,Waldenström U,Olsson SE,Sikström B
    BACKGROUND & AIMS: A randomized multicenter study was performed in order to investigate the acceptance of a low-dose OC (30 micrograms of ethinyloestradiol and 150 micrograms of desogestrel), using a 9 weeks on and 1 week off schedule (prolonged regimen, n = 198), compared to a traditional 3 weeks on, 1 week off schedule (standard regimen, n = 96). Haemoglobin and blood pressure remained the same in both groups during the study. No significant differences were found in body weight changes between the two groups. There was significantly more breakthrough bleeding and spotting in the group with prolonged regimen than in the group with standard regimen, but both breakthrough bleeding and spotting decreased during the trial. Irregular bleeding was significantly less in women who were already using OC, compared to "new starters." No serious side effects occurred. Significantly more women stopped the trial because of bleeding problems in the group with prolonged regimen, while there were significantly more women who stopped the trial because of headache in the group with standard regimen. After completing 12 months, or after premature withdrawal from the study, each women completed a questionnaire. Sixty-three per cent of the women preferred the studied alternative and twenty-six per cent preferred the traditional OC.

    背景与目标: 进行了一项随机多中心研究,以研究低剂量OC (30微克乙炔雌二醇和150微克去氧孕烯) 的接受程度,使用9周和1周的休息时间表 (延长方案,n = 198),与传统的3周相比,休息1周 (标准方案,n = 96)。在研究期间,两组的血红蛋白和血压保持不变。两组之间的体重变化没有显着差异。延长方案组的突破性出血和斑点明显多于标准方案组,但在试验期间突破性出血和斑点均减少.与 “新手” 相比,已经使用OC的女性的不规则出血明显减少。没有发生严重的副作用。在延长治疗方案的组中,由于出血问题而终止试验的女性明显更多,而在标准治疗方案的组中,由于头痛而终止试验的女性明显更多。完成12个月后,或过早退出研究后,每位女性都完成了一份问卷。63% 的女性更喜欢研究的替代方案,而26% 的女性更喜欢传统的OC。
  • 【比较三相口服避孕药与去氧孕烯或左炔诺孕酮对含载脂蛋白A-I的高密度脂蛋白颗粒的影响。】 复制标题 收藏 收藏
    DOI:10.1016/s0026-0495(99)90068-9 复制DOI
    作者列表:Cheung MC,Walden CE,Knopp RH
    BACKGROUND & AIMS: :Recent observations suggest that the risk of coronary artery disease (CAD) is associated with both the level and composition of the two major populations of apolipoprotein (apo)-defined high-density lipoprotein (HDL) particles: those containing both apo A-I and apo A-II [Lp(AI,AII)] and those containing apo A-I without apo A-II [Lp(AI)]. While sex hormones are known to affect HDL, their influence on these apo-defined HDL particles is not known. We have determined the effects of two triphasic oral contraceptive (OC) formulations on these HDL particles in healthy normolipidemic women aged 21 to 35 years. The formulations contain comparable quantities of ethinyl estradiol (EE) and either desogestrel (DG), a minimally androgenic progestin, or levonorgestrel (LN), a more androgenic progestin. Lipid and lipoprotein levels were measured during the third week of the normal menstrual cycle and the sixth month of OC use. The DG/EE formulation significantly increased total cholesterol (C) 15%, triglyceride (TG) 99%, phospholipid (PL) 17%, apo A-I 28%, apo A-II 34%, apo B 21%, very-low-density lipoprotein cholesterol (VLDL-C) 238%, HDL-C 20%, and HDL3-C 28% (P < .02 to .005, n = 11), but not low-density lipoprotein cholesterol (LDL-C). The LN/EE formulation also increased total C 15%, TG 33%, apo A-I 15%, HDL3-C 21% (P < .05, n = 10), apo B 30% (P < .005), and, additionally, LDL-C 19% (P < .05). Both formulations increased Lp(AI,AII) (DG/EE, 34%, P < .005; LN/EE, 24%, P < .01). These changes reflected comparable increases of small (7.0 to 8.2 nm) and medium (8.2 to 9.2 nm) particles in the LN/EE group and a predominant increase of medium-sized particles in the DG/EE group. Also, in the LN/EE group but not the DG/EE group, there were fewer large (9.2 to 11.2 nm) particles. Lp(AI) increased only in the DG/EE group (25%, P = .075) and was due to the presence of more large particles. The level of Lp(AI) did not change in the LN/EE group, but the lipid/A-I ratio of these particles was lower (P = .012) and there were more small particles. Thus, triphasic OC formulations with progestins of different androgenicity had different effects on VLDL, LDL, and the level and composition of HDL particles with and without apo A-II, possibly reflecting estrogen/progestin/androgen balance. Estrogen dominance increases both Lp(AI,AII) and Lp(AI) and favors large Lp(AI) particles, while progestin/androgen dominance increases only Lp(AI,AII) and favors small particles. Because of the importance of HDL in the arterial wall physiology, OC formulations with different estrogen and progestin content may affect arterial wall health to a different extent.
    背景与目标: : 最近的观察结果表明,冠状动脉疾病 (CAD) 的风险与载脂蛋白 (apo) 定义的高密度脂蛋白 (HDL) 颗粒的两个主要人群的水平和组成有关: 同时含有apo A-I和apo A-II [Lp(AI,AII)] 和那些含有载脂蛋白A-I而没有载脂蛋白A-II [Lp(AI)]。虽然已知性激素会影响HDL,但它们对这些载脂蛋白定义的HDL颗粒的影响尚不清楚。我们已经确定了两种三相口服避孕药 (OC) 制剂对21至35岁健康降血脂妇女中这些HDL颗粒的影响。该制剂含有相当数量的乙炔雌二醇 (EE) 和去氧孕烯 (DG) (一种最低雄激素孕激素) 或左炔诺孕酮 (LN) (一种更雄激素孕激素)。在正常月经周期的第三周和使用OC的第六个月期间测量脂质和脂蛋白水平。DG/EE制剂显著增加总胆固醇 (C) 15% 、甘油三酯 (TG) 99% 、磷脂 (PL) 17% 、载脂蛋白A-I 28% 、载脂蛋白A-II 34% 、载脂蛋白B 21% 、极低密度脂蛋白胆固醇 (vldl-c) 238%,hdl-c 20% 和HDL3-C 28% (P <.02至.005,n = 11),但不是低密度脂蛋白胆固醇 (ldl-c)。LN/EE制剂还增加了总C 15% 、TG 33% 、apoa-I 15% 、HDL3-C 21% (P <0.05,n = 10) 、apob 30% (P < .005) 和另外的ldl-c 19% (P <.05)。两种制剂均增加Lp(AI,AII) (DG/EE,34%,P <.005; LN/EE,24%,P <.01)。这些变化反映了LN/EE组中小 (7.0至8.2 nm) 和中等 (8.2至9.2 nm) 颗粒的相当增加,以及DG/EE组中中等大小颗粒的主要增加。此外,在LN/EE组而不是DG/EE组中,较少的大 (9.2至11.2 nm) 颗粒。Lp(AI) 仅在DG/EE组中增加 (25%,P = .075),并且是由于存在更大的颗粒。LN/EE组的Lp(AI) 水平没有变化,但是这些颗粒的脂质/A-I比较低 (P = .012) 并且有更多的小颗粒。因此,具有不同雄激素性的孕激素的三相OC制剂对VLDL,LDL以及有和没有载脂蛋白A-II的HDL颗粒的水平和组成具有不同的影响,可能反映了雌激素/孕激素/雄激素平衡。雌激素优势会增加Lp(AI,AII) 和Lp(AI),并有利于大的Lp(AI) 颗粒,而孕激素/雄激素优势仅增加Lp(AI,AII) 并有利于小颗粒。由于HDL在动脉壁生理中的重要性,具有不同雌激素和孕激素含量的OC制剂可能在不同程度上影响动脉壁健康。
  • 【使用含有30微克乙炔雌二醇和150微克去氧孕烯的口服避孕药的12年临床经验。】 复制标题 收藏 收藏
    DOI:10.1016/0010-7824(94)00010-t 复制DOI
    作者列表:Fotherby K
    BACKGROUND & AIMS: The clinical experience with a combined oral contraceptive (COC) containing 150 micrograms desogestrel and 30 micrograms ethinylestradiol is reviewed. Fourteen clinical trials have been reported involving over 44,000 women for more than 190,000 cycles. None of the 17 pregnancies which occurred (overall Pearl Index 0.12) were due to method failure. The incidences of breakthrough bleeding and spotting after 6 treatment cycles varied from 0.1-6.0% and 2.8-11% of subjects, respectively, and at this time they were not significantly different from pretreatment in most trials. About 90% of subjects maintained regular cycles. The incidence of subjective side effects (approximately 5% for headache, 4% for breast tenderness, 2% for nausea) was low. No significant changes occurred in body weight or blood pressure. In all trials, the COC was well accepted and the rates of discontinuation were similar to those in other COC trials. Pharmacodynamic effects have been widely investigated. There were no significant changes in glucose metabolism or in haematological factors except for possibly minor increases in factors VII and X, fibrinogen and plasminogen. Over thirty studies of the effect of the COC on lipid metabolism have been published; significant increases occur in serum triglycerides, HDL-C and apoprotein A1. SHBG concentrations increase 2-3 fold with a consequent decrease in the levels of free testosterone. This effect can be particularly important therapeutically in women with hyperandrogenic skin disorders and 14 trials in women with these disorders have demonstrated significant clinical improvement with the COC. The findings from the various trials show the COC to be effective and acceptable with no adverse metabolic effects.

    背景与目标: 回顾了含有150微克去氧孕烯和30微克炔雌醇的联合口服避孕药 (COC) 的临床经验。据报道,有14项临床试验涉及44,000多名妇女,治疗超过190,000个周期。发生的17例怀孕 (总体珍珠指数0.12) 中没有一例是由于方法失败引起的。6个治疗周期后突破性出血和斑点的发生率分别为受试者的0.1-6.0% 和2.8-11%,此时与大多数试验中的预处理没有显着差异。大约90% 的受试者保持有规律的周期。主观副作用的发生率低 (头痛约为5%,乳房压痛4%,恶心2%)。体重或血压无明显变化。在所有试验中,COC被广泛接受,停药率与其他COC试验相似。药效学效应已被广泛研究。除了因子VII和X,纤维蛋白原和纤溶酶原可能略有增加外,葡萄糖代谢或血液学因素没有显着变化。已发表了30多项有关COC对脂质代谢影响的研究; 血清甘油三酸酯,hdl-c和载脂蛋白a1显着增加。SHBG浓度增加2-3倍,随之而来的是游离睾丸激素水平的降低。在患有高雄激素性皮肤病的女性中,这种作用在治疗上尤其重要,并且在患有这些疾病的女性中进行的14项试验已证明COC具有显着的临床改善。各种试验的结果表明,COC是有效且可接受的,没有不良代谢作用。
  • 【含去氧孕烯和孕酮的口服避孕药与含左炔诺孕酮的口服避孕药对止血变量的影响: 综述。】 复制标题 收藏 收藏
    DOI:10.1053/ob.1998.v179.a92633 复制DOI
    作者列表:Winkler UH
    BACKGROUND & AIMS: In some studies third-generation oral contraceptives have been reported to be associated with a higher risk of venous thromboembolism than are second-generation oral contraceptives, whereas recent, more refined studies have not confirmed this. The reasons for the alleged differences are under discussion, and differential effects on hemostasis have been proposed. Eighteen studies comparing second- and third-generation oral contraceptives with respect to their effects on hemostasis were analyzed. Significant changes from baseline were reported for many variables with both second- and third-generation oral contraceptives without significant between-group differences. Also, in a combined analysis of nonsignificant changes, no consistent pattern of change emerged for any marker, with the exception of higher factor VII levels associated with third-generation oral contraceptives. However, factor VII is not related to venous thromboembolism risk. In addition, 1 cross-sectional study with an unvalidated assay reported a higher ratio of activated protein C sensitivity with third-generation oral contraceptives. Only 2 components of the hemostatic system (factor VII and activated protein C sensitivity ratio) emerged as potentially differentially affected by second- and third-generation oral contraceptives; the association with venous thromboembolism risk is questionable in the former case and unknown in the latter.

    The initial finding of an increased risk of venous thromboembolism in users of third-generation oral contraceptives (OCs) has not been confirmed in recent, more methodologically refined studies. This article reviews 17 prospective studies with healthy volunteers and one cross-sectional study that compared second- and third-generation OCs in terms of their effects on markers of hemostasis. Significant changes from baseline were reported for many variables with both second- and third-generation OCs. For example, activated partial prothrombin clotting time, protein S, and tissue plasminogen activator and its inhibitor were reduced during OC treatment. However, none of the studies reported statistically significant differences between treatment groups for any of these markers. In a combined analysis of nonsignificant changes, no consistent pattern emerged for any coagulation or fibrinolysis parameter with the exception of higher factor VII levels (not related to venous thromboembolism risk) associated with third-generation formulations. The cross-sectional study with an unvalidated assay found a higher ratio of activated C protein sensitivity with third-generation OCs. Only two components of the hemostatic system--factor VII and activated protein C sensitivity ratio--emerged as potentially differentially affected by second- and third-generation OCs. The association with venous thromboembolism risk is questionable in the former cases and unknown in the latter.

    背景与目标: 在一些研究中,据报道第三代口服避孕药比第二代口服避孕药具有更高的静脉血栓栓塞风险,而最近更精细的研究尚未证实这一点。正在讨论所谓差异的原因,并提出了对止血的不同作用。分析了18项比较第二代和第三代口服避孕药对止血作用的研究。据报道,第二代和第三代口服避孕药的许多变量与基线相比发生了显着变化,而组间没有显着差异。此外,在对非显著变化的综合分析中,除了与第三代口服避孕药相关的较高因子VII水平外,任何标志物都没有出现一致的变化模式。然而,因子VII与静脉血栓栓塞风险无关。此外,一项未经验证的横断面研究报告了第三代口服避孕药对活化蛋白C敏感性的比率更高。止血系统中只有2种成分 (因子VII和活化蛋白C敏感性比) 被第二代和第三代口服避孕药潜在地影响; 在前一种情况下,与静脉血栓栓塞风险的关联值得怀疑,而在后一种情况下则未知。
    在第三代口服避孕药 (OCs) 使用者中,静脉血栓栓塞风险增加的最初发现尚未在最近的方法学上得到证实。本文回顾了17项针对健康志愿者的前瞻性研究,以及一项横断面研究,该研究比较了第二代和第三代oc对止血标志物的影响。据报道,第二代和第三代oc的许多变量均与基线发生了显着变化。例如,在OC治疗期间,活化的部分凝血酶原凝血时间,蛋白质S和组织纤溶酶原激活剂及其抑制剂减少。然而,没有一项研究报告了治疗组之间任何这些标记物的统计学差异。在一项非显著变化的综合分析中,除了与第三代制剂相关的较高因子VII水平 (与静脉血栓栓塞风险无关) 外,任何凝血或纤溶参数均没有出现一致的模式。未经验证的分析的横断面研究发现,第三代oc的活化C蛋白敏感性更高。止血系统中只有两个组成部分-因子VII和活化的蛋白C敏感性比-可能受到第二代和第三代oc的差异影响。前者与静脉血栓栓塞风险的关联值得怀疑,后者则未知。
  • 【两种含炔雌醇和醋酸环丙孕酮或去氧孕烯的口服避孕药对骨量的影响: 为期2年的随访结果。】 复制标题 收藏 收藏
    DOI:10.3109/13625189809051408 复制DOI
    作者列表:Castelo-Branco C,Martínez de Osaba MJ,Pons F,Vanrell JA
    BACKGROUND & AIMS: BACKGROUND:There are conflicting data about the effects of oral contraceptives on bone mass in young women. Moreover, amenorrheic women may also be affected to varying degrees by osteopenia. Both conditions (oral contraceptive use and amenorrhea) are not infrequent in women during their reproductive years.

    AIM:To evaluate the safety for bone mass of two oral contraceptives, one containing cyproterone acetate and the other containing desogestrel.

    METHODS:A total of 67 women between 19 and 29 years of age were studied. Of these women, 35 were selected to receive an oral contraceptive containing 35 mg ethinylestradiol and 2 mg cyproterone acetate. A second group of 32 women received an oral contraceptive containing 30 mg ethinylestradiol and 150 mg desogestrel for 2 years. Immediately before and after the 12th and 24th months of therapy, bone mineral density was assessed by dual X-ray absorptiometry, and hormonal profiles and Ferriman-Gallwey scores were evaluated.

    RESULTS:After the 2-year follow-up, all subjects showed regular cycles, no pregnancies, and no changes in bone mass density. In addition, hirsute subjects showed a decrease of almost 42% in hirsutism scores.

    CONCLUSION:Oral contraceptives containing cyproterone acetate or desogestrel in the studied doses have no deleterious effects on bone marrow.

    背景与目标: 背景 : 关于口服避孕药对年轻女性骨量的影响的数据相互矛盾。此外,闭经妇女也可能受到骨质减少的不同程度影响。两种情况 (口服避孕药和闭经) 在女性生育期间并不少见。
    目的 : 为了评估两种口服避孕药对骨量的安全性,一种含有醋酸环丙孕酮,另一种含有去氧孕烯。
    方法 : 研究了67名19至29岁的女性。在这些妇女中,选择了35名接受口服避孕药,其中含有35 mg炔雌醇和2 mg醋酸环丙孕酮。第二组32名妇女接受含有30 mg炔雌醇和150 mg去氧孕烯的口服避孕药2年。在治疗的第12个月和第24个月之前和之后,通过双重x射线吸收法评估了骨矿物质密度,并评估了激素特征和Ferriman-Gallwey评分。
    结果 : 经过2年的随访,所有受试者均显示出规律的周期,没有怀孕,并且骨密度没有变化。此外,多毛受试者的多毛症评分几乎降低了42%。
    结论 : 研究剂量中含有醋酸环丙孕酮或去氧孕烯的口服避孕药对骨髓没有有害影响。
  • 【口服 (类固醇) 避孕药对低密度脂蛋白受体调节的研究: 去氧孕烯,左炔诺孕酮和乙炔雌二醇在JEG-3细胞系和胎盘组织中。】 复制标题 收藏 收藏
    DOI:10.1016/j.contraception.2007.06.011 复制DOI
    作者列表:Ramakrishnan G,Rana A,Das C,Chandra NC
    BACKGROUND & AIMS: BACKGROUND:The aim of this study was to compare in vitro the role of two oral contraceptives, desogestrel (a less androgenic derivative of levonorgestrel) and levonorgestrel--alone and in combination with ethinyl estradiol--on low-density lipoprotein (LDL) receptor regulation by assessing receptor protein expression and functional effectiveness. STUDY DESIGN:Placental tissue and cultured placental cells (JEG-3) were used to study the expression and endocytotic activity of LDL receptor protein. The expression of the receptor was assessed by immunocytochemistry and immunoblot assays with and without contraceptive challenge. Functioning activity of LDL receptor was studied by measuring the rate of uptake of LDL by placental cells. Quantification of LDL was based on the total cholesterol content of the lipoprotein. RESULTS:A combination of desogestrel (20 ng/mL of incubation medium) and ethinyl estradiol (10 ng/mL of incubation medium) maintained the LDL receptor at high level of expression and functioning mode. In contrast, the double-blind preparation of levonorgestrel (20 ng/mL) and ethinyl estradiol (10 ng/mL) had shown much lower expression as well as receptor-mediated LDL uptake. The concentration of contraceptives used in this study was similar to the prevailing concentration of oral contraceptives in clinical use. CONCLUSION:Higher expression of LDL receptor and enhanced rate of LDL uptake by the receptor protein projects the possibility that there might be less atherosclerosis-related disorders from the combination of desogestrol and ethinyl estradiol.
    背景与目标:
  • 【炔雌醇联合孕二烯酮和去氧孕烯对年轻女性寻常痤疮的临床和激素作用。】 复制标题 收藏 收藏
    DOI:10.1016/0010-7824(96)00005-4 复制DOI
    作者列表:Mango D,Ricci S,Manna P,Miggiano GA,Serra GB
    BACKGROUND & AIMS: The effect of gestodene 75 micrograms (GTD) versus desogestrel 150 micrograms (DSG) combined with 30 micrograms of ethinylestradiol (EE) on acne lesions and plasma androstenedione (A), total testosterone (T), sex hormone binding globulin (SHBG) and "free androgen index" (FAI) was evaluated in an open study on 19 patients aged 18-35 years affected with postpubertal or persistent non-severe acne vulgaris. The patients were randomly allocated into two groups receiving EE-GTD (n = 8) and EE-DSG (n = 11), 21 tablets per cycle for 9 consecutive cycles. Clinical and hormonal evaluations were made between days 17-21 in the cycle before treatment and between days 17-21 of the cycle 3, 6 and 9 of treatment. During treatment, acne improved in most patients, reaching at cycle 9 a low score (absent or minimal) in 62% of the cases in the GTD group (mean acne score = 1.25) and in 90% of the cases in the DSG group (mean acne score = 0.90). Before treatment, about 75% of the patients showed one or more signs of biochemical hyperandrogenism, including elevated FAI (57%), elevated A (15%), elevated total T (15%) and decreased SHBG (21%), and there was evidence of inverse correlation between SHBG and acne scores (p < 0.05). The echogenic texture of the ovaries was multifollicular in 55% of the cases. By the end of the third cycle of treatment, the hormonal changes observed in both groups included significant decreases, with normalization of individual elevated levels of T, and a 3-fold rise of the initial values of plasma SHBG, which showed a further gradual increase at cycle 9 of EE-DSG administration. At cycle 9, normalization of the echogenic ovarian texture was observed. Acne improvement under treatments with estrogen and progestin (EP) could be significantly correlated with the normalization of biochemical hyperandrogenism. In conclusion, the biochemical and clinical efficacy of EE-GTD and EE-DSG indicate that both these preparations can be a good choice in the therapy of acne vulgaris, with a non-significant better clinical result with EE-DSG.

    At the Sacred Heart Catholic University in Rome, Italy, health researchers randomly allocated 19 nulligravidae aged 18-35 with either postpubertal or persistent non-severe acne vulgaris to receive either the combined oral contraceptive (OC) containing 30 mcg ethinyl estradiol (EE) and 75 mcg gestodene (GTD) (Minulet) or 30 mcg EE and 150 mcg desogestrel (DSG) (Marvelon). They aimed to evaluate the effect of GTD and DSG combined with low doses of EE on acne lesions and on hormone levels. The women used the OCs (21 tablets/cycle) for nine consecutive cycles. At baseline, about 75% of all patients had at least one sign of biochemical hyperandrogenism (57% for elevated free androgen index, 15% for elevated androstenedione, 15% for elevated total testosterone, and 21% for reduced sex hormone binding globulin [SHBG]). At baseline, the higher the acne score was, the lower the SHBG level was (p 0.05). The ovaries of 55% of the women had multiple follicles. Acne improved significantly in both groups (mean acne score, 2.9-0.9 for EE/DSG and 2.87-1.25 for EE/GTD; p 0.05). In fact, 62% of cases in the EE/GTD group and 90% of those in the EE/DSG group had either minimal or no acne lesions. Acne improvement during treatment was significantly associated with normalization of biochemical hyperandrogenism. At completion of the third cycle of treatment, both groups experienced significant decreases in hormones. Individual elevated levels of testosterone normalized. The initial values of plasma SHBG had increased 3-fold. SHBG increased gradually to cycle 9 of EE-DSG OC use. At completion of cycle 9, the echogenic ovarian texture returned to normal. These findings suggest that, since both OCs are biochemically and clinically effective, these OCs may be a good treatment for acne vulgaris.

    背景与目标: 孕二烯酮75微克 (GTD) 与去氧孕烯150微克 (DSG) 联合30微克乙炔雌二醇 (EE) 对痤疮皮损及血浆雄烯二酮 (A) 、总睾酮 (T) 、性激素结合球蛋白 (SHBG) 和 “游离雄激素指数” (FAI) 在一项开放研究中评估了19例年龄在18-35岁之间的患有青春期后或持续性非严重寻常痤疮的患者。将患者随机分为两组,分别接受ee-gtd (n = 8) 和ee-dsg (n = 11),每周期21片,连续9个周期。在治疗前周期的第17-21天以及治疗周期的第3、6和9天的第17-21天之间进行了临床和激素评估。在治疗期间,大多数患者的痤疮得到改善,在第9周期,GTD组的62% 病例 (平均痤疮评分 = 1.25) 和DSG组的90% 病例 (平均痤疮评分 = 0.90) 达到低分 (不存在或最小)。治疗前,约75% 的患者表现出一种或多种生化高雄激素血症的迹象,包括FAI升高 (57%),A升高 (15%),总T升高 (15%) 和SHBG降低 (21%),SHBG与痤疮评分呈负相关 (p <0.05)。在55% 情况下,卵巢的回声质地是多卵泡的。到第三个治疗周期结束时,两组中观察到的激素变化均显着降低,个体T水平升高,血浆SHBG初始值升高3倍,这表明在第9周期EE-DSG给药时进一步逐渐增加。在第9周期,观察到回声卵巢质地正常化。雌激素和孕激素 (EP) 治疗下痤疮的改善可能与生化高雄激素血症的正常化显着相关。总之,EE-GTD和EE-DSG的生化和临床疗效表明,这两种制剂都可以作为治疗寻常痤疮的良好选择。EE-DSG的临床效果无明显改善。
    在意大利罗马的圣心天主教大学,健康研究人员随机分配了19例18-35岁患有青春期后或持续性非严重寻常痤疮的nulliravidae,以接受含有30 mcg乙炔雌二醇 (EE) 和75 mcg孕二烯酮 (GTD) (Minulet) 或30 mcg EE和150 mcg去氧孕酮 (DSG) 的联合口服避孕药 (OC) (妈富隆)。他们旨在评估GTD和DSG联合低剂量EE对痤疮病变和激素水平的影响。妇女连续9个周期使用OCs (21片/周期)。在基线时,约75% 的所有患者至少有一个生化高雄激素血症的征象 (57% 游离雄激素指数升高,15% 雄烯二酮升高,15% 总睾酮升高,21% 性激素结合球蛋白降低 [SHBG])。基线时,痤疮评分越高,SHBG水平越低 (p 0.05)。55% 妇女的卵巢有多个卵泡。两组的痤疮均显着改善 (平均痤疮评分,EE/DSG为2.9-0.9,EE/GTD为2.87-1.25; p 0.05)。事实上,EE/GTD组62% 的病例和EE/DSG组90% 的病例具有最小或无痤疮损伤。治疗期间痤疮的改善与生化雄激素过多症的正常化显着相关。在第三个治疗周期完成时,两组的激素均显着降低。个体睾酮水平升高正常化。血浆SHBG的初始值增加了3倍。SHBG逐渐增加到EE-DSG OC使用的第9周期。在第9周期完成时,回声卵巢质地恢复正常。这些发现表明,由于两种oc在生化和临床上都有效,因此这些oc可能是治疗寻常痤疮的好方法。
  • 【含去氧孕烯的双相口服避孕药治疗期间的炔雌醇,3-酮-去孕甾酮,SHBG,CBG和促性腺激素的血清浓度。】 复制标题 收藏 收藏
    DOI:10.1159/000182537 复制DOI
    作者列表:Jung-Hoffmann C,Storch A,Kuhl H
    BACKGROUND & AIMS: :During a cross-over study, the pharmacokinetics of ethinylestradiol (EE) and 3-keto-desogestrel (KDG) were investigated on days 7 and 22 of one cycle of treatment with two biphasic formulations containing 50 micrograms EE (7 tablets) and 50 micrograms EE + 125 micrograms desogestrel (DG) (15 tablets) (50/50 EE) or 40 micrograms EE + 25 micrograms DG (7 tablets) and 30 micrograms EE + 125 micrograms DG (15 tablets) (40/30 EE). Peak serum levels and areas under the curve of EE increased significantly by 50% between days 7 and 22 of those taking 50/50 EE, while during treatment with 40/30 EE, no difference was found between days 7 and 22. Both formulations caused identical KDG levels on day 22. There were only slight differences in the effects of both preparations on sex-hormone-binding globulin (SHBG; +150 to +160%) and on corticosteroid-binding globulin (CBG; +130 to +150%) on day 7. On day 22, the changes were more pronounced with 50/50 EE (SHBG, +310%; CBG, +240%) than with 40/30 EE (SHBG, +250%; CBG, +180%). On day 22 after discontinuation of treatment, the SHBG and CBG levels were still significantly above the control values. Using both formulations, LH and FSH levels were significantly suppressed on day 22, while on day 7 no significant reduction was observed. The rise in the EE levels between days 7 and 22 of 50/50 EE intake and the time course of the EE concentrations during treatment with 40/30 EE appear to be due to an inhibition of hepatic metabolism by the contraceptive steroids, as EE is nearly exclusively bound to albumin which does not change.
    背景与目标: :在交叉研究中,在一个疗程的第7天和第22天研究了乙炔雌二醇(EE)和3-酮-去氧孕烯(KDG)的药代动力学,其中两种双相制剂分别含有50毫克EE(7片)和50毫克微克EE 125微克去氧孕烯(15片)(50/50 EE)或40微克EE 25微克DG(7片)和30微克EE 125微克DG(15片)(40/30 EE)。在服用50/50 EE的患者的7至22天之间,血清峰值水平和EE曲线下的面积显着增加了50%,而在使用40/30 EE的患者中,在7和22天之间没有发现差异。第22天的KDG水平相同。在第7天,两种制剂对性激素结合球蛋白(SHBG; 150%至160%)和对皮质类固醇结合球蛋白(CBG; 130%至150%)的作用仅有微小差异。在第22天,与使用40/30 EE(SHBG,250%; CBG,180%)相比,使用50/50 EE(SHBG,310%; CBG,240%)的变化更为明显。在停药后第22天,SHBG和CBG水平仍显着高于对照值。使用这两种配方,LH和FSH水平在第22天被显着抑制,而在第7天未观察到显着降低。在50/50 EE摄入量的第7天到22天之间,EE水平升高以及在用40/30 EE治疗期间EE浓度随时间变化的过程似乎是由于避孕类固醇抑制了肝代谢,因为EE是几乎只与不变的白蛋白结合。
  • 【孕二烯/乙炔雌二醇和去氧孕烯/乙炔雌二醇的单相口服避孕药的临床比较。拉丁美洲口服避孕药研究组。】 复制标题 收藏 收藏
    DOI: 复制DOI
    作者列表:
    BACKGROUND & AIMS: The efficacy, cycle control, subjective complaints, and safety of monophasic preparations of the oral contraceptives containing gestodene 75 mcg plus ethinyl estradiol 30 mcg versus desogestrel 150 mcg plus ethinyl estradiol 30 mcg were compared in a 6-cycle, open-label, parallel, randomized, multicenter phase IV clinical study in Latin America. Of a total of 176 women in each group, 163 in the gestodene group and 160 in the desogestrel group completed 6 cycles, providing data for 1,015 and 1,006 cycles, respectively. Subject compliance was excellent; pills were missed during only 6.9% of the cycles in each group. No woman became pregnant during the study. Gestodene group exhibited significantly better cycle control as evidenced by the lower incidence of breakthrough bleeding and spotting. Spotting in some cycles was reported by 11.9% of women taking the gestodene-combination compared with 21% of women taking the desogestrel-combination. Based on number of women, 86.4% of the gestodene group reported all cycles were normal (no BTB) compared with 76.7% of the desogestrel group. Also, the women in the gestodene group reported a significantly lower incidence of nuisance side effects during treatment cycles. No amenorrhea was observed for either group. There were no clinically significant differences between groups with respect to body weight, blood pressure, or laboratory evaluations. Seven women withdrew from the gestodene group and 8 women withdrew from the desogestrel group because of adverse reactions. The results of this study indicate that, although both OCs provided effective contraception, in comparison to the desogestrel-combination, the gestodene-containing OC is associated with better cycle control, less bleeding, and fewer subjective complaints.

    背景与目标: 在一个6周期,开放标签,平行,6周期,开放标签,平行,拉丁美洲的随机,多中心IV期临床研究。每组总共176名妇女中,孕二烯酮组中的163名妇女和地索孕酮组中的160名妇女完成了6个周期,分别提供了1,015和1,006个周期的数据。受试者的依从性极好;每组仅在6.9%的周期内漏服药丸。在研究期间,没有女人怀孕。孕二烯酮组表现出明显更好的周期控制,其表现为突破性出血和斑点的发生率较低。据报道,服用孕二烯酮的妇女中有11.9%在某些周期出现斑点,而服用去氧孕烯的妇女中有21%的妇女出现了斑点。根据女性人数,孕二烯酮组中86.4%的人报告所有周期均正常(无BTB),而地索孕酮组的这一比例为76.7%。此外,孕二烯酮组的妇女报告在治疗周期中滋扰性副作用的发生率显着降低。两组均未观察到闭经。两组之间在体重,血压或实验室评估方面没有临床上的显着差异。由于不良反应,有7名妇女从孕二烯酮组退出,有8名妇女从地索孕酮组退出。这项研究的结果表明,尽管两种OC都能提供有效的避孕方法,但与去氧孕烯联合使用相比,含孕二烯的OC具有更好的周期控制,更少的出血和更少的主观主诉。

  • 【含左炔诺孕酮和去氧孕烯的低剂量口服避孕药对凝血的影响:一项交叉研究。】 复制标题 收藏 收藏
    DOI: 复制DOI
    作者列表:Middeldorp S,Meijers JC,van den Ende AE,van Enk A,Bouma BN,Tans G,Rosing J,Prins MH,Büller HR
    BACKGROUND & AIMS: :Combined oral contraceptives (OC) are known to increase the risk of venous thromboembolism. The aim of this randomized, cycle-controlled, cross-over study in 28 healthy volunteers was to assess potential differences between the effects of an OC containing 150 microg levonorgestrel (as representative of the so-called second generation OC) and an OC containing 150 microg desogestrel (as representative of the third generation OC) in combination with 30 microg ethinylestradiol on several coagulation factors and markers of thrombin formation. All participants used each OC for two cycles, and were switched to the other OC after a washout period of two menstrual cycles. The plasma concentrations of factors II, VII, X, and fibrinogen significantly increased during use of both the levonorgestrel- and desogestrel-containing OC's. The plasma concentrations of factor VIII increased, and of factor V decreased, changes which only reached statistical significance during the use of the desogestrel-containing OC. During exposure to the desogestrel-containing OC, as compared with the levonorgestrel-containing OC, both factor VII and factor II showed a greater increase (FVII: 32% and 12% respectively; p <0.0001; FII: 16% and 12% respectively; p = 0.048), whereas factor V showed a greater decrease (-11% and -3% respectively; p = 0.010). Only one of the markers for ongoing coagulation (prothrombin fragment 1+2) showed a significant increase during OC use, whereas concentrations of thrombin-antithrombin complexes and soluble fibrin remained unchanged. For these markers, there was no difference between the tested OC's. We conclude that there are differences between the effects of levonorgestrel and desogestrel-containing OC's on some coagulation factors. Whether these changes provide a biological explanation for the reported differences in venous thromboembolic risk is as yet unclear. The real challenge now becomes to define a pattern of changes in the various systems which, if affected simultaneously, may tip the hemostatic balance towards a prethrombotic state and may lead to overt clinical venous thromboembolism.
    背景与目标: :已知联合口服避孕药(OC)会增加静脉血栓栓塞的风险。这项针对28位健康志愿者进行的随机,周期控制,交叉研究的目的是评估含150微克左炔诺孕酮的OC(代表所谓的第二代OC)与含150克左炔诺孕酮的OC的作用之间的潜在差异。微克去氧孕烯(代表第三代OC)与30微克乙炔雌二醇组合在一起,可用于多种凝血因子和凝血酶形成标记。所有参与者使用每个OC两个周期,并在两个月经周期的冲洗期后切换到另一个OC。在同时使用含左炔诺孕酮和去氧孕烯的OC的过程中,因子II,VII,X和纤维蛋白原的血浆浓度显着增加。血浆VIII因子浓度升高,而V因子浓度降低,这些变化仅在使用含去氧孕烯的OC期间达到统计学显着性。与含左炔诺孕酮的OC相比,暴露于含地索孕烯的OC期间,因子VII和II均显示出更大的增加(FVII:分别为32%和12%; p <0.0001; FII:分别为16%和12% ; p = 0.048),而因子V表现出更大的下降幅度(分别为-11%和-3%; p = 0.010)。持续使用的凝血中只有一种标记物(凝血酶原片段1 2)显示在使用OC期间显着增加,而凝血酶-抗凝血酶复合物和可溶性血纤蛋白的浓度保持不变。对于这些标记,测试的OC之间没有差异。我们得出结论,左炔诺孕酮和含去氧孕烯的OC对某些凝血因子的作用之间存在差异。这些变化是否为所报告的静脉血栓栓塞风险差异提供了生物学解释,目前尚不清楚。现在真正的挑战是确定各种系统的变化模式,如果同时受到影响,则可能使止血平衡趋于血栓前状态,并可能导致临床上明显的静脉血栓栓塞。
  • 【两种含有乙炔雌二醇和去氧孕烯或孕二烯酮的单相口服避孕药的功效和可接受性。】 复制标题 收藏 收藏
    DOI:10.3109/13625189809051413 复制DOI
    作者列表:Halbe HW,de Melo NR,Bahamondes L,Petracco A,Lemgruber M,de Andrade RP,da Cunha DC,Guazelli CA,Baracat EC
    BACKGROUND & AIMS: OBJECTIVE:To assess the contraceptive efficacy, cycle control and acceptability of two monophasic oral contraceptives containing either 30 micrograms ethinylestradiol plus 150 micrograms desogestrel or 30 micrograms ethinylestradiol plus 75 micrograms gestodene.

    METHODS:In a randomized, open-label, six-cycle, group-comparative, multicenter study performed in Brazil, pregnancies, cycle-control parameters, incidence of side-effects and the presence and severity of acne vulgaris were assessed, and blood pressure and body weight were measured at pretreatment and after one, three and six cycles of oral contraceptive use.

    RESULTS:Of the 595 women enrolled, 274 (86.7%) in the desogestrel/ethinylestradiol group and 227 (81.4%) in the gestodene/ethinylestradiol group completed the six cycles, providing data for 1753 and 1487 treatment cycles, respectively. Two pregnancies occurred, one of which (in the desogestrel/ethinylestradiol group) was attributed to user failure, whilst the other (in the gestodene/ethinylestradiol group) was thought to result from method failure. Cycle control was observed to be excellent; the incidences of irregular bleeding and minor side-effects were low in both groups and decreased after an initial increase in the first cycle. Pre-existing acne improved in both groups, whereas blood pressure and body weight remained essentially unchanged.

    CONCLUSIONS:Both desogestrel/ethinylestradiol and gestodene/ethinylestradiol provide effective oral contraception with comparable cycle control and acceptability.

    背景与目标: 目标:评估两种单相口服避孕药的避孕效果,周期控制和可接受性,其中两种避孕药均含有30毫克乙炔雌二醇加150毫克去氧孕烯或30毫克乙炔雌二醇加75毫克雌二醇。

    >方法:在巴西进行的一项随机,开放标签,六周期,组比较的多中心研究中,妊娠,周期控制参数,副作用的发生率以及寻常痤疮的发生和严重程度是

    结果:在接受治疗的前,次,三和六个周期的口服避孕药评估后,测量血压和体重。

    结果:在纳入研究的595名妇女中,有274名(86.7%) )在去氧孕烯/炔雌醇组中为),而在孕二烯/炔雌醇组中为227(81.4%)完成了六个周期,分别提供了1753和1487个治疗周期的数据。发生了两次怀孕,其中一个(在去氧孕烯/乙炔雌二醇组中)归因于用户失败,而另一个(在孕二烯/乙炔雌二醇组中)则归因于方法失败。观察到循环控制非常好;两组的不规则出血和轻微副作用的发生率均较低,并且在第一个周期最初增加后有所下降。两组都已存在痤疮的情况有所改善,而血压和体重却基本保持不变。

    结论:去氧孕烯/乙炔雌二醇和孕二烯/乙炔雌二醇均能提供有效的口服避孕药,并且具有可比的周期控制能力和可接受性。

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