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.

译文

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。

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