Kovacs L, Sas M, Resch B A, Ugocsai G, Swahn M L, Bygdeman M, Rowe P J
Contraception. 1984 May;29(5):399-410. doi: 10.1016/0010-7824(84)90014-3.
RU 486, a new antiprogestational compound, was given to 37 women seeking termination of pregnancy and with amenorrhea of 42 days or less. One patient was found at the second follow-up visit to have an extrauterine pregnancy. The patients received either 25 mg, 50 mg or 100 mg RU 486 twice daily for four days. All patients attended three follow-up visits, one, two and five to six weeks after the start of therapy. The start, duration and amount of bleeding as well as plasma progesterone, beta-hCG and cortisol concentrations were determined for each treatment day and at the follow-up visits. All patients but three started to bleed during treatment. Frequency of complete abortion was 61% (22 out of 36 patients). In only three patients was the pregnancy unaffected by treatment. The clinical efficacy of the treatment was not dose-dependent. Most of the patients experienced only minor side effects in terms of mild uterine pain, nausea and vomiting. However, two patients suffered from heavy bleeding requiring blood transfusion and curettage. In the patients with complete abortion, beta-hCG values decreased significantly but not until the first follow-up visit. The plasma progesterone also decreased. The decrease appeared earlier with the higher daily dose of RU 486. Cortisol concentrations increased during treatment with all 3 dosage regimens but the levels remained within the normal range. It is concluded that treatment with RU 486 may provide a novel therapy for "menstrual regulation" but the efficacy of the treatment needs to be improved to compete with alternatives such as vacuum aspiration.
RU 486,一种新型抗孕激素化合物,被给予37名寻求终止妊娠且闭经42天或更短时间的女性。在第二次随访时发现一名患者为宫外孕。患者每天两次接受25毫克、50毫克或100毫克RU 486治疗,持续四天。所有患者在治疗开始后的一、二和五至六周进行了三次随访。测定了每个治疗日以及随访时的出血开始时间、持续时间和出血量,以及血浆孕酮、β-人绒毛膜促性腺激素(β-hCG)和皮质醇浓度。除三名患者外,所有患者在治疗期间开始出血。完全流产的发生率为61%(36名患者中的22名)。只有三名患者的妊娠未受治疗影响。治疗的临床疗效不依赖剂量。大多数患者仅经历了轻微的副作用,如轻度子宫疼痛、恶心和呕吐。然而,两名患者出现大出血,需要输血和刮宫。在完全流产的患者中,β-hCG值显著下降,但直到第一次随访时才下降。血浆孕酮也下降。每日RU 486剂量越高,下降出现得越早。在所有三种给药方案治疗期间,皮质醇浓度均升高,但水平仍在正常范围内。结论是,RU 486治疗可能为“月经调节”提供一种新的疗法,但需要提高治疗效果以与诸如真空吸引术等替代方法竞争。