黄体早期服用低剂量米非司酮作为妇女常规避孕方法的初步研究

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目的:探讨米非司酮用于妇女常规避孕的可行方法。方法:共74例自愿受试人员,于规律月经第15日开始,口服米非司酮5 mg,按疗程递减顺序分别为A组(研究Ⅰ期)每日1次连服4天,B组(研究Ⅱ期)每日1次连服3天,C组(研究Ⅲ期)隔日1次共服2天,观察避孕效果及月经周期改变情况,对可能月经推迟3天及以上者行尿HCG、B超等检查排除早孕。结果:A组43例受试125周期,122例次月经如期来临,3例次月经推迟6~9天,尿HCG、B超等检查阴性,有效率100.0%,月经正常率97.6%。B组68例(A组43例+新入受试25例)受试286周期,282例次月经如期来临,4例次月经推迟5~8天,尿HCG、B超等检查阴性,有效率100.0%,月经正常率98.6%。C组6例(新入受试人员)受试12周期,9例次月经推迟6~9天,尿HCG、B超等检查阴性,有效率100.0%,月经正常率25.0%。A、B两组共获411受试周期,避孕有效率均达100.0%,月经正常率98.3%;C组月经周期正常率显著低于A、B组(P<0.01),研究暂时终止。A、B两组避孕效果及对月经的影响差异无统计学意义(P>0.05)。结论:黄体早期(内膜分泌期早期)阶段短程、小剂量应用米非司酮有较好的避孕效果,且对月经周期无明显的影响,月经规律者可用于每月的常规性避孕。初步研究认为较佳的剂量-时效关系为米非司酮5mg/d连用3天。 Objective: To explore the feasible method of mifepristone for routine contraception in women. Methods: A total of 74 volunteers, regular menstruation began 15 days, oral mifepristone 5 mg, according to the order of decline in treatment A group (study Ⅰ) once daily for 4 days, group B (Study Ⅱ) once daily for 3 consecutive days, C (study Ⅲ) once daily for 2 days, observe the effect of contraception and changes in menstrual cycle, menstruation may be delayed for 3 days and above urinary HCG B super-test to exclude early pregnancy. Results: In group A, 43 patients were enrolled in 125 cycles and 122 patients presented with menstrual cycle as scheduled. Three patients had delayed menstruation for 6-9 days. Urine HCG and B ultrasound were negative. The effective rate was 100.0% and the normal menstruation rate was 97.6%. In group B, 68 patients (43 in group A and 25 in newly enrolled patients) underwent 286 cycles. 282 patients had menstruation as scheduled. 4 patients had delayed menstruation for 5 to 8 days. Urine HCG and B ultrasound were negative. The effective rate was 100.0 %, Normal menstrual rate 98.6%. Six patients in group C (newly recruited) were enrolled in 12 cycles. Nine patients had delayed menstruation 6 to 9 days. Urine HCG and B ultrasound were negative. The effective rate was 100.0% and the normal menstruation rate was 25.0%. There were 411 cycles of test in both A and B groups. The effective rate of contraception reached 100.0% and the normal rate of menstruation was 98.3%. The normal rate of menstrual cycle in group C was significantly lower than that in group A and B (P <0.01). There was no significant difference in contraceptive effectiveness between groups A and B and menstruation (P> 0.05). Conclusion: Mifepristone has a good contraceptive effect in short corpus luteum (early stage of endometrial secretion) and low dose, and has no obvious effect on menstrual cycle. Regular menstruation can be used in routine contraception every month. Preliminary studies suggest that the better dose-response relationship is mifepristone 5mg / d for 3 days.
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