1.5mg左炔诺孕酮肠溶胶囊用于紧急避孕的临床多中心研究  

A randomized,multicentre study on comparing levonorgestrel enteric-capsules and tablets for emergency contraception

作　　者：李丽[1] 楚光华 经小平[3] 李来宝[1] 吴尚纯[1] 

机构地区：[1]国家人口计生委科学技术研究所,北京100081 [2]陕西省妇幼保健院 [3]北京市朝阳医院

出　　处：《中国计划生育学杂志》2014年第5期319-324,共6页Chinese Journal of Family Planning

摘　　要：目的：比较1．5mg左炔诺孕酮（LNG）肠溶胶囊和口服片剂用于紧急避孕的临床效果、副作用和对月经的影响。方法：在全国30个医疗或计划生育技术服务机构进行随机对照性研究。将符合条件并在无保护性生活后72h内要求紧急避孕的2880例妇女随机分配于口服1．5mgLNG肠溶胶囊组（胶囊组）和口服1．5mgLNG片组（片剂组），门诊随访的方式观察两组用药后不良反应的发生情况及妊娠情况。结果：在2880例妇女中失访5例，最终有2868例纳入效果分析，其中胶囊组1908例，片剂组960例。每组各有7例妊娠，妊娠率分别为0．37％和0．73%。与片剂相比，胶囊剂的相对危险度为0．5，双侧检验95％的可信区间为0．18～1．43。两种药物可预防91％～95％未经治疗的预期妊娠。随服药时间的延迟，效果有下降的趋势；若服药后再有无保护性生活，妊娠率几乎增加了1倍。服药后24h内及1h内恶心、呕吐的发生率，片剂组显著高于胶囊组，其中胶囊组无妊娠，片剂组2例妊娠，妊娠率为5．9％。其他方面不良反应及阴道流血发生率较低。胶囊组与片剂组下次月经按期来潮者分别为73．5％和70％，与平时月经相似者分别为84．3％和80。3％，经期在7d内者分别为98．3％和98．7％。结论：1．5mgLNG肠溶胶囊用于紧急避孕安全有效，可减少胃肠道不良反应。Objective： To compare the efficacy, side effects and the influence on the next menstruation of levonorgestret （LNG） enteric--capsules （Caps） to tablets （Tabs） in emergency contraception. Methods： A randomized multicentre trial was conducted in 30 hospital or family planning institutes around China. A total of 2880 women with regular cycles and history of unprotected intercourse within 72 hours were recruited and randomly assigned to two study groups. Sin- gle dose of 1.5 mg I.NG enteric--capsule or tablet was taken in Caps group and Tabs group. Follow--up visit was con- ducted on the 7th day of the expected menstruation to evaluate the contraceptive efficacy and to record side effects and menstruation. Contraceptive efficacy was calculated by Dixon＇s test method. Results： Five women were lost to follow up. The total valid subjects in Caps and Tabs group were 1908 and 960 respectively. Seven pregnancies occurred in each group, with 0.37% and 0.73% of the pregnancy rate respectively. The relative risk of pregnancy of treatment with1. 5mg LNG Cap in comparison with Tab was 0.5 （95%CI： 0.18--1.43）. The two drugs prevented about 91% to 95% of the anticipated pregnancy if no measure had been adopted. The efficacy decreased along with the delay of both of the two drugs administration. The pregnancy rate nearly doubled in the women who had unprotected sex after treatment. The incidences of nausea and vomit of the Tab group were significantly higher than those of the Cap group within 24h and lh of the treatment （P〈0.001）. Among these women, there were 2 pregnancies （pregnancy rate was 5.9%） oc- curred in Tab group whereas no pregnancy in Cap group. Other side effects were uncommon and mild. The percentage of subjects who had their next menstruation before or after the expected menstruation 3 days in the two groups was73.5% and 70% respectively. The menstrual period less than 7 days were 98.3% and 98.7%. Conclusion% 1.Stag of LNG enteric--Caps is effective and safe for emergency contrace

关 键 词：左炔诺孕酮 避孕 肠溶胶囊剂 片剂 避孕效果 剂型效应关系 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]