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Contraception:避孕器LNG20的有效性和安全性

2015-05-14 Mechront 译 MedSci原创

Eisenberg DL等人纳入了16-45岁具有正常月经周期和要求避孕的未生育过的和生育过的女性,对其进行了一项非盲、部分随机试验,通过3年数据评估新的设计为可以使用7年以上的52mg左炔诺孕酮宫内节育器(LNG20)的有效性和安全性。初始结局指标为16-35岁女性按珀尔指数计算的妊娠率和有效性。其中36-45岁女性纳入该研究仅仅是针对LNG20的安全性的研究。研究期间研究人员对所有参与者大约每

Eisenberg DL等人纳入了16-45岁具有正常月经周期和要求避孕的未生育过的和生育过的女性,对其进行了一项非盲、部分随机试验,通过3年数据评估新的设计为可以使用7年以上的52mg左炔诺孕酮宫内节育器(LNG20)的有效性和安全性。

初始结局指标为16-35岁女性按珀尔指数计算的妊娠率和有效性。其中36-45岁女性纳入该研究仅仅是针对LNG20的安全性的研究。研究期间研究人员对所有参与者大约每3个月采用面对面或电话随访方式进行随访。

该研究共对1600名16-35岁女性和151名36-45岁女性使用了LNG20装置,其中1011 (57.7%)名未生育过女性和438(25.1%)肥胖女性。研究结果显示,1714 (97.9%)名女性证实了LNG20的有效性。研究期间共观察到6例妊娠,其中4例为异位妊娠。使用LNG201年其珀尔指数为0.15 (95% CI 0.02-0.55),使用2年其珀尔指数为0.26 (95% CI 0.10-0.57) ,而第三年其珀尔指数为0.22 (95% CI 0.08-0.49)。3年间累积有生命的怀孕率为0.55 (95% CI 0.24-1.23)。有62(3.5%)名参与者没能完成3年的研究,其大部分(50 [80.6%])在使用第一年期间离开研究。在停止使用LNG20并且想要怀孕的女性通常在12个月内自然受孕。研究期间有10(0.6%)名女性诊断为盆腔炎性疾病。有26(1.5%)名女性因为出血而停止使用LNG20。

通过对未生育和生育女性3年的研究表明,LNG20是高度安全和有效的。 


小知识:

珀尔指数是国际上通用的用来衡量某种避孕方法可靠性的指标。例如:如果100位成年妇女采用某方法避孕,1年时间内,有1名妇女怀孕,该方法的珀尔指数即是1.0。因此,珀尔指数越高,避孕的失败率就越大。反之珀尔指数越低,所采用的避孕方法就更有效。

原始出处:

Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015 .

本文系Medsci原创编译整理!转载需要先获得授权,并附原文链接。谢谢!

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    2015-09-14 xiaoyeshuang
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    2015-12-05 xiaoyeshuang
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    2015-10-25 shanyongle
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    2016-01-30 bsmagic9140
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    2015-05-17 huaxipanxing

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