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墨西哥未生育女性中三种不同宫内节育器的比较随机研究。

A comparative randomized study of three different IUDs in nulliparous Mexican women.

作者信息

Otero-Flores J B, Guerrero-Carreño F J, Vázquez-Estrada L A

机构信息

Reproductive Health Coordination, Division of Family Planning. Mexican Institute of Social Security IMSS, Mier y Pesado 120, Colonia del Valle, Mexico 03100, DF, Mexico City, Mexico.

出版信息

Contraception. 2003 Apr;67(4):273-6. doi: 10.1016/s0010-7824(02)00519-x.

Abstract

With the aim to evaluate the clinical performance of intrauterine devices (IUDs) especially designed for nulliparous women (TCu 380 Nul and ML Cu 375 sl), a prospective randomized, single-blind study comparing them with standard TCu 380 A, was carried out. We included 1170 healthy nulliparous women randomly allocated to receive any of the three types of IUDs and conducted follow-up for 1 year of use. Continuation and termination rates were evaluated by gross cumulative life table analysis and compared by the log-rank test. Continuation rates (95% confidence interval) at the end of the study for TCu 380 A, TCu 380 Nul and ML Cu 375 sl were 29.5% (+/-12.9), 85.9% (+/-5.3) and 85.4% (+/-5.8), respectively (p < 0.001). There were six pregnancies during the first 3 months of use, for a failure rate of 1% (+/-0.6) in the TCu 380 A group, 0.5% (+/-0.3) in TCu 380 Nul, and no pregnancy in ML Cu 375 sl (p < 0.05). Especially designed IUDs for nulliparous women had a better clinical profile compared with the standard IUD. This may improve the use of IUD in this population.

摘要

为评估专门为未生育女性设计的宫内节育器(IUDs,TCu 380 Nul和ML Cu 375 sl)的临床性能,开展了一项前瞻性随机单盲研究,将其与标准的TCu 380 A进行比较。我们纳入了1170名健康未生育女性,随机分配她们接受三种IUD中的任何一种,并对其使用情况进行了1年的随访。通过总体累积生命表分析评估持续率和终止率,并通过对数秩检验进行比较。在研究结束时,TCu 380 A、TCu 380 Nul和ML Cu 375 sl的持续率(95%置信区间)分别为29.5%(±12.9)、85.9%(±5.3)和85.4%(±5.8)(p<0.001)。在使用的前3个月中有6例妊娠,TCu 380 A组的失败率为1%(±0.6),TCu 380 Nul组为0.5%(±0.3),ML Cu 375 sl组无妊娠(p<0.05)。与标准IUD相比,专门为未生育女性设计的IUD具有更好的临床特征。这可能会改善该人群对IUD的使用。

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