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依伴侬的临床概况:一种单棒式依托孕烯避孕植入剂。

Clinical profile of Implanon: a single-rod etonogestrel contraceptive implant.

作者信息

Croxatto H B

机构信息

Instituto Chileno de Medicina Reproductiva, Santiago, Chile.

出版信息

Eur J Contracept Reprod Health Care. 2000 Sep;5 Suppl 2:21-8.

Abstract

This 3-year study investigating the contraceptive efficacy and tolerability of Implanon in 635 volunteers demonstrates that it was well tolerated and had excellent, reversible, contraceptive efficacy. No pregnancies (Pearl index, 0; 95% CI 0.0-0.2) occurred during 1,200 woman-years of exposure. Irregular bleeding, mainly frequent and prolonged, was the primary reason for discontinuation (19.0%). Infrequent bleeding (29-51%) was the most common bleeding disturbance. Adverse events, other than bleeding irregularities, were generally mild to moderate in intensity and resulted in 9.3% of discontinuations. Over 85% of women with dysmenorrhea at baseline noted an improvement at the end of treatment, while 4% reported new or worsened symptoms. The most commonly reported non-bleeding adverse events were breast pain (16%), acne (12.6%), vaginitis (12%) and pharyngitis (10.5%). However, acne present at enrolment improved or disappeared during treatment in 59% of women. Less than 5% of women experienced implant site symptoms after insertion or removal, mainly mild pain of short duration. Average insertion and removal times were 2.2 and 5.4 min, respectively. In most women, menses returned to normal within 3 months of implant removal. Of those using no contraceptive method, 13.8% became pregnant within 90 days. Implanon represents a highly effective contraceptive option for women.

摘要

这项针对635名志愿者开展的为期3年的研究,调查了依伴侬的避孕效果和耐受性,结果表明其耐受性良好,具有出色的、可逆的避孕效果。在1200妇女年的暴露期间未发生妊娠(Pearl指数为0;95%可信区间为0.0 - 0.2)。不规则出血,主要是频繁和持续时间长,是停药的主要原因(19.0%)。出血不频繁(29 - 51%)是最常见的出血紊乱情况。除出血异常外,不良事件的强度一般为轻至中度,导致9.3%的人停药。基线时有痛经的妇女中,超过85%在治疗结束时症状有所改善,而4%报告有新的症状或症状加重。最常报告的非出血性不良事件为乳房疼痛(16%)、痤疮(12.6%)、阴道炎(12%)和咽炎(10.5%)。然而,入组时存在痤疮的妇女中,59%在治疗期间痤疮有所改善或消失。不到5%的妇女在植入或取出后出现植入部位症状,主要是持续时间短的轻度疼痛。平均植入和取出时间分别为2.2分钟和5.4分钟。在大多数妇女中,月经在植入物取出后3个月内恢复正常。在未采取避孕措施的妇女中,13.8%在90天内怀孕。依伴侬是女性一种高效的避孕选择。

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