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比较左炔诺孕酮宫内节育系统与复方避孕药的前瞻性多中心研究:最终结果

Prospective multicentre study comparing levonorgestrel implants with a combined contraceptive pill: final results.

作者信息

Kirkman R J, Bromham D R, O'Connor T P, Sahota J E

机构信息

Palatine Centre, Manchester.

出版信息

Br J Fam Plann. 1999 Jul;25(2):36-40.

Abstract

Norplant is a hormonal, long term method of contraception requiring the sub-dermal placement of six flexible capsules containing levonorgestrel in the inner aspect of the upper non-dominant arm. This open, prospective, multicentre, parallel group study, comparing the acceptability of Norplant and a combined pill, was originally designed to follow 700 subjects for five years, but was discontinued early. The main outcome criteria were duration of use and reason for discontinuation if appropriate. This final analysis, concerning the 364 subjects who used the implant and 307 subjects who used a gestodene/ethinyloestradiol combined pill, shows a statistically significantly higher (p<0.001) continuation rate amongst the implant users at 83.4 per cent compared to the pill users at 64.4 per cent at one year and this difference decreased only slightly by two years. The most common reasons for discontinuation by the end of the study were adverse events in both groups (menstrual and then mood changes in the implant group and mood changes and then headaches in the pill group). From the whole cohort the proportion which were 'very satisfied' were higher in the implant group (28.5 per cent compared to 14.6 per cent). This study confirms, in the UK, a high continuation rate for implant users similar to other countries as reported in the literature. If acceptability and continuation rates are similar in the none study setting, then a substantial number of women will seek removal of the implant and possible reinsertion five years after the time of initial high popularity (ie 1999). Doctors need to be prepared for this possible high level of activity.

摘要

诺普兰是一种激素类长效避孕方法,需要在上臂非优势侧内侧皮下植入6个含左炔诺孕酮的柔性胶囊。这项开放性、前瞻性、多中心、平行组研究比较了诺普兰和复方口服避孕药的可接受性,最初设计是对700名受试者进行为期5年的随访,但提前终止。主要结局标准为使用时长及(如适用)停药原因。这项针对364名使用植入剂的受试者和307名使用孕二烯酮/炔雌醇复方口服避孕药的受试者的最终分析显示,植入剂使用者的持续率在统计学上显著更高(p<0.001),一年时为83.

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