Efficacy, safety and acceptability of the use of 68 mg etonogestrel contraceptive subdermal implant for up to 5 years compared with up to 3 years: a systematic review.
Jessica Chen, Jen Sothornwit, Asantesana Kamuyango, Nancy Kidula, James Kiarie, Melanie Cedrone, Nancy Santesso, Sarita Sonalkar
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引用次数: 0
Abstract
Background: Prolonging the use of the etonogestrel (ENG) implant beyond the currently approved duration of 3 years could offer substantial benefits including improved accessibility, reduced need for replacements and overall lower healthcare costs. The purpose of this systematic review is to examine the current evidence regarding the effectiveness, safety and acceptability of the use of the ENG implant for up to 5 years.
Methods: We searched PubMed, Embase, Scopus, Global Health, CINAHL, ClinicalTrials.gov, Global Index Medicus, Cochrane Central Register of Controlled Trials and International Clinical Trials Registry Platform from 1996 to 2024. Our study population included reproductive-aged women using the 68 mg single-rod ENG contraceptive implant. We included randomised controlled trials, retrospective and prospective cohort studies, case-control studies and conference presentations. Outcomes included those related to efficacy, safety and acceptability. The primary contraceptive efficacy outcome was Pearl Index between the third and fifth years of placement compared to that within 3 years.
Results: We identified seven relevant studies. No pregnancies were noted among 860 participants within years 3-4 or among 306 participants within years 4-5. No important safety events were identified. Discontinuation of the implant due to bleeding was higher in the first 3 years of use (20.6%), compared with years 3-5 (5.4%). Due to the non-comparative nature of the studies and the overall low sample sizes of the studies, evidence certainty was deemed to be low or very low using the GRADE criteria.
Conclusions: Current evidence, despite its low certainty, does not carry signals of potential concerns with regard to extended use, with potential for benefit.
背景:延长etonogestrel (ENG)植入物的使用时间超过目前批准的3年,可以提供实质性的好处,包括改善可及性,减少更换需求和总体降低医疗成本。本系统综述的目的是检查目前关于使用ENG植入物长达5年的有效性、安全性和可接受性的证据。方法:检索PubMed、Embase、Scopus、Global Health、CINAHL、ClinicalTrials.gov、Global Index Medicus、Cochrane Central Register of Controlled Trials和国际临床试验注册平台,检索时间为1996 - 2024年。我们的研究人群包括使用68毫克单棒ENG避孕植入物的育龄妇女。我们纳入了随机对照试验、回顾性和前瞻性队列研究、病例对照研究和会议报告。结果包括与疗效、安全性和可接受性相关的结果。第3 ~ 5年的主要避孕效果指标为珍珠指数,与第3年的比较。结果:我们确定了7项相关研究。860名参与者在第3-4年没有怀孕,306名参与者在第4-5年没有怀孕。未发现重大安全事件。因出血而停用植入物的比例在使用前3年(20.6%)高于3-5年(5.4%)。由于研究的非比较性和研究的总体样本量较小,使用GRADE标准,证据确定性被认为是低或非常低。结论:目前的证据,尽管它的低确定性,并没有传递潜在的信号,关于延长使用的潜在问题,有潜在的好处。
期刊介绍:
BMJ Sexual & Reproductive Health is a multiprofessional journal that promotes sexual and reproductive health and wellbeing, and best contraceptive practice, worldwide. It publishes research, debate and comment to inform policy and practice, and recognises the importance of professional-patient partnership.