Regional Resource Hub for Health Technology Assessment, Indian Council of Medical Research, National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, 400012, India.
Health Technology Assessment Secretariat, Department of Health Research, Ministry of Health and Family Welfare, New Delhi, India.
Reprod Health. 2021 Jan 6;18(1):4. doi: 10.1186/s12978-020-01054-y.
BACKGROUND: Unintended pregnancies (UIP) have a significant impact on health of women and the health budget of countries. Contraception is an effective way to prevent UIPs. The study objective was to collate evidence on clinical effectiveness of etonogestrel subdermal implant (ESI), continuation rate and side effect profile among eligible women of reproductive age group, as compared to levonorgestrel intrauterine system (LNG-IUS), copper intrauterine device (Cu-IUD) and depot medroxy progesterone acetate injections; other types of contraceptive implants were excluded as comparators. METHODS: The protocol of the systematic review was registered in Prospero (registration number: CRD42018116580). MEDLINE via PubMed, Cochrane library and web of science were the electronic databases searched. A search strategy was formulated and studies from 1998 to 2019 were included. Clinical trial registries and grey literature search was done. Critical assessment of included studies was done using appropriate tools. A qualitative synthesis of included studies was done and a meta-analysis was conducted in RevMan software for continuation rates of ESI as compared to other long acting reversible contraceptives (LARC) e.g. LNG IUS and Cu-IUD. RESULTS: The search yielded 23,545 studies. After excluding 467 duplicates, 23,078 titles were screened and 51 studies were included for the review. Eight of the 15 studies reporting clinical effectiveness reported 100% effectiveness and overall pearl index ranged from 0 to 1.4. One-year continuation rates ranged from 57-97%; 44-95% at the end of second year and 25-78% by 3 years of use. Abnormal menstruation was the most commonly reported side effect. There was no significant difference in bone mineral density at 1 year follow-up. The meta-analyses showed that odds ratio (OR) of 1-year continuation rate was 1.55 (1.36, 1.76) for LNG-IUS vs. ESI and 1.34 (1.13, 1.58) for copper-IUD vs. ESI; showing that continuation rates at the end of one-year were higher in LNG-IUS and copper-IUD as compared to ESI. CONCLUSION: ESI is clinically effective and safe contraceptive method to use, yet 1-year continuation rates are lower as compared to LNG-IUS and copper-IUD, mostly attributed to the disturbances in the menstruation.
背景:意外怀孕(UIP)对妇女健康和国家卫生预算有重大影响。避孕是预防 UIP 的有效方法。本研究的目的是整理关于左炔诺孕酮皮下埋植剂(ESI)的临床效果、续用率和不良反应特征的证据,将其与左炔诺孕酮宫内节育系统(LNG-IUS)、铜宫内节育器(Cu-IUD)和醋酸甲羟孕酮长效注射剂进行比较;其他类型的避孕植入物被排除作为对照。
方法:系统评价的方案已在 Prospero(注册号:CRD42018116580)中注册。检索了 MEDLINE 通过 PubMed、Cochrane 图书馆和 Web of Science 电子数据库。制定了检索策略,并纳入了 1998 年至 2019 年的研究。进行了临床试验登记处和灰色文献搜索。使用适当的工具对纳入的研究进行了批判性评估。对纳入的研究进行了定性综合分析,并在 RevMan 软件中对 ESI 与其他长效可逆避孕方法(LARC)如 LNG IUS 和 Cu-IUD 的续用率进行了荟萃分析。
结果:检索结果为 23545 项研究。排除 467 项重复后,筛选了 23078 个标题,纳入了 51 项研究进行综述。15 项报告临床效果的研究中有 8 项报告了 100%的效果,总体珍珠指数范围为 0 至 1.4。一年续用率为 57-97%;第二年结束时为 44-95%,第三年为 25-78%。异常子宫出血是最常见的不良反应。1 年随访时骨密度无显著差异。荟萃分析显示,LNG-IUS 与 ESI 相比,1 年续用率的优势比(OR)为 1.55(1.36,1.76),Cu-IUD 与 ESI 相比,OR 为 1.34(1.13,1.58);这表明 LNG-IUS 和 Cu-IUD 在一年结束时的续用率高于 ESI。
结论:ESI 是一种临床有效且安全的避孕方法,但与 LNG-IUS 和 Cu-IUD 相比,1 年续用率较低,主要归因于月经紊乱。
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