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米索前列醇单独用于早期药物流产的有效性和安全性:一项更新的系统评价和荟萃分析。

Effectiveness and safety of misoprostol-only for first-trimester medication abortion: An updated systematic review and meta-analysis.

机构信息

Gynuity Health Projects, New York, NY, United States.

Elon University, Department of Mathematics and Statistics, Elon, NC, United States.

出版信息

Contraception. 2023 Nov;127:110132. doi: 10.1016/j.contraception.2023.110132. Epub 2023 Jul 29.

Abstract

OBJECTIVES

This study aimed to update our 2019 systematic review of data on the effectiveness and safety of misoprostol-only for first-trimester abortion.

STUDY DESIGN

We searched PubMed on December 18, 2022, to find published articles describing the outcomes of treatment with misoprostol-only for abortion of viable intrauterine pregnancy at ≤91 days of gestation. From each article identified, two authors independently abstracted relevant data about each group of patients treated with a distinct regimen. We assessed the risk of bias using four defined indicators. We estimated the proportion of patients with treatment failure using meta-analytic methods as well as the proportion hospitalized or transfused after treatment. We examined associations between treatment failure and selected characteristics of the groups.

RESULTS

We identified 49 papers with 66 groups that collectively included 16,354 evaluable patients, of whom 2960 (meta-analytic estimate 15%, 95% CI 12%, 19%) had treatment failures. Of 9228 patients assessed for ongoing pregnancy after treatment, 521 (meta-analytic estimate 6%, 95% CI 5%, 8%) had that condition. Failure risk was significantly associated with misoprostol dose, the total allowed number of doses, the maximum duration of dosing, and certain indicators of risk of bias. Among 11,007 patients allowed to take at least three misoprostol doses, the first consisting of misoprostol 800 mcg administered vaginally, sublingually, or buccally, the meta-analytic estimate of the failure risk was 11% (95% CI 8%, 14%). At most, 0.2% of 15,679 evaluable patients were hospitalized or received transfusions.

CONCLUSIONS

Although some studies in this updated review were adjudicated to have a high risk of bias, the results continue to support the key conclusion of our 2019 analysis: misoprostol-only is effective and safe for the termination of first-trimester intrauterine pregnancy.

IMPLICATIONS

Misoprostol-only is a safe and effective option for medication abortion in the first trimester if mifepristone is unavailable or inaccessible.

摘要

目的

本研究旨在更新我们 2019 年关于米索前列醇单独用于孕 91 天以内早期妊娠流产的有效性和安全性的系统评价。

研究设计

我们于 2022 年 12 月 18 日在 PubMed 上检索,以查找描述米索前列醇单独用于治疗孕 91 天以内活胎宫内妊娠的结局的已发表文章。从每篇文章中,两位作者独立提取关于每个用不同方案治疗的患者组的相关数据。我们使用四个定义的指标评估偏倚风险。我们使用荟萃分析方法估计治疗失败的患者比例,以及治疗后住院或输血的患者比例。我们检查了治疗失败与组的某些特征之间的关联。

结果

我们共识别了 49 篇文献,涉及 66 个组,共纳入了 16354 例可评估患者,其中 2960 例(荟萃分析估计 15%,95%CI 12%,19%)治疗失败。在治疗后评估 9228 例继续妊娠的患者中,521 例(荟萃分析估计 6%,95%CI 5%,8%)有此情况。失败风险与米索前列醇剂量、允许使用的总剂量数、最大给药时间以及某些偏倚风险指标显著相关。在 11007 例允许至少使用 3 次米索前列醇的患者中,第 1 次给予阴道、舌下或颊部米索前列醇 800 mcg,荟萃分析估计的失败风险为 11%(95%CI 8%,14%)。最多有 0.2%的 15679 例可评估患者需要住院或输血。

结论

尽管本更新综述中的一些研究被判定为存在高偏倚风险,但结果继续支持我们 2019 年分析的关键结论:米索前列醇单独用于孕早期宫内妊娠流产是有效且安全的。

意义

如果米非司酮不可用或无法获得,米索前列醇单独是孕早期药物流产的安全有效选择。

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