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基于临床与自我使用药物流产的临床结局的前瞻性、对照研究。

A prospective, comparative study of clinical outcomes following clinic-based versus self-use of medical abortion.

机构信息

Ipas, Chapel Hill, North Carolina, USA

University of Health Sciences, Phnom Penh, Cambodia.

出版信息

BMJ Sex Reprod Health. 2023 Oct;49(4):300-307. doi: 10.1136/bmjsrh-2022-201722. Epub 2023 Mar 9.

Abstract

BACKGROUND

To determine whether clinical outcomes differ among women accessing a combined medical abortion regimen from a health clinic when compared with those accessing it from a pharmacy.

METHODS

We conducted a multicentre, prospective, comparative, non-inferiority study of participants aged ≥15 years seeking medical abortion from five clinics and five adjacent pharmacy clusters in three provinces of Cambodia. Participants were recruited in-person at the point of purchase (clinic or pharmacy). Follow-up for self-reported pill use, acceptability, and clinical outcomes occurred by telephone at days 10 and 30 after mifepristone administration.

RESULTS

Over 10 months, we enrolled 2083 women with 1847 providing outcome data: 937 from clinics and 910 from pharmacies. Most were early in their pregnancy (mean gestational age of 6.3 and 6.1 weeks, respectively) and almost all took the pills correctly (98% and 96%,). Additional treatment needed to complete the abortion was non-inferior for the pharmacy group (9.3%) compared with the clinic group (12.7%). More from the clinic group received additional care from a provider, such as antibiotics or diagnostics tests, than those from the pharmacy group (11.5% and 3.2%,), and one ectopic pregnancy (pharmacy group) was successfully treated. Most said they felt prepared for what happened after taking the pills (90.9% and 81.3%, respectively, p=0.273).

CONCLUSIONS

Self-use of a combined medical abortion product resulted in comparable clinical outcomes as use following a clinical visit, consistent with existing literature on its safety and efficacy. Registration and availability of medical abortion as an over-the-counter product would likely increase women's access to safe abortion.

摘要

背景

为了确定与从诊所获取组合药物流产方案的女性相比,从药房获取该方案的女性在临床结局上是否存在差异。

方法

我们在柬埔寨三个省的五家诊所和五家相邻的药房集群中进行了一项多中心、前瞻性、比较性、非劣效性研究,纳入了年龄≥15 岁、寻求药物流产的参与者。参与者在购买药物时(诊所或药房)进行面对面招募。在米非司酮给药后第 10 天和第 30 天,通过电话对自我报告的用药情况、可接受性和临床结局进行随访。

结果

在 10 个月期间,我们招募了 2083 名女性,其中 1847 名提供了结局数据:937 名来自诊所,910 名来自药房。大多数人怀孕早期(平均妊娠龄分别为 6.3 周和 6.1 周),且几乎所有人都正确服用了药物(分别为 98%和 96%)。需要额外治疗以完成流产的比例在药房组(9.3%)与诊所组(12.7%)之间无显著差异。与药房组相比,更多的诊所组接受了提供者提供的额外护理,如抗生素或诊断性检查(11.5%和 3.2%),并且一名宫外孕(药房组)得到了成功治疗。大多数人表示,她们对服药后的情况有所准备(分别为 90.9%和 81.3%,p=0.273)。

结论

自行使用组合药物流产产品的效果与临床就诊后使用该产品的效果相当,这与该产品的安全性和有效性的现有文献一致。将药物流产注册并作为非处方药物上市可能会增加女性获得安全流产的机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b93e/10579469/e4529eb84f11/bmjsrh-2022-201722f01.jpg

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