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药师调配米非司酮药物流产

Medication Abortion With Pharmacist Dispensing of Mifepristone.

机构信息

Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, and the Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, Oakland; the Department of Pharmacy, University of California San Diego Health; the Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Diego, San Diego; the Department of Obstetrics and Gynecology, University of Washington; Planned Parenthood of the Great Northwest and Hawaiian Islands, Seattle, Washington; the Division of Research, Kaiser Permanente Northern California, Oakland; and the Department of Obstetrics and Gynecology, University of California, Davis, Davis, California.

出版信息

Obstet Gynecol. 2021 Apr 1;137(4):613-622. doi: 10.1097/AOG.0000000000004312.

Abstract

OBJECTIVE

To estimate effectiveness and acceptability of medication abortion with mifepristone dispensed by pharmacists.

METHODS

We conducted a prospective cohort study at eight clinical sites and pharmacies in California and Washington State from July 2018 to March 2020. Pharmacists at participating pharmacies underwent a 1-hour training on medication abortion. We approached patients who had already been evaluated, counseled, and consented for medication abortion per standard of care. Patients interested in study participation gave consent, and the clinician electronically sent a prescription to the pharmacy for mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 800 micrograms buccally. Participants were sent web-based surveys about their experience and outcomes on days 2 and 14 after enrollment and had routine follow-up with study sites. We extracted demographic and clinical data, including abortion outcome and adverse events, from medical records. We performed multivariable logistic regression to assess the association of pharmacy experience and other covariates with satisfaction.

RESULTS

We enrolled 266 participants and obtained clinical outcome information for 262 (98.5%), of whom two reported not taking either medication. Of the 260 participants with abortion outcome information, 252 (96.9%) and 237 (91.2%) completed day 2 and 14 surveys, respectively. Complete medication abortion (primary outcome) occurred for 243 participants (93.5%, 95% CI 89.7-96.1%). Four participants (1.5%, 95% CI 0.4-3.9%) had an adverse event, none of which was serious or related to pharmacist dispensing. In the day 2 survey, 91.3% (95% CI 87.1-94.4%) of participants reported satisfaction with the pharmacy experience. In the day 14 survey, 84.4% (95% CI 79.1-88.8%) reported satisfaction with the medication abortion experience. Those reporting being very satisfied with the pharmacy experience had higher odds of reporting overall satisfaction with medication abortion (adjusted odds ratio 2.96, 95% CI 1.38-6.32).

CONCLUSION

Pharmacist dispensing of mifepristone for medication abortion is effective and acceptable to patients, with a low prevalence of adverse events.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT03320057.

摘要

目的

评估药剂师配发米非司酮进行药物流产的效果和可接受性。

方法

我们在加利福尼亚州和华盛顿州的 8 个临床地点和药房进行了一项前瞻性队列研究。参与药房的药剂师接受了 1 小时的药物流产培训。我们接触了已经接受过评估、咨询和同意按照标准进行药物流产的患者。有兴趣参与研究的患者给予同意,临床医生将米非司酮 200mg 的电子处方发送给药房,24-48 小时后再由口腔给予米索前列醇 800 微克。参与者在入组后第 2 天和第 14 天通过网络调查了他们的体验和结果,并在研究地点进行了常规随访。我们从病历中提取人口统计学和临床数据,包括流产结果和不良事件。我们进行了多变量逻辑回归分析,以评估药房经验和其他协变量与满意度的关系。

结果

我们共招募了 266 名参与者,并获得了 262 名(98.5%)参与者的临床结局信息,其中 2 名报告未服用任何一种药物。在有流产结局信息的 260 名参与者中,分别有 252 名(96.9%)和 237 名(91.2%)完成了第 2 天和第 14 天的调查。243 名参与者(93.5%,95%CI 89.7-96.1%)完成了完全药物流产(主要结局)。4 名参与者(1.5%,95%CI 0.4-3.9%)发生了不良事件,但均不严重或与药剂师配药无关。在第 2 天的调查中,91.3%(95%CI 87.1-94.4%)的参与者报告对药房体验满意。在第 14 天的调查中,84.4%(95%CI 79.1-88.8%)的参与者报告对药物流产体验满意。对药房体验非常满意的参与者对药物流产总体满意度的报告几率更高(调整后的比值比 2.96,95%CI 1.38-6.32)。

结论

药剂师配发米非司酮进行药物流产对患者有效且可接受,不良事件发生率较低。

临床试验注册

ClinicalTrials.gov,NCT03320057。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d938/7984759/eaa2aa5a699b/ong-137-613-g001.jpg

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