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津巴布韦 2014-2019 年大规模常规自愿男性包皮环切计划中的不良事件趋势。

Adverse Event Trends Within a Large-Scale, Routine, Voluntary Medical Male Circumcision Program in Zimbabwe, 2014-2019.

机构信息

Department of Global Health, University of Washington, Seattle, WA.

Zimbabwe Technical Training and Education Center for Health (ZIMTTECH), Harare, Zimbabwe.

出版信息

J Acquir Immune Defic Syndr. 2021 Oct 1;88(2):173-180. doi: 10.1097/QAI.0000000000002751.

Abstract

BACKGROUND

Between 2008 and 2020, over 22.6 million male circumcisions (MCs) were performed among men ≥10 years in 15 priority countries of East and Southern Africa. Few studies from routine MC programs operating at scale describe trends of adverse events (AEs) or AE rates over time.

SETTING

Routine program data from a large MC program in Zimbabwe.

METHODS

χ2 compared characteristics of patients with AEs. Univariable and multivariable logistic models examined factors associated with AE severity. Cochran-Armitage trend tests compared AE rate trends by year (2014-2019), age, and MC method (2017-2019).

RESULTS

From 2014 to 2019, 469,000 men were circumcised; of the total men circumcised, 38%, 27%, and 35% were conducted among individuals aged 10-14; 15-19; and ≥20 years, respectively. Most MCs (95%) used surgical (dorsal slit or forceps-guided) methods; 5% were device based (PrePex). AEs were reported among 632 (0.13%) MCs; 0.05% were severe. From 2015 to 2019, overall AE rates declined from 34/10,000 to 5/10,000 (P-value <0.001). Severe AE rates also decreased over this period from 12/10,000 to 2/10,000 (P-value <0.001). AE rates among younger clients, aged 10-14 (18/10,000) were higher than among older age men (9/10,000) aged ≥20 years (P < 0.001); however, there was no significant association between age and AE severity.

CONCLUSION

AE rates each year and over time were lower than the World Health Organization acceptable maximum (2% AEs). ZAZIC quality assurance activities ensured guideline adherence, mentored clinicians to MC competency, promoted quality client education and counseling, and improved AE reporting over time. Decreases in AE rates are likely attributed to safety gains and increasing provider experience.

摘要

背景

在 2008 年至 2020 年期间,在东非和南非的 15 个重点国家,为 10 岁及以上男性进行了超过 2260 万例男性包皮环切术(MC)。很少有来自大规模常规 MC 项目的研究描述随着时间的推移不良事件(AE)或 AE 发生率的趋势。

地点

津巴布韦一个大型 MC 项目的常规项目数据。

方法

卡方比较 AE 患者的特征。单变量和多变量逻辑模型检查了与 AE 严重程度相关的因素。Cochran-Armitage 趋势检验比较了按年份(2014-2019 年)、年龄和 MC 方法(2017-2019 年)划分的 AE 发生率趋势。

结果

2014 年至 2019 年,共有 46.9 万名男性接受了环切术;在接受环切术的男性中,分别有 38%、27%和 35%的年龄在 10-14 岁、15-19 岁和≥20 岁。大多数 MC(95%)采用手术(背部切开或钳子引导)方法;5%采用器械(PrePex)。在 632 例(0.13%)MC 中报告了 AE;0.05%为严重。2015 年至 2019 年,AE 总体发生率从 34/10000 下降到 5/10000(P 值<0.001)。在此期间,严重 AE 发生率也从 12/10000 下降到 2/10000(P 值<0.001)。年龄在 10-14 岁的年轻患者(18/10000)的 AE 发生率高于年龄在≥20 岁的老年患者(9/10000)(P<0.001);然而,年龄与 AE 严重程度之间没有显著关联。

结论

每年和随着时间的推移,AE 发生率均低于世界卫生组织可接受的最高值(2%的 AE)。ZAZIC 质量保证活动确保了指南的遵守,指导临床医生达到 MC 能力水平,促进了高质量的客户教育和咨询,并随着时间的推移提高了 AE 报告的质量。AE 发生率的下降可能归因于安全性的提高和提供者经验的增加。

相似文献

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