Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings
Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings
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DOI：
10.1097/qai.0b013e3182354e65
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发表时间：
2011-12-15
影响因子：
3.6
通讯作者：
Binagwaho, Agnes
中科院分区：
文献类型：
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作者：
Bitega, Jean Paul;Ngeruka, Muyenzi Leon;Binagwaho, Agnes
目的：评估 PrePex 装置对成年男性进行非手术包皮环切术的安全性和有效性，作为卢旺达艾滋病毒综合预防计划的一部分。方法：单中心 6 周非对照研究，其中健康男性使用 PrePex 装置进行包皮环切术，该装置采用固定环夹紧包皮，导致远端坏死。在研究的第一阶段，5名受试者在无菌环境中测试了该程序的可行性；在主要阶段，另外 50 名受试者在非无菌环境中由医生或护士进行了包皮环切术。结果指标包括包皮环切术的成功率、完全愈合的时间、疼痛和不良事件。结果：在可行性阶段，所有 5 名受试者均实现了完整的包皮环切术，且无不良事件。在主要阶段，所有 50 名受试者均实现了包皮环切术，其中 1 例在装置移除后出现弥漫性水肿，仅通过最少的干预即可解决。除了在移除装置期间短暂疼痛外（大多数情况下是放置后第 7 天），疼痛非常轻微。整个手术过程不流血，不需要麻醉，不需要缝合，也不需要无菌环境。受试者没有与手术相关的病假/缺勤天数。完全愈合的中位时间是移除装置后 21 天。没有发生错误放置的情况，也没有设备出现机械问题。结论：PrePex 设备对于无需麻醉或无菌环境的非手术成年男性包皮环切术是安全有效的，并且可能有助于大规模包皮环切计划以降低 HIV 感染风险，特别是在资源有限的环境中。
Objective: To assess the safety and efficacy of the PrePex device for nonsurgical circumcision in adult males as part of a comprehensive HIV prevention program in Rwanda.Methods: Single-center 6-week noncontrolled study in which healthy men underwent circumcision using the PrePex device, which employs fitted rings to clamp the foreskin, leading to distal necrosis. In the first phase of the study, the feasibility of the procedure was tested on 5 subjects in a sterile environment; in the main phase, an additional 50 subjects were circumcised in a nonsterile setting by physicians or a nurse. Outcome measures included the rate of successful circumcision, time to complete healing, pain, and adverse events.Results: In the feasibility phase, all 5 subjects achieved complete circumcision without adverse events. In the main phase, all 50 subjects achieved circumcision with 1 case of diffuse edema after device removal, which resolved with minimal intervention. Pain was minimal except briefly during device removal (day 7 after placement in most cases). The entire procedure was bloodless, requiring no anesthesia, no suturing, and no sterile settings. Subjects had no sick/absent days associated with the procedure. Median time for complete healing was 21 days after device removal. There were no instances of erroneous placement and no mechanical problems with the device.Conclusion: The PrePex device was safe and effective for nonsurgical adult male circumcision without anesthesia or sterile settings and may be useful in mass circumcision programs to reduce the risk of HIV infection, particularly in resource-limited settings.