Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Center for TB Research, Johns Hopkins University, Baltimore, MD, United States of America.
PLoS One. 2018 Mar 26;13(3):e0194271. doi: 10.1371/journal.pone.0194271. eCollection 2018.
The PrePex medical male circumcision (MMC) device is relatively easy to place and remove with some training. PrePex has been evaluated in several countries to assess feasibility and acceptability. However, several studies have reported pain associated with removal.
To assess safety of PrePex and whether analgesia administered prior to removal reduces pain experienced by participants.
A multi-site non-randomized, prospective cohort study in which adult (18-45 years old) males requesting PrePex device male circumcision, were enrolled in six South African clinics from July 2014 to March 2015. Participants were routinely provided with analgesia shortly after the surveillance commenced following a protocol review. Analgesia regimen for device removal depended on medication availability at clinics.
Of 1023 enrolled participants who had PrePex placed, 98% (1004) had the device removed at a study clinic. Their median age was 25 (IQR: 21-30) years. HIV sero-positivity was 3.6% (37/1023). Nurses placed and removed half of all devices. Adverse events were experienced by 2.4% (25/1023) of participants; 15 required surgical intervention: device displacement (5/14), early removals (3/14), self-removals (5/14) and insufficient skin removed (2/14). Majority (792: 79%) of participants received analgesia. Most received either paracetamol-codeine (33%), lidocaine (29%) or EMLA and Oral Combination (28%). A lower proportion of participants who received any analgesia (except for lidocaine) prior to PrePex removal experienced severe pain compared to those who received no analgesia (16.6% vs. 29%: p = 0.0001).
Reported adverse events during this PrePex active surveillance were similar to previous reports and to those of surgical circumcision. Pain medication provided prior to removal is effective at decreasing severe pain during PrePex device removal.
PrePex 医学男性环切（MMC）装置相对容易放置和移除，只需经过一些培训。PrePex 已在多个国家进行了评估，以评估其可行性和可接受性。然而，几项研究报告了与移除相关的疼痛。
评估 PrePex 的安全性，以及在移除前给予镇痛是否会减轻参与者的疼痛。
这是一项多地点、非随机、前瞻性队列研究，纳入了 2014 年 7 月至 2015 年 3 月期间在南非六家诊所要求使用 PrePex 装置进行男性环切的成年（18-45 岁）男性。根据方案审查，参与者在监测开始后不久常规接受镇痛。移除设备的镇痛方案取决于诊所的药物供应情况。
在已接受 PrePex 放置的 1023 名入组参与者中，98%（1004 名）在研究诊所移除了设备。他们的中位年龄为 25（IQR：21-30）岁。HIV 血清阳性率为 3.6%（37/1023）。护士放置和移除了所有设备的一半。2.4%（25/1023）的参与者出现不良事件；15 人需要手术干预：设备移位（5/14）、提前移除（3/14）、自行移除（5/14）和皮肤切除不足（2/14）。大多数（792：79%）参与者接受了镇痛。大多数人接受了扑热息痛-可待因（33%）、利多卡因（29%）或 EMLA 和口服联合用药（28%）。与未接受任何镇痛的参与者相比，接受 PrePex 移除前任何镇痛（除利多卡因外）的参与者经历严重疼痛的比例较低（16.6% vs. 29%：p = 0.0001）。
在这项 PrePex 主动监测期间报告的不良事件与之前的报告和手术环切术的报告相似。在移除 PrePex 装置前给予的止痛药物可有效减轻移除过程中的严重疼痛。
