EngenderHealth, New York, NY 10001, USA.
J Acquir Immune Defic Syndr. 2011 May 1;57(1):e7-12. doi: 10.1097/QAI.0b013e3182158967.
To assess safety, preliminary efficacy, and acceptability of the Shang Ring, a novel disposable device for adult male circumcision in Kenya.
Forty HIV-negative men were recruited in Homa Bay, Kenya. Circumcisions were performed by a trained physician or nurse working with 1 assistant. Follow-up was conducted at 2, 7, 9, 14, 21, 28, 35, and 42 days after circumcision. Rings were removed on day 7. Pain was assessed using a visual analog scale (VAS) (0 = no pain, 10 = worst possible). Men were interviewed at enrollment and on days 7 and 42.
All 40 procedures were completed successfully. Mean procedure and device removal times were 4.8 (SD ± 2.0) and 3.9 (SD ± 2.6) minutes, respectively. There were 6 mild adverse events, including 3 penile skin injuries, 2 cases of edema, and 1 infection; all resolved with conservative management. In addition, there were 3 partial ring detachments between days 2-7. None required treatment or early ring removal. Erections with the ring were well tolerated, with a mean pain score of 3.5 (SD ± 2.3). By day 2, 80% of men were back to work. At 42 days, all participants were very satisfied with their circumcision and would recommend the procedure to others.
Our results demonstrate that the Shang Ring is safe for further study in Africa. Acceptability of the Shang Ring among participants was excellent. With short procedure times, less surgical skill required, and the ease with which it can be used by nonphysicians, the Shang Ring could facilitate rapid roll-out of male circumcision in sub-Saharan Africa.
评估 Shang Ring 在肯尼亚进行成年男性包皮环切术的安全性、初步疗效和可接受性。
在肯尼亚的霍马湾招募了 40 名 HIV 阴性男性。由经过培训的医生或护士与 1 名助手一起进行包皮环切术。在包皮环切术后 2、7、9、14、21、28、35 和 42 天进行随访。第 7 天取下戒指。疼痛使用视觉模拟量表（VAS）（0 = 无痛，10 = 最痛）进行评估。在入组时和第 7 天和第 42 天对男性进行了访谈。
所有 40 例手术均成功完成。平均手术和器械移除时间分别为 4.8（SD ± 2.0）和 3.9（SD ± 2.6）分钟。有 6 例轻度不良事件，包括 3 例阴茎皮肤损伤、2 例水肿和 1 例感染；所有病例均通过保守治疗解决。此外，在第 2-7 天之间有 3 例部分戒指脱落。没有一个需要治疗或提前取环。带戒指勃起可耐受，平均疼痛评分为 3.5（SD ± 2.3）。第 2 天，80%的男性恢复工作。42 天时，所有参与者对包皮环切术非常满意，并愿意向他人推荐该手术。
我们的结果表明，Shang Ring 在非洲进一步研究是安全的。参与者对 Shang Ring 的接受程度非常好。Shang Ring 具有手术时间短、所需手术技能少、非医务人员易于使用等特点，可促进撒哈拉以南非洲地区男性包皮环切术的快速推广。
