Author's reply: A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.
Author's reply: A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.
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作者的回复：在博茨瓦纳进行的一项关于新生儿男性包皮环切术的 Mogen 钳与 Plastibell 的随机试验。
DOI：
10.1097/qai.0b013e3182a0f011
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发表时间：
2013
期刊：
影响因子：
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通讯作者：
Plank,RebecaM
中科院分区：
文献类型：
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作者：
Plank,RebecaM
背景：男性包皮环切术可以降低男性通过异性性行为感染HIV-1的风险。新生儿男性包皮环切术（NMC）有许多潜在的优势，包皮环切术在老年人，但鲜为人知的是它的可行性和安全性，在资源有限的settings.Methods：我们进行了一项随机试验，在博茨瓦纳东南部的摩根钳和Plastibell，2常用的设备NMC。在产后6周和4个月进行随访。不良事件，父母的满意度，和工作人员的印象recorded.Results：302名男性新生儿随机，300（99%）进行包皮环切术，153（51%）与摩根钳，147（49%）与Plastibell。Mogen夹臂中没有重大不良事件，但Plastibell夹臂中有2起重大不良事件（均为近端移位环，必须由研究人员取出）。与Plastibell相比，Mogen钳的轻微不良事件更常见，特别是切除的皮肤太少和形成皮肤桥或粘连（分别为12对1和11对3，均P< 0.05）。Mogen钳夹组中有5例（3%）婴儿发生轻微出血，Plastibell组中无一例发生轻微出血（P= 0.03）。超过94%的母亲报告高度或完全满意的procedure.Conclusions：NMC可以在博茨瓦纳进行的不良事件率低，家长满意度高。虽然Plastibell的迁移和保留风险很小，但在无法立即紧急就医的地区，Mogen夹可能对NMC更安全。
Background:Male circumcision can reduce the risk of heterosexually acquired HIV-1 infection in men. Neonatal male circumcision (NMC) has many potential advantages over circumcision at older ages, but little is known about its feasibility and safety in resource-limited settings.Methods:We performed a randomized trial in southeastern Botswana of Mogen clamp and Plastibell, 2 commonly used devices for NMC. Follow-up visits occurred at 6 weeks and 4 months postpartum. Adverse events, parental satisfaction, and staff impressions were recorded.Results:Of 302 male neonates randomized, 300 (99%) underwent circumcision, 153 (51%) with Mogen clamp, and 147 (49%) with Plastibell. There were no major adverse events in the Mogen clamp arm, but there were 2 major adverse events in the Plastibell arm (both were a proximally migrated ring that had to be removed by study staff). Minor adverse events were more common with the Mogen clamp compared with the Plastibell, specifically removal of too little skin and formation of skin bridges or adhesions (12 versus 1 and 11 versus 3, respectively, all P< 0.05). Five (3%) infants in the Mogen clamp arm and none in the Plastibell arm had minor bleeding (P= 0.03). More than 94% of mothers reported being highly or completely satisfied with the procedure.Conclusions:NMC can be performed in Botswana with a low rate of adverse events and high parental satisfaction. Although the risk of migration and retention of the Plastibell is small, the Mogen clamp may be safer for NMC in regions where immediate emergent medical attention is not available.