Kigozi Godfrey, Gray Ronald H, Wawer Maria J, Serwadda David, Makumbi Frederick, Watya Stephen, Nalugoda Fred, Kiwanuka Noah, Moulton Lawrence H, Chen Michael Z, Sewankambo Nelson K, Wabwire-Mangen Fred, Bacon Melanie C, Ridzon Renee, Opendi Pius, Sempijja Victor, Settuba Absolom, Buwembo Denis, Kiggundu Valerian, Anyokorit Margaret, Nkale James, Kighoma Nehemia, Charvat Blake
Rakai Health Sciences Program, Entebbe, Uganda.
PLoS Med. 2008 Jun 3;5(6):e116. doi: 10.1371/journal.pmed.0050116.
The objective of the study was to compare rates of adverse events (AEs) related to male circumcision (MC) in HIV-positive and HIV-negative men in order to provide guidance for MC programs that may provide services to HIV-infected and uninfected men.
A total of 2,326 HIV-negative and 420 HIV-positive men (World Health Organization [WHO] stage I or II and CD4 counts > 350 cells/mm3) were circumcised in two separate but procedurally identical trials of MC for HIV and/or sexually transmitted infection prevention in rural Rakai, Uganda. Participants were followed at 1-2 d and 5-9 d, and at 4-6 wk, to assess surgery-related AEs, wound healing, and resumption of intercourse. AE risks and wound healing were compared in HIV-positive and HIV-negative men. Adjusted odds ratios (AdjORs) were estimated by multiple logistic regression, adjusting for baseline characteristics and postoperative resumption of sex. At enrollment, HIV-positive men were older, more likely to be married, reported more sexual partners, less condom use, and higher rates of sexually transmitted disease symptoms than HIV-negative men. Risks of moderate or severe AEs were 3.1/100 and 3.5/100 in HIV-positive and HIV-negative participants, respectively (AdjOR 0.91, 95% confidence interval [CI] 0.47-1.74). Infections were the most common AEs (2.6/100 in HIV-positive versus 3.0/100 in HIV-negative men). Risks of other complications were similar in the two groups. The proportion with completed healing by 6 wk postsurgery was 92.7% in HIV-positive men and 95.8% in HIV-negative men (p = 0.007). AEs were more common in men who resumed intercourse before wound healing compared to those who waited (AdjOR 1.56, 95% CI 1.05-2.33).
Overall, the safety of MC was comparable in asymptomatic HIV-positive and HIV-negative men, although healing was somewhat slower among the HIV infected. All men should be strongly counseled to refrain from intercourse until full wound healing is achieved.
http://www.ClinicalTrials.gov; for HIV-negative men #NCT00425984 and for HIV-positive men, #NCT000124878.
本研究的目的是比较HIV阳性和HIV阴性男性中与男性包皮环切术（MC）相关的不良事件（AE）发生率，以便为可能为HIV感染和未感染男性提供服务的MC项目提供指导。
在乌干达拉凯农村地区进行的两项独立但程序相同的MC预防HIV和/或性传播感染试验中，共有2326名HIV阴性男性和420名HIV阳性男性（世界卫生组织[WHO]I期或II期，CD4细胞计数>350个/mm³）接受了包皮环切术。在术后1 - 2天、5 - 9天以及4 - 6周对参与者进行随访，以评估手术相关不良事件、伤口愈合情况以及性交恢复情况。比较了HIV阳性和HIV阴性男性的AE风险和伤口愈合情况。通过多因素逻辑回归估计调整后的优势比（AdjORs），并对基线特征和术后性交恢复情况进行了调整。入组时，HIV阳性男性比HIV阴性男性年龄更大、更可能已婚、报告的性伴侣更多、避孕套使用率更低且性传播疾病症状发生率更高。HIV阳性和HIV阴性参与者中中度或重度AE的风险分别为3.1/100和3.5/100（AdjOR 0.91，95%置信区间[CI] 0.47 - 1.74）。感染是最常见的AE（HIV阳性男性中为2.6/100，HIV阴性男性中为3.0/100）。两组中其他并发症的风险相似。术后6周时，HIV阳性男性伤口完全愈合的比例为92.7%，HIV阴性男性为95.8%（p = 0.007）。与等待伤口愈合后恢复性交的男性相比，伤口愈合前恢复性交的男性AE更常见（AdjOR 1.56，95% CI 1.05 - 2.33）。
总体而言，无症状HIV阳性和HIV阴性男性中MC的安全性相当，尽管HIV感染者的伤口愈合稍慢。应强烈建议所有男性在伤口完全愈合前避免性交。
http://www.ClinicalTrials.gov；HIV阴性男性试验编号#NCT00425984，HIV阳性男性试验编号#NCT000124878。
