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期刊来源：Ann Intern Med

原文链接：https://doi.org/10.7326/M23-3317

摘要内容如下：

背景

观察性研究表明，自愿医学男性包皮环切术（VMMC）可降低男男性行为者（MSM）感染HIV的风险。需要随机对照试验（RCT）来证实这一点。

客观

评估VMMC在预防男男性行为人群（MSM）HIV感染中的作用。

设计

长达12个月随访的随机对照试验。（中国临床试验注册中心：CHICTR2000039436）。

设置

中国8个城市。

参与者

年龄在18至49岁之间的未割包皮的HIV血清阴性男性，自我报告主要进行插入性肛交，并且在过去6个月中有2个或更多的男性性伴侣。

干预

VMMC。

测量

在基线、3个月、6个月、9个月和12个月时进行HIV快速检测。在基线、6个月和12个月时进行行为问卷调查和其他性传播感染测试。主要结果是使用意向性治疗分析的HIV血清转化。

结果

该研究在干预组中招募了124名男性，在对照组中招募了123男性，他们分别贡献了120.7人年和123.1人年的观察期。干预组中有0例血清转换（0例感染[95%CI，0.0至3.1例感染]/100人-年），对照组中有5例血清转换（4.1例感染[CI，1.3至9.5例感染]/100人-年）。HIV风险比为0.09（CI，0.00至0.81；P=0.029），干预组的HIV发病率较低（log-rank P=0.025）。梅毒、单纯疱疹病毒2型和阴茎人乳头瘤病毒的发病率在两组间无统计学差异。没有证据表明存在艾滋病毒风险补偿。

局限性

HIV血清转化很少，随访期有限。

结论

在以插入式肛交为主的MSM人群中，VMMC能有效预防HIV感染；应将MSM纳入VMMC指南。

主要资金来源

中国国家科技重大专项。

英文原文如下：

Abstracts

BACKGROUND  Observational studies suggest that voluntary medical male circumcision (VMMC) may lower HIV risk among men who have sex with men (MSM). A randomized controlled trial (RCT) is needed to confirm this.

OBJECTIVE  To assess the efficacy of VMMC in preventing incident HIV infection among MSM.

DESIGN  An RCT with up to 12 months of follow-up. (Chinese Clinical Trial Registry: ChiCTR2000039436).

SETTING  8 cities in China.

PARTICIPANTS  Uncircumcised, HIV-seronegative men aged 18 to 49 years who self-reported predominantly practicing insertive anal intercourse and had 2 or more male sex partners in the past 6 months.

INTERVENTION  VMMC.

MEASUREMENTS  Rapid testing for HIV was done at baseline and at 3, 6, 9, and 12 months. Behavioral questionnaires and other tests for sexually transmitted infections were done at baseline, 6 months, and 12 months. The primary outcome was HIV seroconversion using an intention-to-treat analysis.

RESULTS  The study enrolled 124 men in the intervention group and 123 in the control group, who contributed 120.7 and 123.1 person-years of observation, respectively. There were 0 seroconversions in the intervention group (0 infections [95% CI, 0.0 to 3.1 infections] per 100 person-years) and 5 seroconversions in the control group (4.1 infections [CI, 1.3 to 9.5 infections] per 100 person-years). The HIV hazard ratio was 0.09 (CI, 0.00 to 0.81; P = 0.029), and the HIV incidence was lower in the intervention group (log-rank P = 0.025). The incidence rates of syphilis, herpes simplex virus type 2, and penile human papillomavirus were not statistically significantly different between the 2 groups. There was no evidence of HIV risk compensation.

LIMITATION  Few HIV seroconversions and limited follow-up period.

CONCLUSION  Among MSM who predominantly practice insertive anal intercourse, VMMC is efficacious in preventing incident HIV infection; MSM should be included in VMMC guidelines.

PRIMARY FUNDING SOURCE  The National Science and Technology Major Project of China.

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