随机分配临床试验显示包皮环切术可保护抗HIV感染达65%


  July 26, 2005 (里约热内卢) - 一项于国际AIDS协会第3届HIV病原学与治疗会议中发表的随机分配试验结果显示,成年男性在接受包皮环切术后,HIV的感染机率可以降低65%;这项研究的对象为南非3,035位具性能力的异性恋男性。
  
  在追踪21个月过后,研究人员发现,包皮环切术在10位潜在HIV感染例中,预防了6到7例;即使在性行为的参数调整过后,此项结果并未改变。
  
  法国University Versailles Saint-Quentin的Bertran Auvert博士向记者表示,包皮环切术组的患者中,或许HIV的感染率有了提升,但我们对这项研究的结果并无更深的了解;Auvert指出,这项研究业经许多道德组织的认可。
  
  研究人员先对异性恋的男性作确认,年龄介于18到24岁之间,皆为健康且性能力活跃者;这些试验者皆表示,若包皮环切可以降低HIV感染的风险,他们都愿意接受手术;这些男性皆来自约翰尼斯堡附近的Orange农场,目前的包皮切割率为20%,此一族群具有偏高的HIV传染率;在试验之前,研究人员进行了一项可行性前导试验,结果发现,约70%的男性表示,如果包皮切割可以安全的带来助益,他们都愿意考虑接受手术。
  
  有意愿的试验者被以随机的方式接受包皮环切术,或等待20个月再接受手术;手术组中,医师们先以局部麻醉,再使用消毒的外科手术法进行前包皮的切除。
  
  Auvert医师表示,21个月过后,研究人员对69个HIV新发病例作诊断,其中对照组有51位,皆未接受包皮切割,试验组有18位,皆已接受包皮切割;亦即,保护的效果达到65%( 95% CI,范围40%到80%)。
  
  Auvert指出,因为这些男性都为异性恋者,这些数据所牵涉的只是来自女性的传染,所以并无关于男性与男性之间,或男性对于女性之间的传染数据。
  
  Bill and Melinda Gates基金会HIV/AIDS与肺结核计画主任暨国际AIDS协会会长Helene Gayle博士向记者表示,如果今天的研究结果得到证实,这应是有关HIV感染预防医学上的一大进步;Gayle博士表示,观察性的试验在1980年代即已进行过,结果皆指出,包皮切割可能有助于对抗HIV的感染。
  
  但是,Gayle也指出,在未获得更好的数据之前,我们不应该全面执行成年男性的包皮环切手术;值得注意的是,未受过训练的人员及本研究报告所衍生的安全问题;我们希望确定人们不会对安全性产生误解,也不希望因此而提升高危险的行为。
  
  HIV/AIDS (UNAIDS)联合国家计画组织立刻发表了一份声明,UNAIDS在文中强调,该项临床试验的发现尚且需要更多的研究来证实其再现性,该项试验结果是否具有更普遍化的应用,也应该予以证实。
  
  即使包皮环切术经证实可以降低罹感染HIV的风险,这也不表示男性单靠包皮切除即可以在性行为中预防HIV的感染,其性伴侣也无法因此而获得HIV感染的防护效果;任何新的干预治疗模式皆不可以低估现行的保护措施,也不可以忽视现行HIV传染的防护策略。
  
  French Agence Nationale de Recherches sur le SIDA资助本研究。

Circumcision Provided 65% Prot

By Karla Harby
Medscape Medical News

July 26, 2005 (Rio de Janeiro) — Adult male circumcision has been found to provide a 65% protective effect against infection with HIV in a randomized trial of more than 3,035 sexually active, heterosexual men in South Africa, according to findings presented here at the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment.

After 21 months of follow-up, researchers found that circumcision prevented 6 to 7 of 10 potential infections. This outcome was not changed after controlling for sexual behavior variables.

"We had no [advance] idea of the result. We could have seen an increase in HIV infection in the circumcised group," Bertran Auvert, PhD, of the University Versailles Saint-Quentin in France, told reporters. Dr. Auvert noted that this study was approved by relevant ethics committees.

The researchers conducted the trial by first identifying heterosexual men between the ages of 18 and 24 years, who were healthy and sexually active, and who said they were willing to be circumcised if it could be proven to reduce their risk of HIV infection. These men were living in Orange Farm, a neighborhood near Johannesburg, South Africa, with high rates of HIV transmission and an existing male circumcision rate of approximately 20%. Prior to this study, the researchers had conducted a feasibility pilot study that found that 70% of men would consider circumcision if it were beneficial and safe.

Subjects willing to be circumcised were then randomized to receive immediate circumcision or to wait 20 months for the procedure. In the intervention group, medical physicians removed the penile foreskin after administering local anesthetic and using sterile surgical procedures.

At 21 months, the researchers diagnosed 69 new HIV cases, 51 in the control group that had yet to be circumcised, and 18 in the group that had been circumcised, Dr. Auvert said. This translates into a 65% protective effect (with a 95% confidence interval of 40% to 80%).

Because these men are heterosexual, these data concern transmission only from women to men, Dr. Auvert said. He added that these data are not informative regarding man-to-man transmission or man-to-woman transmission.

Helene Gayle, PhD, MPH, president of the International AIDS Society and director of the Bill and Melinda Gates Foundation's HIV/AIDS and Tuberculosis Program, who was not involved in the research, told reporters, "If today's results are confirmed, this would be a major advance for prevention" of HIV infections. Dr. Gayle noted that observational studies dating to the 1980s suggest that circumcision may be protective against HIV.

But Dr. Gayle added that "Adult male circumcision should not be implemented for prevention until we have better data." She expressed concern about the safety of circumcisions conducted by untrained persons and also how this report could affect behavior. "We want to make sure people do not develop a false sense of security and increase their high-risk behaviors," Dr. Gayle said.

The Joint United Nations Programme on HIV/AIDS (UNAIDS) immediately issued a statement to reporters saying that "UNAIDS emphasizes that more research is needed to confirm the reproducibility of the findings of this trial and whether or not the results have more general application." The statement added:

If male circumcision is confirmed to be an effective intervention to reduce the risk of acquiring HIV, this will not mean that men will be prevented from becoming infected with HIV during sexual intercourse through circumcision alone. Nor does male circumcision provide protection for sexual partners against HIV infection.... Any new prevention modality must not undermine existing protective behaviours and prevention strategies that reduce the risk of HIV transmission.

The study was funded by the French Agence Nationale de Recherches sur le SIDA.

3rd IAS: Abstract TuOa0402. Presented July 26, 2005.

Reviewed by Gary D. Vogin, MD

    
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