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改变了传统的男性包皮环切手术概念


一种更加安全、有效和可接受的男性包皮环切器械和手术方法


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Shang Ring facilitates widespread circumcision in Africa
中国商环促进在非洲推广男性包皮环切术

06/08/2012

中国商环促进在非洲推广男性包皮环切术

一项非洲研究表明一种男性包皮环切器械与传统手术包皮环切术相比有多个优势

2012年8月3日(华盛顿特区)——一项非洲研究表明,一种男性包皮环切器械与传统手术包皮环切术相比有多个优势。

来自位于肯尼亚基苏木的两性健康的Quentin Awori是这项研究的研究者之一,他在AIDS 2012:第19届国际AIDS大会上报告了他们的研究结果。Awori医生报告说,使用商环更加容易和快速,能使男性包皮环切在非洲更加广泛地推广,减少HIV感染风险。先前的多项研究已经表明男性包皮环切能降低异性HIV感染风险大约60%。

由2个同心环组成的商环包皮环切器械,比传统男性包皮环切手术更加容易使用,传统手术要求高水平的手术技能。用手术消毒液擦洗手术部位,在阴茎根部环形注射局部麻醉剂,将内环套在阴茎体上后,包皮外翻至内环,然后将外环放置在内环和包皮上,多余的包皮被切除。手术部位用邦迪包扎。无需缝合。大多数卫生专业人员,而不仅是外科医生,都能在接受培训后使用商环器械,这就使得它在低资源地区的应用极具吸引力。

7天后,拆除外环,再将内环与结痂分离后拆除内环,愈合中的伤口用邦迪包扎。整个手术花费的时间比传统男性包皮环切手术更短。

Awori医生在肯尼亚的一个研究项目点(商环,n=97;传统手术,n=103)和赞比亚的一个研究项目点(商环,n=97;传统手术,n=103)进行了一项随机对照临床试验,以比较商环与传统男性包皮环切手术。肯尼亚受者的平均年龄为20.9岁,赞比亚受者的平均年龄为24.1岁。在肯尼亚,84.5%的受者为单身,在赞比亚,80.3%的受者为单身。

商环与传统包皮环切术在视觉模拟疼痛评分上没有统计学上的显著差异。商环术后1小时的平均疼痛评分在肯尼亚为4.1在赞比亚为3.6,而传统手术分别为3.6和3.1。术后第2天,最高平均疼痛评分为1.1。

从开始手术到愈合估计的平均时间商环为44.1天,传统手术为38.9天(差异,5.2天; 95%置信区间,2.7至7.8天,P <.001)。不过,Awori医生解释说,这些数据只是粗略的估计。最近的4次研究随访是在术后第21、28、32和60天。他说,如果在商环的平均愈合时间,第44天附近有一次研究随访,报告的平均愈合时间可能会更短。

在术后第42天,76.3%的接受过商环手术的受试者已经愈合,而85.3%的接受过传统包皮环切手术的受试者愈合。

商环与传统包皮环切手术的不良反应率相似(3.6% VS 3.5%)。最常见的不良事件是伤口裂开;不过,由于商环无需缝合,需要使用一个修改的伤口裂开定义。

2次商环手术(第1次为放置,第2次为拆除)需要的总时间为传统包皮环切手术时间的大约一半。

第1次商环手术需要大约7分钟,拆环需要大约3分钟;传统手术需要大约20分钟(P < .001 在2个研究项目点)。

在实施手术的2名医生和4名非医生中,5人认为使用商环手术“特别容易”,1人认为商环手术“更容易”使用。类似地,5人“强烈偏好”商环,1人“有点偏好”商环。

在肯尼亚,95.7%的商环受试者和85.9%的传统包皮环切术受试者对他们的手术后外观结果“非常满意” (P < .02)。在赞比亚,分别为96.8%和71.3%表示“非常满意” (P < .001)。在赞比亚使用的传统包皮环切手术方法与在肯尼亚使用的略微不同。

鉴于低的疼痛评分,低不良反应发生率,手术时间更短的优势,医护人员偏好,以及受者对商环手术后外观效果的满意度,Awori医生认为,商环可以促进在非洲的自愿男性包皮环切的规模化。

会议的主持人Jason Reed医生,华盛顿美国国务院全球艾滋病协调员办公室男性包皮环切项目高级顾问告诉Medscape Medical News的记者,“使用商环,最重要的发现是节省时间“,这在向人群提供广泛的自愿医学男性包皮环切服务时是重要的。 “我们正试图节省几分钟,这样我们就可以让每个手术提供者...做更多的手术”,Reed医生解释说。

然而,艾滋病毒检测和咨询,男性包皮环切的益处与风险信息,以及知情同意是必需的。Reed医生说:“我们并没有一个巨大的普通辅导员短缺,他们可以提供艾滋病毒检测和咨询服务,我们这样做,我们可以比较容易地培训他们,” “真正的人力资源限制是有资质的护士和医生......如果以器械为基础的手术服务可及,通过一个手术服务小组在一天内有更多的人可接受这个器械的手术,那么我们显然需要增加普通辅导员或有资质的艾滋病毒检测和咨询工作人员来应付这额外的工作量。“

本研究未接受任何商业资助。Aworia医生和Reed医生披露没有任何相关经济关系。

记者:Daniel M. Keller

AIDS 2012: XIX International AIDS Conference: Abstract TUAC0404. Presented July 24, 2012.
Medscape Today
http://www.medscape.com/
http://www.medscape.com/viewarticle/768614
http://www.eatg.org/eatg/Global-HIV-News/Prevention/Shang-Ring-facilitates-widespread-circumcision-in-Africa



06/08/2012


Shang Ring facilitates widespread circumcision in Africa

An African study has shown that a male circumcision device has several advantages over conventional surgical circumcision.

August 3, 2012 (Washington, DC) — An African study has shown that a male circumcision (MC) device has several advantages over conventional surgical circumcision.

The results were presented here at the AIDS 2012: XIX International AIDS Conference by one of the researchers, Quentin Awori, MBChB, from EngenderHealth in Kisumu, Kenya. Dr. Awori reported that the Shang Ring is easier and faster to use, and could make MC more widespread in Africa, thereby reducing the risk for HIV infection. Previous studies have shown that MC can reduce the risk for heterosexual transmission by about 60%.

The device, which consists of 2 concentric rings, is easier to use than conventional MC surgery, which requires a high level of technical skill. The field is prepared with surgical scrub solution, an inner ring is slipped over the shaft of the penis, the foreskin is everted over it, and local anesthetic is injected around the circumference of the base of the penis. Then the outer ring is attached over the inner ring and the foreskin, and the foreskin is cut away. The area is bandaged; no sutures are required. Most health professionals, not only surgeons, can be trained to use the device, which makes it attractive for use in low-resource settings.

After 7 days, the outer ring is removed, the inner ring is separated from the scab and removed, and the area is bandaged. The entire procedure takes less time than conventional surgical MC.

Dr. Awori conducted a randomized clinical trial to compare the Shang Ring with conventional MC at a site in Kenya (Shang Ring, n = 97; conventional MC, n = 103) and a site in Zambia (Shang Ring, n = 100; conventional MC, n = 98). The mean age of the Kenyan patients was 20.9 years and of the Zambian patients 24.1 years. In Kenya, 84.5% of the patients were single and in Zambia, 80.3% were.

There were no statistically significant differences in pain, measured on a visual analogue scale, between the 2 techniques. The 1-hour postoperative mean pain scores with the ring were 4.1 in Kenya and 3.6 in Zambia, compared with 3.6 and 3.1, respectively, for conventional MC. On day 2, the highest mean pain score was 1.1.

The estimated mean time to healing from the initial procedure was 44.1 days with the ring and 38.9 days with conventional MC (difference, 5.2 days; 95% confidence interval, 2.7 to 7.8 days; P < .001). But Dr. Awori explained that these figures are rough estimates. The last 4 study visits took place on days 21, 28, 32, and 60. If there had been a study visit around day 44, the mean time to healing with the ring procedure, the average length of time to healing reported might have been shorter, he said.

On day 42, 76.3% of patients who underwent the ring procedure were healed, as were 85.3% of patients who underwent conventional MC.

Adverse events rates for the ring and conventional procedures were similar (3.6% vs 3.5%). The most common adverse event in both procedures was wound dehiscence; however, because no sutures are used with the Shang Ring, a modified definition of dehiscence was used.

The total time for the 2 ring procedure visits was about half the time for the conventional MC procedure.

The first ring procedure takes about 7 minutes and removal of the ring takes about 3 minutes; the conventional procedure takes about 20 minutes (P < .001 at both trial sites).

Of the 2 physicians and 4 nonphysicians performing the procedures, 5 considered the ring procedure "much easier" and 1 considered it "easier" to use. Similarly, 5 had a "strong preference" for the ring and 1 had a "slight preference" for it.

In Kenya, 95.7% of ring patients and 85.9% of conventional MC patients were "very satisfied" with the cosmetic results of their procedure (P < .02). In Zambia, 96.8% and 71.3%, respectively, were "very satisfied" (P < .001). A slightly different technique for conventional MC was used in Zambia.

Given the low pain scores, low adverse-effect rates, time advantage, provider preference, and patient satisfaction with the ring procedure, Dr. Awori believes that the Shang Ring could facilitate a scale-up of voluntary MC in Africa.

Session moderator Jason Reed, MD, MPH, senior technical advisor for male circumcision programming at the Office of the Global AIDS Coordinator, US Department of State, in Washington, DC, told Medscape Medical News that "with the Shang Ring, the most significant findings are the time savings," which is important when offering widespread voluntary medical MC to a population. "We're trying to save...minutes so that we can enable a single provider...to do more," Dr. Reed explained.

Still, HIV testing and counseling, information about the benefits and risks of MC, and informed consent are required. "We don't have a tremendous shortage of lay counselors who can provide the HIV testing and counseling component, and where we do, we can fairly easily train them," Dr. Reed said. "The real human resource constraint is in credentialed nurses and physicians.... If device-based services were available and many, many more people could receive the device in a given day by a given provider team, then we would obviously need to increase the number of lay counselors or credentialed HIV testing and counseling staff to take care of that extra volume."

The study received no commercial funding. Dr. Awori and Dr. Reed have disclosed no relevant financial relationships.

By Daniel M. Keller, PhD

AIDS 2012: XIX International AIDS Conference: Abstract TUAC0404. Presented July 24, 2012.
Medscape Today

http://www.medscape.com/
http://www.medscape.com/viewarticle/768614
http://www.eatg.org/eatg/Global-HIV-News/Prevention/Shang-Ring-facilitates-widespread-circumcision-in-Africa

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