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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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HIV/AIDS: Adult male circumcision – new developments
艾滋病毒/艾滋病:成年男性包皮环切新发展

HIV/AIDS: Adult male circumcision – new developments
艾滋病毒/艾滋病:成年男性包皮环切 - 新发展

有争议的Tara KLamp一次性包皮环切器

图片来源:世界卫生组织

 

【罗马2011年7月25日PlusNews报道】题:艾滋病毒/艾滋病:成年男性包皮环切 - 新发展

 

医学上的男性包皮环切术作为世界卫生组织(WHO)认可的预防艾滋病毒的方法已经四年多了,并且大多数国家仍然在使用相对昂贵,需要麻醉的手术方法,至少需要2名卫生工作者和6个星期的伤口愈合期。然而,一些新的器械可能彻底改变手术的时间,工作量和费用,以便使这些国家能够迅速扩大他们的项目实施。

 

世界卫生组织曾经批准了3个器械(Gomco Clamp,Mogen Clamp和Plastibell)用于婴幼儿男性包皮环切,但是没有批准1个用于成年男性包皮环切。2011年2月,世界卫生组织制定了一份针对成年男性包皮环切器械临床评估的框架文件。

 

其中一些正在接受调查的包皮环切器械包括:

 

中国商环:商环由一个内环和外环组成,包皮被夹放在内环和外环之间而被切除,在7天的愈合期内阴茎头和冠状沟被完全暴露,7天后去除内外环。

 

在中国进行的临床试验已经证明商环是安全的。在肯尼亚西部的霍马湾进行的预试验研究使用商环对40名艾滋病毒阴性男子进行了包皮环切,结果发现6例轻度不良事件,包括皮肤损伤(3)、水肿(2)和轻度感染(1)【注:这些不良事件均已通过保守护理解决。J Acquir Immune Defic Syndr. 2011 May 1; 57(1): e7-e12; 2011 Feb 21. [Epub ahead of print]】。


还有几项使用商环的临床研究尚在进行中,包括在肯尼亚和赞比亚进行的可接受性,安全性研究,和在肯尼亚和乌干达进行的与传统外科手术方法的随机对照试验。

 

以色列PrePex:PrePex使用2个环和一个施放器用于限制包皮的血液供应,7天后包皮连同器械被去除。此方法不需要麻醉。

在卢旺达进行的1项40例男性包皮环切研究结果发现的1例不良事件发生在去除器械时,需要17天愈合时间。在卢旺达和津巴布韦更多的研究正在进行中和计划中。卢旺达政府计划使用PrePex器械来大规模实施男性包皮环切。

 

马来西亚Tara KLamp – 由Gurcharan Singh研制,Tara KLamp已在马来西亚被广泛用于男孩包皮环切,包括在公立医院和割礼运动。这个器械夹在包皮上阻断包皮的血液供应,并在7到10天后包皮与器械一起脱落,但有时需要通过手术去除器械。

 

在莱索托和南非Tara KLamp的推广颇有争议。 2009年,在南非奥兰治农庄的1项随机对照试验发现,使用Tara KLamp的35名男子中有37%的不良事件,相对照,在手术组的34名男子中的不良事件为3.4%。使用Tara KLamp包皮环切的男子还报告了糟糕的疼痛。由于高得令人无法接受的不良事件率,该试验被提前终止,研究人员同时指出,“鉴于在这项研究中发现的居高不下的不良事件率,我们郑重提醒不要在年轻的成年人中使用,我们建议在儿童使用Tara KLamp进行包皮环切时要小心评估这个器械的手术步骤”。

 

然而, 2009年祖鲁王亲善祖韦利蒂尼批准了在夸祖鲁 - 纳塔尔的男孩使用Tara KLamp实施传统包皮环切。它被用在大约875人(35000人的1/4)进行包皮环切,但是没有报告并发症的数据。南非活动家组,治疗行动运动拒绝批准Tara KLamp,强调指出,它“在成年男性使用的风险太大,更不应该在公共卫生系统使用Tara KLamp”。

 

2011年6月,南非政府宣布,它不会使用Tara KLamp作为其官方男性包皮环切规模实施的一部分。根据世界卫生组织,没有进一步的有关Tara KLamp的临床研究计划。

 

kr/kn/mw

主题:艾滋病毒/艾滋病预防(PlusNews),- PlusNews,

 

【这份报告并不一定反映联合国的意见】

 


HIV/AIDS: Adult male circumcision – new developments

Photo: WHO

The controversial Tara KLamp

 

 

ROME, 25 July 2011 (PlusNews) - Medical male circumcision has been a World Health Organization (WHO)-endorsed HIV prevention method for more than four years, with most countries still using relatively expensive surgical procedures that require anaesthetic, at least a couple of health workers and a six-week healing period. However, several new devices could revolutionize the amount of time, labour and money involved, enabling countries to rapidly scale up their programmes.

 

WHO has approved three devices – the Gomco Clamp, the Mogen Clamp and the Plastibell – for infant male circumcision, but none for adult male circumcision. In February 2011, the organization developed a framework for the clinical evaluation of devices for adult male circumcision.

 

Some of the devices under investigation include:

 

The Shang Ring – Developed in China, the Shang Ring comprises an inner and outer ring; the foreskin is placed between them and cut off, leaving the glans exposed during the seven-day healing period, after which the device is removed.

 

Clinical trials in China have found the device to be safe, and a pilot study in western Kenya’s Homa Bay found six mild adverse events – including skin injury, oedema and mild infection – when the device was tested on 40 HIV-negative men. 【 J Acquir Immune Defic Syndr. 2011 May 1; 57(1): e7-e12; 2011 Feb 21. [Epub ahead of print]

 

Several more studies on the Shang Ring are ongoing, including in Kenya and Uganda, on acceptability, safety and randomized controlled trials in Kenya and Zambia comparing it to surgical procedures.

 

The PrePex Device - Developed in Israel, the PrePex uses two rings and an applicator to restrict blood supply to the foreskin, which is removed, together with the device, after seven days. This method requires no anaesthesia.

 

A study of 40 men in Rwanda found one adverse event at removal of the device and a healing time of 17 days. More studies are ongoing and planned in Rwanda and Zimbabwe. The Rwandan government plans to scale up male circumcision using the PrePex device.

 

The Tara KLamp - Developed by Gurcharan Singh in Malaysia, the Tara KLamp has been widely used there for the circumcision of boys, including in public sector hospitals and circumcision campaigns. The device clamps on the foreskin so that the blood supply is cut off, and after seven to 10 days the foreskin is supposed to fall off with the clamp, but sometimes the clamp has to be surgically removed.

 

It has also been controversially promoted in Lesotho and South Africa. In 2009, a randomized controlled trial in Orange Farm, South Africa, found adverse events of 37 percent in the 35 men in the Tara KLamp study, against 3.4 percent in the 34 men in the surgical arm. Men circumcised using the KLamp also reported worse pain. The trial was stopped early due to the unacceptably high rate of adverse events, with the researchers noting that, “given the high rates of adverse events in this study and the low number of available studies, we strongly caution against the use of the TK for young adults, and we recommend careful evaluation of the procedure when performed on children”.

 

Nevertheless, Zulu king Goodwill Zwelithini in 2009 endorsed the KLamp for use in the traditional circumcision of boys in KwaZulu-Natal. It was used in about a quarter of the 35,000 circumcisions conducted; little data has emerged on complications. South African activist group, the Treatment Action Campaign declined to endorse the KLamp, stating that it was “simply too risky for use on male adults and should not be used in the public health system”.

 

In June 2011, the South African government announced that it would not be using the Tara KLamp as part of its official male circumcision scale-up. According to WHO, no further clinical studies of the Tara KLamp are planned.

 

kr/kn/mw

Theme (s): HIV/AIDS (PlusNews), Prevention - PlusNews,

 

[This report does not necessarily reflect the views of the United Nations]

 

SOURCE: http://www.irinnews.org/report.aspx?ReportID=93311

 

 

 
 
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