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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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无需缝合、无需医护人员拆除、能安全脱落的一次性包皮环切器械

Disposable device that enables circumcision without stitches safely detaches without need for removal by healthcare staff
无需缝合、无需医护人员拆除、能安全脱落的一次性包皮环切器械

Michael Carter
Published: 17 April 2012


根据JAIDS杂志在线发表的一项研究,一种无需缝合的包皮环切手术器械通常在手术佩戴器械超过7天后能自动脱落。这项研究也表明这种非侵入性器械既安全,又能被患者和医护人员接受。

作者们相信,称做商环(Shang Ring)的器械能帮助在那些HIV普遍流行的国家实施包皮环切预防HIV项目的规模化。

“我们证明了,如果延期到术后7天以后拆除器械,器械会最终脱落而不会发生明显的问题,”作者们在论文中写道。“在那些预约拆除器械的回访不方便的地区,等待商环自动脱落可能是一个合适的服务提供策略。”

WHO(世界卫生组织)和UNAIDS(联合国艾滋病规划署)推荐男性包皮环切作为在那些HIV普遍流行的国家降低HIV感染风险的一种方法。

然而,缺少接受过培训的医护人员正在阻碍某些地区实现项目规模化的努力。来自肯尼亚和美国的研究人员先前的研究已经证明,称做商环的一种用于成年男性包皮环切的一次性器械是安全和有效的。

商环已经被用于超过20万例中国男性的包皮环切。该器械有2个环用来夹住包皮,然后通过手术切除多余包皮。这种方法允许包皮环切而无需缝合。通常建议包皮环切7天后拆除器械。注意到商环不同于Tara-Klamp包皮环切器械是重要的,Tara-Klamp与高发生率的并发症相关,而且在南非受到了强烈的批评。

但是,提供包皮环切服务的医护人员担心一些男性不能够按预约的日期回来拆环。

因此,一个国际研究团队设计了一项涉及50名肯尼亚男性参与的应用商环进行包皮环切的研究,以观察器械是否会自动脱落,以及评估自动脱落的安全性和可接受性。

参与者被随机分为3组,分别设定其拆环时间在术后7天(15人)、14天(15人)或21天(20人)。所有参与者均为HIV阴性、年龄18岁以上。他们中的大多数寻求包皮环切的动机为预防HIV。研究参与者分别在术后7、14、21、28和42天以及拆环2天后随访。

所有男性接受包皮环切后未发现并发症。88%的研究参与者完成了这项42天的研究。

有9名男性其包皮太紧以致不能直接外翻将包皮锁夹在两个环之间,因此,需要在他们的包皮上做一个小的切口(平均1.5 cm长)。

一共有17名男性在术后7天拆除器械。这17名包括该研究随机分组在术后7天拆环的全部15人,以及分组在术后14天拆环的1人由于失误而拆环,另1人为分组在术后21天拆环因其请求提前拆环。

总体上,28名参与者(58%)都已在研究回访时拆环,包括在他们的预定的研究日期的21名,其余7名由于部分脱环后环与伤口摩擦疼痛或不适而请求拆环。

拆环过程很顺利,平均耗时2.5 min (0~8)。要求参与者在手术中对照一个10分的(视觉模拟评分)尺进行疼痛评分(10分表示最疼)。平均的报告疼痛评分为3.8分,拆环后大约10 min内降低到1分。在拆环后的这些男性中,50%的人在拆环当日至少已经部分脱环。

对于那些仍然戴环的参与者,在术后7、14、21天至少部分脱环的几率分别为26%、94%和100%。

在那些戴环超过建议的7天的参与者中,67%的人出现完全脱环。大多数(22人中的18人)发生在术后10至16天。在术后7、14、21天,自动脱环的累计几率分别为0%、56%和94%。

46名(92%)男性的伤口完全愈合。2人在完全愈合前从随访中流失。不过,另2人在术后42天还未完全愈合。在术后2周不论是拆除或经历自动脱落的男性中,没有明显的更早的愈合趋势(p = 0.13)。

没有严重的不良反应报告,但是,6人报告了疼痛。

概括起来,这些参与者报告说在戴环时仅很少影响他们的日常生活。不过,1/4的男性抱怨阴茎勃起时有疼痛或不适。所有医护人员报告说他们发现商环器械的使用“非常容易”。

“我们的结果提供了增加的证据,即商环有助于在次沙哈拉非洲地区实施男性包皮环切预防HIV项目的快速规模化,”作者们得出结论。“我们未发现严重的不良后果如果男性不能按时回来拆环。”

参考文献:

Barone MA et al. Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment. J Acquir Immune Defic Syndr, online edition. DOI: 10.1097/QAI. 0b013e31824ea1f2, 2012.(Click here for the free abstract.)


Disposable device that enables circumcision without stitches safely detaches without need for removal by healthcare staff

Michael Carter

Published: 17 April 2012

 

A device that allows for circumcision without the need for stitches often detaches spontaneously if worn for over seven days, according to a study published in the online edition of the Journal of Acquired Immune Deficiency Syndromes. The research also showed that the non-invasive device was safe and acceptable to both patients and healthcare staff.


The authors believe the device – called the Shang Ring – could help scale-up circumcision programmes in countries with generalised HIV epidemics.


“We demonstrated that if removal is delayed beyond 7 days, the device will eventually detach without significant problems,” write the authors. “Waiting for the Shang Ring to fall off might be a suitable service delivery strategy in settings where a removal visit may be inconvenient.”


WHO (World Health Organization) and UNAIDS recommend male circumcision as a way of reducing the risk of infection with HIV in countries with generalised epidemics.


However, a lack of trained healthcare personnel is hampering rollout efforts in some settings. Investigators from Kenya and the US have previously shown that a disposable device called the Shang Ring can be safely and effectively used for adult male circumcision.


The Shang Ring has been used to circumcise over 200,000 Chinese men. The device has two rings used to sandwich the foreskin, which is then surgically removed. It allows for circumcision without the need for stitches. It is recommended that the device should be removed seven days after circumcision.It is important to note that the Shang Ring is not the same as the Tara-Klamp circumcision device, which is associated with a high rate of complications and has been strongly criticised by activists in South Africa.


But there is some concern that men may be unable to return for device removal at this timepoint.


Therefore, an international team of investigators designed a study involving 50 Kenyan men undergoing circumcision using the Shang Ring to see if the device would detach spontaneously, and to assess its safety and acceptability.


The participants were randomised into three groups, with removal of the device scheduled to occur after seven (15 men), 14 (15 men) or 21 (20 men) days. All the men were HIV-negative and aged over 18. Most cited protection against HIV as their motivation for seeking circumcision. Participants were followed up 7, 14, 21, 28 and 42 days after circumcision and two days after removal of the Shang Ring.


All the men were circumcised without complications. The 42-day study was completed by 88% of patients.


In nine men, the foreskin was too tight for it to be sandwiched between the device. A small slit (median 1.5 cm) was therefore made in their foreskins.


A total of 17 men had the device removed on day seven. This included all 15 individuals randomised to this study arm, as well as one individual in the day-14 study arm whose device was mistakenly removed and a patient in the 21-day arm who requested removal.


Overall, 28 (58%) participants had the device removed at a study visit, including 21 on their scheduled study day and a further seven who requested removal due to pain or discomfort from a partially detached ring rubbing against the wound.


Removal of the ring was uneventful and took a median of 2.5 minutes (range, 0 to 8). Patients were asked to grade the pain during this procedure on a ten-point scale (ten being the highest). The median reported pain score was 3.8, which decreased to 1.0 within approximately ten minutes of removal. Of the men who had the device removed, 50% had at least partial detachment on the day of the procedure.


For the men still wearing the Shang Ring, the probability of at least partial detachment at days 7, 14 and 21 was 26, 94 and 100% respectively.


Complete detachment occurred in 67% of men who wore the device for more than the recommended seven days. In most cases (18 of 22), this occurred between 10 and 16 days after circumcision. The cumulative probability of spontaneous detachment as days 7, 14 and 21 were 0, 56 and 94% respectively.


In 46 men (92%), complete wound healing was achieved. Two men were lost to follow-up before complete healing. However, two men had not experienced complete healing by day 42. There was a non-significant trend (p = 0.13) for earlier healing among men who either had the device removed or who experienced spontaneous detachment approximately two weeks after circumcision.


No severe adverse events were reported, but six patients reported pain.


Generally, the men reported only minimal disruption to their everyday lives when wearing the Shang Ring. Nevertheless, a quarter of men complained of pain or discomfort during erections. All the healthcare staff reported that they found use of the device “very easy”.


“Our results contribute to the growing body of evidence that the Shang Ring could facilitate rapid roll-out male circumcision in sub-Saharan Africa,” conclude the authors. “We found no evidence of serious consequences if men do not return on time for removal.”


Reference

Barone MA et al. Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment. J Acquir Immune Defic Syndr, online edition. DOI: 10.1097/QAI. 0b013e31824ea1f2, 2012.(Click here for the free abstract.)



Source: http://www.aidsmap.com/en/Email-a-friend/tpl/1412195/page/2274024/
 
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