Premature ejaculation spray coming to clinical climax
早泄患者福音：PE治疗药物进入最后临床研究阶段
By Anna Lewcock

31/10/2007- A nifty spray-on solution could make all the difference for men plagued with problem of climaxing too soon, as the product makes its final thrust in clinical development.
一种极佳的液体喷雾剂已进入临床研究的最后冲刺阶段，这对于那些饱受性高潮来得太快的男士来说意义非凡。
Plethora Solutions has developed the handy spray-on product, which will presumably arouse much interest from the 30 per cent of the male population thought to suffer from premature ejaculation (PE).
由Plethora Solutions制药公司开发的该喷雾剂，预计将会得到占男性30%的早泄（PE）患者的极大兴趣。
While erectile dysfunction has garnered much publicity thanks to the likes of high profile treatments such as Pfizer's Viagra (sildenafil citrate), PE has had to make do as the neglected younger brother, with no products currently approved to treat the problem.
由于诸如辉瑞公司的伟哥等类似高效药物的问世，勃起功能障碍已经引起大家的高度关注，被大家忽视的难兄难弟PE也应如此，但目前尚没有批准相应的治疗药物。
The only options available to PE patients today are off-label use of products such as antidepressants (with all the associated side effects) or penile desensitisers, with topically applied options carrying the impracticalities of slow onset of action, messiness or loss of sensation altogether.
眼下可供PE患者选择的唯一方法就是服用说明书适应症以外的药物，如抗抑郁药（尽管属于副作用）或局部应用阴茎失敏药物，导致起效慢、难以控制或丧失感觉等不切实际的效果。
Plethora, however, believes it could have the first product on the market that is quick, user-friendly, and can increase the time between penetration and ejaculation four fold.
Plethora制药公司相信该药物将成为首个上市的快速、易于使用且能够延长插入至射精时间4倍之久的产品。
The product is a combination of well-known anaesthetics lidocaine (7.5mg) and prilocaine (2.5mg) which together form a eutectic mixture (i.e. the melting point of the mixture is lower than the two components separately).
该产品是由熟知的麻醉药物利多卡因（7.5mg）和丙胺卡因（2.5mg）混合形成的一种低溶混合物。
However, Plethora discovered that this mixture dissolves easily in a non-CFC propellant, creating the possibility of a spray-on product that delivers pure active drug.
Plethora制药公司发现该混合物易溶于非氟里昂抛射剂中，从而可以制成气雾剂的产品来释放活性药物。
The formulation is only absorbed by non-keratinised skin (i.e. open or broken skin), and therefore only penetrates the glans at the tip of the penis and not the shaft.
该制剂只能通过非角质化皮肤吸收（如开放或受伤皮肤），因而只作用于龟头而非阴茎干。
One of the key advantages over other products that PE patients currently have to use is that Plethora's PSD502 formulation kicks in in under five minutes - much quicker than other products that can take over half an hour to take effect, or off-label use of anti-depressants that need to be taken for several months before any result can be seen.
与PE患者目前所用的其它产品相比，Plethora公司的 PSD502配方最主要的优势之一在于5分钟内即可起效，远远快于其它产品所需半小时之久，而抗抑郁药则需服用数月后方可见效。
On top of this, the effects of the spray-on treatment last for at least two hours, with the topical application meaning no systemic absorption to cause safety issues, and the rapid drying time of just a few minutes means the product will not get transferred to partners.
此外，该气雾剂效果至少持续2个小时，局部应用可避免全身吸收而导致的安全隐患，几分钟的快速干燥时间也意味着该药物不会转移给性伴侣。
But most importantly, the Plethora formulation has been shown to increase the time from penetration to ejaculation within the vagina by four times - from 0.93 minutes in a placebo group to 3.7 minutes with the spray-on solution.
最为重要的是，该制剂业已证实可延长插入至射精时间4倍之久，安慰剂组为0.93分钟，用药组为3.7 分钟。
While this might not sound like a vast improvement, for the significant proportion of the male population who have difficulty controlling ejaculation or lasting more than a minute or so, it could be the first product approved specifically for the condition that makes real difference to their sexual performance.
虽然对于那些难以控制射精或难以持续时间超过1分钟的男士而言，这似乎听起来并非是一个巨大的改进，但它可能成为针对该疾病的首个获得批准的药物，这对于他们的性生活质量意义确实重大。
The product should cost no more than the options currently being prescribed by physicians, and will come with a two to four month supply of treatment (depending on how often it's used).
该药物2-4个月的用药费用将不会高于目前所用的处方药物（取决于用药频率）。
Plethora announced the initiation of Phase III trials of the product yesterday, with pivotal studies expected to take no more than 12-15 months, and product launch anticipated towards the end of 2009 - just in time for Christmas.
Plethora公司昨天宣布启动关键的III期临床试验，时间不会超过12-15个月，预期在2009年底上市，届时正值圣诞节假期。
"Premature ejaculation is much more prevalent than erectile dysfunction," Plethora's chief business officer Sandrine Cailleteau pointed out to in-PharmaTechnologist.com.
“PE比ED更为普遍。” Plethora公司首席运营官Sandrine Cailleteau对in-PharmaTechnologist网站记者说道。
"With no approved treatment available, we hope to have the first product approved for this indication…it has the potential to be front line therapy."
“鉴于目前还没有批准的药物，我们希望拥有该适应症的首个批准药物，它将可能成为一线治疗药物。”
The potential revenues for the product could therefore be enormous; with the erectile dysfunction market currently raking in around $3bn (?2.1bn) a year (half coming from Viagra), and the premature ejaculation market significantly larger, Plethora could be looking at some serious cash coming from its spray-on treatment.
该药物潜在收益巨大。因为目前ED市场粗略估计每年为30亿美元（半数来自伟哥），而PE市场更为广阔，因而Plethora公司将因该气雾剂而财源滚滚。
In addition to the PE market, Plethora is also looking at the use of the PSD502 formulation in pain management, and has already reported promising results from early studies in burns patients receiving skin grafts.
除PE市场之外，Plethora公司还正着眼于将PSD502配方开发镇痛药物，接受皮肤移植的烧伤患者早期研究结果已经显示出其前景光明。

编译：

早泄患者福音：PE治疗药物进入最后临床研究阶段

据in-PharmaTechnologist 网站报道，由Plethora Solutions制药公司开发的一种治疗早泄（PE）的效果极佳的气雾剂已进入临床研究的最后冲刺阶段，这对于那些饱受性高潮来得太快的男士来说意义非凡。

约有30%的男性罹患PE之苦，但目前尚没有相应的治疗药物获得批准。PE患者只有选择服用说明书适应症以外的药物（如抗抑郁药），或局部应用阴茎失敏药物。但这些药物起效慢、难以控制效果或出现感觉丧失等不良结果。而Plethora制药公司开发的该药物，有望成为首个获准上市的速效、易于使用、延长射精时间4倍之久的PE新药。

该产品的活性成分是由熟知的麻醉药物利多卡因（7.5mg）和丙胺卡因（2.5mg）的低溶混合物，该混合物易溶于非氟里昂抛射剂中，从而可以制成气雾剂的剂型来释放活性药物。该药物只能通过非角质化皮肤吸收，因而只作用于龟头而非阴茎干。

药物基于Plethora公司的 PSD502配方，其最大优势之一在于5分钟内即可起效，远远快于其它产品所需半小时之久，而抗抑郁药则需服用数月后方可见效。此外，该气雾剂药效至少持续2个小时，而局部应用可避免全身吸收而导致的安全隐患，几分钟的快速干燥时间也意味着该药物不会转移给性伴侣。当然最为重要的是，业已证实该药物可延长插入至射精时间4倍之久（安慰剂组为0.93分钟，用药组为3.7 分钟。）。该药物2-4个月的用药费用将不会高于目前所用的处方药物。

Plethora公司昨天宣布启动关键的III期临床试验，时间不会超过12-15个月，预期在2009年底上市，届时正值圣诞节假期。

该药物潜在收益巨大。因为目前ED市场粗略估计每年为30亿美元（半数来自伟哥），而男性中PE较ED更为普遍，因而市场更为广阔，Plethora公司将因该气雾剂而财源滚滚。

除PE市场之外，Plethora公司还正着眼于将PSD502配方用于开发镇痛药物，接受皮肤移植的烧伤患者早期研究结果也已经显示出其前景光明。

  早泄是指阴茎插入阴道后，在女性尚未达到性高潮，而男性的性交时间短于5分钟，提早射精而出现的性交不和谐障碍，早泄带有普遍性，

一般男性30%均有此情况，问题虽小，但性生活质量 不高，会引起阳痿等其他性功能障碍，后果严重，应引起重视，及早治疗。

1.阳痿、早泄的起因有很多，常见的有手淫、肾虚、人为损伤等。

2.你现在这个情况因该早点关注，如果不早解决，心理压力变大，很快就会变成 重度的阳痿、早泄、甚至永远丧失性能力。我们在临床上发现

很多男性朋友，有早泄、性交时间短、勃起不硬、挺而不久或硬几分钟就软，有的甚至勃起都困难，但为了节省点小钱，忍着、将就将就，结

果最后彻底不行了再来看大夫，此时已经错过了最佳的治疗时期，在想彻底康复比较困难、也费钱。

3.无论是哪种原因引起的阳痿或早泄，自身是无法恢复的，只能通过药物来改善和治疗，比如大家比较熟悉的美国伟哥等，但这个毕竟是西药

成分，不建议大家使用。

4.可以考虑使用些中药的产品，你的情况建议你积极贴用中成药双扶阳贴来调理，这样副作用也小，不会对你的身体造成二次的伤害，注意营

养和休息，适当节制性生活比较好

5.另外，有些网站或广告宣称可以通过 器械或自己按摩等物理方法治疗阳痿、早泄，这是不科学的，你不要去乱搞，物理治疗是无法治疗阳痿

、早泄的。我们在临床上经常遇到一些男性朋友 由于什么都不懂，听别人说或则看一些不正规的资料，自己在家里乱搞，结果导致阴茎海绵体

永久性损伤，永远丧失性能力。

参考资料：http://www.shuangfuyang.com