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美国推出女版“伟哥”：滚床单前45分钟，用针注射进体内

admin2个月前 (12-23)皮肤科2

它似乎既不够安全，也不够有效。

性方面的难言之隐，不仅男性会有，一些女性同样会有。

据说，光美国就有600万女性患有机能减退的性欲障碍（hypoactive sexual desire disorder，简称HSDD）——大量女同胞们对性提不起兴趣，又或是在滚床单中状态欠佳，直接影响了生活质量。("About six million U.S. women experience HSDD, but few women receive treatment for the condition," - Reuters)

(图via Getty)

为了改善广大女性的性功能障碍问题，最近，美国就推出了一款新药：这款名叫"Vyleesi"（唯乐思）的药，就是用来提高女性性欲的。

俗称女版伟哥。

▲Vyleesi (图via AP)

上个月，千呼万唤始出来的唯乐思，终于被美国食药管理局给批准了……

The U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

美国食品药品管理局批准了唯乐思（主要成分布美诺肽），用以治疗绝经前妇女的机能减退的性欲障碍。

There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment. Today’s approval provides women with another treatment option for this condition, said Hylton V. Joffe, M.D., c, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

一些女性在没有任何已知原因的情况下，性欲下降并引发了明显的痛苦。她们可以从安全有效的药物治疗中受益，改善现状。医学博士、美国骨质、生殖和泌尿药物评估和研究中心众人Hylton V. Joffe说。

As part of the FDA’s commitment to protect and advance the health of women, we’ll continue to support the development of safe and effective treatments for female sexual dysfunction.

食药管理局承诺保护和促进女性的健康。作为这一承诺的一部分，我们将继续支持开放安全和有效的女性性功能障碍治疗方法。

▲FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women (via fda.gov)

(图via Getty)

不过……虽然上面这位专家说得倒好，还强调了治疗药物的安全有效，但唯乐思这款药的表现，却有些打脸。

因为，它似乎既不够安全，也不够有效。

首先，根据《华盛顿邮报》的说法，唯乐思非常的麻烦：需要在马上要滚床单之前才能使用，而且药物不是口服，得自己注射到体内。

Patients inject Vyleesi under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity. Patients should not use more than one dose within 24 hours or more than eight doses per month.

患者需在预期的性行为发生前至少45分钟，在腹部或大腿的皮肤下注射唯乐思。24小时内使用的剂量不能超过一剂，或者每月的使用剂量不能超过八剂。

▲A new female Viagra approved by FDA despite skepticism (via WP)

▲差不多就是这样注射的 (图via Getty)

亲爱的，咱滚床单吗？

等等，我先扎一针。

——然后往自个儿肚皮上一duang。再坐等45分钟。

而且，据英国《卫报》报道，唯乐思不仅用起来麻烦，还大概率附赠了头晕恶心等副作用……

Side effects reported during clinical trials included mild to moderate nausea lasting no more than two hours and mostly occurred over the first three doses, Amag said. About 40% of patients in clinical trials experienced nausea.

Amag制药公司表示，在临床试验报告中，唯乐思的副作用包括了轻到中度的、持续时间不超过两小时的恶心，主要发生在前三次注射期间。在临床试验中，约有40%的患者感到了恶心。

▲Vyleesi: latest attempt at female Viagra approved by US regulators (via The Guardian)

除了恶心外，副作用还有头痛、潮红等等。("Side effects during the trial included headaches, flushing and nausea." - WP)

这还不算啥。更惨的是，当你因使用唯乐思遭了这么多罪，它可能还……不起作用……

看看美国食药局的报告，可以说是很无奈了：

The effectiveness and safety of Vyleesi were studied in two 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized HSDD.

针对唯乐思的有效性与安全性，研究人员对1247名患性欲衰退的绝经前女性进行了24周的随机、双盲、安慰剂对照试验。

In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo.

在这些试验中，接受唯乐思治疗的患者里，约25%的患者性欲得分增加了1.2或以上（分数范围1.2-6.0之间，得分越高表示性欲越强）。而接受安慰剂治疗的患者中，性欲增加的比例约为17%。

There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events.

从研究的开始到结束，唯乐思治疗组在满足性事的数量上（与安慰剂组）并没有明显差异。

Vyleesi does not enhance sexual performance.

唯乐思并不能提高性能力。

▲FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women (via fda.gov)

……所以搞了半天，美国批准这个药有个锤子用？

但别说，除了唯乐思之外，美国之前还批准过一个同样堪称女版伟哥的药：Addyi（阿迪依）

▲Addyi (图via DIANA ZUCKERMAN)

阿迪依是15年批准上市的，当时是美国的第一款治疗女性欲减退的药物。

和如今的唯乐思比起来，阿迪依的表现就更令人无语了：它效果更有限、用起来更麻烦、副作用更明显。

Addyi was approved under intense pressure from advocacy groups despite a review by scientists at the Food and Drug Administration (FDA) that deemed it minimally effective and possibly unsafe.

尽管美国食药局的科学家认为，阿迪依的效果微乎其微，而且可能不够安全，但它还是在支持团体的巨大压力下，获得了上市批准。

▲Vyleesi: latest attempt at female Viagra approved by US regulators (via The Guardian)

Addyi never really took off, partly because it is a daily pill that takes a while to work, and the product carries a "black box" label that warned of serious side effects such as dizziness and low blood pressure when the drug was taken with alcohol.

阿迪依从未获得过成功。部分原因在于它是一种药片，得每日服用，而且需要一段时间才能起作用。并且，该药品带有一个黑匣子标签，警告与酒精一起服用会产生严重副作用，如头晕和低血压。（即服用阿迪依就得严格禁酒）

▲A new female Viagra approved by FDA despite skepticism (via WP)

▲万艾可（伟哥，右）是蓝色药片，阿迪依（左）则是充满少女感的粉色药片 (图via Lisa Chiu/CGTN)

不过……虽然这些药都副作用大且收效甚微，但至少女性的性福能被公众关注，并大大方方地拿出来讨论、寻找解决方案，总归是件好事。

毕竟，每10位女性中至少有一个患有HSDD（性欲障碍），更有多达1/3的女性受到过相关问题的困扰：

Conservative estimates say 10 percent of women have HSDD, but some research suggests the condition is under-diagnosed and affects closer to 33 percent of women, says Heather L. Beall, MD, a gynecologist at Northwestern Medicine McHenry Hospital.

西北医科大学麦克亨利医院的妇科医生Heather L. Beall博士表示，据保守估计，有10%的女性患有性欲障碍。但一些研究表明，这类疾病的诊断不足，实际影响了近33%的女性。

▲1 in 10 Women Has This Sexual Disorder—and Doesn’t Even Know It (via msn.com)