女用助興藥平均每月增加滿意性行爲半次

Half of one satisfying sexual encounter a month. That is the average benefit a woman gets when she takes the new female libido drug, sometimes called the “female Viagra,” researchers reported Monday.

週一（2月29日），研究人員報道：婦女們在服用一種新型女用助興藥（有時也稱爲“女用偉哥”）後，一個月裏滿意的性行爲次數平均可以增加半次。

Last year the Food and Drug Administration approved the drug, flibanserin, making it the first drug available to treat low sexual desire in women. It was promoted by a group of women’s rights activists who argued it was unfair that men had numerous drugs to boost sexual function while women had nothing.

該藥物名叫氟班色林(flibanserin)，去年獲得了美國食品和藥品監督管理局(Food and Drug Administration, F.D.A.)的批准，從而成爲了第一種用於治療女性性慾低下的藥物。這是一羣女權主義者大力敦促的結果。她們認爲，男人們有好多藥物可以促進性功能，而女人們卻什麼都沒有，太不公平。

But public health groups and some other women’s groups contended that the science did not justify its approval. The drug’s effects were modest, they said, and not worth side effects such as sleepiness, dizziness, fatigue and nausea. And the risk of some side effects increased with alcohol consumption.

然而，部分公共衛生組織和其他一些婦女團體對此表示異議，聲稱該藥物的獲批缺乏足夠的科學依據。他們說，這種藥物的作用平平，不足以抵消其副作用，如嗜睡、頭暈、疲勞和噁心等。而且，飲酒還會加大某些副作用的風險。

In the new study, published in JAMA Internal Medicine, researchers found benefits that were slightly more modest than those submitted to the F.D.A. during the approval process. The researchers analyzed eight studies of about 5,900 women, using a method that involved pooling the data. They concluded that treatment with flibanserin, now marketed as Addyi, resulted in “one-half of an additional sexually satisfying encounter per month.” (The study did not define what “one-half” of a sexually satisfying encounter was.)

在發表在《美國醫學會期刊：內科學》雜誌(JAMA Internal Medicine)上的一項新研究中，研究人員發現，該藥物的效益比審批過程中提交給F.D.A.的材料中顯示的略低。研究人員採用數據彙總等方法，分析了涉及5900名婦女的八項研究。他們的結論是：接受氟班色林（商品名爲Addyi）治療的女性“一個月裏滿意的性行爲次數平均可以增加半次”（該研究並未給“半次”滿意的性行爲做出定義）。

That result was not very different from original findings of three clinical trials submitted to the F.D.A. as support for the drug’s approval. Those trials found that once women started taking the drug, they had an average of about one additional satisfying sexual encounter a month, on top of the two to three they were having already. That result lifted the benefits above the bar of being scientifically meaningful, but barely. Still, it was enough for the agency’s approval.

該結果與當初藥物審批過程中提交給F.D.A.的三個臨牀試驗的結果大同小異。那些試驗發現，從婦女們開始服用該藥物起，她們一個月裏滿意性行爲的次數平均增加了一次，最多可以增加兩到三次。這些結果表明，該藥物的效益勉強達到了“具有科學意義”的標準——但已經足以獲得F.D.A.的批准了。

In a statement, Dr. Tage Ramakrishna, the chief medical officer at Valeant, the company that now owns the drug, said that the new analysis confirmed the findings of the clinical trials and “provided little additional context.” He said the way the analysis was done, combining data from a number of different studies, carried “less statistical weight” than the randomized trials .

該藥物的當前持有者——Valeant製藥國際公司的首席醫務官塔格·羅摩克里希納(Tage Ramakrishna)博士在一份聲明中表示，上述新分析證實了臨牀試驗的結果，且“沒提供什麼新東西”。他說，該分析合併了來自衆多不同研究的數據，其“統計權重低於”隨機試驗。

The drug was approved last June, after twice being rejected by the agency over several years. In the clinical trial results submitted, women taking the drug also reported on monthly questionnaires that they felt more desire, although the difference compared with a placebo was also meager — only about 0.3 points on a scale ranging from 1.2 to 6.0.

繼此前若干年裏兩次遭到F.D.A.拒絕後，該藥物終於在去年6月通過了審批。在提交給F.D.A.的臨牀試驗結果中，服用該藥物的婦女們還在每月的問卷調查中報告，她們感到性慾增強了，只是與安慰劑差異甚微——在評分範圍爲1.2到6.0分的量表中僅差0.3分上下。

Experts who had opposed the drug’s approval said the JAMA analysis, which confirmed that the drug increased the risk of dizziness, sleepiness, nausea and fatigue, underscored the meagerness of the benefit.

反對該藥物過審的專家們則稱，JAMA的分析證實，該藥物確會增加頭暈、嗜睡、噁心和疲勞的風險，反過來更顯出其效益的微乎其微。

“An additional half a satisfying sexual encounter a month — is that meaningful?” asked Dr. Adriane Fugh-Berman, the director of PharmedOut, a project at Georgetown University that questions the influence of drug companies on the practice of medicine. “I think only the women can answer that, but perhaps they already have with their lack of enthusiasm for getting prescriptions.”

“一個月平均可增加半次滿意的性行爲——這有意義麼？”安德萊內·傅柏曼(Adriane Fugh-Berman)博士問道，他在喬治城大學(Georgetown University)領導了PharmedOut項目，質疑製藥公司對醫療實踐的影響。“我認爲這個問題只有婦女們自己才能回答，但或許她們的興趣缺缺已經表明了她們的態度。”

The drug is not selling well. As of early January, Addyi was generating only 240 to 290 prescriptions a week, according to a report last week by David Maris, an analyst at Wells Fargo Securities, who cited the prescription tracker IMS Health as the source of the data. Mr. Maris estimated that sales of Addyi were running at a rate of $11 million a year, well below the $100 million to $150 million in sales that Valeant said it hoped to achieve this year.

這種藥物並不暢銷。上週富國銀行集團(Wells Fargo Securities)的分析師戴維·馬里斯(David Maris)在一份報告中指出，根據艾美仕市場研究公司(IMS Health)的處方跟蹤數據，截至1月初，一週裏只有240到290張Addyi的處方開出。馬里斯先生估計，Addyi的年銷售額約爲每年1100萬美元，遠低於Valeant公司的預期——今年達到1億至1億5000萬美元。

Still, some said the drug helped. Dr. Lauren Streicher, an associate clinical professor of obstetrics and gynecology at the Feinberg School of Medicine at Northwestern Memorial Hospital in Chicago, said a number of her patients have taken the drug and reported significant increases in libido. None has discontinued use because of side effects, she said.

不過，也有人說這種藥有些用處。西北大學費恩柏格醫學院（obstetrics and gynecology，位於芝加哥）的婦產科臨牀副教授勞倫·施特賴歇爾(Lauren Streicher)博士說，她的一部分患者在服藥後報告性慾顯著上升。她還說，沒有人因副作用而停藥。

The analysis was undertaken by researchers in Europe, but one of the study’s authors, Dr. Ellen Laan, an associate professor in the Department of Sexology and Psychosomatic Obstetrics and Gynecology at the Academic Medical Center at the University of Amsterdam, has been an opponent of the drug. Last year, she helped organize a letter to the F.D.A. opposing the approval and signed another letter to Congress that said the argument about gender equality was “misleading and dangerous.”

前述新分析由歐洲的研究人員完成，但該研究的作者之一，荷蘭阿姆斯特丹大學(University of Amsterdam)學術醫學中心(Academic Medical Center)的性學和心理婦產科系(Department of Sexology and Psychosomatic Obstetrics and Gynecology)副教授埃倫·拉恩(Ellen Laan)博士一直對該藥物持反對態度。去年，她協助組織致函F.D.A.反對該藥物通過審批，並在給國會(Congress)的另一封信上簽名，表示那些聲稱該藥物的審批關乎性別平等的論調“誤導人心，十分危險”。