女性睪固酮處方增加，遭拒與延誤也隨之上升

作者：Mrinalika RoyBy Mrinalika Roy

9月15日（路透）——根據路透訪問超過半打醫師、護理師與病患，愈來愈多女性轉向睪固酮療法來處理更年期症狀，卻在藥局遇到意想不到的處方延誤與拒絕調劑。Sept 15 (Reuters) - Women increasingly turning to testosterone therapy to manage menopause symptoms are running into unexpected prescription delays and denials at pharmacies, according to interviews with more than half a dozen doctors, nurses and patients.

美國目前沒有核准供女性使用的睪固酮產品；不過，睪固酮的仿單標示外使用正在增加，主要用於治療與更年期相關、持續性的性慾低下。這也是目前唯一已有醫療指引與療效證據的適應症。There is no U.S.-approved testosterone product for women, although its off-label use is on the rise, primarily to treat persistently low sexual desire related to menopause, the only condition for which medical guidelines and evidence of efficacy currently exist.

一些臨床醫師也開立睪固酮，用於疲倦、肌力流失等更年期相關症狀，儘管這類用途缺乏醫療指引。Some clinicians are also prescribing it for menopause-related symptoms such as fatigue and loss of muscle strength, despite a lack of medical guidance for that use.

更年期學會（The Menopause Society）與另外半打醫學組織，只支持更年期女性因性慾低下障礙使用睪固酮。The Menopause Society and half a dozen other medical organizations only back testosterone use for hypoactive sexual desire disorder in menopausal women.

梅約診所女性健康中心主任、同時也是更年期學會醫務主任的史蒂芬妮・福比昂醫師（Dr. Stephanie Faubion）說：「我們沒有任何女性相關證據顯示，睪固酮能改善肌肉量、骨密度、情緒、身心健康，或其實任何其他指標。」"We do not have any evidence in women that it will improve muscle mass or bone density or mood or well-being or really any other metric," said Dr. Stephanie Faubion, director of Mayo Clinic's Center for Women's Health and medical director of The Menopause Society.

她說：「一般大眾與社群媒體宣稱睪固酮的用途，其實並不是我們有資料支持的用途。」"What testosterone is being touted for in the lay public and on social media is not really what we have data for," she said.

處方激增SURGING PRESCRIPTIONS

睪固酮使用增加之際，整體而言也有更多女性轉向荷爾蒙療法；這同樣受到社群媒體推動，近期也受到美國食品暨藥物管理局（FDA）影響，該局支持使用雌激素與黃體素治療更年期症狀，認定其安全且有效。一些臨床醫師會在這些療法之外一併開立睪固酮。Testosterone's rise comes as more women turn to hormone therapy overall, also driven by social media and, more recently, by the FDA, which backed estrogen and progesterone use for menopause symptoms as safe and effective. Some clinicians prescribe testosterone alongside these therapies.

醫療保健分析公司Truveta為路透獨家進行的資料分析顯示，從2023年1月到2026年7月，女性取得睪固酮處方的比率大增146%，幾乎成長為三倍。An exclusive data analysis for Reuters by healthcare analytics firm Truveta shows the rate of women receiving a testosterone prescription jumped 146%, nearly tripling, from January 2023 to July 2026.

美國食品暨藥物管理局將於週四舉行公開工作坊，檢視更年期女性使用睪固酮的證據。美國衛生部長小羅伯特・甘迺迪（Robert F. Kennedy Jr.）與國防部長彼得・赫格塞斯（Pete Hegseth）都曾推廣這類使用；赫格塞斯也把部隊中的睪固酮濃度作為議題。The U.S. Food and Drug Administration will hold a public workshop on Thursday to review evidence for testosterone use in menopausal women, which has been promoted by Health Secretary Robert F. Kennedy Jr. and Defense Secretary Pete Hegseth, who has made an issue of testosterone levels among the troops.

儘管醫療服務提供者可以依其認為適當的方式開立已核准藥物，一名FDA發言人表示，這些仿單標示外用途尚未經該局評估其安全性、療效或劑量。While healthcare providers can prescribe approved medicines any way they see fit, an FDA spokesperson said these off-label uses have not been evaluated by the agency for safety, efficacy or dosing.

女性患者的變通做法WORKAROUNDS FOR WOMEN

由於沒有核准給女性使用的睪固酮，患者必須分裝原本為男性設計的包裝產品；這些產品的劑量往往是她們所需劑量的好幾倍。With no approved testosterone for women, patients must divide packaged versions designed for men often at many times the doses they're seeking.

華府女性健康護理師珍妮佛・拉諾夫（Jennifer Lanoff）表示，亞馬遜藥局（Amazon Pharmacy）今年首次拒絕她所屬診所開出的處方。Jennifer Lanoff, a women's health nurse practitioner in Washington, D.C., said Amazon Pharmacy rejected prescriptions from her practice for the first time this year.

她說：「我們一直都有開立（仿單標示外睪固酮處方）。這是臨床指引建議的。亞馬遜以前沒有給我們帶來問題。」「我不確定到底發生了什麼，或他們為什麼拒絕。他們說那是一項新政策。」"We've done (off-label testosterone prescriptions) forever. It's clinical guidelines recommended. Amazon has not given us a problem before," she said. "I don't know exactly what happened or why they rejected. They say it was a new policy."

拉諾夫表示，她改寫部分處方後曾有些成功；在這類處方中，患者會丟棄剩餘凝膠，而不是把劑量分出來留待日後使用。Lanoff said she has had some success rewriting prescriptions under which patients discard leftover gel rather than splitting doses for later use.

亞馬遜藥局表示，為確保安全且合規調劑，該藥局不調劑部分要求女性自行調整劑量的睪固酮處方。該公司補充說，這項政策並非專門針對睪固酮，也不是基於患者的生理性別或性別認同。Amazon Pharmacy said it does not dispense some testosterone prescriptions that require women to customize doses in order to ensure safe and compliant dispensing. It added that the policy is not specific to testosterone or based on a patient's sex or gender identity.

該公司表示，會將顧客轉介至可為特殊劑量混合成分的複方調劑藥局。The company said it refers customers to compounding pharmacies that mix ingredients for specialized doses.

拉諾夫表示，複方調劑的睪固酮三個月份量約100美元；相較之下，在商業藥局使用折扣後，10個月份量約30美元。Compounded testosterone can cost about $100 for a three-month supply compared with $30 after discounts for a 10-month supply at a commercial pharmacy, Lanoff said.

接受訪問的醫師、護理師與病患表示，多數保險公司不給付女性使用睪固酮。Most insurance companies do not cover testosterone for women, the doctors, nurses and patients said.

護理師、Mystic Valley Sexual Wellness創辦人梅根・普萊斯（Magen Price）表示，她診所目前使用睪固酮的80名患者中，超過三分之一曾遇到處方相關問題，包括在CVS與Walgreens藥局。Magen Price, a nurse practitioner and founder of Mystic Valley Sexual Wellness, said more than one-third of the 80 patients in her practice who currently use testosterone have encountered issues with their prescriptions, including at CVS and Walgreens pharmacies.

普萊斯告訴路透，這些問題從去年開始，並且已經惡化。The issues that began last year have worsened, Price told Reuters.

住在波士頓市郊、55歲的平面設計師艾美・史旺（Amy Swan）今年3月第一次想領取睪固酮凝膠處方時，以為只是去一趟藥局就能完成。When Amy Swan, a 55-year-old graphic designer outside Boston, tried to fill her first testosterone gel prescription in March, she expected a simple pharmacy visit.

結果，她花了好幾週，才讓一家藥局願意接受GoodRx折價券，將費用降低25%。Instead, she spent weeks trying to get a pharmacy to honor a GoodRx discount coupon that would reduce the cost by 25%.

史旺說：「光是為了拿到這一張處方，就耗掉了我好幾個小時。」"Hours of my time were lost just being able to get this one prescription," Swan said.

CVS表示，其藥局經常為女性調劑外用睪固酮凝膠處方。其他設有大型藥局的零售商，包括Walgreens、Costco與Walmart，未回應採訪請求。Kroger拒絕評論。CVS said its pharmacies regularly fill prescriptions for topical testosterone gel for women. Other retailers with large pharmacies including Walgreens, Costco and Walmart did not respond to requests for comment. Kroger declined to comment.

諮詢公司ProPharma藥師兼產品生命週期管理主管凱文・席柏（Kevin Schipper）表示，藥局可能因擔心劑量準確性與用藥安全，以及一次性包裝若被打開後重複使用所涉及的穩定性、保存與汙染問題，而拒絕調劑處方。Kevin Schipper, a pharmacist and director of product lifecycle management at consulting firm ProPharma, said pharmacies may decline prescriptions due to concerns over dosing accuracy and medication safety, as well as stability, storage and contamination if single-use packaging is opened and reused.

此外，由於睪固酮是管制藥物——類似含可待因的阿斯匹靈——各州也都有政府要求的紀錄保存規定。Because it is a controlled substance — similar to aspirin with codeine — each state also has record-keeping requirements for the government.

安全性試驗TRIALS FOR SAFETY

根據ClinicalTrials.gov，目前有超過30項研究女性因各種健康狀況使用睪固酮的試驗正在進行或規劃中，其中包括由Marius Pharmaceuticals贊助、最快將於今年稍晚啟動的性功能障礙試驗。Over 30 trials studying testosterone use for various health conditions in women are underway or planned, according to ClinicalTrials.gov, including a Marius Pharmaceuticals-sponsored sexual dysfunction trial due to start as soon as later this year.

Aviva Bio正在開發新一代睪固酮產品，目標是處理使用這種荷爾蒙所伴隨的乳癌風險。Aviva Bio is developing a next-generation testosterone product that would address breast cancer risk associated with use of the hormone.

女性目前使用的產品包括品牌與學名睪固酮凝膠，例如艾伯維（AbbVie）的AndroGel、Keenova Therapeutics的Testim，以及Upsher-Smith的Vogelxo。Products currently used by women include branded and generic testosterone gels, such as AbbVie's AndroGel, Keenova Therapeutics' Testim and Upsher-Smith's Vogelxo.

Upsher-Smith拒絕評論是否計畫開發專供女性使用的睪固酮產品。艾伯維與Keenova未回應採訪請求。Upsher-Smith declined to comment on whether it plans to develop testosterone products specifically for women. AbbVie and Keenova did not respond to requests for comment.

加州大學聖地牙哥分校醫學臨床教授辛西亞・史圖恩克爾（Cynthia Stuenkel）表示，她希望FDA能優先評估專為女性設計的睪固酮產品。Cynthia Stuenkel, a clinical professor of medicine at the University of California, San Diego, said she hopes the FDA will prioritize evaluating a testosterone product designed for women.

她說：「這當然會讓臨床醫師更容易且更有信心開立睪固酮，也讓女性更容易、更有信心使用專為她們劑量設計的睪固酮。」"This would certainly ease the ability of clinicians to more confidently prescribe testosterone and for women to more easily and confidently use testosterone specifically dosed for them," she said.

（班加羅爾Mrinalika Roy報導；Caroline Humer與Bill Berkrot編輯）(Reporting by Mrinalika Roy in Bengaluru; Editing by Caroline Humer and Bill Berkrot)