作者：Marlene Busko
出處：WebMD醫學新聞
November 21, 2008（紐奧良訊）－一項小型研究結果顯示，自行製造由植物抽取出來的荷爾蒙面霜可能不僅可以改善停經症候群，包括憂鬱、焦慮或是疼痛，這個藥物可能也有抗發炎作用，且不會增加血栓形成。
泰勒德州大學健康科學中心的研究者們發現，75位即將停經或是停經後的婦女，接受量身訂做的荷爾蒙補充治療，以面霜的方式塗抹在皮膚上，其一年後的安全性與療效是有希望的。
主要作者Kenna Stepenson醫師向Medscape精神學表示，一年後的研究數據是相當令人興奮的。我們認為調配好的經皮吸收荷爾蒙將可以緩解停經症狀，但是我們並沒有預期到，該藥物也有抗發炎、血液方面以及心臟代謝上的好處。
這項研究結果發表在2008年美國心臟醫學會科學座談會中。
【未經證實的安全性與療效】
Stepenson醫師表示，在美國，大約有1,500萬名女性處於即將停經或已經停經的狀態，這些婦女發生心血管疾病的風險較高。
由於婦女健康促進計劃的結果顯示，傳統荷爾蒙治療會增加乳癌、中風與失智症的風險，更多女性目前正在尋求停經症候群的替代療法；這些症狀包括熱潮紅、夜間盜汗、睡眠品質不佳與情緒起伏。
她指出，我們看到這個族群使用調配經皮吸收荷爾蒙的比例逐漸增加，但是這些劑型的安全性與療效的研究並不多。
為了研究調配經皮吸收荷爾蒙補充療法對於血液系統與抗發炎的作用，研究團隊收納150即將停經與停經後婦女，年齡介於30~70歲之間；其中一半被分派接受尋常性照護，另一半被分派接受調配面霜。尋常照護的定義是使用結合型雌性激素與甲氧基煌體激素為主的傳統荷爾蒙補充療法。
經皮吸收荷爾蒙療法包括由植物取得的雌性激素，黃體激素與部分的雄性激素及dehydroepiandrostenedione（DHEA）。
接受經皮吸收治療組的病患，根據她們的荷爾蒙血中濃度來量身訂做荷爾蒙治療；這些婦女每天使用該面霜一到兩次，以達到目標劑量。
雖然黃體激素與DHEA在美國不需處方就可以取得，但是這項研究中所使用的劑量，就像處方藥物一樣，是比較高的。
【令人欣喜的數據】
在12個月後，接受試驗治療的受試者：
* 以漢米爾頓憂鬱指標、漢米爾頓焦慮指標的憂鬱及焦慮指數顯著下降。
* 以Greene週期分數評估的生活品質與停經症狀顯著改善，例如熱潮紅與夜間盜汗。
* 沒有有害的血液方面作用，纖維蛋白酶原與第七因子沒有顯著增加，且第八因子及第一型胞漿素活化抑制劑並沒有顯著改變。
* 沒有有害的抗發炎作用，例如C反應蛋白（CRP）顯著下降，且介白素（IL）-6並無顯著變化。
* 有益的心臟代謝作用，收縮血壓、脈壓、空腹血糖與空腹三酸甘油酯顯著下降。
【仍嫌過早】
Stepenson醫師表示，所有荷爾蒙都是不一樣的，且所有荷爾蒙製劑也是不同的；這些藥物之間對發炎、栓塞因子以及心血管生物標記的風險與作用都是不同的。
她附帶表示，在這項研究中，使用經皮吸收植物抽取荷爾蒙女性的CRP與三酸甘油酯濃度較低，然而，其他研究證實接受傳統動物或合成荷爾蒙治療病患，其CRP與三酸甘油酯濃度是上升的。
她表示，需要更大型的研究來證實該療法是否為傳統荷爾蒙補充治療良好的替代療法。
【病患喜歡這樣】
Stepenson醫師表示，許多即將停經與已經停經且有情緒症狀的婦女，可能正在使用抗憂鬱藥物或是抗焦慮藥物，但是透過治療原本的疾病，荷爾蒙的變化，我們看到焦躁不安的症狀有顯著的改善。
她附帶表示，在她的臨床執業中，接受調配經皮吸收荷爾蒙補充療法的病患，喜歡使用這種給藥方式，因為這很簡單且副作用較少，其耐受性很好，且對於情緒問題及荷爾蒙相關問題，例如陰道乾澀與夜間盜汗來說是有效的。
她附帶表示，以有訓練過的藥師來調配經皮吸收荷爾蒙補充療法是很重要的；國際製備藥品藥師學會，協助這項研究的進行，該學會於網路上列出符合資格的藥師名單。可以從美國專業製備中心（PCCA）與PCCA位於加拿大的網站獲得其他的資訊。
黃體激素基金會與國際製備藥品藥師學會部分贊助這項研究。該研究作者表示沒有相關資金上的往來。
AHA 2008: Hormone Cream May Aid Menopausal Symptoms Without Increasing Thrombotic Risk
By Marlene Busko
Medscape Medical News
November 21, 2008 (New Orleans, Louisiana) — Custom-compounded plant-derived hormone cream may not only improve menopausal symptoms, including depression, anxiety, and pain, it may also provide an anti-inflammatory effect without increasing blood-clot formation, a small study suggests.
Researchers at the University of Texas Health Science Center, in Tyler, found promising 1-year safety and efficacy results in 75 peri- and postmenopausal women who received individually formulated hormone-replacement therapy applied as a cream to the skin.
"The 1-year findings are pretty encouraging," lead author Kenna Stephenson, MD, told Medscape Psychiatry. "We thought compounded transdermal hormones would relieve menopausal symptoms, but we didn't anticipate that they would also have a favorable effect on inflammatory, hemostatic, and cardiometabolic pathways."
The study was presented here at the American Heart Association 2008 Scientific Sessions.
Unproven Safety and Efficacy
In the United States, about 15?million women are currently peri- or postmenopausal and, as such, have an increased risk for cardiovascular disease, said Dr. Stephenson.
Since the Women's Health Initiative study showed an increased risk for breast cancer, stroke, and dementia with conventional hormone therapy, more women have been seeking alternative treatments for menopausal symptoms, such as hot flashes, night sweats, disrupted sleep, and irritability.
"We've seen an increase in the use of compounded transdermal hormone therapies among this population, but the safety and efficacy of these formulations have not been studied," she said.
To evaluate the hemostatic and anti-inflammatory effects of a compounded transdermal hormone-replacement therapy, the researchers recruited 150 peri- and postmenopausal women, aged 30 to 70 years.
Half were assigned to usual care and the rest were assigned to the compounded cream. Usual care was defined as conventional hormone therapy of conjugated equine estrogens and medroxyprogesterone.
The transdermal hormonal therapy consisted of plant-derived estrogen, progesterone, and sometimes testosterone and dehydroepiandrostenedione (DHEA).
Subjects in the transdermal-cream group were prescribed individualized therapy on the basis of their hormone levels. The women applied the cream to the skin once or twice daily to receive the target dose.
Although progesterone and DHEA are available over the counter in the United States, the doses of prescribed therapy, such as those used in the study, are much higher.
Encouraging Findings
At 12 months, the subjects who received the study treatment had:
Significant decreases in depression and anxiety, as assessed by the Hamilton Depression Scale and the Hamilton Anxiety Scale
Significant improvements in quality of life and menopausal symptoms, such as hot flashes and night sweats, as assessed by the Greene Climacteric Scale
No harmful hemostatic effects, as indicated by significant decreases in fibrinogen and factor?VII, and no significant changes in factor?VIII or plasminogen activator inhibitor type?I.
No harmful anti-inflammatory effects, as shown by significant decreases in C-reactive protein (CRP), and no significant changes in interleukin-6
Beneficial cardiometabolic effects, as shown by significant decreases in systolic blood pressure, pulse pressure, fasting glucose, and fasting triglycerides.
Still Early Days
"All hormones are not equal, and all hormone preparations are not equal," said Dr. Stephenson. "There are distinctly different risks and effects on inflammatory and thrombotic factors and cardiovascular biomarkers."
In this study, CRP and triglycerides decreased in women who received transdermal plant-derived compound hormones, whereas other studies have shown increased CRP and triglycerides in women receiving conventional equine and synthetic hormone therapy, she added.
However, "larger clinical trials are needed to determine whether this therapy is a good alternative to conventional hormone-replacement therapy," she said.
"Patients Like It"
"Many perimenopausal and postmenopausal women with mood symptoms may be given antidepressant therapy or anti-anxiety therapy, but by treating the underlying cause — hormonal changes — we see a statistically significant improvement in dysphoria," said Dr. Stephenson.
She added that patients in her clinical practice who receive compounded transdermal hormone-replacement therapy like it because it is easy, there are few adverse effects, it is very well tolerated, and it is effective for mood symptoms and hormone-related symptoms, such as vaginal dryness and night sweats."
It is important, she added, that a trained compounding pharmacist prepare transdermal hormone-replacement therapy. The International Academy of Compounding Pharmacists, which helped fund the study, lists such pharmacists on their Web site. Other information is available from the Professional Compounding Centers of America (PCCA) and the PCCA Canada Web sites.
The study was partly funded by the Progesterone Foundation and the International Academy of Compounding Pharmacists. The study authors have disclosed no relevant financial relationships.
American Heart Association (AHA) 2008 Scientific Sessions: Abstract 5071. Presented November 11, 2008.
[ 本帖最後由 goodcat1111 於 2008-12-2 11:08 編輯 ] |
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