Arzoxifene可增加停經後婦女的骨質密度


  June 2, 2009 — 根據線上發表於4月7日臨床內分泌學與代謝期刊的一項隨機安慰劑控制FOUNDATION試驗的兩年結果,每天服用20 mg Arzoxifene,與正常或低骨質停經後婦女的脊椎及髖骨骨質密度(BMD)增加有關,對於子宮和子宮內膜並無影響。
  
  Bethesda健康研究中心的M. Bolognese醫師等人寫道,Arzoxifene是一種benzothiophene類雌激素致效劑/拮抗劑,發展用來預防和治療骨質疏鬆,降低停經後婦女的侵犯性乳癌風險。
  
  研究目標是評估每天20 mg Arzoxifene對於BMD、子宮安全性與整體安全性的效果。研究對象是FOUNDATION試驗中,331名正常或低骨質的停經後婦女。
  
  西班牙馬德里Palacios婦女健康研究中心主任Santiago Palacios醫師獲邀進行評論時向Medscape Ob/Gyn & Women's Health表示,作者們指出Raloxifene是目前選擇性雌激素受體調節劑(SERMs)用於預防和治療骨質疏鬆的黃金標準。靜脈栓塞風險增加是基本的副作用。這表示需要新的SERM、不只要減少脊椎骨折與髖骨骨折發生率,還要維持預防高風險婦女乳癌的效果,最後減少副作用的風險,例如熱潮紅。
  
  在這項研究中,相較於安慰劑,Arzoxifene與顯著增加腰椎BMD (+2.9%)與整個髖骨BMD (+2.2%)有關,也減少了骨骼代謝的生化標記。在研究開始後6個月首次出現BMD上的差異,在研究開始後3個月的評估發現骨骼代謝生化標記上的差異。相較於安慰劑,Arzoxifene對於乳房密度沒有改變或僅略為減少。
  
  開始時與追蹤期間針對子宮內膜切片的回顧顯示,Arzoxifene組並沒有子宮內膜增生或致癌的證據。經陰道超音波顯示,兩組之間子宮內膜厚度差異並不顯著。熱潮紅、子宮息肉、陰道出血發生率差異也不顯著。
  
  研究作者寫道,對於骨質正常或偏低的停經後婦女,每天20 mg Arzoxifene可增加脊椎和髖骨的BMD,對於子宮和子宮內膜並無影響。
  
  Arzoxifene組相較於安慰劑組,唯一顯著增加的副作用是陰道黴菌感染。Palacios醫師因此建議研究Arzoxifene對於陰道菌叢與黏膜的影響,以確認Arzoxifene對於陰道是否有雌激素效果。
  
  Palacios醫師結論表示,Arzoxifene之動物實驗與第2期試驗的資料顯示,這是一個比Raloxifene更強效但副作用更少的SERM 。不過,我們必須等待目前正在進行的第3期臨床試驗有關預防骨質疏鬆骨折與高風險婦女之乳癌的結果,以及驗證現有臨床試驗的副作用,方能證明這是一個新的、且更有效、更安全的SERM。
  
  Lilly研究實驗室資助本研究,聘用其中4名作者,提供發言獎助金/諮商費用給其他2名作者。 Palacios醫師宣告沒有相關財務關係。
  
  J Clin Endocrinol Metabol. 線上發表於2009年4月7日。
  

Computer-Based Screenings Increase Detection Rate for Intimate-Partner Violence

By Barbara Boughton
Medscape Medical News

June 1, 2009 — Domestic abuse is a serious health issue for many women, but there are barriers in many healthcare settings to detecting and discussing intimate-partner violence. Women may be hesitant to admit they are involved in a relationship where violence has occurred, and in acute healthcare settings, physicians are often pressed for time and uncomfortable with initiating discussions about domestic abuse. However, these barriers may be addressed and overcome by computer-based screening — an innovation that may eventually find its way to healthcare clinics and hospitals in the United States.

In a new study published online June 1 in the Annals of Internal Medicine, Canadian researchers found that interactive computer-based screening for domestic violence increased the detection rate for this health risk and enhanced doctor-patient communication about intimate-partner violence or control.

In the randomized trial of 293 women in partner relationships, researchers tested computer-based screening against usual care in a busy urban, academic, hospital-affiliated family-practice clinic in Toronto, Ontario. They found that intimate-partner violence or control was more often detected by computer-based assessment (18% vs 9%; adjusted relative risk [RR], 2.0; 95% CI, 0.9 – 4.1) than in the usual-care group.

Physicians provided with a printout detailing the women's health risks also discussed intimate-partner violence more often in the computer-screened group than the usual-care group (35% vs 25%; adjusted RR, 1.4; 95% CI, 1.1 – 1.9). The overall rate of domestic violence or control for both groups was 22%, with no statistical difference between the computer-based-screening and usual-care groups (20% vs 23%). The prevalence of physical or sexual violence was 11% in both groups.

"While we know that patients are often very reluctant to spontaneously disclose domestic violence, it's very important for healthcare providers to ask about these health risk factors," said study investigator Farah Ahmad, PhD, from the Dalla Lana School of Public Health at the University of Toronto.

"At the same time, we know that in healthcare settings today, acute care is a priority, and many physicians are not comfortable with talking about psychosocial issues. So computerized-based screening is a very innovative way to address barriers to the detection and discussion of intimate-partner violence," she told Medscape Psychiatry.

Well-Received by Physicians and Patients

Each patient in the computer-based screening group completed a touch-screen test with questions about domestic violence as well as a range of other psychosocial and health issues, such as depression; alcohol, tobacco, and street-drug use; and risk for sexually transmitted infection. Eleven participating physicians then received a 1-page health-risk report attached to the patient's medical record during her clinic visit.

Any "yes" answer to questions about intimate-partner violence was included in the physician reports, and these were also labeled "Possible partner abuse — assess for victimization."

After completing the test, all women received a computer-generated recommendation sheet about their reported health risks, including domestic violence, with the contact numbers of appropriate community agencies. The computer-generated reports given to physicians also included relevant community referral.

Dr. Farah noted that the computer-generated reports were tailored to report each woman's health risks, particularly domestic abuse, and helped each doctor probe for more details about intimate-partner violence.

"They knew that the patient was ready to disclose, and it was an easy issue to address because it was printed right in front of them. They also didn't have to take time to look for referrals but just had to deal with management of their patients' health risks," she said.

In general, patients also thought the computer-based screening had benefits — many liked the anonymity of completing a test via computer touch screen. "Some patients had some concerns about privacy — about having information about themselves on a computer — and others worried that using a computer-based test might cause loss of personal time with their doctors," Dr. Ahmad said.

A Lot of Potential

"Computer-based screening has a lot of potential; it makes it easier for practitioners because domestic violence is a very uncomfortable subject," said Harise Stein, MD, from Stanford University Medical Center, in California, and cochair of the Family Abuse Prevention Council there.

"As well as enhancing patient-physician discussion, it's anonymous. Computer-based tools could also be used for people who speak a different language or have disabilities — so it has tremendous potential," Dr. Stein told Medscape Psychiatry.

At the same time, she cautioned that patients should be informed of the limits of confidentiality surrounding issues of domestic violence. Some states in the United States, for instance, have mandatory reporting requirements for physicians who learn of domestic violence, and patients would need to be informed of this fact, she said.

"The computer-based survey in this study is really not that different from paper-based questionnaires, except that the providers got the information in a more synthesized way. Some patients may also view it as more anonymous," added Brigid McCaw, MD, medical director of the family violence-prevention services for Kaiser Permanente in northern California.

Yet Dr. McCaw noted that as the United States moves toward electronic medical records, computer-based screenings for domestic violence are likely to become part of routine patient assessments. While Kaiser Permanente still uses paper-based screenings for domestic violence, the health plan will soon include domestic-violence questions on a volunteer online health assessment available to its members, Dr. McCaw said.

"In the future, domestic-violence information is likely to be linked to the patient's electronic medical record. In this way, you have the opportunity for the patient to receive continuity of care when they see different clinicians," she said.

The study was funded by the Canadian Institutes of Health Research and the Ontario Women's Health Council. Drs. Ahmad, Stein and McCaw report no relevant financial disclosures.

Ann Intern Med. Published online June 1, 2009.

    
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