非典型抗精神病藥物可能是厭食症安全且有效的治療


  July 17, 2008 — 一項初期隨機分派、雙盲、安慰劑控制研究結果顯示,olanzapine(Zyprexa,禮來藥廠),一種用於治療精神分裂症與雙極性異常的非典型抗精神病藥物,可能是罹患嚴重厭食症女性一個有效且安全的治療。
  
  來自於安大略渥太華健康醫院、由Hany Bissada醫師領導的研究團隊發現,相較於安慰劑,olanzapine使體重增加的速度變快,比較早達到標準的身體質量指數,同時降低強迫症候群的速度也較快,兩組間的不良反應並無顯著差異。
  
  Bissada醫師向Medscape精神學與精神健康表示,我們需要更大型的研究,但無論如何,根據這些結果我們可以有信心地說,我們相信olanzapine是厭食症有效的起始治療,截至目前,該疾病並沒有穩定有效的藥物。
  
  這項研究發表於7月16日的美國精神醫學期刊。
  
  【最高的死亡率】
  Bissada醫師表示,厭食症是所有精神疾病中死亡率最高的,影響了約0.5%年齡介於15到24歲的女性,它因為最難以治療而惡名昭彰。
  
  治療方式包括延長住院天數以穩定體重,合併精神諮詢;以選擇性血清素再回收抑制劑(SSRIs)以及標準安神藥物治療,並未被證實可以加速體重增加的速度、或是降低精神症狀,包括憂鬱、焦慮、身影扭曲、或是擺脫不了拒絕體重增加的感覺。
  
  Bissada醫師指出,針對olanzapine的主要原因是,罹患精神分裂症病患長期使用所觀察到的體重增加。除此之外,該藥物對雙極性異常病患產生一種情緒調整作用,且被核准作為強迫症候群病患抗憂鬱治療的輔助療法。
  
  他表示,由於這個藥物有許多有趣且吸引人的地方,因此我們決定進行這項隨機分派研究。
  
  【不良反應方面沒有差異】
  為了這項研究,研究者收納34位確定罹患厭食症,且被轉介至單一醫院為主的日間飲食異常計畫中的病患進行研究。
  
  病患們被隨機分派接受olanzapine或安慰劑,加上每天住院治療,總共進行10週;這些藥物以彈性劑量療程方式處方,從最低劑量的2.5 mg,接著以每個星期2.5 mg緩慢地增加到最高劑量的每天10 mg。
  
  這項研究的主要試驗終點是藥物對於體重增加作用,次級試驗終點是針對其他精神症狀的作用,包括焦慮、憂鬱與強迫症。
  
  Bissada醫師表示,10週後,相較於安慰劑組,接受藥物治療組病患體重增加較多,且速度較快,研究結果在統計上有顯著差異;此外,病患對於體重增加的厭惡感也明顯降低。
  
  當該藥物有抗焦慮與抗憂鬱的作用傾向時,這樣的效果並未達到統計上的顯著差異;Bissada醫師表示,這可能是因為這項研究的收納病患人數不足;此外,研究者們並未在兩組之間發現不良反應的差異。
  
  與olanzapine潛在相關的嚴重不良反應,包括體重增加過多、高血糖與糖尿病,這些與高劑量、長期治療有關,短期較低劑量並未發生類似的問題。
  
  他表示,在厭食症上,我們使用olanzapine暫時獲得病患可以耐受進食且接受體重增加的主意。
  
  【第一個反應通常是驚恐】
  Bissada醫師指出,以olanzapine治療此疾病最大的挑戰是讓病患認同這項治療;厭食症病患非常害怕體重增加,因此當提供他們會使體重增加的藥物時,他們的第一個反應是驚恐。
  
  他表示,你必須耐心地向他們解釋,並再三向這些病患保證這個藥物不會讓他們過重,或是在一夜之間變得肥胖,同時要強調開給他們治療厭食症的劑量比使用於精神分裂症的劑量低得多。
  
  Bissada醫師希望進行一個相似、但較大型的多中心研究,目前正在尋找合作夥伴;他表示,olanzapine可能值得使用於對治療反應不佳的厭食症病患。
  
  他指出,臨床醫師在治療嚴重厭食症病患時,當病患拒絕進食,可能需要考慮提供這些病患使用較低的劑量(每天2.5至5 mg),及有病患可以隨時停藥的認知。
  
  這項研究由禮來藥廠經費贊助。作者表示沒有相衝突的股份。

Atypical Antipsychotic May Be Safe, Effective Treatment for Anorexia Nervosa

By Caroline Cassels
Medscape Medical News

July 17, 2008 — Preliminary results from a randomized, double-blind, placebo-controlled trial suggest olanzapine (Zyprexa, Eli Lilly), an atypical antipsychotic used to treat schizophrenia and bipolar disorder, may be a safe, effective therapy for women with severe anorexia nervosa.

Led by Hany Bissada, MD, investigators at the Ottawa Health Hospital, in Ontario, found that compared with placebo, olanzapine resulted in a greater rate of increase in weight, earlier achievement of target body-mass index, and a greater rate of decrease in obsessive symptoms, with no difference in adverse effects between the 2 study groups.

"We need to do a much larger study, but nevertheless, based on these results, we can confidently say there is a reason to believe olanzapine may be useful in the initial treatment for anorexia nervosa, where to date, we've had no consistently successful drugs," Dr. Bissada told Medscape Psychiatry & Mental Health.

The study is published online July 16 in the American Journal of Psychiatry.

Highest Mortality Rate

Notoriously difficult to treat, anorexia nervosa has the highest mortality rate of all psychiatric disorders, affecting 0.5% of women aged 15 to 24 years, said Dr. Bissada.

Treatment consists of extended hospital stays to stabilize weight, as well as psychological counseling. Drug therapy with selective serotonin reuptake inhibitors (SSRIs) and standard neuroleptics have not been effective in increasing the rate of weight gain or reducing the psychological symptoms, including depression, anxiety, distorted body image, and obsessions that perpetuate resistance to weight gain.

One of the major reasons for looking at olanzapine in anorexia, said Dr. Bissada, was its observed long-term adverse effect of weight gain in patients with schizophrenia. Further, the drug produces a mood-modulating effect observed in bipolar patients and has also been used as adjunctive therapy to antidepressant treatment in patients with obsessive disorders.

"This was an interesting and attractive medication for many reasons, so we decided to conduct this randomized controlled trial," he said.

No Difference in Adverse Effects

For the study, the investigators recruited 34 female patients with confirmed anorexia nervosa who had been referred to a hospital-based daytime eating-disorders program at a single center.

Patients were randomly assigned to olanzapine or placebo, plus day hospital treatment, for a 10-week period. The drug was prescribed according to a flexible-dose regimen, starting at a minimum dose of 2.5 mg and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day.

The study's primary end point was the effect of the drug on weight gain. A secondary end point was to look at its impact on other psychological symptoms, including anxiety, depression, and obsessive/compulsive behavior.

After 10 weeks, patients in the active-treatment group gained more weight, at a faster rate, than those on placebo, a finding that was statistically significant, said Dr. Bissada. In addition, patients' obsession about weight gain was also significantly reduced.

While there was a trend toward antianxiety and antidepressant effects, this did not reach statistical significance. However, said Dr. Bissada, this may have been due to the small number of study subjects. In addition, the researchers found no difference in adverse effects between the 2 study groups.

Potentially serious adverse effects associated with olanzapine, including excessive weight gain, hyperglycemia, and diabetes, are linked to high-dose, long-term therapy and do not apply to short-term treatment with a smaller dose.

"In anorexia, we use olanzapine temporarily to get patients to a level where they can tolerate eating and accept the idea of weight gain," he said.

Panic Often First Reaction

One of the major challenges in treating this disease with olanzapine, said Dr. Bissada, is getting patients to agree to the therapy. "Anorexia nervosa patients are so afraid of weight gain that, when you offer them a medication that induces weight gain, their first reaction is panic.

"You have to be patient and explain and reassure these patients that this drug will not make them overweight or obese overnight and underscore the fact that the doses prescribed for anorexia are much, much smaller than doses prescribed for schizophrenia," he said.

Dr. Bissada hopes to conduct a similar, but much larger, multicenter trial and is currently looking for collaborators. In the meantime, he said, olanzapine may be worth a try in refractory anorexic patients.

"Clinicians treating patients with severe anorexia nervosa, who adamantly refuse to eat, may want to consider offering such patients a trial of this drug at a small dose (2.5 to 5 mg/day), with the understanding that the patient can stop it at any time," he said.

The study was supported by a grant from Eli Lilly. The authors report no competing interests.

Am J Psychiatry. Published online June 16, 2008. Abstract

    
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