2008年1月25日 星期五

讀"扭曲的醫療生態" ( 李秉穎) *附New Warning About Botox

關於"熱門的美容科" 其實並非真的"沒事"

Group Seeks New Warning About Botox


■ 李秉穎

報載 台灣醫師因為醫療糾紛被定罪的比率高於其他各國,其實醫師被不當定罪只是台灣社會不公平對待醫界的其中一點,更多的是辱罵、威脅,甚至人身傷害。筆者與一 群關心台灣醫界的同好,曾在民國九十三年對相關事件做過一次問卷調查。發現將近一半執業醫師都遇過醫療糾紛,有過糾紛的事件包括要求賠償(七十五%)、被 辱罵(三十一%)、法律訴訟(二十三%)、人身傷害(六%)。試想,有哪一個「正常」行業會有這麼高比率被罵、被打、被告?那些要求提高醫師被定罪比率的 個人或團體,認為這是社會公義嗎?

醫界被不公平對待的結果是,少糾紛的皮膚科變成年輕醫師的最熱門科系,攸關民眾生命保障的重症科別,則乏 人問津。前述調查中,醫學生家長有高達四十四%的比率,希望自己的子女將來任職皮膚科。也發現許多醫師對於目前執業科別並不滿意,其中有三分之二都是因為 醫療糾紛太多而覺得不如歸去。大約四分之一的醫師考慮過要轉科,而轉科的第一志願則又是皮膚科(三十%)。優秀人才紛紛轉向少糾紛科別,對醫療品質當有負 面影響。

該次調查有個問題,假設有一種外科急症,不開刀的死亡率為九十%,開刀的死亡率為四十%。依照一般的想法,當然應該開刀。執業醫師 在假設自己生病的情形下,要求馬上開刀與完全由醫師決定的比率大約各佔一半。但如果是面對民眾生病,則只有二十四%會積極勸說開刀,其他都是讓家屬決定。 其間的差距來自於醫療糾紛太多所產生的防衛性心態,雖然開刀讓病人的存活率提升,但只要遇上開刀死亡,就很可能會引起醫療糾紛。





  衛生署藥政處處長廖繼洲表示,肉毒桿菌素是一種神經肌肉阻斷劑,國內核准用來治療肌肉痙攣、斜視、痙攣性斜頸症等疾病,在美容方面,所核准的則 是使用於除皺眉紋。此次美國致死案例,主要是治療斜頸症時,醫師施打的劑量或位置不對,而產生嚴重副作用所致。廖繼洲:『他可能劑量打得太多,或是打到比 接近喉嚨的地方,因此喉嚨麻痺,吞嚥困難,產生吸入性的肺炎而致死。』


  衛生署進一步指出,國內自開放肉毒桿菌素上市後,共接獲十四例不良反應通報病例,包括胸悶、腹痛、便秘等,並沒有接獲肌肉麻痺、吞嚥困難等副作 用,也沒有亡案例。國內醫師的醫療水準都很高,相信不會出現施打劑量或位置不對的狀況,衛生署會密切注意此事發展,並呼籲醫師要小心使用肉毒桿菌。

Group Seeks New Warning About Botox

Published: January 25, 2008

WASHINGTON — Botox and a similar injected drug have been associated with 16 deaths, four of them in children, and scores of serious injuries that occurred after the drug spread to vital organs, a health advocacy group says.

The drug, a neurotoxin that is used to relax muscles, should come with a far stronger warning label and patients should be given a letter detailing its risks, the group, Public Citizen, said in a petition filed Thursday with the Food and Drug Administration.

Julie Zawisza, a spokeswoman for the agency, said she could not comment while the petition was under review.

Executives at Allergan, the maker of Botox, issued a statement saying that adverse reactions were rare. And because many patients who get the drug are seriously ill, the company said, it is not proved that Botox caused the reactions. Solstice Neurosciences, the maker of a similar drug, Myobloc, did not return a message for comment.

Perhaps best known as a wrinkle remover, Botox is also approved to treat cervical dystonia, a painful knotting of neck muscles. Doctors inject it into multiple spots on the neck, relieving sometimes disabling pain for weeks or months.

But the injection sites sometimes come perilously close to the esophagus, causing partial paralysis that can lead patients to have difficulty swallowing and suffer aspiration pneumonia, caused by breathing in food or liquids, Public Citizen said.

Of the 16 people who died, only one is known to have been undergoing a cosmetic treatment for wrinkles. Most of the others suffered muscle problems or their condition was unknown.

The deaths might have been prevented had patients been adequately warned of the possible dangers, said Dr. Sidney M. Wolfe, director of Public Citizen’s health research group. The labels for Botox and Myobloc mention the issue but not prominently enough, Dr. Wolfe said.

“Nobody should die from the medical use of Botox,” Dr. Wolfe said. “The fact that they are shows that patients don’t have a clue about these problems.”

Health authorities in Europe have done a far better job of highlighting the drugs’ dangers, Dr. Wolfe said. The authorities in Britain and Germany have required drug manufacturers to send letters to doctors warning of the dangers.

On Aug. 9, the Danish Medicines Agency published an analysis of adverse events associated with the products. The analysis found 600 problems associated with the drugs, the petition stated. Half of the serious problems associated with the drugs occurred after the toxin spread, the petition said.

The drugs’ labels in Europe have a prominent section titled “special warnings and precautions for use” that warns of the dangers of the spread of the toxin. The Danish authorities also warned that muscle weakness associated with Botox may be long-lasting, especially among children, the elderly and those suffering serious neurological problems.

Patients in Europe also receive a leaflet warning them to seek medical help if they have trouble breathing, experience dry mouth or have trouble swallowing.

The drugs’ manufacturers and others have reported to the F.D.A. 658 cases of problems associated with Botox and Myobloc, Public Citizen said.

1 則留言:

高藥師 提到...