美政府覈准治療狼瘡新藥

The first new drug to treat lupus in a half century - and the first ever specifically developed to treat the autoimmune disorder - is heading to market in the United States. Under the trade name Benlysta, it is the first federally-approved drug to be derived from genomics, the study of genes and their functions.

美國食品和藥物管理局50年來覈准了第一種治療自身免疫性疾病“狼瘡”的新藥“本利斯塔”(Benlysta)。這是美國聯邦政府覈准的第一種根據基因組學研發出來的藥。基因組學是研究遺傳因子及其功能的學科。

Eva Gaskin has been married for 17 years. But one day four years ago, she suddenly was unable to recognize her husband, and became convinced that he had killed her family. Doctors said these strange mental episodes were symptoms of lupus cerebritis, which caused inflammation in her brain tissues.

伊娃·加斯金和她的丈夫結婚17年了。4年前的一天，她突然不認識她的丈夫了，還認爲她的丈夫殺害了她全家。據醫生介紹，這些奇怪的精神狀態是狼瘡性腦炎的症狀，也就是她的腦組織出現炎症。

"I had anxiety. I had insomnia," says Gaskin. "I had lots of things going on that we really did not understand and that was very frightening for my family until I got on the proper treatment, and those kinds of issues started to subside. But at first it was very scary.”

伊娃說：“我那時焦慮，失眠，有許多不知原因的現象，把我的家人嚇壞了。直到我獲得適當的治療，那些問題纔開始消失。但開始時，真的非常嚇人。”

The brain inflammation that made Eva see her husband as a stranger and a killer soon moved to her lungs, and her breathing became painful. Lupus is a potentially fatal disease. It develops when the body's protector cells stop differentiating between healthy cells and bacteria. As a result, the immune system starts attacking its own body instead of protecting it from bacteria, viruses and parasites.

那種使伊娃把丈夫當作陌生人和殺人兇手的腦組織炎症很快又轉到她的肺部，使她呼吸困難。狼瘡是一種潛在性的致命疾病，在身體內的自衛細胞無法分辨健康細胞和細菌之際逐漸形成。結果，免疫系統開始攻擊自己的身體，而不是爲了保護身體免遭細菌、病毒和寄生蟲的侵襲。

Until now, lupus sufferers have treated their varied symptoms - from mental disorders to skin rashes and painful joints - with a combination of drugs, including painkillers, steroids and anti-malarial medicines. Aside from being insufficient, these treatments have also carried the risk of toxicity.

迄今，醫生治療狼瘡患者各種症狀，從精神失常、皮疹到關節疼痛，都是使用不同的藥物，包括止痛劑、類固醇和抗瘧疾藥物。這種治療方法除了效果有限，可能還有毒性。

But now, for the first time in 50 years, the U.S. Food and Drug Adminsitration has approved a new drug specifically to treat lupus.

經過50年的時間，美國食品藥物管理局終於首次覈准了一種新藥“本利斯塔”，專門治療狼瘡。“It’s so exciting to see that a drug is coming out that targeted specifically for lupus patients because in the past we have been taking drugs that have been found helpful but not specifically for us,” says Gaskin.

狼瘡病人伊娃·加斯金說：“看到這種專門狼瘡患者的新藥，太讓人高興了。我們過去一直服用的那些藥雖然也有幫助，但並不是專門治療狼瘡的。”

Benlysta also represents a medical milestone. Its American developer, Human Genome Sciences, calls it the first drug derived from the genetic mapping of human proteins.

“本利斯塔”也標誌着醫藥發展的一個里程碑。研發這種藥物的美國“人類基因組科學公司”指出，這是第一個根據人類蛋白質基因圖譜研發出來的藥物。

Company vice-president Barry Labinger says the firm is proud of the fact that after so many years of research, development, and clinical trials, they finally have an anti-lupus drug that directly targets the autoimmune disorder.

公司副總裁巴里·拉賓吉爾表示，他們經過多年的研究、發展和臨牀試驗，終於研製出針對自身免疫系統病症的抗狼瘡藥物，他們爲此感到自豪。

“Benlysta works on the immune system by blocking a part of the immune system that becomes over-active in the presence of autoimmune disease," says Labinger. "Autoimmnue disease in particular tends to happen far more frequently in women and people of color and so Benlysta turns out to be an important drug for those patients, as well as a broader population for anybody who has lupus.”

拉賓吉爾說：“本利斯塔阻隔在出現自身免疫系統疾病時免疫系統中過度活躍的那一部分。自身免疫系統疾病更多發生在婦女和有色人種中。對這些病患、以及任何狼瘡病人，本利斯塔都是一種非常重要的藥物。”

Lupus affects women nine times more than it does men. And it occurs disproportionately in African-American, Hispanic and Asian populations.

女性罹患狼瘡的機率比男性高9倍，而且在非裔、拉美裔和亞裔中偏高。但是拉賓吉爾表示，本利斯塔不是萬靈丹，也不適用於所有病人。

Labinger says Benlysta is not a miracle drug, and it's not for everyone. “It is a very important step forward. There is room for more than one treatment for lupus patients over time and we hope that this is a first step towards a number of advances for patients with lupus.”

他說：“這是向前邁進的重要一步。對於狼瘡患者的治療，還有更多的發展空間。我們希望，這只是朝研製各種先進藥物治療狼瘡病患邁出的第一步。”

Human Genome Sciences will soon begin a large study of African-American lupus patients.

拉賓吉爾說，人類基因組科學公司很快將開始對非裔美國人狼瘡患者展開大規模研究。

In the meantime, lupus sufferer Eva Gaskin says her condition is stable for now, but she's relieved she has Benlysta to fall back on if her lupus should flare up again.

與此同時，狼瘡患者伊娃·加斯金說，她的病情現在比較穩定。另外，她知道，如果舊疾復發，可以服用本利斯塔，所以感到放心。