美政府核准治疗狼疮新药

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.

美国食品和药物管理局50年来核准了第一种治疗自身免疫性疾病“狼疮”的新药“本利斯塔”(Benlysta)。这是美国联邦政府核准的第一种根据基因组学研发出来的药。基因组学是研究遗传因子及其功能的学科。

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·加斯金和她的丈夫结婚17年了。4年前的一天，她突然不认识她的丈夫了，还认为她的丈夫杀害了她全家。据医生介绍，这些奇怪的精神状态是狼疮性脑炎的症状，也就是她的脑组织出现炎症。

"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.”

伊娃说：“我那时焦虑，失眠，有许多不知原因的现象，把我的家人吓坏了。直到我获得适当的治疗，那些问题才开始消失。但开始时，真的非常吓人。”

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.

那种使伊娃把丈夫当作陌生人和杀人凶手的脑组织炎症很快又转到她的肺部，使她呼吸困难。狼疮是一种潜在性的致命疾病，在身体内的自卫细胞无法分辨健康细胞和细菌之际逐渐形成。结果，免疫系统开始攻击自己的身体，而不是为了保护身体免遭细菌、病毒和寄生虫的侵袭。

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，医生治疗狼疮患者各种症状，从精神失常、皮疹到关节疼痛，都是使用不同的药物，包括止痛剂、类固醇和抗疟疾药物。这种治疗方法除了效果有限，可能还有毒性。

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.

经过50年的时间，美国食品药物管理局终于首次核准了一种新药“本利斯塔”，专门治疗狼疮。

“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.

狼疮病人伊娃·加斯金说：“看到这种专门狼疮患者的新药，太让人高兴了。我们过去一直服用的那些药虽然也有帮助，但并不是专门治疗狼疮的。”

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”也标志着医药发展的一个里程碑。研发这种药物的美国“人类基因组科学公司”指出，这是第一个根据人类蛋白质基因图谱研发出来的药物。

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.

公司副总裁巴里·拉宾吉尔表示，他们经过多年的研究、发展和临床试验，终于研制出针对自身免疫系统病症的抗狼疮药物，他们为此感到自豪。

“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.”

拉宾吉尔说：“本利斯塔阻隔在出现自身免疫系统疾病时免疫系统中过度活跃的那一部分。自身免疫系统疾病更多发生在妇女和有色人种中。对这些病患、以及任何狼疮病人，本利斯塔都是一种非常重要的药物。”

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

女性罹患狼疮的机率比男性高9倍，而且在非裔、拉美裔和亚裔中偏高。但是拉宾吉尔表示，本利斯塔不是万灵丹，也不适用于所有病人。

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.”

他说：“这是向前迈进的重要一步。对于狼疮患者的治疗，还有更多的发展空间。我们希望，这只是朝研制各种先进药物治疗狼疮病患迈出的第一步。”

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

拉宾吉尔说，人类基因组科学公司很快将开始对非裔美国人狼疮患者展开大规模研究。

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.

与此同时，狼疮患者伊娃·加斯金说，她的病情现在比较稳定。另外，她知道，如果旧疾复发，可以服用本利斯塔，所以感到放心。

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