紅斑狼瘡有重大臨床發(fā)現(xiàn)

Lupus is a potentially fatal autoimmune disorder that impacts roughly 5 million people worldwide, and yet it still has no known cause or cure.

紅斑狼瘡是一種潛在的致命自身免疫疾病，世界上大約有500萬(wàn)人患有這種疾病，但目前病因未知，尚無(wú)治療方法。

Today, most treatments come with a whole bunch of adverse side effects, and given how little we know, finding new avenues for medicine has proved extremely difficult.

今天，大多數(shù)療法都伴隨著很多有害的副作用。并且鑒于我們的認(rèn)識(shí)不深，找到新的醫(yī)學(xué)手段十分困難。

In the past six decades, only one drug for lupus has been approved by the United States Food and Drug Association and it's still unavailable to many. Now, an international three-year clinical trial offers the first real hope for patients in half a century.

過(guò)去的六十年間，只有一種治療紅斑狼瘡的藥物得到美國(guó)食品藥品監(jiān)督管理局(FDA)的批準(zhǔn)，并且大部分人難以獲取這種藥。現(xiàn)在，一項(xiàng)為時(shí)三年的國(guó)際臨床試驗(yàn)讓病人看到了半個(gè)世紀(jì)以來(lái)第一絲真正的希望。

The Phase 3 trial, called TULIP-2, tested a drug called anifrolumab on a randomised selection of 180 people with lupus, giving them 300 mg every four weeks for 48 weeks.

這項(xiàng)3期試驗(yàn)叫做TULIP-2，隨機(jī)選取180名紅斑狼瘡患者，測(cè)試一種叫做anirolumab的藥物，讓他們每4周服用300毫克藥物，持續(xù)48周。

Compared to the placebo, which was given to a further 182 participants who also had lupus, the authors say anifrolumab produced a statistically significant and clinically-meaningful reduction in the disease.

另外182名紅斑狼瘡患者則服用安慰劑。作者說(shuō)與安慰劑相比，anifrolumab在統(tǒng)計(jì)學(xué)上顯著降低了紅斑狼瘡疾病活動(dòng)度，具有重大臨床意義。

After 52 weeks, not only only did this drug reduce autoimmune activity in the relevant organs of many of the treated patients, it also reduced the rate of flare-ups - which include fever, painful joints, fatigue and rashes - and lessened the need for steroids.

52周后，這種藥物不僅減少了患者相關(guān)器官的自身免疫活動(dòng)，還減少了新癥狀的爆發(fā)，包括發(fā)燒、關(guān)節(jié)疼痛、疲勞和皮疹等，減少了患者對(duì)類固醇的使用需求。

"There is now a strong body of evidence demonstrating the benefit of anifrolumab, and we look forward to bringing this potential new medicine to patients with systemic lupus erythematosus as soon as possible," says Mene Pangalos, the executive vice president of BioPharmaceutical R&D.

梅內(nèi)·潘加洛斯，R&D生物制藥的執(zhí)行副總裁說(shuō)，“現(xiàn)在有很多強(qiáng)有力的證據(jù)證明了anifrolumab的療效，我們期待盡快將這種潛在的新藥帶給系統(tǒng)性紅斑狼瘡患者。”