Lupus is a potentially fatal autoimmune disorder that impacts roughly 5 million people worldwide, and yet it still has no known cause or cure.
红斑狼疮是一种潜在的致命自身免疫疾病,世界上大约有500万人患有这种疾病,但目前病因未知,尚无治疗方法。
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,大多数疗法都伴随着很多有害的副作用。并且鉴于我们的认识不深,找到新的医学手段十分困难。
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.
过去的六十年间,只有一种治疗红斑狼疮的药物得到美国食品药品监督管理局(FDA)的批准,并且大部分人难以获取这种药。现在,一项为时三年的国际临床试验让病人看到了半个世纪以来第一丝真正的希望。
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.
这项3期试验叫做TULIP-2,随机选取180名红斑狼疮患者,测试一种叫做anirolumab的药物,让他们每4周服用300毫克药物,持续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名红斑狼疮患者则服用安慰剂。作者说与安慰剂相比,anifrolumab在统计学上显著降低了红斑狼疮疾病活动度,具有重大临床意义。
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,这种药物不仅减少了患者相关器官的自身免疫活动,还减少了新症状的爆发,包括发烧、关节疼痛、疲劳和皮疹等,减少了患者对类固醇的使用需求。
"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.
梅内·潘加洛斯,R&D生物制药的执行副总裁说,“现在有很多强有力的证据证明了anifrolumab的疗效,我们期待尽快将这种潜在的新药带给系统性红斑狼疮患者。”
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