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翻译丨唐文瑞
审核丨臧金成 陈志锦
美国食品药物管理局批准德拉沙星(Baxdela)用于皮肤感染
美国食品和药物管理局(FDA)最近批准了一种名为德拉沙星(Baxdela，Melinta疗法)的抗生素，用于治疗严重或危及生命的感染，包括特别难以治疗的感染。
德拉沙星，属于氟喹诺酮类，明确可应用于由某些革兰氏阴性菌和革兰氏阳性菌引起的急性细菌性皮肤和皮肤组织感染(ABSSSIs) ，包括MRSA引起的感染。但FDA警告说，为了遏制耐药细菌的发展，临床医生应该只在感染被证实或强烈怀疑是细菌感染的时候才用德拉沙星进行治疗。
对于已知对氟喹诺酮类过敏的患者来说，德拉沙星是禁用的。
这种新药以片剂或静脉注射剂施用，在其标签上有一个方框警告。它提示，德拉沙星等氟喹诺酮类药物会导致残疾和潜在不可逆的不良事件，比如肌腱炎肌腱破裂、周围神经病变和中枢神经系统等影响。如果患者出现了上述的不良事件，临床医生应该停止使用德拉沙星。也应该避免已知重性肌无力史的病人使用德拉沙星，喹诺酮类药物可能会该病的病情。
FDA根据两项随机临床试验，确定德拉沙星是安全有效的，实验在包括大约1500名有急性细菌性皮肤和皮肤组织感染的成年人中进行，将新药与万古霉素和氨曲南联合静脉注射相比较；在一项研究中，德拉沙星从开始到结束都是静脉注射，而在另一项研究中，患者开始静脉注射德拉沙星，然后转为口服。在这两项研究中，48至72小时内，至少20%的病人中，德拉沙星与万古霉素和氨曲南联合使用在收缩皮肤损害方面的效果一样有效。
德拉沙星临床试验中最常见的不良反应是恶心、腹泻、头痛、转氨酶升高和呕吐。
FDA加速通过了德拉沙星的审核，并将其指定为合格的感染病药品。
关于德拉沙星的更多信息，请访问FDA网站。
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FDA Approves Delafloxacin (Baxdela) for Skin Infections
The US Food and Drug Administration (FDA) today approved an antibiotic called delafloxacin (Baxdela, Melinta Therapeutics) to treat serious or life-threatening infections, including one that's particularly tough to beat.
A fluoroquinolone, delafloxacin is specifically indicated in adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by certain gram-positive and gram-negative pathogens, including methicillin-resistant Staphylococcus aureus. The FDA cautions that, for the sake of curbing the development of drug-resistant bacteria, clinicians should order delafloxacin only when an infection is proven or strongly suspected to be bacterial in nature.
Delafloxacin is contraindicated for patients with known hypersensitivity to fluoroquinolones.
The new drug, administered as a tablet or through intravenous infusion, comes with a boxed warning on its label. It states that fluoroquinolones such as delafloxacin are associated with disabling and potentially irreversible adverse events such as tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Clinicians should discontinue the use of delafloxacin if patients experience these adverse events. They also should avoid delafloxacin in patients with a known history of myasthenia gravis, which may be exacerbated by fluoroquinolones.
The FDA determined that delafloxacin was safe and effective based on two randomized clinical trials involving roughly 1500 adults with ABSSSIs that compared the new drug with an intravenous combination of vancomycin plus aztreonam. In one study, delafloxacin was administered intravenously from start to finish, while in the other, patients started out on intravenous delafloxacin and then switched to the tablet version. In both studies, delafloxacin proved just as effective as the combination of vancomycin and aztreonam in shrinking skin lesions by at least 20% within 48 to 72 hours.
The most common adverse events seen in the clinical trials were nausea, diarrhea, headache, higher levels of transaminase, and vomiting.
The FDA had designated delafloxacin as a qualified infectious-disease product, entitling it to an expedited review.
More information about delafloxacin is available on the FDA website .
来源：http://www.medscape.com/viewarticle/881827
图文丨那颜
审稿丨陈文森 卢先雷
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发表于 2017-6-25 21:53:47