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奥他万星:治疗急性细菌性皮肤和皮肤结构感染的综述。

Oritavancin: a review in acute bacterial skin and skin structure infections.

机构信息

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.

出版信息

Drugs. 2015 Nov;75(16):1891-902. doi: 10.1007/s40265-015-0478-7.

Abstract

Oritavancin (Orbactiv(®)) is a new generation lipoglycopeptide approved for use in adult patients with acute bacterial skin and skin structure infections (ABSSSI). It is administered as a single 1200 mg intravenous infusion over 3 h. In phase 3 trials in adult patients with ABSSSI, oritavancin was noninferior to vancomycin in terms of a composite outcome (cessation of spreading or reduction in the size of the baseline lesion, absence of fever and no rescue antibacterials required; primary endpoint) assessed at an US FDA-recommended early timepoint of 48-72 h after initiation of treatment. Oritavancin was also noninferior to vancomycin in terms of a ≥20 % reduction in the baseline lesion size at the early timepoint and clinical cure rate 7-14 days after the end of treatment. Oritavancin was generally well tolerated in the phase 3 trials, with most treatment-emergent adverse reactions being mild in severity. The most common adverse events occurring in oritavancin recipients were nausea, headache, vomiting, limb and subcutaneous abscesses, and diarrhoea. Oritavancin offers a number of potential advantages, including a convenient single dose treatment that may shorten or eliminate hospital stays, a reduction in healthcare resource utilization and cost, no need for dosage adjustment in patients with mild to moderate hepatic or renal impairment, no need for therapeutic drug monitoring, and elimination of compliance concerns. Therefore, oritavancin is a useful treatment option for adults with ABSSSI.

摘要

奥利万星(Orbactiv(®))是一种新型糖肽类抗生素,获批用于治疗成人急性细菌性皮肤和皮肤结构感染(ABSSSI)。该药的用法为静脉输注,单剂 1200mg,输注时间 3 小时。在 ABSSSI 成人患者的 3 期临床试验中,在治疗开始后 48-72 小时这一美国 FDA 推荐的早期时间点,奥利万星治疗组在复合终点(感染停止扩散或基线损伤缩小,无发热且无需使用抗菌药物补救治疗;主要终点)方面不劣效于万古霉素。在早期时间点,奥利万星治疗组的基线损伤缩小率≥20%,治疗结束后 7-14 天的临床治愈率与万古霉素相当。在 3 期临床试验中,奥利万星总体耐受性良好,大多数治疗期间出现的不良反应严重程度为轻度。奥利万星组最常见的不良事件为恶心、头痛、呕吐、肢体和皮下脓肿以及腹泻。奥利万星具有许多潜在优势,包括使用方便的单剂治疗,可能缩短或消除住院时间,减少医疗资源的利用和成本,无需根据患者的肝肾功能损伤程度调整剂量,无需进行治疗药物监测,消除了患者用药依从性方面的担忧。因此,奥利万星是治疗 ABSSSI 成人患者的一种有效治疗选择。

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