Adis drug profile - Dalbavancin

Adis drug profile - Dalbavancin
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DOI:
10.2165/00003495-200868050-00006
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发表时间:
2008-01-01
期刊:
影响因子:
11.5
通讯作者:
Keating, Gillian M.
Keating, Gillian M.
中科院分区:
医学1区
文献类型:
--
作者:
Anderson, Vanessa R.;Keating, Gillian M.

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Dalbavancin是一种半合成糖肽抗菌剂,对与复杂皮肤和皮肤结构感染(cSSSIs)相关的革兰氏阳性细菌有活性。它是一个两剂量的方案,静脉注射超过30分钟,每周一次。在两项随机对照试验中,dalbavancin(第1天1000mg和第8天500mg)对csssi成人患者的疗效进行了检验。在每项研究中,主要的疗效衡量标准是在临床可评估患者的治愈试验或随访中取得的临床成功。在一项随机、对照、双盲、多国、111期试验中,达尔巴伐辛的疗效不低于利奈唑胺,临床成功率分别为88.9%和91.2%。在一项随机、开放标签、多中心、11期试验中,达尔巴万辛的临床成功率为94%,比较药物的临床成功率为76%。成人csssi患者对Dalbavancin的耐受性一般良好,大多数不良事件为轻度或中度严重程度。
Dalbavancin is a semisynthetic glycopeptide antibacterial agent that is active against Gram-positive bacteria associated with complicated skin and skin structure infections (cSSSIs). It is administered as a two-dose regimen intravenously infused over 30 minutes once weekly.The efficacy of dalbavancin (1000 mg on day 1 and 500 mg on day 8) has been examined in two randomized controlled trials in adults with cSSSIs. In each study, the primary efficacy measure was clinical success at the test-of-cure or follow-up visit in clinically evaluable patients.In a randomized, controlled, double-blind, multinational, phase 111 trial, dalbavancin was noninferior to linezolid, with clinical success rates of 88.9% and 91.2%.In a randomized, open-label, multicentre, phase 11 trial, clinical success rates were 94% with dalbavancin and 76% with comparator antibacterials.Dalbavancin was generally well tolerated by adult patients with cSSSIs, with most adverse events being of mild or moderate severity.