A retrospective TBNET assessment of linezolid safety, tolerability and efficacy in multidrug-resistant tuberculosis
A retrospective TBNET assessment of linezolid safety, tolerability and efficacy in multidrug-resistant tuberculosis
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DOI：
10.1183/09031936.00009509
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发表时间：
2009-08-01
影响因子：
24.3
通讯作者：
Lange, C.
中科院分区：
文献类型：
--
作者：
Migliori, G. B.;Eker, B.;Lange, C.
利奈唑胺用于治疗耐多药/广泛耐药结核病（TB）患者，尽管缺乏关于其安全性、耐受性和有效性的临床数据。我们在四个欧洲国家进行了一项回顾性、非随机、非盲观察性研究，评估了利奈唑胺在耐多药/广泛耐药结核病治疗中的安全性和耐受性。疗效评价比较了45例利奈唑胺治疗组和110例利奈唑胺未治疗组的终点。在195名耐多药/广泛耐药结核病患者中，85人接受了利奈唑胺平均221天的治疗。其中，85例患者中有35例（41.2%）出现了利奈唑胺引起的主要副作用（贫血、血小板减少症和/或多发性神经病变），27例（77%）患者需要停药。大多数副作用发生在治疗60天后。每日两次给药比每日一次给药产生更多的主要副作用（p=0.0004），没有发现疗效差异。接受/不接受利奈唑胺治疗的患者的结果相似（p=0.8），尽管接受利奈唑胺治疗的患者有更多的一线（p=0.002）和二线（p=0.02）耐药，并且以前的治疗方案数量较多（4.5比2.3;p=0.07）。在个体化多药方案中添加利奈唑胺600毫克，可提高细菌转化的机会，仅在最复杂的耐多药/广泛耐药结核病病例中提供更好的治疗成功机会。它的安全性不能保证在有其他更安全的替代品的情况下使用。
Linezolid is used to treat patients with multidrug-resistant (MDR)/extensively drug-resistant (XDR)-tuberculosis (TB) cases, although clinical data on its safety, tolerability and efficacy are lacking.We performed a retrospective, nonrandomised, unblinded observational study evaluating the safety and tolerability of linezolid at 600 mg q.d. or b.i.d. in MDR/XDR-TB treatment in four European countries. Efficacy evaluation compared end-points of 45 linezolid-treated against 110 linezolid-nontreated cases.Out of 195 MDR/XDR-TB patients, 85 were treated with linezolid for a mean of 221 days. Of these, 35 (41.2%) out of 85 experienced major side-effects attributed to linezolid (anaemia, thrombocytopenia and/or polyneuropathy), requiring discontinuation in 27 (77%) cases. Most side-effects occurred after 60 days of treatment. Twice-daily administration produced more major side-effects than once-daily dosing (p=0.0004), with no difference in efficacy found. Outcomes were similar in patients treated with/without linezolid (p=0.8), although linezolid-treated cases had more first-line (p=0.002) and second-line (p=0.02) drug resistance and a higher number of previous treatment regimens (4.5 versus 2.3; p=0.07).Linezolid 600 mg q.d. added to an individualised multidrug regimen may improve the chance of bacteriological conversion, providing a better chance of treatment success in only the most complicated MDR/XDR-TB cases. Its safety profile does not warrant use in cases for which there are other, safer, alternatives.