 本/期/解/讀 阿奇霉素對需要住院治療的AECOPD患者的療效（BACE）分析：一項(xiàng)多中心、隨機(jī),、雙盲,、安慰劑對照試驗(yàn) Azithromycin during Acute COPD Exacerbations Requiring Hospitalization (BACE): a Multicentre, Randomized, Double‐blind, Placebo‐controlled Trial 關(guān)鍵詞 大環(huán)內(nèi)脂類，復(fù)合物,，事件時(shí)間,，治療失敗，再入院 作者： Kristina Vermeersch, et al. 翻譯： 北京協(xié)和醫(yī)院呼吸內(nèi)科 孫宇新 黃 慧 文獻(xiàn)來源： AJRCCM. 2019 May 3. DOI: 10.1164/rccm.201901-0094OC  背景及目的 阿奇霉素可預(yù)防COPD患者發(fā)生急性加重（AECOPD）,，但其對需住院治療的AECOPD患者的療效尚不明確,。本研究在患者初入院時(shí)即在標(biāo)準(zhǔn)治療基礎(chǔ)上加用小劑量的阿奇霉素3月，來探究阿奇霉素是否可減少AECOPD治療失?。═F）的發(fā)生,。 方 法 本研究是研究者發(fā)起的，多中心,、隨機(jī),、雙盲、安慰劑對照試驗(yàn)中,，納入吸煙≥10包年且前一年急性加重次數(shù)≥1次的AECOPD住院患者,，在入院后48小時(shí)內(nèi)被隨機(jī)（1:1）分為阿奇霉素組或安慰劑組。在全身激素聯(lián)合抗生素的AECOPD標(biāo)準(zhǔn)治療基礎(chǔ)上加用研究藥物（負(fù)荷劑量500mg/d×3d,，維持劑量250mg Qod×3m）,。隨訪6個(gè)月，主要終點(diǎn)是3月內(nèi)TF事件的發(fā)生率（TF-治療失敗是指：因COPD需全身激素和/或抗生素加強(qiáng)化治療(TI),、需升級治療級別,、需再入院治療（SH），以及全因死亡率,。 結(jié) 果 共篩選出301例患者,，隨機(jī)分為阿奇霉素組(147例)和安慰劑組(154例)。3個(gè)月內(nèi)阿奇霉素組TF率為49%,，安慰劑組TF率為60% 【HR=0.73,；95%CI為（0.53-1.01）；p=0.0526】,。比較3個(gè)月內(nèi)阿奇霉素組與安慰劑組的TI率,、SH率和死亡率分別為47% vs 60%(p=0.0272),、13% vs 28%(p=0.0024)和2% vs 4%(p=0.5075)。停藥6月后阿奇霉素相關(guān)的該療效不復(fù)存在,。 結(jié) 論 對于需住院治療的感染性AECOPD患者,，連續(xù)3月的低劑量阿奇霉素維持治療可顯著降低AECOPD高危期TF的發(fā)生；且為維持該療效,，建議適當(dāng)延長阿奇霉素使用時(shí)間,。 原文摘要 Rationale Azithromycin prevents acute exacerbations in COPD (AECOPD); however, its value in the treatment of AECOPD requiring hospitalization is yet to be defined. Objective We investigated whether a 3-month intervention with low-dose azithromycin could decrease treatment failure (TF) when initiated at hospital admission and added to standard care. Methods In an investigator-initiated, multi-centre, randomized, double·blind, placebo-controlled trial, patients hospitalized for an AECOPD, with a smoking history of ≥ 10 pack-years and ≥ 1 exacerbation in the previous year, were randomized (1:1) within 48-hours of admission to azithromycin or placebo. The study drug (500mg/day for 3 days) was administered on top of a standardized acute treatment of systemic corticosteroids and antibiotics, and subsequently continued for 3 months (3m) (250mg/2days). Patients were followed-up for 6m thereafter. Time-to-first event analyses evaluated the TF rate within 3m as a novel primary endpoint in the intention-to-treat population, with TF defined as the composite of treatment intensification with systemic corticosteroids and/or antibiotics (TI), step-up in hospital care or readmission for respiratory reasons (SH) or all‐cause mortality. Main results 301 patients were randomized to azithromycin (n=147) or placebo (n=154). The TF rate within 3m was 49% in the azithromycin and 60% in the placebo group (HR=0.73; 95%CI 0.53-1.01; p=0.0526). TI, SH and mortality rates within 3m were 47% vs 60% (p=0.0272), 13% vs 28% (p=0.0024) and 2% vs 4% (p=0.5075), respectively. Clinical benefits were lost 6m after withdrawal. Conclusions 3m of azithromycin for infectious AECOPD requiring hospitalization may significantly reduce TF during the highest risk period. Prolonged treatment seems needed to maintain clinical benefits.  文字來源：孫宇新 黃 慧 |
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