A randomised controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation.
A randomised controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation.
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DOI：
10.1136/thoraxjnl-2014-205998
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发表时间：
2015-05
期刊：
影响因子：
10
通讯作者：
Ward C
中科院分区：
文献类型：
--
作者：
Corris PA;Ryan VA;Small T;Lordan J;Fisher AJ;Meachery G;Johnson G;Ward C
我们对肺移植后闭塞性毛细支气管炎综合征(BOS)患者进行了阿奇霉素治疗的安慰剂对照试验。我们将阿奇霉素(250 mg隔日，12 周)与安慰剂进行了比较。主要结果是12 周时第一秒用力呼气量的变化。48名患者被随机分为两组(阿奇霉素25例，安慰剂23例)。在随机抽样后，有两人没有BOS，这是确定的。46例患者被分析为意向治疗(ITT)，有33个“完成者”。ITT分析包括在研究结束后使用开放标签阿奇霉素治疗的安慰剂患者。ITT分析(n=46,177个观察)估计治疗(阿奇霉素和安慰剂)之间FEV1的平均差异为0.035 L，95%CI为−0.112 L和0.182 L(p=0.6)。在研究结束时被确认为随机服用安慰剂的5名患者(4名FEV1迅速消失，1名撤回同意)接受了救援开放标签阿奇霉素，随后的FEV1在12 周有所改善。研究完成显示，治疗组(阿奇霉素和安慰剂)之间的FEV1估计平均差值为0.278 L，平均差值的95%可信区间为0.170 L和0.386 L(p=<；0.001)。在阿奇霉素组的23名ITT患者中，有9名患者的FEV1FEV1较基线增加10%。在服用安慰剂的患者中，没有患者在服用安慰剂时第一秒用力肺活量≥较基线增加10%(p=0.002)。七个严重的不良事件，三个阿奇霉素，四个安慰剂组，被认为与研究药物无关。阿奇霉素治疗改善了BOS患者的FEV1，似乎优于安慰剂。这项研究为在BOS中启动阿奇霉素治疗的临床实践提供了证据。欧盟-CTR2006-000485-36/GB。
We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation. We compared azithromycin (250 mg alternate days, 12 weeks) with placebo. Primary outcome was FEV1 change at 12 weeks. 48 patients were randomised; (25 azithromycin, 23 placebo). It was established, post randomisation that two did not have BOS. 46 patients were analysed as intention to treat (ITT) with 33 ‘Completers’. ITT analysis included placebo patients treated with open-label azithromycin after study withdrawal. The ITT analysis (n=46, 177 observations) estimated mean difference in FEV1 between treatments (azithromycin minus placebo) was 0.035 L, with a 95% CI of −0.112 L to 0.182 L (p=0.6). Five withdrawals, who were identified at the end of the study as having been randomised to placebo (four with rapid loss in FEV1, one withdrawn consent) had received rescue open-label azithromycin, with improvement in subsequent FEV1 at 12 weeks. Study Completers showed an estimated mean difference in FEV1 between treatment groups (azithromycin minus placebo) of 0.278 L, with 95% CI for the mean difference: 0.170 L to 0.386 L (p=<0.001). Nine of 23 ITT patients in the azithromycin group had ≥10% gain in FEV1 from baseline. No patients in the placebo group had ≥10% gain in FEV1 from baseline while on placebo (p=0.002). Seven serious adverse events, three azithromycin, four in the placebo group, were deemed unrelated to study medication. Azithromycin therapy improves FEV1 in patients with BOS and appears superior to placebo. This study strengthens evidence for clinical practice of initiating azithromycin therapy in BOS. EU-CTR, 2006-000485-36/GB.
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影响因子：
10
作者：
KELLY, C;WARD, C;WALTERS, EH
通讯作者：
WALTERS, EH
影响因子：
2
作者：
Senn, Stephen
通讯作者：
Senn, Stephen
影响因子：
2.2
作者：
Porhownik, Nancy R.;Batobara, Wael;Bshouty, Zoheir
通讯作者：
Bshouty, Zoheir
DOI：
10.1136/bmj.c332
发表时间：
2010-03-23
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Schulz KF;Altman DG;Moher D;CONSORT Group
通讯作者：
CONSORT Group
影响因子：
24.3
作者：
Forrest, IA;Murphy, DM;Corris, PA
通讯作者：
Corris, PA