A randomised controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation

被引:121
作者
Corris, Paul A. [1 ,2 ]
Ryan, Victoria A. [3 ]
Small, Therese [1 ]
Lordan, James [1 ]
Fisher, Andrew J. [1 ,2 ]
Meachery, Gerard [1 ]
Johnson, Gail [1 ]
Ward, Chris [2 ]
机构
[1] Freeman Rd Hosp, Inst Transplantat, Newcastle Upon Tyne NE7 7DN, Tyne & Wear, England
[2] Inst Cellular Med, Newcastle Upon Tyne NE2 4HH, Tyne & Wear, England
[3] Newcastle Univ, Inst Hlth & Soc, Newcastle Upon Tyne NE2 4HH, Tyne & Wear, England
基金
英国医学研究理事会;
关键词
LONG-TERM AZITHROMYCIN; BRONCHOALVEOLAR LAVAGE; MAINTENANCE AZITHROMYCIN; NEUTROPHILIA; RECIPIENTS; ASTHMA; RISK;
D O I
10.1136/thoraxjnl-2014-205998
中图分类号
R56 [呼吸系及胸部疾病];
学科分类号
摘要
Background We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation. Methods We compared azithromycin (250 mg alternate days, 12 weeks) with placebo. Primary outcome was FEV1 change at 12 weeks. Results 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. Outcome 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who were identified at the end of the study as having been randomised to placebo (four with rapid loss in FEV1, one withdrawn consent) had received rescue open-label azithromycin, with improvement in subsequent FEV1 at 12 weeks.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. Conclusions 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.
引用
收藏
页码:442 / U150
页数:9
相关论文
共 40 条
  • [1] [Anonymous], THESIS NEWCASTLE U U
  • [2] [Anonymous], RESP MED LECT NOTES
  • [3] [Anonymous], AM J RESP CRIT CARE
  • [4] [Anonymous], MLWIN VERSION 2 28
  • [5] Medical progress - Lung transplantation
    Arcasoy, SM
    Kotloff, RM
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1999, 340 (14) : 1081 - 1091
  • [6] Long-Term Clarithromycin Therapy in the Management of Lung Transplant Recipients
    Benden, Christian
    Boehler, Annette
    [J]. TRANSPLANTATION, 2009, 87 (10) : 1538 - 1540
  • [7] Tests of airway function in detecting and monitoring treatment of obliterative bronchiolitis after lung transplantation
    Chacon, RA
    Corris, PA
    Dark, JH
    Gibson, GJ
    [J]. JOURNAL OF HEART AND LUNG TRANSPLANTATION, 2000, 19 (03) : 263 - 269
  • [8] The Registry of the International Society for Heart and Lung Transplantation: Twenty-seventh official adult lung and heart-lung transplant report-2010
    Christie, Jason D.
    Edwards, Leah B.
    Kucheryavaya, Anna Y.
    Aurora, Paul
    Dobbels, Fabienne
    Kirk, Richard
    Rahmel, Axel O.
    Stehlik, Josef
    Hertz, Marshall I.
    [J]. JOURNAL OF HEART AND LUNG TRANSPLANTATION, 2010, 29 (10) : 1104 - 1118
  • [9] The small airways and distal lung compartment in asthma and COPD: a time for reappraisal
    Contoli, M.
    Bousquet, J.
    Fabbri, L. M.
    Magnussen, H.
    Rabe, K. F.
    Siafakas, N. M.
    Hamid, Q.
    Kraft, M.
    [J]. ALLERGY, 2010, 65 (02) : 141 - 151
  • [10] A Randomised Controlled Trial of Azithromycin Therapy in Bronchiolitis Obliterans Syndrome (BOS) Post Lung Transplantation
    Corris, P. A.
    Small, T.
    Ryan, V. A.
    Lordan, J.
    Fisher, A. J.
    Meachery, G.
    Johnson, G.
    Ward, C.
    [J]. JOURNAL OF HEART AND LUNG TRANSPLANTATION, 2012, 31 (04) : S67 - S67