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肺移植后阿奇霉素预防治疗:一项随机对照试验的事后分析。

Prophylactic Azithromycin Therapy After Lung Transplantation: Post hoc Analysis of a Randomized Controlled Trial.

机构信息

Lung Transplant Unit, Division of Respiratory Diseases, Department of Clinical and Experimental Medicine, KULeuven and UZ Leuven, Leuven, Belgium.

Department of Thoracic Surgery, KULeuven and UZ Leuven, Leuven, Belgium.

出版信息

Am J Transplant. 2016 Jan;16(1):254-61. doi: 10.1111/ajt.13417. Epub 2015 Aug 4.

Abstract

Prophylactic azithromycin treatment has been demonstrated to improve freedom from bronchiolitis obliterans syndrome (BOS) 2 years after lung transplantation (LTx). In the current study, we re-evaluated the long-term effects of this prophylactic approach in view of the updated classification system for chronic lung allograft dysfunction (CLAD). A retrospective, intention-to-treat analysis of a randomized controlled trial comparing prophylactic treatment with placebo (n = 43) versus azithromycin (n = 40) after LTx was performed. Graft dysfunction (CLAD), graft loss (retransplantation, mortality), evolution of pulmonary function and functional exercise capacity were analyzed 7 years after inclusion of the last study subject. Following LTx, 22/43 (51%) patients of the placebo group and 11/40 (28%) patients of the azithromycin group ever developed CLAD (p = 0.043). CLAD-free survival was significantly longer in the azithromycin group (p = 0.024). No difference was present in proportion of obstructive versus restrictive CLAD between both groups. Graft loss was similar in both groups: 23/43 (53%) versus 16/40 (40%) patients (p = 0.27). Long-term pulmonary function and functional exercise capacity were significantly better in the azithromycin group (p < 0.05). Prophylactic azithromycin therapy reduces long-term CLAD prevalence and improves CLAD-free survival, pulmonary function, and functional exercise capacity after LTx.

摘要

预防性阿奇霉素治疗已被证明可改善肺移植(LTx)后 2 年支气管闭塞性细支气管炎综合征(BOS)的无病生存率。在目前的研究中,鉴于慢性肺移植物功能障碍(CLAD)的更新分类系统,我们重新评估了这种预防性方法的长期效果。对一项比较预防性治疗与安慰剂(n=43)与阿奇霉素(n=40)的随机对照试验进行了回顾性、意向性治疗分析。在纳入最后一名研究对象 7 年后,分析了移植物功能障碍(CLAD)、移植物丢失(再次移植、死亡)、肺功能和功能运动能力的演变。LTx 后,安慰剂组的 22/43(51%)例患者和阿奇霉素组的 11/40(28%)例患者曾发生 CLAD(p=0.043)。阿奇霉素组 CLAD 无生存时间显著延长(p=0.024)。两组间阻塞性与限制性 CLAD 的比例无差异。两组间的移植物丢失相似:安慰剂组 23/43(53%)与阿奇霉素组 16/40(40%)患者(p=0.27)。阿奇霉素组长期肺功能和功能运动能力明显更好(p<0.05)。LTx 后预防性阿奇霉素治疗可降低长期 CLAD 发生率,并提高 CLAD 无生存时间、肺功能和功能运动能力。

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