Budesonide/Formoterol for Bronchiolitis Obliterans after Hematopoietic Stem Cell Transplantation

被引：84

作者：

Bergeron, Anne ^{[1
,4
]}

Chevret, Sylvie ^{[2
,4
]}

Chagnon, Karine ^{[1
,5
]}

Godet, Cendrine ^{[6
]}

Bergot, Emmanuel ^{[8
]}

de Latour, Regis Peffault ^{[3
]}

Dominique, Stephane ^{[10
]}

de Revel, Thierry ^{[11
]}

Juvin, Karine ^{[12
]}

Maillard, Natacha ^{[7
]}

Reman, Oumedaly ^{[9
]}

Contentin, Nathalie ^{[13
]}

Robin, Marie ^{[3
]}

Buzyn, Agnes ^{[14
]}

Socie, Gerard ^{[3
]}

Tazi, Abdellatif ^{[1
,4
]}

机构：

[1] Univ Paris Diderot, Sorbonne Paris Cite, Hop St Louis, AP HP,Serv Pneumol, Paris, France

[2] Univ Paris Diderot, Sorbonne Paris Cite, Hop St Louis, AP HP,Serv Biostat & Informat Med, Paris, France

[3] Univ Paris Diderot, Sorbonne Paris Cite, Hop St Louis, AP HP,Hematol Greffe, Paris, France

[4] Univ Paris Diderot, Sorbonne Paris Cite, Biostat & Clin Epidemiol Res Team, Paris, France

[5] Univ Montreal, Hop Maisonneuve Rosemont, Serv Pneumol, Montreal, PQ, Canada

[6] CHU La Miletrie, Serv Malad Infect & Med Interne, Poitiers, France

[7] CHU La Miletrie, Serv Hematol, Poitiers, France

[8] CHU Caen, Serv Pneumol & Cancerol Thorac, F-14000 Caen, France

[9] CHU Caen, Serv Hematol, F-14000 Caen, France

[10] Hop Charles Nicolle, Dept Pneumol, Rouen, France

[11] Hop Instruct Armees Percy, Serv Hematol, Clamart, France

[12] Hop Europeen Georges Pompidou, AP HP, Serv Pneumol, Paris, France

[13] Ctr Henri Becquerel, Dept Hematol, F-76038 Rouen, France

[14] Hop St Antoine, AP HP, Serv Hematol, F-75571 Paris, France

来源：

AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE | 2015年 / 191卷 / 11期

关键词：

obstructive lung disease; inhaled long-acting bronchodilator and steroids; lung chronic graft-versus-host disease; VERSUS-HOST-DISEASE; CHRONIC GVHD; BONE-MARROW; DIAGNOSIS; THERAPY; TRIALS; RISK; SCT;

D O I：

10.1164/rccm.201410-1818OC

中图分类号：

R4 [临床医学];

学科分类号：

100218 [急诊医学];

摘要：

Rationale: Systemic steroids are the standard treatment for bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic stem cell transplantation (HSCT) despite their poor efficacy and disabling side effects. Objectives: To evaluate the effectiveness and tolerance of budesonide/formoterol as an alternative treatment for BOS after HSCT. Methods: In this randomized, double-blind, placebo-controlled study, We randomly assigned 32 HSCT recipients with mild/severe BOS to receive budesonide/formoterol or placebo for 6 months. The primary outcome was the change in the FEV1 after 1 month of treatment (M1) compared with the baseline value. Patients were unblinded at M1 if there was no improvement in the FEV1. Those who had initially received placebo were switched to budesonide/formoterol. Intention-to-treat analysis was performed to assess the primary outcome. Additional analyses took scheduled treatment contamination into account. Measurements and Main Results: At M1, the median FEV1 increased by 260 ml in the budesonide/formoterol arm compared with 5 ml in the placebo arm (P = 0.012). The median increases in the FEV1 at M1 relative to the baseline value for the treated and placebo groups were 13 and 0%, respectively (P = 0.019). Twenty-five patients received budesonide/formoterol during the study. The median difference in the FEV1 between the baseline and after 1 month of treatment for these patients was +240 ml (P = 0.0001). The effect of budesonide/formoterol on the FEVI was maintained in the 13 patients who completed 6 months of treatment. Conclusions: Budesonide/formoterol administration led to a significant improvement in the FEV1 in patients with mild/severe BOS after allogeneic HSCT.

引用

页码：1242 / 1249

页数：8

共 27 条

[1]

[Anonymous], RESP MED

[2]

[Anonymous], COCHRANE DATABASE SY

[3]

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