Azithromycin for Prevention of Exacerbations of COPD

被引：894

作者：

Albert, Richard K. ^{[1
]}

Connett, John ^{[3
]}

Bailey, William C. ^{[6
]}

Casaburi, Richard ^{[8
]}

Cooper, J. Allen D., Jr. ^{[6
]}

Criner, Gerard J. ^{[9
]}

Curtis, Jeffrey L. ^{[10
,11
]}

Dransfield, Mark T. ^{[6
,7
]}

Han, MeiLan K. ^{[10
]}

Lazarus, Stephen C. ^{[12
,13
]}

Make, Barry

Marchetti, Nathaniel ^{[9
]}

Martinez, Fernando J. ^{[10
]}

Madinger, Nancy E. ^{[2
]}

McEvoy, Charlene ^{[14
]}

Niewoehner, Dennis E. ^{[4
,5
]}

Porsasz, Janos ^{[8
]}

Price, Connie S. ^{[1
,2
]}

Reilly, John ^{[4
,5
]}

Scanlon, Paul D. ^{[15
]}

Sciurba, Frank C. ^{[16
]}

Scharf, Steven M. ^{[17
]}

Washko, George R. ^{[18
]}

Woodruff, Prescott G. ^{[12
,13
]}

Anthonisen, Nicholas R. ^{[19
]}

机构：

[1] Univ Colorado Denver, Hlth Sci Ctr, Dept Med, Denver, CO USA

[2] Univ Colorado Denver, Dept Med, Div Infect Dis, Denver, CO USA

[3] Univ Minnesota, Sch Publ Hlth, Div Biostat, Minneapolis, MN 55455 USA

[4] Univ Minnesota, Dept Med, Minneapolis, MN 55455 USA

[5] Minneapolis Vet Affairs VA Med Ctr, Med Serv, Div Pulm Med, Minneapolis, MN USA

[6] Univ Alabama Birmingham, Dept Med, Div Pulm Allergy & Crit Care Med, Birmingham, AL 35294 USA

[7] Birmingham VA Med Ctr, Pulm Sect, Birmingham, AL USA

[8] Harbor UCLA Med Ctr, Dept Med, Div Resp & Crit Care Physiol & Med, Torrance, CA 90509 USA

[9] Temple Univ, Div Pulm & Crit Care Med, Dept Med, Philadelphia, PA 19122 USA

[10] Univ Michigan, Dept Med, Div Pulm & Crit Care Med, Ann Arbor, MI 48109 USA

[11] Ann Arbor VA Med Ctr, Div Pulm & Crit Care Med, Ann Arbor, MI USA

[12] Univ Calif San Francisco, Dept Med, Div Pulm & Crit Care Med, San Francisco, CA USA

[13] Univ Calif San Francisco, Inst Cardiovasc Res, San Francisco, CA USA

[14] HealthPartners Res Fdn, Pulm Crit Care & Sleep Dept, St Paul, MN USA

[15] Mayo Clin, Div Pulm & Crit Care Med, Rochester, MN USA

[16] Univ Pittsburgh, Dept Med, Div Pulm & Crit Care Med, Pittsburgh, PA USA

[17] Univ Maryland, Dept Med, Div Pulm & Crit Care, Baltimore, MD 21201 USA

[18] Brigham & Womens Hosp, Dept Med, Div Pulm & Crit Care Med, Boston, MA 02115 USA

[19] Resp Hosp, Winnipeg, MB, Canada

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2011年 / 365卷 / 08期

基金：

美国国家卫生研究院;

关键词：

OBSTRUCTIVE PULMONARY-DISEASE; FLUTICASONE PROPIONATE; HEALTH OUTCOMES; SALMETEROL; TIOTROPIUM; ERYTHROMYCIN; MANAGEMENT; FREQUENCY; EFFICACY; PLACEBO;

D O I：

10.1056/NEJMoa1104623

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Acute exacerbations adversely affect patients with chronic obstructive pulmonary disease (COPD). Macrolide antibiotics benefit patients with a variety of inflammatory airway diseases. Methods We performed a randomized trial to determine whether azithromycin decreased the frequency of exacerbations in participants with COPD who had an increased risk of exacerbations but no hearing impairment, resting tachycardia, or apparent risk of prolongation of the corrected QT interval. Results A total of 1577 subjects were screened; 1142 (72%) were randomly assigned to receive azithromycin, at a dose of 250 mg daily (570 participants), or placebo (572 participants) for 1 year in addition to their usual care. The rate of 1-year follow-up was 89% in the azithromycin group and 90% in the placebo group. The median time to the first exacerbation was 266 days (95% confidence interval [CI], 227 to 313) among participants receiving azithromycin, as compared with 174 days (95% CI, 143 to 215) among participants receiving placebo (P < 0.001). The frequency of exacerbations was 1.48 exacerbations per patient-year in the azithromycin group, as compared with 1.83 per patient-year in the placebo group (P = 0.01), and the hazard ratio for having an acute exacerbation of COPD per patient-year in the azithromycin group was 0.73 (95% CI, 0.63 to 0.84; P< 0.001). The scores on the St. George's Respiratory Questionnaire (on a scale of 0 to 100, with lower scores indicating better functioning) improved more in the azithromycin group than in the placebo group (a mean [+/- SD] decrease of 2.8 +/- 12.8 vs. 0.6 +/- 11.4, P = 0.004); the percentage of participants with more than the minimal clinically important difference of -4 units was 43% in the azithromycin group, as compared with 36% in the placebo group (P = 0.03). Hearing decrements were more common in the azithromycin group than in the placebo group (25% vs. 20%, P = 0.04). Conclusions Among selected subjects with COPD, azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects. Although this intervention could change microbial resistance patterns, the effect of this change is not known. (Funded by the National Institutes of Health; ClinicalTrials. gov number, NCT00325897.)

引用

页码：689 / 698

页数：10

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