Azithromycin for Bronchial Asthma in Adults: An Effectiveness Trial
Azithromycin for Bronchial Asthma in Adults: An Effectiveness Trial
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DOI：
10.3122/jabfm.2012.04.110309
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发表时间：
2012-07-01
影响因子：
2.9
通讯作者：
Yale, Steven
中科院分区：
文献类型：
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作者：
Hahn, David L.;Grasmick, Mike;Yale, Steven
背景资料：大环内酯类药物具有抗菌和抗炎特性，可能是有用的，在治疗慢性asthene.Methods：我们进行了一项随机，安慰剂对照，双盲有效性试验，每周12次剂量的阿奇霉素，随机化后随访1年，在成人持续性哮喘。测量包括总体哮喘症状，哮喘生活质量（AQL）和哮喘控制。合格的受试者谁拒绝参加随机化提供入组到一个平行的开放标签（OL）阿奇霉素治疗arm.Results：筛选的304名成人哮喘患者，97（32%）入组：38名被随机分配到阿奇霉素，37名被随机分配到安慰剂，22名选择在OL科目。OL受试者的重度持续性哮喘发生率高于随机化受试者（分别为32%和8%; P = 0.012）。在1年时，与安慰剂组相比，随机分配至阿奇霉素组的受试者更有可能出现AQL评分较基线增加≥ 1个单位，但这种差异无统计学意义（36% vs安慰剂组21%; P = 0.335）。与安慰剂相比，OL受试者的总体哮喘症状较基线有显著改善（P =.0196），AQL（P = 0.0006），哮喘控制（P =.0148）.结论：随机接受阿奇霉素治疗的成人哮喘患者在哮喘结局方面未显示出统计学显著性改善，尽管该研究在检测15%的临床改善（需要治疗的数量= 7）方面效力不足。选择OL治疗的重度持续性哮喘成人患者记录了哮喘症状、AQL和哮喘控制的临床改善，这些改善在OL阿奇霉素治疗完成后持续存在（需要治疗的人数= 2）。（J Am Board Fam Med 2012; 25：442 - 459.）
Background: Macrolides have antimicrobial and anti-inflammatory properties that may be useful in the treatment of chronic asthma.Methods: We performed a randomized, placebo-controlled, double-blinded effectiveness trial of 12 weekly doses of adjunctive azithromycin, with follow-up to 1 year after randomization, in adults with persistent asthma. Measurements included overall asthma symptoms, asthma quality of life (AQL), and asthma control. Eligible subjects who declined to participate in randomization were offered enrollment into a parallel open-label (OL) azithromycin treatment arm.Results: Of 304 adult asthma patients screened, 97 (32%) were enrolled: 38 were randomized to azithromycin, 37 were randomized to placebo, and 22 opted in as OL subjects. OL subjects had higher rates of severe persistent asthma compared with randomized subjects (32% vs 8%, respectively; P = .012). At 1 year, compared with the placebo arm, subjects randomized to azithromycin were more likely to have an AQL score >= 1 unit increase compared with baseline, but this difference was not statistically significant (36% vs 21% for placebo; P = .335). Compared with placebo, OL subjects had significant improvements in overall asthma symptoms from baseline (P = .0196), AQL (P = .0006), and asthma control (P = .0148).Conclusions: Adults with asthma who were randomized to azithromycin did not show statistically significant improvement in asthma outcomes, although the study was underpowered to detect clinical improvement in 15% (number needed to treat = 7). Adults with severe persistent asthma who elected OL treatment documented clinical improvements in asthma symptoms, AQL, and asthma control that persisted after completion of OL azithromycin (number needed to treat = 2). (J Am Board Fam Med 2012;25:442-459.)