阿奇霉素对持续未控制哮喘成人患者病情加重及生活质量的作用：一项随机双盲安慰剂对照研究
2017/08/08
摘要
背景：哮喘急性加重是全球医疗卫生行业的一项巨大负担。持续未控制的成人哮喘患者在维持治疗的基础上需要附加其他治疗。大环内酯类抗生素具有抗炎、抗菌、抗病毒作用，可能对哮喘的治疗有所助益。
目的：本研究的目的是评估未控制的持续哮喘患者在吸入中高剂量糖皮质激素及长效支气管舒张剂的基础上口服阿奇霉素对病情控制的有效性及安全性。
方法：这是一项随机双盲安慰剂对照研究，为了明确口服阿奇霉素是否能减低在应用吸入激素及长效支气管舒张剂基础上仍有哮喘症状的成人（≥18岁）患者急性加重的频率.有听力异常或病理性QTc间期延长为排除标准。病人被随机分入口服阿奇霉素（500mg/次 每日三次）组及安慰剂组（每日三次），观察时间为48周。主要观察终点为48周内哮喘中重度加重的次数及生活质量评估。
结果：在2009年6月12日至2015年1月31日之间，共有420名患者被随机分入不同的观察组内（213名在口服阿奇霉素组，207名在口服安慰剂组）。与安慰剂组相比，阿奇霉素能减低哮喘急性加重频率（阿奇霉素组急性加重：1.07/病人·年，95%CI 0.85-1.29；安慰剂组急性加重：1.86/病人·年，95%CI 1.54-2.18；IRR 0.59，95%CI 0.47-0.74；p<0.0001）阿奇霉素组急性加重1次以上的患者比例为61%，安慰剂组为94%（p<0.0001）。阿奇霉素能显著改善哮喘相关的生活质量（调整平均差异0.36，95%CI 0.21-0.52，p=0.001）。阿奇霉素组更常引起腹泻。（阿奇霉素组72名发生腹泻、发生率34%，安慰剂组39名发生腹泻、发生率19%，p=0.001）
结论：本研究表明，症状持续的哮喘成人患者口服阿奇霉素48周后能减低哮喘急性加重频率及改善生活质量。阿奇霉素对于持续哮喘患者来说可能是一项有效的辅助治疗。
Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial
Peter G Gibson, Ian A Yang, John W Upham, Paul N Reynolds, Sandra Hodge, Alan L James, Christine Jenkins, Matthew J Peters, Guy B Marks, Melissa Baraket, Heather Powell, Steven L Taylor, Lex E X Leong, Geraint B Rogers, Jodie L Simpson
Abstract
BACKGROUND:Exacerbations of asthma cause a substantial global illness burden. Adults with uncontrolled persistent asthma despite maintenance treatment require additional therapy. Macrolide antibiotics have anti-inflammatory, antibacterial, and antiviral effects that
might be beneficial in asthma.
OBJECTIVE:The aim of this study was to assess the efficacy and safety of oral azithromycin as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high dose inhaled corticosteroids plus a long-acting bronchodilator
METHODS:We did a randomised, double-blind, placebo controlled parallel group trial to determine whether oral azithromycin decreases the frequency of asthma exacerbations in adults (≥18 years) with symptomatic asthma despite current use of inhaled corticosteroid and long-acting bronchodilator, and who had no hearing impairment or abnormal prolongation of the corrected QT interval. Patients were randomly assigned (1:1) to receive azithromycin 500 mg or placebo three times per week for 48 weeks. Primary efficacy endpoints were the rate of total (severe and moderate) asthma exacerbations over 48 weeks and asthma quality of life.
RESULTS:Between June 12, 2009, and Jan 31, 2015, 420 patients were randomly assigned (213 in the azithromycin group and 207 in the placebo group). Azithromycin reduced asthma exacerbations (1·07 per patient-year [95% CI 0·85–1·29]) compared with placebo (1·86 per patient-year [1·54–2·18]; incidence rate ratio [IRR] 0·59 [95% CI 0·47–0·74]; p<0·0001). The proportion of patients experiencing at least one asthma exacerbation was reduced by azithromycin treatment (127 [61%] patients in the placebo group vs 94 [44%] patients in the azithromycin group, p<0·0001). Azithromycin significantly improved asthma-related quality of life (adjusted mean difference, 0·36 [95% CI 0·21–0·52]; p=0·001). Diarrhoea was more common in azithromycin-treated patients (72 [34%] vs 39 [19%]; p=0·001).
CONCLUSIONS:Adults with persistent symptomatic asthma experience fewer asthma exacerbations and improved quality of life when treated with oral azithromycin for 48 weeks. Azithromycin might be a useful add-on therapy in persistent asthma.
背景：哮喘急性加重是全球医疗卫生行业的一项巨大负担。持续未控制的成人哮喘患者在维持治疗的基础上需要附加其他治疗。大环内酯类抗生素具有抗炎、抗菌、抗病毒作用，可能对哮喘的治疗有所助益。
目的：本研究的目的是评估未控制的持续哮喘患者在吸入中高剂量糖皮质激素及长效支气管舒张剂的基础上口服阿奇霉素对病情控制的有效性及安全性。
方法：这是一项随机双盲安慰剂对照研究，为了明确口服阿奇霉素是否能减低在应用吸入激素及长效支气管舒张剂基础上仍有哮喘症状的成人（≥18岁）患者急性加重的频率.有听力异常或病理性QTc间期延长为排除标准。病人被随机分入口服阿奇霉素（500mg/次 每日三次）组及安慰剂组（每日三次），观察时间为48周。主要观察终点为48周内哮喘中重度加重的次数及生活质量评估。
结果：在2009年6月12日至2015年1月31日之间，共有420名患者被随机分入不同的观察组内（213名在口服阿奇霉素组，207名在口服安慰剂组）。与安慰剂组相比，阿奇霉素能减低哮喘急性加重频率（阿奇霉素组急性加重：1.07/病人·年，95%CI 0.85-1.29；安慰剂组急性加重：1.86/病人·年，95%CI 1.54-2.18；IRR 0.59，95%CI 0.47-0.74；p<0.0001）阿奇霉素组急性加重1次以上的患者比例为61%，安慰剂组为94%（p<0.0001）。阿奇霉素能显著改善哮喘相关的生活质量（调整平均差异0.36，95%CI 0.21-0.52，p=0.001）。阿奇霉素组更常引起腹泻。（阿奇霉素组72名发生腹泻、发生率34%，安慰剂组39名发生腹泻、发生率19%，p=0.001）
结论：本研究表明，症状持续的哮喘成人患者口服阿奇霉素48周后能减低哮喘急性加重频率及改善生活质量。阿奇霉素对于持续哮喘患者来说可能是一项有效的辅助治疗。
(中日友好医院呼吸与危重症医学科 张科文 摘译 林江涛 审校)
(www.thelancet.comPublishedonlineJuly4,2017http://dx.doi.org/10.1016/S0140-6736(17)31281-3)
(www.thelancet.comPublishedonlineJuly4,2017http://dx.doi.org/10.1016/S0140-6736(17)31281-3)
Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial
Peter G Gibson, Ian A Yang, John W Upham, Paul N Reynolds, Sandra Hodge, Alan L James, Christine Jenkins, Matthew J Peters, Guy B Marks, Melissa Baraket, Heather Powell, Steven L Taylor, Lex E X Leong, Geraint B Rogers, Jodie L Simpson
Abstract
BACKGROUND:Exacerbations of asthma cause a substantial global illness burden. Adults with uncontrolled persistent asthma despite maintenance treatment require additional therapy. Macrolide antibiotics have anti-inflammatory, antibacterial, and antiviral effects that
might be beneficial in asthma.
OBJECTIVE:The aim of this study was to assess the efficacy and safety of oral azithromycin as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high dose inhaled corticosteroids plus a long-acting bronchodilator
METHODS:We did a randomised, double-blind, placebo controlled parallel group trial to determine whether oral azithromycin decreases the frequency of asthma exacerbations in adults (≥18 years) with symptomatic asthma despite current use of inhaled corticosteroid and long-acting bronchodilator, and who had no hearing impairment or abnormal prolongation of the corrected QT interval. Patients were randomly assigned (1:1) to receive azithromycin 500 mg or placebo three times per week for 48 weeks. Primary efficacy endpoints were the rate of total (severe and moderate) asthma exacerbations over 48 weeks and asthma quality of life.
RESULTS:Between June 12, 2009, and Jan 31, 2015, 420 patients were randomly assigned (213 in the azithromycin group and 207 in the placebo group). Azithromycin reduced asthma exacerbations (1·07 per patient-year [95% CI 0·85–1·29]) compared with placebo (1·86 per patient-year [1·54–2·18]; incidence rate ratio [IRR] 0·59 [95% CI 0·47–0·74]; p<0·0001). The proportion of patients experiencing at least one asthma exacerbation was reduced by azithromycin treatment (127 [61%] patients in the placebo group vs 94 [44%] patients in the azithromycin group, p<0·0001). Azithromycin significantly improved asthma-related quality of life (adjusted mean difference, 0·36 [95% CI 0·21–0·52]; p=0·001). Diarrhoea was more common in azithromycin-treated patients (72 [34%] vs 39 [19%]; p=0·001).
CONCLUSIONS:Adults with persistent symptomatic asthma experience fewer asthma exacerbations and improved quality of life when treated with oral azithromycin for 48 weeks. Azithromycin might be a useful add-on therapy in persistent asthma.
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