长期小剂量罗红霉素与阿奇霉素治疗稳定期COPD的临床对比研究

Clinical comparative study of long-term low-dose roxithromycin and azithromycin in the treatment of stable COPD

目的研究长期应用小剂量罗红霉素与小剂量阿奇霉素在稳定期COPD患者维持治疗中的疗效。方法 60例COPD患者随机分为罗红霉素组20例,阿奇霉素组20例和对照组20例。在常规治疗基础上,罗红霉素组每天口服一次小剂量罗红霉素150mg,阿奇霉素组每天口服一次小剂量阿奇霉素125mg,对照组仅给予常规治疗,疗程为1年。各组患者均允许吸氧,常规治疗吸入糖皮质激素、支气管扩张剂和长效β受体激动剂。同时比较三组FEV1、FEV1/FVC、6min步行距离、呼吸困难评分、生活质量评分、加重发作频率(人/年)和用药不良反应情况。结果罗红霉素组累计急性发作频率为3个月7次,6个月10次,12个月14次;阿奇霉素组累计急性加重频率为3个月5次,6个月8次,12个月10次;对照组累计急性发作频率3个月10次,6个月15次,12个月24次,三组间对比差异无统计学意义(P>0.05)。罗红霉素组与阿奇霉素组患者在FEV1/FVC(%)、6min步行距离、呼吸困难评分、PaO2、PaCO2和痰量上均较对照组有较明显改善。结论长期口服小剂量阿奇霉素和罗红霉素效果安全有效,可改善肺功能、缓解呼吸困难、延缓气道重塑,改善COPD患者生活质量。

Objective To investigate the efficacy of long-term low-dose roxithromycin and azithromycin in maintenance therapy of stable COPD patients. Methods A total of 60 COPD patients were randomly divided into roxithromycin group(20 cases), azithromycin group(20 cases)and control group(20 cases). On the basis of conventional therapy, the roxithromycin group was given low-dose of 150 mg once a day orally, and the azithromycin group was given low-dose of 125 mg once a day orally. The control group was only given conventional treatment. The treatment course was one year. All patients were admitted to oxygen, routine treatment of inhaled corticosteroids, inhaled bronchodilators, and long-acting beta-agonists. Compared the FEV1, FEV1/FVC, 6 min walking distance, dyspnea score, quality of life score, aggravated seizure frequency(person/year)and adverse drug reactions of the three groups. Results The cumulative frequency of acute seizures in the roxithromycin group was 7 times at 3 th month, 10 times at 6 th month, and 14 times at 12 th month, the cumulative frequency of acute exacerbations in the azithromycin group was 5 times at 3 th month, 8 times at 6 th month, and 10 times at 12 th month. In the control group, the cumulative frequency of acute attacks was 10 times at 3 th month, 15 times at 6 th month, and 24 times at 12 th month. There was no significant difference among the three groups(P>0.05). FEV1/FVC(%), 6 min walking distance, dyspnea scores, PaO2, PaCO2 and sputum levels of patients with erythromycin and azithromycin significantly improved compared with the control group. Conclusion Long-term and low-dose azithromycin and erythromycin is safe and effective, which can improve lung function, relieve dyspnea, delay airway remodeling and improve the quality life of COPD patients.