长期小剂量罗红霉素对稳定期慢性阻塞性肺疾病的影响

目的评价长期口服小剂量罗红霉素对稳定期慢性阻塞性肺疾病(COPD)急性加重频率、肺功能、血清C反应蛋白和痰中病原菌的影响。方法稳定期COPD患者100例中,随机分为治疗组50例(给予罗红霉素150mg,每日1次口服)和对照组50例。两组允许吸氧、口服稳定剂量的茶碱、吸入支气管扩张剂和吸入糖皮质激素。疗程6个月。记录研究期间患者发生COPD急性加重的频率和程度,测量入选时和结束时肺功能第1s用力呼气容积占预计值百分比(FEV1占预计值%)、血清C反应蛋白和观察期间的痰培养。结果 92例患者完成研究,共发生COPD急性加重90人次,治疗组28人次,对照组62人次,差别有统计学意义(P0.01);治疗组7人发生2次以上急性加重,对照组17人,差别有统计学意义(P0.05);治疗组严重急性发作6人次,对照组12人次,差别无统计学意义。FEV1占预计值%在发生COPD急性加重的患者([48.8±12.0)%]比没有发生急性加重者([56.3±12.6)%]更低(P0.05)。治疗组在治疗前、后FEV1占预计值%分别为(54.3±12.4)%和(53.7±13.1)%,血清C反应蛋白分别为5.1(2.9,6.8)mg/L和4.5(3.0,7.0)mg/L,较对照组无改善,两组痰培养在细菌分布和耐药性方面差别无统计学意义。结论长期小剂量罗红霉素可以减少稳定期COPD患者急性加重频率。

Effect of Long-term Low-dose treatment with Roxithromycin in Stable Chronic Obstructive Pulmonary Disease

Objective To investigate the effects of low-dose and long-term roxithromycin therapy on the seizure frequency, FEV1% predicted, serum C-reactive protein and pathogens in sputum samples in patients with COPD. Methods A prospective, randomized, controlled study was performed. 100 patients of stable COPD were randomly assigned to roxithromycin treatment group （n=50, received roxithromycin 150 mg per day and base therapy） and control group （n=50, received base therapy） over 6 months. Results 92 patients completed the study. There were a total of 90 moderate to severe exacerbations, 28 occurred in the treatment group and 62 occurred in the control group （P〈0.01）. Seventeen patients in the control group and 7 patients in the treated group had two or more exacerbations （P〈0.05）. Six patients in the treatment group had severe exacerbations, with no differences between control group （12 patients） （P〉0.05）. FEV,% predicted in the event of acute exacerbations of COPD patients （48.8±12.0） were lower than those who did not occur with acute exacerbation （56.3±12.6） （P〈0.05）. There were no differences between the treatment group and the control group in terms of stable FEV1% predicted, serum C-reactive protein and distribution of pathogens in sputum samples and their drug resistance over the 6-month study period. Conclusion Roxithromycin therapy has beneficial effects on the prevention of exacerbations in COPD patients.