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[摘要]
目的 研究口服阿奇霉素和罗红霉素对稳定期慢性阻塞性肺疾病(COPD)的疗效、肺功能及炎性因子的差异性。方法 150例稳定期COPD患者随机分为对照组、罗红霉素组和阿奇霉素组。对照组给予COPD常规治疗,包括休息、吸氧、戒烟、沙美特罗/氟替卡松吸入剂,每次1吸,每日2次,吸入异丙托溴铵溶液每次500 μg,每日1次、氨茶碱片每次0.1 g,每日3次等;阿奇霉素组在对照组基础上给予阿奇霉素分散片250 mg,每日1次口服。罗红霉素组在对照组基础上给予罗红霉素软胶囊300 mg,每日1次。疗程均为6月。比较治疗前后3组患者肺功能、炎性因子、生活质量评分、运动耐受力及急性加重频率和首次急性加重时间间隔。结果 145例患者完成试验,对照组、罗红霉素组和阿奇霉素组分别为50、48、47例。治疗前,3组患者1 s用力呼气容积(FEV1)、用力肺活量(FVC)、第1秒用力呼气容积与用力肺活量比值(FEV1/FVC),白细胞介素-8(IL-8)、肿瘤坏死因子-α(TNF-α)、C-反应蛋白(CRP)、圣乔治问卷(SGRQ)生活质量评分和6min步行距离(6MWD)均无显著性差异。治疗后,罗红霉素组和阿奇霉素组的FEV1、FVC和FEV1/FVC均大于对照组,IL-8、TNF-α和CRP小于对照组,SGRQ评分小于对照组,6MWD大于对照组,急性加重频率小于对照组,首次急性加重时间间隔大于对照组,差异均有统计学意义(P<0.05)。阿奇霉素组的FEV1、FVC和FEV1/FVC均大于罗红霉素组,IL-8、TNF-α和CRP小于罗红霉素组,SGRQ评分小于罗红霉素组,6MWD大于罗红霉素组,急性发作率小于罗红霉素组,急性加重间隔大于罗红霉素组,差异均有统计学意义(P<0.05)。治疗期间,3组不良反应/不良事件发生率均无显著性差异。结论 长期口服阿奇霉素对稳定期COPD患者改善肺功能水平、降低气道炎性因子、减少急性发作率均显著优于罗红霉素,值得推广。
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[Abstract]
Objective To comparative study clinical efficacy pulmonary function and inflammatory factor of oral azithromycin and roxithromycin in stable chronic obstructive pulmonary disease (COPD). Methods 150 patients with stable COPD were randomly divided into control group, roxithromycin group (300 mg/d) and azithromycin group (250 mg/d), all groups continuously treated for 6 months. Index of pulmonary function (including FEV1, FVC, FEV1/FVC)and inflammatory factor (including IL-8, TNF-α, CRP), Quality of Life (SGRQ score), sports tolerance (6MWD), acute exacerbation frequency and first acute exacerbation interval before and after treatment were compared between the three groups.Results 145 patients completed the trial, control group, azithromycin group and roxithromycin group respectively were 50, 48 and 47. Before treatment, three group of FEV1, FVC, FEV1/FVC, IL-8, TNF-α, CRP, SGRQ score and 6MWD all had no significant difference. After treatment, FEV1, FVC and FEV1/FVC of azithromycin group and roxithromycin group significantly higher than that of control group, IL-8, TNF-α and CRP lever lowe than that of control group, SGRQ score significantly lowe than that of control group, 6MWD significantly longer than that of control group, acute exacerbation frequency significantly lower than that of control group, first acute exacerbation interval significantly longer than that of control group, all of the difference had statistical significance (P<0.05). Meanwhile the FEV1, FVC and FEV1/FVC of azithromycin group significantly higher than that of roxithromycin group, IL-8, TNF- α and CRP significantly lower than that of roxithromycin group, SGRQ score significantly lowe than that of that of roxithromycin group, 6MWD significantly longer than that of roxithromycin group, the acute attack rate was less than that of roxithromycin, and the acute exacerbation interval was greater than that of roxithromycin. All of the difference had statistical significance (P<0.05). There was no significant difference in the incidence of adverse reactions/adverse events between three groups. Conclusion Long-term oral azithromycin is superior to roxithromycin in improvement of lung function, reduction of airway inflammatory factors, and reduction of acute exacerbation rate in patients with stable COPD.
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