RESUMEN
Objective To observe the benefits and safety of different maintenance doses of azithromycin for long-term treatment in adult patients with non-cystic fibrosis (CF) bronchiectasis. Methods One hundred and thirty-two indigenous outpatients (>18 years old) with stable non-CF bronchiectasis were enrolled. All patients were randomly assigned to a control group and two treatment groups. Patients in the azithromycin fixed-dose treatment group received oral azithromycin (250 mg daily) and ambroxol hydrochloride (30 mg, 3 times/d). Azithromycin progressively decreased dosage treatment group received oral azithromycin (250 mg daily for 8 weeks-250 mg 3 times/week for 8 weeks-250 mg 2 times/week for 10 weeks) and ambroxol hydrochloride (30 mg, 3 times/d). Subjects in control group only received ambroxol hydrochloride therapy. The course of treatment lasted for 26 weeks. Spirometry, exacerbations, sputum microbiology, quality of life, dyspnea scores and adverse effects were monitored after treatment for 26 weeks. Results One hundred and twenty-nine evaluable subjects completed the study. After treatment, the level of percentage of estimated value forced expiratory volume in 1 second (FEV1% Pred) in azithromycin fixed-dose treatment group and azithromycin progressively decreased dosage treatment group was significantly higher than that before treatment: (83.01 ± 5.79)% vs. (79.39 ± 3.53)%, (84.97 ± 5.10)% vs. (80.94 ± 3.46)%, P<0.05. Forced expiratory flow between 25% and 75% of vital capacity (FEF25%- 75%) was also increased in two groups: (54.87 ± 5.72) % vs. (51.86 ± 8.16)%, (55.65 ± 3.39)% vs. (53.46 ± 5.75)% , there was significant difference (P<0.05). But the levels of above parameters between two groups after treatment had no significant differences (P >0.05). The parameters of FEV1% Pred, forced expiratory volume in 1 second (FEV1)/forced ventilatory capacity (FVC) and FEF25%-75%were lower compared to those before treatment in the control group (P <0.05). However, the scores of LRTI-VAS and FACED in control group after treatment were decreased slightly: (20.55 ± 1.76) scores vs. (21.34 ± 1.86) scores, P<0.05; (4.16 ± 0.75) scores vs. (4.36 ± 0.72) scores, P > 0.05. Seven episodes of acute exacerbation was occured during 26 weeks, 2 cases exited. The others did not interrupt azithromycin treatment during acute exacerbation. Drug-related adverse reactions were mild. Conclusions For adult stable patients with non-CF bronchiectasis, the clinical symptoms and airflow limitation are improved after long-term treatment of low-dose azithromycin. Similar effects on FACED score and LRTI-VAS score are observed in patients with progressively decreased dosage of azithomycin.
RESUMEN
Objective To observe the benefits and safety of low-dose azithromycin maintenance treatment on pulmonary function and quality of life in patients with bronchiectasis. Methods Thirty-seven adult bronchiectasis patients accompanied with chronic purulent respiratory tract symptoms were selected, and all the patients were given azithromycin 250 mg oral, once/d for 12 months. The respiratory symptoms, pulmonary function and quality of life before treatment and 16, 52 weeks after treatment were observed. Results Among 37 patients with bronchiectasis, 3 cases were lost, 1 case was in the follow-up of the 16th week, and 2 cases exited because of acute exacerbation. There were no statistical differences in body mass index (BMI) and inspiratory capacity percentage of estimated value (IC%Pred) before treatment, 16 and 52 weeks after treatment (P>0.05). The C-reactive protein (CRP), forced expiratory volume in 1 second (FEV1)/ forced ventilatory capacity (FVC), forced expiratory flow between 25% and 75% of vital capacity percentage of estimated value (FEF25-75%Pred), modified British medical research council dyspnea scale (mMRC) score 16 and 52 weeks after treatment were significantly better than those before treatment:(15.33 ± 4.00) and (9.21 ± 3.04) mg/L vs. (25.59 ± 9.82) mg/L, (75.94 ± 5.59)%and (75.52 ± 7.06)% vs. (72.14 ± 5.62)%, (60.22 ± 10.90)% and (63.73 ± 6.54)% vs. (55.44 ± 9.16)%, (1.75 ± 0.69) and (1.41 ± 0.56) scores vs. (2.19 ± 0.74) scores;the low respiratory tract infection visual analog scale (LRTI- VAS) score, FEV1 percentage of estimated value (FEV1% Pred) and chronic obstructive pulmonary disease assessment test (CAT) score 52 weeks after treatment were significantly better than those before treatment: (17.74 ± 3.76) scores vs. (21.57 ± 4.47) scores, (70.31 ± 4.07)% vs. (66.95 ± 5.48)%and (18.06 ± 3.32) scores vs. (21.54 ± 4.89) scores, and there were statistical differences (P<0.05). In the course of treatment, 5 cases might be associated with the drug adverse reactions, but the symptoms were mild. No patients exited because of adverse reaction. Five patients had 7 episodes of acute exacerbation, among whom 2 cases exited and the other 3 cases did not interrupt azithromycin treatment during acute exacerbation. Conclusions For adult patients with bronchiectasis, the long-term treatment of low-dose azithromycin (250 mg/d) can improve the respiratory symptoms and quality of life, and reduce the airflow limitation of peripheral airway.