Orriols R, Roig J, Ferrer J, Sampol G, Rosell A, Ferrer A, Vallano A
Servei de Pneumologia, Hospital Universitari General Vall d'Hebron, Barcelona, Spain.
Respir Med. 1999 Jul;93(7):476-80. doi: 10.1016/s0954-6111(99)90090-2.
The aim of this study was to investigate the long-term effectiveness and safety of inhaled antibiotic treatment in non-cystic fibrosis patients with bronchiectasis and chronic infection by Pseudomonas aeruginosa, after standard endovenous and oral therapy for long-term control of the infection had failed. After completing a 2-week endovenous antibiotic treatment to stabilize respiratory status, 17 patients were randomly allocated to a 12-month treatment either with inhaled ceftazidime and tobramycin (group A) or a symptomatic treatment (group B). One patient from group A abandoned inhaled treatment because of bronchospasm and another from group B died before the end of the study. The remaining 15 patients, seven from group A and eight from group B, completed the study. Both groups had similar previous characteristics. The number of admissions and days of admission (mean +/- SEM) of group A [0.6 (1.5) and 13.1 (34.8)] were lower than those of group B [2.5 (2.1) and 57.9 (41.8)] (P < 0.05). Forced vital capacity (FVC), forced expiratory volume in 1 sec (FEV1), PAO2 and PACO2 were similar in the two groups at the end of follow-up, showing a comparable decline in these parameters. There were no significant differences either in the use of oral antibiotics or in the frequency of emergence of antibiotic-resistant bacteria between groups. Microbiological studies suggested that several patients had different Pseudomonas aeruginosa strains. None of the patients presented impaired renal or auditory function at the end of the study. This study suggests that long-term inhaled antibiotic therapy may be safe and lessen disease severity in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection by Pseudomonas aeruginosa which do not respond satisfactorily to antibiotics administered via other routes.
本研究的目的是，在通过标准静脉内和口服疗法长期控制感染失败后，调查吸入性抗生素治疗对支气管扩张且受铜绿假单胞菌慢性感染的非囊性纤维化患者的长期有效性和安全性。在完成为期2周的静脉内抗生素治疗以稳定呼吸状况后，17名患者被随机分配接受为期12个月的治疗，其中一组（A组）接受吸入性头孢他啶和妥布霉素治疗，另一组（B组）接受对症治疗。A组有1名患者因支气管痉挛放弃吸入治疗，B组有1名患者在研究结束前死亡。其余15名患者，A组7名，B组8名，完成了研究。两组之前的特征相似。A组的住院次数和住院天数（平均值±标准误）[0.6（1.5）和13.1（34.8）]低于B组[2.5（2.1）和57.9（41.8）]（P<0.05）。随访结束时，两组的用力肺活量（FVC）、第1秒用力呼气量（FEV1）、动脉血氧分压（PAO2）和动脉血二氧化碳分压（PACO2）相似，这些参数的下降幅度相当。两组在口服抗生素的使用或抗生素耐药菌出现频率方面均无显著差异。微生物学研究表明，部分患者感染的是不同的铜绿假单胞菌菌株。研究结束时，所有患者的肾功能和听力均未受损。本研究表明，对于支气管扩张且受铜绿假单胞菌慢性支气管感染、对其他途径给予的抗生素反应不佳的非囊性纤维化患者，长期吸入性抗生素治疗可能是安全的，且可减轻疾病严重程度。
