| Background:Bronchiectasis is defined as a symptom of permanently dilated airways incurred by chronic bronchial inflammation, which is caused various microorganisms and repeated or chronic infection. This symptom was first described by Rene Theophile Laennec in1819. Bronchiectasis is characterized by the dilating of the local airway, mucous secretion, mucosal inflammation, leading to increased sputum production and chronic cough.The bronchiectasis include Non-Cystic fibrosis bronchiectasis and fibrosis bronchiectasis.The latter isn’t our study scope.The aetiology for Non-Cystic fibrosis bronchiectasis(NCFB) are intricate, but they share the same pathophysiological process, containing three main elements of vicious recycling:inflammation, infection and damage (the function of enzyme). Thanks to varieties of causes for this disease, the organism cannot remove the micro-organisms, which results in infection and inflammatory reaction. Inflammation can protect against the invasion of extraneous matters. Nevertheless, when this response fails to eliminate the aggressors, the inflammation may change into chronic inflammation, inducing bronchial wall destroy and irreversible dilatation. The over-reaction triggered by bacterial infection can even exist even when the infection has been under control, resulting in an increased production of proinflammatory cytokines and/or uncontrolled activation of activated cells. The inflammation of bronchiectasis is characterized by monocyte and neutrophil, which cause the usual presence of airflow chronic bronchial obstruction and a frequent bronchial hyperresponsiveness.Some statistics showed that airflow was restricted to approximately an half of the patients with bronchiectasis. The change of pulmonary function was intimately related to the range and character of the disease. The pulmonary function has not changed in localization bronchiectasis; and bronchiectasis in column has little impacted pulmonary function, and the dilation of cystic seriously destroyed the bronchus and was complicated by obstructive emphysema. Data indicated that the pulmonary function of bronchiectasis frequently appears obstructive ventilation dysfunction and minority of them were mixed,33%-76%of cases can be present the airway hyper-reactivity.At present, there has been not an effective treatment with the bronchiectasis. Some researches showed that high dose IC could improve clinical symptom and quality of life of the patient with bronchiectasis and relieve airway inflammation, but could’t completely eliminate airway inflammation.however, it was worried about side effects such as cough、dry mouth、dysphonia、dental ulcer、sneezing. There has been little side effect if the patient should inhale a small dose IC,but it can’t improve clinical symptom and quality of life.lt was demonstrated that Long Acting β2Adrenergics (LABA) and Inhaled Corticosteroids (IC) have shown a synergistic effect when they are combined together in a single device. The treatment can deplete dosage of IC and display satisfactory efficacy and safety. Several small scale studies in abroad have observed that, in patients with bronchiectasis, ICS and LABA can positively influence certain key parameter, such as symptom,exercise tolerance and quality of life, without affecting lung function.The disease incidence is higher in our country and the aetiology is different from the abroad.There has been not reported that the effective treatment with the bronchiectasis of ICS and LABA in our country.Objective:It’s to evaluate the efficacy and safety of fluticasone/salmeterol (F/S) in the inhaled treatment of non-cystic fibrosis (CF) bronchiectasis and nonreversible airflow limitation.Materials and Methods:This clinical trial is a6-month randomized, double-blind, parallel-groups, prospective study and its respondents are60patients with non-CF bronchiectasis and nonreversible airflow limitation diagnosed by high-resolution CT scan of the chest from June,2010to August,2011.They are divided into two groups: Group A which received F/S combined treatment (50/250μg q12h), and the Control Group which got the conventional treatment with salbutamol, antibacterials and apophlegmatic. And during the whole process of the study, sporadic treatment with β2-agonists (salbutamol) was permitted as needed to both groups. The variables contain the clinical conditions, health-related quality of life (HRQL), acute exacerbation times, pulmonary function, the amount of β2-adrenergic (salbutamol) agonist, potentially pathogenic microorganisms (PPMs) isolates, and side effects. Analysis was performed for statistical analysis with the version of SPSS13.0. All data were expressed as mean±standard error of the mean.Comparison of basic characteristics between both groups was performed by the chi-square test in the case of dichotomous or qualitative variables, and by the Student’s t-test when the variables are quantitative, or the corresponding non-parametric tests were applied if they did not follow a normal distribution. P-value less than0.05was considered statistically significant.Results:The study group receiving an F/S combined treatment showed a significant improvement, both clinically and statistically, in the following symptoms, such as the dyspnea, and number of cough, and number of days without use of β2-adrenergic agonists. And the improvement in HRQL is also significant. There is no statistical difference in pulmonary functional parameters or in PPMs isolates, although the pulmonary function is improved. Generally an important reduction in side effects is found in both groups, including acute exacerbation times.Conclusion:Inhaled F/S combined treatment in a single inhaler is more effective and safer compared to salbutamol (S) treatment as needed treatment in patients with non-CF bronchiectasis. |
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