Comparison of the efficacy and safety of beclometasone dipropionate suspension for nebulization and beclometasone dipropionate via a metered-dose inhaler in paediatric patients with moderate to severe exacerbation of asthma.

Nebulization simplifies the administration of effective inhaled medications to young asthmatics who experience hand-to-lung co-ordination problems and inspiratory difficulties associated with metered-dose and dry-powder inhalers, respectively. The objective of this double-blind, double-dummy multicentre, randomized, parallel-group study was to compare the efficacy and safety of corticosteroids given by nebulization or metered-dose inhalation in paediatric patients with exacerbation of asthma. Following a 24-h run-in period, 151 patients, aged 6-16years, with moderate to severe exacerbation of asthma were randomized to one of two treatment groups for 4 weeks: beclometasone dipropionate (BDP) suspension for nebulization 1,600 microg day(-1) b.i.d. given via a nebulizer (n = 75), or BDP spray 800 microg day(-1) b.i.d. given via a metered-dose inhaler (MDI) plus spacer (BDP MDI) (n = 76). Superimposable and statistically significant improvements over baseline were noted at study end for the two treatment groups in the various efficacy parameters evaluated (pulmonary function tests, asthma symptoms scores, and the use of rescue salbutamol). The primary efficacy endpoint was the morning pulmonary expiratory flow rate (PEFR). In the BDP nebulization group, mean morning PEFR increased statistically significantly from 233.2 +/- 86.31 min(-1) to 322.0 +/- 101.81 min(-1), while in the BDP MDI group the increase was from 222.9 +/- 87.31 min(-1) to 314.9 +/- 96.61 min(-1). Moreover, an additional 4-week treatment period at half doses, completed by 26 patients, demonstrated that improvements were maintained or further enhanced. The two treatments were equally well tolerated. A total of 25 and 26 patients in the BDP nebulization and BDP MDI groups, respectively reported adverse events during the treatment period, and these were generally mild. In conclusion, the results of this study demonstrate that BDP suspension for nebulization 1,600 microg day(-1) given via a nebulizer and BDP spray 800 microg day(-1) given via an MDI plus spacer are equally effective, with an acceptable safety and tolerability profile, when used in paediatric patients with moderate to severe asthma exacerbation.

[Unilateral lung transplantation and its long term complications. (case report)]. / Transplantul pulmonar unilateral si complicatiile sale la distanta (prezentare de caz).

The authors are revising the evolution of a female patient with idiopathic pulmonary fibrosis which suffered an unilateral lung transplant. This was followed by a long list of complications (chronic reject reaction, gastro-enteritis, CMV and Herpes virus infection, bone fractures, recurrent respiratory infections etc). These events are analyzed, pointing out the attitude in the new post-transplant conditions.

[The late results of short-term chemotherapy in benign forms of tuberculosis in children]. / Rezultatele tardive ale chimioterapiei de scurta durata în formele benigne de tuberculoza la copii.

The study included 359 cases of primary tuberculosis (benign forms) in children aged 0-14 years, out of which 181 non-complicated and 178 complicated forms. The therapeutical regimens were: 3HEZ2/3HE2 (study subgroup) and 6HE2/3H2 (control) for non-complicated forms, and 3HRZ2/3HR2 (study subgroup) and 3HES2/3HE2/3H2 (control) for complicated ones. Late results (5 years after treatment end) were very good (from clinical, radiological, bacteriological points of view) in 100% of cases. Thus, short-course regimens are preferable to longer ones (over 6 months) in the chemotherapy of the benign forms of pulmonary tuberculosis in children.

Clinical management of bronchial asthma with inhaled high-dose beclomethasone dipropionate (Beclomet 250--Orion).

The efficacy of inhaled high-dose beclomethasone dipropionate (BDP) in intrinsic and cortico-dependent asthma was studied in 12 asthmatics (3 males and 9 females), average age 39 years (range 17-62 years), with a mean duration of the disease of 9 years (range 2-20 years). The patients were instructed to use one actuation (250 micrograms), three times daily or two actuations three times daily in severe cases in which dyspnoea persisted during the intake of oral corticosteroids. The results during the 6 month follow-up period were: Clinical: dyspnoea, wheeze and cough disappeared or diminished, oral administration of corticosteroids stopped or the daily dose was reduced, the intake of beta-agonists decreased; Functional: after 2-4 weeks, in almost all cases, the base line values of FEV 1.0 and Raw were normal and hyperinflation significantly diminished after the first month of BDP therapy. Clinical and functional improvement were maintained during the follow-up period; no side-effects were revealed.

[The value of the spirographic examination in the follow-up with time of the lung functional states in children with bronchial asthma]. / Valoarea examenului spirografic pentru urmarirea în timp a starii functionale pulmonare la copiii cu astm bronsic.

28 Children with bronchial asthma, aged 6-18 years, were followed up for varying time intervals, between 3 months and over 5 years. In the cases studied, 7-8 functional tests were used under different clinical conditions: asymptomatic, manifested clinical form of the bronchial asthma, crisis of expiratory dyspnea in various severeness degrees. For an easy use of the method in the pediatric network, the lung functional investigation consisted only of spirographic examination (CV (vital capacity), VEMS (max. expir. ventilation per second) VEMS/CV ratio). The study has to show which of the lung functional parameters, measured on the maximum and forced spirogram, are the most useful for the best evaluation of the functional state of the asthmatic child. The VEMS value proved to be the most correct one for appreciating the presence and severeness degree of the obstructive syndrome The slight variation of the VEMS/CV ratio showed that the information given by this parameter cannot reveal enough the alteration of the lung function in child. For a better evaluation of the lung functional state in the asthmatic child, the routine spirographic examination, has to be completed with more "sensible" tests, such as FEF25-755 and MEF59 and with other functional parameters measured by plethysmographic examination (VGT, Raw).

[The time variations in pulmonary functional parameters in children with bronchial asthma]. / Studiul variatiilor în timp ale unor parametri functionali pulmonari la copii cu astm bronsic.

28 children with bronchial asthma, between 6 and 18 years old, were followed by a varied period of time - 3 months - 5 years. 7-8 functional tests were carried out. The cases were studied in different clinical phases: asymptomatic, manifest, crisis of bronchial asthma. The functional pulmonary investigation included: spirographic examination [vital capacity (VC), maximum expiratory volume per second (MEVS) the VC/MEVS ratio], plethysmographic examination (VGT, Raw), measurement of the maximum instantaneous expiratory flows on the flux-volume curve (MEF50). The average value, standard residual deviation and the variation coefficient were calculated for each parameter studied in different clinical moments. The results are presented on 3 groups: per total, symptomatic and asymptomatic. The analysis of the data found showed that the variation of the parameters measured during repeated functional examinations in children with bronchial asthma ranges within broad limits (2.9%-11.5%); the broadest variation was recorded for Raw followed by MEF50 and the slightest variation was that of the VC/MEVS ratio. This indicated the lower value of the information furnished by this ratio in children, in appreciating the presence or severeness degree of the obstructive syndrome.

[The relation of severe obstructive disorders to ventilation found in young patients with bronchitis and bronchopulmonary diseases in childhood]. / Studiul relatiilor dintre tulburarile obstructive severe ale ventilatiei întîlnite la bronsitici tineri si afectiunile bronhopulmonare în copilarie.

Of the patients with chronic obstructive pulmonary disease (COLD) and severe obstructive syndrome, 39 whose age was under 40 were selected. In 23 of them, the anamnesis revealed bronchopulmonary affections in childhood, that required admission into the hospital (19 were non-smokers). Of the rest of 16 patients, 14 were hard smokers that started to smoke before the age of 14. The functional picture was severely modified, similarly to that of the COLD patients in the 6th decade of life. This suggests that the degradation process started in the childhood, and that the chronic respiratory diseases and/or smoking at an early age had an important role.