[A clinicoeconomic model of basic therapy for bronchial asthma].

The paper is dedicated to analysis of the most wide-spread variants of bronchial asthma (BA) basic therapy. The analysis was based on the results of a large (1362 patients from 34 Russian cities) pharmacoepidemiological study. Different models of pharmacotherapy were assessed on the basis of clinical data (the frequency of symptoms), the risk of BA exacerbation, the volume of public health resources used, and the cost of treatment. The results of the study showed that the use of set combinations of inhaled glucocorticosteroids and long-acting , beta2-adrenostimulators was most effective and rational from economic perspective under real clinical conditions.

A health-related quality-of-life comparison of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone and noncorticosteroid treatment in asthma: a randomized clinical study in Russia.

BACKGROUND: In Russia, current therapy for the long-term management of asthma is mainly nonsteroidal. This situation provides the opportunity to evaluate new asthma treatments in a patient cohort with little previous exposure to inhaled corticosteroids. OBJECTIVES: To compare the effect of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone, on the health-related quality of life (HRQL) of patients with mild to moderate asthma. METHODS: A double-blind, parallel-group, randomized, 12-week study compared formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone with an open control group of the investigator's choice of noncorticosteroid therapy. Patients completed the Short Form 36 (SF-36) and the Asthma Quality of Life Questionnaire (AQLQ). RESULTS: The improvement in HRQL scores for patients treated with noncorticosteroids was significantly less (p < 0.05) than those treated with formoterol plus budesonide and budesonide alone in all domains of the SF-36 and AQLQ with one marginal exception (budesonide versus investigator's choice, SF-36, Mental Component Scale, p = 0.053). Improvements in HRQL scores of formoterol plus budesonide, compared with budesonide alone, although generally higher, were not significantly different. Formoterol plus budesonide was more effective in improving lung function and reducing both symptoms and the need for relief terbutaline inhalation. CONCLUSION: Formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone significantly improved the HRQL of patients with mild to moderate asthma compared with noncorticosteroid treatment.

[Pharmacodynamics of inhalation broncholytic agents introduced in a single dose by nebulizer in patients with severe exacerbation of bronchial asthma]. / Farmakodinamika ingaliatsionnykh bronkholitikov pri odnokratnom vvedenii cherez nebulaizer u bol'nykh s tiazhelym obostreniem bronkhial'noi astmy.

AIM: To study pharmacodynamics and safety of inhalatory beta-2-adrenostimulators and M-cholinolytics given via nebulizer in patients with severe exacerbation of bronchial asthma (BA). MATERIAL AND METHODS: The study covered 78 patients with severe exacerbation of BA (mean age--48.6 +/- 15.0 years). The patients were randomized into 4 groups: 23, 20, 18 and 17 patients, respectively. They were treated with: ventolin nebuly (2.5 mg), berodual (0.25 mg ipratropium bromide and 0.5 mg phenoterol), atrovent (0.5 mg), berotek (1.0 mg by nebulizer Pulmo-Aide 56501). Efficiency and safety of the treatment was assessed by the data of external respiration function, arterial blood gases and ECG each 30 min for 3 hours. RESULTS: In patients with severe exacerbation of BA pharmacodynamics of all the studied drugs was characterized by less duration and potency of the action. Salbutamol and berotek were effective for 180 min, atrovent--for 30-60 min. Inhalation broncholytics had no such serious side effects as prolongation of corrected interval Q-T or onset of arrhythmia. Berotek demonstrated longer action on heart rate than salbutamol. CONCLUSION: Severe complication of BA is treated more effectively with combination of beta 2-adrenomimetic with atrovent.

The safety and efficacy of formoterol (Oxis) turbuhaler plus budesonide (Pulmicort) turbuhaler in mild to moderate asthma: a comparison with budesonide Turbuhaler alone and current non-corticosteroid therapy in Russia.

Current therapy in Russia for long-term management of asthma is mainly non-steroidal. This provided the opportunity to compare the efficacy and safety of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone in adults (n=338) with mild to moderate asthma who had little previous exposure to inhaled corticosteroids. The 12-week study followed a randomised, double-blind, parallel group design and included an open control group of patients who were treated with conventional non-corticosteroid therapy. Patients treated with formoterol plus budesonide benefited from a significantly greater improvement in their pulmonary function and asthma symptoms compared with budesonide alone (95% Cl of difference in mean morning peak expiratory flow [PEF] 8.7-36.3 l/min, p=0.0015). Non-corticosteroid treatment was significantly less effective than formoterol plus budesonide and budesonide alone (95% CIs of differences in mean morning PEF were 36.4-63.6 l/min and 14.1-41.1 l/min, respectively, both p=0.0001). Although the incidence and frequency of adverse events was not significantly different between the groups, formoterol plus budesonide and budesonide alone were better tolerated than non-corticosteroid treatment, and there were fewer incidences of asthma deterioration. Overall, formoterol Turbuhaler plus budesonide Turbuhaler was the safest and most effective treatment.

[Comparative efficacy of single Berodual inhalation in patients with bronchial asthma: nebulization against dose-adjusted aerosol]. / Sravnenie farmakodinamiki odnokratnoí ingaliatsii beroduala s pomoshch'iu nebulaízera i v vide dozirovannogo aérozolia u bol'nykh bronkhial'noí astmoí.

The trial included 34 patients with moderate non-atopic asthma in exacerbation. After arrest of the acute attack the patients inhaled berodual via nebulizer (a single dose of 0.5 ml -125 micrograms ipratropium bromide and 250 micrograms phenoterol) or aerosol (40 micrograms ipratropium and 100 micrograms phenoterol). As shown by body plethysmography and peak-flowmetry, nebulizer therapy was characterized by earlier onset of broncholytic effect which stood longer, more pronounced effect at the level of small and middle bronchi, absence of side effects. The authors believe that berodual inhalations through nebulizer are an effective modality in the treatment of bronchial asthma in severe exacerbation.

[The efficacy of inhaled glucocorticosteroids in different dosage regimens and in combination with theophylline preparations in bronchial asthma patients]. / Effektivnost' ingaliatsionnykh gliukokortikosteroidov pri razlichnom rezhime dozirovaniia i v kombinatsii s preparatami teofillina u bol'nykh bronkhial'noi astmoi.

The authors compare basic body plethysmography and peak flowmetry parameters, quality of life in 37 patients suffering from moderate or severe bronchial asthma. They received for 8 months low-dose glucocorticosteroids (group 1), high-dose glucocorticosteroids (group 2) and combination of low-dose glucocorticosteroids with long-acting theophyllin drugs (group 3). All the parameters assessed, quality of life was better in groups 2 and 3 (p < 0.05). Patients from these groups had also less frequent exacerbations of the disease which appeared less severe. From group 3 patients those who suffered longer and had marked emphysema showed a greater response.

[Kombipek in the therapy of patients with broncho-obstructive lung diseases]. / "Kombipék" v terapii bol'nykh bronkhoobstruktivnymi zabolevaniiami legkikh.

Bronchodilator combipek of Russian produce was tested in 43 patients with bronchial asthma of various severity. Combipek contains 200 mg of theophylline and 8 mg of salbutamol. Pharmacokinetics of the drug was evaluated after a single administration and upon obtaining equilibrium concentration. Functional and clinical evidence showed a prolonged effect and safety of the drug in long-term treatment of bronchial asthma. Adverse effects emerged in 13 (30.2%) patients. They were typical for theophylline and beta 2-adrenostimulators. Combipek is advocated as a treatment of choice in patients with nocturnal asphyxia, in those who can hardly tolerate large doses of theophylline and beta 2-adrenostimulators.

[The relationship of the theophylline concentration in the saliva and the blood serum in patients with a broncho-obstructive syndrome]. / Izuchnie sviazi kontsentratsii teofillina v sliune i v syvorotke krovi u bol'nykh s bronkhoobstruktivnym sindromom.

Theophylline salivary and serum concentrations (Tser and Tsal) were quantified after a single dose administration of theophylline drugs: euphylline (2.4% solution, 10 ml i.v. jet and 0.15 orally), theo-dur, retaphil, theopek, theobilong (0.3 g orally). The drugs were given to patients with broncho-obstructive syndrome. The samples were obtained within 6 and 24 hours upon administration for euphylline and other drugs, respectively. Tser and Tsal were determined at high-performance liquid chromatography. The authors revealed a linear relationship between Tser and Tsal in different time intervals. The percentage factors and formulas of Tser calculation by its Tsal values have been estimated.

[The pharmacodynamics of theophylline (euphylline)]. / Farmakodinamika teofillina (éufillina).

A single intravenous administration of 2.4%-10.0 euphylline to 35 patients with obstructive affections of the lungs entailed a broncholytic effect in large airways in patients with reversible obstruction under sub-therapeutical theophylline concentrations in the serum. In patients with mixed type of the obstruction and restrictive disturbances ineffective ventilation got worse, ventilation-perfusion relations disagreed, hemoglobin affinity to oxygen grew, pulmonary artery pressure dropped against the signs of pulmonary hypertension, EEG changed according to asynchronism pattern corresponding to brain hyperactivity. There was also elevation of both norepinephrine and epinephrine serum levels due to slow parenchymatous hepatic circulation which inhibited clearance of the substances. There was no relationship between changes in the indices and theophylline concentrations in the range 3.8-8.8 micrograms/ml.

[A comparative study of the pharmacokinetics of oral preparations of theophylline]. / Sravnitel'noe izuchenie farmakokinetiki peroral'nykh preparatov teofillina.

The pharmacokinetics of five preparations of theophylline--euphylline and sustained-release forms (theo-dura, retaphylline, theopac and theobilong) was studied in 50 patients with the broncho-obstructive syndrome. Blood serum theophylline concentration was determined by high performance liquid chromatography. The main differences in the pharmacokinetic parameters manifested themselves in the period of half-absorption--the least one for euphylline and the greatest one for theopac. A close correlation between blood serum theophylline concentration and the profile of theophylline release from theopac tablets was revealed. The equal theophylline concentration in blood serum was determined on the 4th and 7th days of the course treatment with sustained-release preparations administered twice a day, the concentration values ranged within the subtherapeutic level. An increase of the dose by 50-150 mg/day resulted in an increase of blood serum theophylline concentration within the therapeutic range.

[Clinical effectiveness of delayed-action theophylline preparations]. / Klinicheskaia éffektivnost' prolongirovannykh preparatov teofillina.

Clinical efficiency of course treatment has been assessed for 5 long-acting drugs of theophylline series: retaphylline (Finland), theo-dur (Sweden), durophylline (Yugoslavia), theopek and theobilong (USSR). The drugs were tested in 139 patients with chronic++ bronchial obstruction. It was established that first-line therapy with theophylline should be started with low doses (400 mg/day) and last for 3 days to define individual sensitivity to theophylline drugs followed by increasing doses. On day 7 serum theophylline levels were to be measured for control and dose correction. In cross administration and adequate doses the drugs activity was similar. For patients suffering from nocturnal asthma attacks it was an atypical doze regimen implying administration of two-thirds of the day, dose in the evening that produced the highest effect. The incidence and severity of CNS, cardiovascular and gastrointestinal side effects varied with the dose blood concentration and individual sensitivity to theophylline.