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.

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.

[Ebastine in the treatment of seasonal allergic rhinitis]. / Ebastin pri lechenii sezonnogo allergicheskogo rinita.

AIM: To test the efficiency and tolerance of the second generation antihistamine drug ebastin (kestine) in patients with seasonal allergic rhinitis (SAR). MATERIALS AND METHODS: Kestin was given for 3 weeks in doses 10 and 20 mg/day to 226 patients with SAR running for 6.8 +/- 6.1 years. SAR symptoms relief, subjective effects, side effects were studied. RESULTS: The total index of rhinitis symptoms diminished from 11.6 to 1.2 scores. Subjective response was registered in 82% of the patients, objective in 77%. Neither treatment aggravations nor serious side effects occurred. 2 patients had drowsiness, head aches, dizziness and discontinued treatment. CONCLUSION: Kestin is effective in SAR, had no serious side effects, is well tolerated.

[Participation of neutrophils in the pathogenesis of allergic inflammation: inhibitory-protease index in assessing and predicting atopic illnesses]. / Uchastie neitrofilov v patogeneze allergicheskogo vospaleniia: ingibitorno-proteaznyi indeks v otsenke i prognozirovanii atopicheskikh zabolevanii.

Total trypsin-like (BAEE esterase), elastase-like (BOC esterase) and antitryptic activities were studied in blood serum of patients with atopic diseases. The elastase-like activity was increased in blood serum of all the patients examined during the acute period of the disease; the enzyme activation depended on the pathology severity and clinical picture manifestations. The increase in blood plasma total proteolytic activity correlated with reverse alteration in blood antitryptic potential. The data obtained suggest that activation of neutrophils occurred in atopic diseases, thus the rate of elastase-like activity in blood might be used as an objective pattern in examination of patients and in checking of treatment course. The developed inhibitory-protease index may serve also as a criterion in evaluation of the pathological state severity.

[Comparative study of the effectiveness of equivalent doses of the preparation ditek, disodium cromoglycate and fenoterol in atopic bronchial asthma]. / Sravnitel'naia éffektivnost' ékvivalentnykh doz preparata "Ditek", dinatrievogo khromoglikata i fenoterola pri atopicheskoi bronkhial'noi astme.

18-45-year-old patients with atopic bronchial asthma free of associated inflammatory diseases received ditek, lomudal and berotek (28, 10 and 10 patients, respectively). Biochemical assessment of allergic inflammation activity demonstrated that ditek is most effective of the above three drugs both in relation to induction of clinical remission and to inhibition of allergic inflammation.

[The use of Russian allergoids for the specific immunotherapy of pollinosis]. / Primenenie otechestvennykh allergoidov dlia spetsificheskoi immunoterapii pollinozov.

For three years 128 pollinosis patients received specific immunotherapy with cereals, weed and tree pollen allergens manufactured by the Scientific and Industrial Amalgamation "Allergen" (Stavropol). For comparison, a group of 42 patients was treated with the corresponding allergens according to the commonly used treatment scheme. Patients who had earlier undergone treatment with water-saline extracts of allergens, that proved to be ineffective, formed a special group. In sensitive patients reaction to the skin test with allergoids was by half less pronounced than reaction to the skin test with allergens. In allergometric titration on the nasal mucosa, reaction to the introduction of allergoids could be registered when they were used at a 10- to 100-fold higher concentration than allergens. The course of specific immunotherapy with allergoids was found to lead to a decrease in the level of allergen-specific IgE antibodies (p > 0.05) and total IgE (p < 0.01). An increase in the level of IgG antibodies was noted (p < 0.01). Specific immunotherapy with allergoids was more effective than that with water-saline extracts of allergens. The use of allergoids made it possible to prescribe specific immunotherapy to a wider circle of patients.

[Characteristics of 2 clinico-pathogenetic variants of the atopic form of bronchial asthma]. / K kharakteristike dvukh kliniko-patogeneticheskikh variantov atopicheskoi formy bronkhial'noi astmy.

IgE- and IgG-reagins were investigated in the sera of 120 patients with atopic bronchial asthma. Two clinicopathogenetic variants of disease were defined with relation to the genetic variants of disease were defined with relation to the main immunological mechanism: IgE-dependent (in 78 patients) and IgE-IgG-dependent (in 42 patients). Variations in a clinical picture, the results of specific allergological examination, the level of total serum IgE in different variants of the atopic form of bronchial asthma were established. Specific immunotherapy produced a good effect in the IgE-dependent variant. In the patients with the IgE-IgG-dependent variant specific immunotherapy with a house dust allergen proved to be ineffective in most cases.

[Activity of the prekallikrein-kallikrein system and characteristics of its regulation in various allergies]. / Aktivnost' sistemy prekallikrein-kallikrein i osobennosti ee regulatsii pri nekotorykh allergicheskikh zabolevaniiakh.

Activity of kallikrein and content of prekallikrein were estimated in blood serum of 34 patients with atopy and of 17 patients with urticaria by means of the chromatographic procedure. In these patients activity of alpha 1-proteolytic inhibitor (alpha 1-PI) and alpha 2-macroglobulin (alpha 2-MG) was studied. At the acute period of pollinosis activation of the kallikrein-kinin system was found, which correlated with the disease aggravation. During specific immunotherapy of the patients with atopy activation of the kallikrein-kinin system occurred, which depended on the total concentration of allergen administered. At the same time, activation of the kallikrein-kinin system, observed under conditions of urticaria, was most distinct in the patients with chronic relapsing urticaria and was related to the degree of the disease aggravation. Preparations of proteinase inhibitors analogous to contrical were only short-term effective in chronic relapsing urticaria. In the patients with distinct aggravation of pollinosis inhibitory activity of alpha 2-MG was markedly increased which occurred apparently as a result of blood pachyemia simultaneously with activation of the kallikrein-kinin system. Distinct increase in the alpha 1-PI activity was not found in the patients with pollinosis and urticaria even at the step of pronounced aggravation. Phenotyping of the inhibitor in 10 patients with a marked decrease in its activity enabled to find 6 persons exhibiting the heterozygous genotype with a defect allele.

[Experimental study of the allergenic activity of the pollen of Cyclachena xanthifolia]. / Eksperimental'noe izuchenie allergennoi aktivnosti pyl'tsy tsiklakheny durnishnikolistnoi.

Comparative studies of Cyclachena xantifolia and Ambrosia artemisifolia have been carried out by light, scanning and electron microscopy. Cyclachena xantifolia allergic properties have been examined in guinea-pigs. Senstization of animals has caused the increased number of immunocompetent cells in regional and distant lymph nodes, the appearance of high titers of reagin-like antibodies capable of fixing in the skin. Injection of the proper dose of allergen has resulted in the development of anaphylactic shock of different severity. The role of Cyclachena xantifolia in the etiology of pollinoses has been ascertained.