Efficacy and safety of nebulizer therapy in patients with bronchial asthma of elderly and senile age at the prehospital stage

The dissertation is devoted to optimising the delivery of emergency care to elderly and senile patients with bronchial asthma at the pre-hospital stage. It examines the epidemiological, etiological, and pathogenetic features of the disease in older age groups, as well as the specific clinical presentation and course of bronchial asthma in elderly patients. The study compares the efficacy and safety of nebuliser therapy and conventional treatment in the relief of exacerbations, and contrasts the effects of Berodual and salbutamol administered via nebuliser under emergency medical service conditions. The work proposes a staged system for introducing nebuliser therapy at the pre-hospital stage, encompassing a treatment method, equipping teams, staff training, and effectiveness monitoring, together with a patient protocol and registration card.

Relevance of the Problem

Bronchial asthma (BA) is one of the most common diseases in contemporary society [100, 188, 122]. According to WHO data, it occurs in 4–10% of the world's population. In Russia, BA is diagnosed in 2–4% of patients [19, 97].

At present, the international consensus on the treatment of BA is reflected in the "Global Strategy for the Treatment and Prevention of Bronchial Asthma" (WHO, 1996). In Russia, its adapted version formed the basis of the Federal Programme "Chronic Obstructive Pulmonary Diseases" (1999) and the Federal Guidelines on the Use of Medicinal Products (2002).

The treatment and prevention of BA is a comprehensive task, in which various levels of the healthcare system participate. The effectiveness of treatment and the quality of life of patients depend on the adequacy and timeliness of therapy at each stage and on the continuity between stages.

A special place in the strategy for the treatment of BA exacerbations is occupied by pre-hospital care. Its timeliness and quality are a fundamentally important condition for improving care for BA patients, making it possible to prevent progressive worsening of the condition, to reduce the frequency and duration of inpatient treatment, and to improve the quality of life [27].

As a rule, the first medical institution to which patients with BA exacerbation turn is the emergency medical service (EMS). According to the National Scientific and Practical Society for Emergency Medical Care (NNPOSMP), over the last three years the number of calls related to BA attacks in the Russian Federation has tended to increase. Thus, in Moscow from 1998 to 2000 the number of calls rose from 50,519 to 55,906; in Bryansk from 3,068 to 3,185; in Nalchik from 2,279 to 2,608; and in Pyatigorsk from 768 to 812. It should be noted that two thirds of EMS calls concerning BA involve elderly and senile patients. Given the changing demographic situation and the redistribution of the age structure of the population due to an increase in the number of people over 60, this indicator will continue to grow progressively over the next decade [45, 71].

Modern treatment of BA exacerbations presupposes the use only of selective short-acting beta-2-adrenoceptor agonists, anticholinergic agents, their combinations, glucocorticosteroids, and, in exceptional cases, methylxanthines [23]. At the same time, in practice the range of medications used, especially at the pre-hospital stage, is quite broad and includes a number of additional agents (Corglycon, Dimedrol, Suprastin, No-Spa, Lasix, Atropine, etc.). The unjustified prescription of outdated medications that have lost their clinical relevance and are of low efficacy contributes to poor quality of treatment, polypharmacy, and an inevitable increase in adverse effects [27, 83]. To a considerable extent this promotes an increase in the number of repeat EMS calls and hospitalisations and unjustifiably raises the cost of treatment. Naturally, elderly and senile BA patients find themselves in a worse position.

The advent of highly selective bronchospasmolytics and new methods of drug delivery necessitates the improvement of therapy for BA patients under EMS conditions. In the modern treatment of BA exacerbations, nebuliser therapy is becoming increasingly widespread; it is based on the delivery of high doses of drugs, in particular selective short-acting beta-2-agonists, anticholinergics, and glucocorticosteroids, in aerosol form directly into the bronchi in order to obtain a pharmacodynamic effect within a short period of time [113, 194, 228, 283]. This is particularly relevant for patients of older age groups, since with age the sensitivity of bronchial beta-2-receptors decreases [30], which requires a higher concentration of a bronchodilator to relieve a BA exacerbation.

Thus, the high rate of seeking EMS care among elderly BA patients, the frequent use of medications of low efficacy and with excessive risk of adverse effects, and the age-related pharmacokinetic features of the agents used have determined the aim of the present study.

Aim of the Work

To optimise the delivery of emergency care to elderly and senile patients with BA at the pre-hospital stage.

Research Objectives

1. To develop a method of nebuliser therapy for elderly and senile BA patients and criteria for its effectiveness.

2. To evaluate the efficacy and safety of nebuliser and conventional therapy in elderly and senile BA patients at the pre-hospital stage.

3. To compare, by the principal clinical and pharmacodynamic parameters, the effectiveness of Berodual and salbutamol in patients of older age groups at the pre-hospital stage.

Scientific Novelty

For the first time, a staged system has been created for the introduction of nebuliser therapy into EMS practice, comprising the development of a treatment method, equipping EMS teams with nebulisers and peak flow metres, staff training, monitoring of treatment effectiveness, patient questionnaires, and the involvement of healthcare administrators and medical companies in joint work.

A system for assessing the clinical effectiveness of the treatment used has been developed that is adapted to EMS conditions and includes monitoring of the dynamics of clinical data and control of peak expiratory flow (PEF).

The advantages of nebuliser therapy over conventional treatment have been demonstrated with respect to both efficacy and safety, as well as to the frequency of adverse effects, repeat calls, and hospitalisations in the relief of BA attacks in elderly and senile patients at the pre-hospital stage.

The advantage of nebuliser therapy over metered-dose aerosol inhalers has been revealed. According to the results of patient questionnaires, the action of nebuliser therapy was rated by the majority of patients as more rapid, more effective, and longer-lasting.

It has been established that the use of nebuliser therapy at the pre-hospital stage is 1.7 times more cost-effective than conventional therapy.

Practical Significance

Within the framework of the study, a protocol and an individual patient registration card applicable to pre-hospital conditions were developed.

A method has been developed for the inhalational administration of beta-2-agonists (salbutamol) and their combination with an M-anticholinergic agent (Berodual) by means of a nebuliser, depending on the severity of the BA attack in elderly and senile patients at the pre-hospital stage.

The optimal doses and regimens of Berodual and Ventolin for the relief of BA attacks of varying severity in elderly and senile patients have been determined.

It has been shown that nebuliser therapy of BA exacerbations in elderly and senile patients at the pre-hospital stage is a more effective method than conventional treatment, regardless of concomitant pathology and the severity of the BA exacerbation, and produces a significantly smaller number of adverse effects.

It has been shown that, with conventional therapy using a combination of two or more drugs, effectiveness is achieved in more than half of the patients but is accompanied in 43% of cases by adverse effects, predominantly cardiac rhythm disturbances, which is associated with the arrhythmogenic action of Euphyllin on the myocardium.