Background: Allergic rhinitis is a high-prevalence disease that affects quality of life (QOL), sleep quality and productivity of patients. According to the ARIA initiative, it is classified as intermittent and persistent, the latter being the most troublesome.
Methods: The aim of this randomized, open-label, 6-month, pilot study was to determine whether levocetirizine 5 mg administered continuously once daily in the morning was better than levocetirizine 5 mg on-demand in symptomatic subjects with persistent allergic rhinitis. Total and individual symptom scores were recorded in a diary card throughout the study. QOL, quality of sleep, nasal cytology, rate of drug intake, and safety were also assessed at pre-defined time-points.
Results: In all, adult patients (31 in each group) were enrolled, of whom 22 dropped out. Both treatment regimens considerably decreased the total and individual symptoms scores from baseline and achieved similar levels up to week 14. Continuous treatment was generally better than on-demand from week 15 onwards, reaching statistical significance from weeks 17 to 21 (from week 19 to 21 for nasal pruritus). Both regimens substantially improved QOL and sleep quality. Both treatments were well tolerated, although the on-demand group reported more adverse events.
Conclusion: The present open label study in 62 patients indicates that levocetirizine 5 mg reliably controls persistent rhinitis over a period of 6 months, and shows a trend to be more effective in controlling the symptoms of rhinitis, improving QOL and decreasing nasal inflammation, when administered as long-term continuous therapy rather than as on-demand therapy.
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Въведение: Алергичният ринит е широко разпространено заболяване, което засяга качеството на живот, качеството на съня и продуктивността на пациентите. Според ARIA той се класифицира като интермитентен и персистиращ, като персистиращият е най-обезпокоителен.
Методи: Целта на това рандомизирано, отворено, 6-месечно, пилотно проучване е да определи дали levocetirizine 5 mg, прилаган постоянно веднъж дневно сутринта, е по-ефективен от levocetirizine 5 mg, прилаган при нужда при симптоматични пациенти с персистиращ алергичен ринит. Общият и индивидуалният симптомни скорове са записвани в дневник по време на проучването. Качество на живот, качество на съня, назална цитология, степен на прием на лекарството и безопасност също са оценявани на предварително определени периоди от време.
Резултати: Включени са възрастни пациенти (31 във всяка група), от които 22 са отпаднали. И двата режима на лечение значително намаляват общите и индивидуални симптомни скорове от началото и постигат подобни нива до 14-та седмица. Поддържащото лечение е като цяло по-ефективно от лечението при нужда от 15-тата седмица нататък, достигайки статистическа сигнификантност от 17 до 21-ва седмица (от 19 до 21 за назален пруритус). И двата режима на лечение в значителна степен подобряват качеството на живот и качеството на съня. И двата режима на лечение са добре толерирани, въпреки че в групата за прием при нужда са съобщени повече нежелани лекарствени реакции.
Заключение: Настоящото отворено проучване при 62 пациенти показва, че levocetirizine 5 mg надеждно контролира персистиращия ринит за период от 6 месеца и показва тенденция да бъде по-ефективен в контролирането на симптомите на ринита, подобрявайки качеството на живот и намалявайки назалното възпаление, когато е прилаган като продължително поддържащо лечение, отколкото като лечение при нужда.
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