Abstract

AIM: to assess the changes in hemorrhoids symptoms and satisfaction with treatment against the background of treatment with a combined topical product Relief® Pro.PATIENTS AND METHODS:multicenter prospective non-interventional cohort study was done in 13 clinical centers in Russia. The study included patients aged 18 to 65 years with acute hemorrhoids of stages 1–2 treated with the combined product Relief® Pro (rectal suppositories, cream or a combination thereof). The follow-up period was up to 14 days (in the case of 2 visits to the clinical center after receiving the initial data). The analysis was performed on the basis of data obtained at Visit 2 (5–7 days of therapy) and Visit 3 (10–14 days of therapy) vs the initial data (Visit 1). Following criteria were used: the severity of hemorrhoid symptoms on the Sodergren scale, the severity of hemorrhoid symptoms (pain, bleeding, itching, edema, the presence of discharge, a feeling of discomfort), the size of the largest hemorrhoid node, the satisfaction of the doctor and the patient with treatment, assessment of the patient’s adherence to recommendations for lifestyle changes and treatment, evaluation of the use of the drug Relief® were evaluated as endpoints About the treatment process and patient preferences regarding the dosage form of the prescribed drug. In addition, adverse events were evaluated.RESULTS: the study included 1000 patients aged 18 to 65 years (men — 54.5%, women — 45.5%) Patients had grade 1 acute hemorrhoids (330 patients), grade 2 acute hemorrhoids (345 patients) and exacerbation of chronic hemorrhoids (325 patients). The drug Relief® Pro rectal cream was used by 333 patients; suppositories — 383 patients; joint therapy with both dosage forms — 284 patients. During follow-up (visits 2 and 3), positive dynamics was observed in patients — a decrease in the severity of hemorrhoid symptoms both during objective examination and according to patient questionnaires. So, according to the patients’ estimates, the use of Relief® Pro, regardless of the form, led to a decrease in the severity or disappearance of the main symptoms of hemorrhoids — bleeding, itching, edema, the presence of discharge, discomfort already by Visit 2 and in almost all patients by the end of observation. A similar change of the symptoms due the digital examination: by day 5–7, the severity of edema and bleeding in the perianal region, bleeding decreased. About 96% of patients and about 97% of doctors were satisfied with the treatment. Application of both forms of Relief® The ABM was characterized by good tolerability: there were no adverse events associated, according to the researcher, with the studied drug.CONCLUSIONS: combined topical product Relief® Pro is effective for hemorrhoids.

Highlights

  • The effectiveness of combined topical product with fluocortolone pivalate and lidocaine for hemorrhoids: results of a multicenter observational study

  • Наиболее часто во всех подгруппах терапии выявлялся зуд умеренной степени выраженности

  • Dynamics of assessing the severity of hemorrhoidal disease on the Sodergren scale: data obtained during a standardized patient survey

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Summary

ОРИГИНАЛЬНЫЕ СТАТЬИ

Эффективность лечения геморроя комбинированным препаратом, содержащим флуокортолона пивалат и лидокаина гидрохлорид: результаты многоцентрового наблюдательного исследования. ЦЕЛИ: оценить динамику выраженности основных симптомов геморроя и удовлетворенности лечением на фоне терапии комбинированным топическим препаратом Релиф® Про. В исследование включали пациентов в возрасте от 18 до 65 лет с острым геморроем 1–2 стадий, получавших лечение комбинированным препаратом Релиф® Про в форме суппозиториев, крема или их комбинации. Независимо от лекарственной формы лечение приводило к уменьшению степени выраженности или исчезновению основных симптомов геморроя — кровоточивости, зуда, отека, наличия отделяемого, дискомфорта уже к Визиту 2 и практически у всех пациентов к окончанию наблюдения. Эффективность лечения геморроя комбинированным препаратом, содержащим флуокортолона пивалат и лидокаина гидрохлорид: результаты российского многоцентрового наблюдательного исследования.

КЛЮЧЕВЫЕ ТЕЗИСЫ
ЦЕЛИ И ЗАДАЧИ ИССЛЕДОВАНИЯ
ПАЦИЕНТЫ И МЕТОДЫ
Форма геморроя
Уровень физической активности
Локализация самого большого геморроидального узла
Общая сумма баллов по шкале Sodergren
Findings
Изменение относительно исходного уровня
Full Text
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