Abstract

Background. Despite the advances achieved in recent years in the treatment of AD, prevention and rehabilitation of patients, who suffering from this disease, belong to the most difficult tasks of practical dermatovenerology.
 Objective. The aim of this study was to assess the efficacy, safety and tolerability of Reglisam Cream in the complex therapy of patients with atopic dermatitis.
 Methods. The study involved 48 patients with atopic dermatitis, who were divided into two groups. There were two observation periods for each patient: 28 days the period of exacerbation therapy, and 6 months basic care and prevention of relapses.
 In exacerbation period all patients used external moisturizers in addition to topical glucocorticosteroids: in group I (study group) patients applied Reglisam Cream to the skin; in group II (control group) cold cream. After the period of exacerbation patients of group I were prescribed basic therapy Reglisam Cream for 6 months, patients of group II cold cream. In each group were assessed the therapeutic efficacy, safety and tolerability of treatment. During the study were conducted registration of adverse events, assessment of the dermatological status with the determination of the intensity of pruritus according to the visual analogue 10-point scale, the calculation of the severity index of the disease and the area of the lesion in eczema / atopic dermatitis (EASI) and the dermatological index of quality of life (DLQI), measurement of skin moisture, general clinical research.
 Results. In the first 28 days of acute atopic dermatitis period therapy, the EASI index decreased on average by 76% from 20.4 to 4.8 points (p 0,05), in group II by 57% from 19.7 to 8.4 points (p 0,05); the intensity of pruritus after treatment with Reglisam Cream in the dynamics decreased by 70% and amounted to 2.3 points, which was lower than in the comparison group 4.1 points (p 0,05); the level of skin hydration in group I was 36.8 units, during the treatment period increased by 80%, and was higher than in group II 26.7 units. (p 0,05); DLQI in group I decreased by 68%, amounting to 4.7 points, and was almost 2 times less than in group II 9.2 points (p 0.05).
 In group I for 6 months were registered a statistically lower frequency of exacerbations of atopic dermatitis (28%) than in group II (63%). The average duration of atopic dermatitis remission in group I was 22.4 weeks, for 4 weeks more than in group II (p 0,05). Meanwhile the average duration for the exacerbation period of atopic dermatitis in group I was more than 3.5 times less in comparison with group II; the average EASI in group I did not exceed 6.4 points and was significantly lower than that in group II (p 0,05).
 Conclusion. The use Reglisam Cream as basic skin care in patients with AD increases the duration of remission and reduces the frequency and duration of relapses of the disease, leads to an improvement the quality of life, a decrease in the intensity of pruritus and a significant increase in the moisture content of the stratum corneum of the epidermis. The obtained clinical results allow us to recommend Reglisam Cream as an effective external agent in the complex therapy of patients with AD.

Highlights

  • Despite the advances achieved in recent years in the treatment of AD, prevention and rehabilitation of patients, who suffering from this disease, belong to the most difficult tasks of practical dermatovenerology

  • The study involved 48 patients with atopic dermatitis, who were divided into two groups

  • During the study were conducted registration of adverse events, assessment of the dermatological status with the determination of the intensity of pruritus according to the visual analogue 10-point scale, the calculation of the severity index of the disease and the area of the lesion in eczema / atopic dermatitis (EASI) and the dermatological index of quality of life (DLQI), measurement of skin moisture, general clinical research

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Summary

Background

Despite the advances achieved in recent years in the treatment of AD, prevention and rehabilitation of patients, who suffering from this disease, belong to the most difficult tasks of practical dermatovenerology. В каждой группе была выполнена оценка терапевтической эффективности, безопасности и переносимости лечения на 7, 14, 21 и 28-й дни терапии: оценка дерматологического статуса с определением интенсивности зуда по визуально-аналоговой балльной шкале (ВАШ), подсчетом индекса тяжести заболевания и площади поражения при экземе/АД (EASI) и дерматологического индекса качества жизни (ДИКЖ) [11]; проведение измерения влажности кожи (корнеометрии) в 4 точках (аппаратом SKIN-O-MAT); выполнение исследований клинического анализа крови, общего анализа мочи, биохимического анализа крови (общий белок, общий билирубин, аланин­ аминотрансфераза (АлАТ), аспартатаминотрансфераза (АсАТ), гамма-глутамилтранспептидаза (ГГТП), щелочная фосфатаза (ЩФ), глюкоза, креатинин и их интерпретации); регистрация нежелательных явлений и оценка переносимости наружных средств по шкале от 0 до 4 баллов, где максимальное значение соответствовало хорошей переносимости, а 0 баллов — потребности в отмене средства. X — медиана, x0,25 — нижний квартиль, x0,75 — верхний квартиль, § — статистически значимые отличия в группе до начала лечения и после терапии; * — статистически значимые различия между группами, р < 0,05

Группа II Значение ДИКЖ
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