To the question of the use of alimamazine (Teraligen®) in patients with atopic dermatitis in combination with anxiety-depressive disorder

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Abstract

The purpose of this trial was to study the effectiveness and safety of the preparation Teraligen® (alimemazine) solution for intramuscular injection (ampoules 5.0 mg of alimemazine tartrate in 1 ml, 5 ml) in adults with moderate atopic dermatitis combined with anxiety-depressive disorder. The study involved 69 patients (42% women and 58% men, the average age was 31.3 years with a diagnosis of moderate atopic dermatitis (on the SCORAD index of itching), combined with anxiety (according to the Hospital Anxiety and Depression Scale - HADS), as well as with the negative impact of the disease on the quality of life of the patient (based on the Dermatology life Quality Index). Patients received a course of treatment with Teraligen® by intramuscular injection of 25 mg (5 ml) 2 times in day. The duration of alimemazine treatment was 10 days (starting with the first dose of the drug) with a further observation period of 28±1 days. All patients treated with Teraligen® (alimemazine) noted a gradual improvement in the condition, expressed by a decrease in the severity of the underlying symptoms of atopic dermatitis. The mean value of the absolute values of the SCORAD index of pruritus by the 11th day decreased by 18.7 times (p<0.0001), the average value of the itching index (according to the SCORAD scale), by the 11th day of therapy decreased by 4.95 times (p<0.0001). The proportion of patients who reached the level of SCORAD index of 29 points or less by day 11 reached 100%. The proportion of patients with disappearance or decrease in the manifestation of the symptom "skin pruritus" (2 points or less) by day 11 was 98.4% of patients. The proportion of patients with complete disappearance of skin pruritus by the 11th day was 71.9% (p<0.0001). Therapy with Teraligen® marked a significant increase in the proportion of patients who have reached the target level of 10 points or less in terms of anxiety and depression (HADS); p<0.0001; attained at the end of the treatment, the low level of anxiety and depression remained virtually unchanged throughout the observation period (38±1 days). Patients noted a significant decrease in the negative impact of the disease on social and functional activity. In addition, a high safety profile of the study drug was established, only one adverse event was identified - drowsiness of a mild degree 3.1% (in 2 patients). Thus, Teraligen® (alimemazine) is useful for complex therapy of atopic dermatitis, accompanied by anxiety-depressive and other psychoneurological disorders.

About the authors

A. S Edin

A.I.Burnazyan Federal Medical Biophysical Center of FMBA of Russia

Email: anton7819@gmail.com
канд. мед. наук, начальник отд. клинических исследований 123098, Russian Federation, Moscow, ul. Marshala Novikova, d. 23

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