RU2334515C2 - Application of "day" tranquilliser phenibute and anti-depressant - selective inhibitor of serotonin re-uptake trittico during treatment of psoriasis - Google Patents

Abstract

FIELD: medicine, dermatology.

SUBSTANCE: psoriasis is suggested to be treated using "day" tranquilliser phenibute and anti-depressant - selective inhibitor of serotonin re-uptake trittico.

EFFECT: normalisation of vegetative disbalance and increased number of patients with remission lasting longer than a year.

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Description

The invention relates to medicine, in particular to dermatovenerology, and can be used in the treatment of psoriasis.

Known methods of treating psoriasis using sedatives and antipsychotics (preparations of bromine, chlorpromazine, thioridazine) to normalize the psycho-emotional state and sleep [Psoriasis // Guide for the treatment of skin diseases / A.L. Mashkilleyson, A.Ya. Rubins. / Ed. A.L. Mashkillayson. - M., 1990. - S.305-321].

The disadvantages of these methods are: 1) the low effectiveness of treatment due to the non-selective effect of these drugs not taking into account the spectrum of neurotic disorders; 2) the risk of complications (drowsiness, the phenomenon of "bromism", extrapyramidal disorders, allergic reactions, toxic retinopathy, etc.); 3) a long duration of treatment and frequent relapses of the disease.

The purpose of the invention is to increase the efficiency, eliminate complications of treatment, reduce the duration of treatment and reduce the frequency of relapse of the disease by normalizing mental reactions and the state of the autonomic nervous system of patients with psoriasis.

The goal is achieved by the use of a “daytime” phenibut tranquilizer and an antidepressant, a selective trittico serotonin reuptake inhibitor, for treatment.

Like other tranquilizers, phenibut has a pronounced anti-anxiety effect, but differs in a number of properties: it has elements of nootropic activity, does not have muscle relaxant and anticonvulsant effects, and does not cause drowsiness. For this reason, Phenibut does not have side effects such as drowsiness, dizziness, gait uncertainty, skin itching, nausea, constipation, menstrual irregularities, and decreased libido.

Phenibut is usually well tolerated. At the first doses of the drug or overdose, drowsiness may occur. When using small therapeutic doses, this effect is not observed.

The selective serotonin reuptake inhibitor trittiko (trazodone) belongs to a new generation of antidepressants. Unlike non-selective monoamine reuptake inhibitors (tricyclic - amitriptyline, imipramine, etc. and tetracyclic - maprotiline, mianserin, etc.) it does not have anticholinergic activity. For this reason, the selective serotonin reuptake inhibitor has no side effects associated with the effect on the autonomic nervous system, such as orthostatic hypotension, tachycardia, constipation, urinary retention, etc., which accompany the use of non-selective antidepressants. Side effects that occur when taking trittiko - drowsiness, headache, dizziness, insomnia, lowering blood pressure are relatively rare and pass with a decrease in dose. When using small therapeutic doses, these effects are not observed [Katzung B.G. Basic and clinical pharmacology: In 2 volumes. T.1. / Per. from English - M. - St. Petersburg: Binom - Nevsky Dialect, 1998. - S.550-557; Kukes V.G. Clinical Pharmacology: Uch. / Scientific. ed. A.Z. Baychurina. - 2nd ed., Revised. and. add. - M: MEOTA MEDICINE, 1999. - S.447-460; Mashkovsky M.D. Medicines: In 2 tons. T.1. - 14th ed. - M. - New wave, 2002. - S.55-119].

The method is implemented as follows. Psoriasis patients are prescribed a combination of phenibut and trittiko. The drugs are used in minimal therapeutic doses according to the following scheme: tab. Phenibut 250 mg in the morning and 250 mg in the evening, tab. trittico 150 mg at bedtime. The duration of phenibut intake is 21 days, trittiko is 60 days.

We conducted a comparative assessment of the effectiveness of treatment of patients with psoriasis according to the standard scheme (sedatives, “Hungarian” scheme with calcium gluconate, physiotherapy, external drugs in accordance with the process stage) and using complex therapy, including phenibut and trittiko. For this, the following groups of patients were formed: group 1 - patients with psoriasis, the therapy of which included phenibut and trittiko (trazodone) (n = 22); Group 2 - psoriasis patients who received conventional therapy (n = 30). The effectiveness of complex therapy was evaluated by the dynamics of the clinical picture - the severity index of the course of psoriasis (PASI), the psychological state of patients, the state of the autonomic nervous system.

In patients receiving standard treatment, compared with the group receiving complex treatment, a slower decrease in PASI was noted during the first three weeks. In addition, in the group of patients receiving complex treatment, PASI decreased by 80.0% 7 days earlier, which corresponds to the clinical assessment of "significant improvement" than in the standard treatment group (Table 1).

Table 1 The dynamics of PASI in psoriasis patients during treatment Index Gr. Before treatment 7 day of treatment 14 day treatment 21 days of treatment 28 day of treatment PASI one 32.0 ± 8.0 29.6 ± 7.7 20.1 ± 7.2 * 7.9 ± 4.3 ** 5.2 ± 1.1 2 33.0 ± 8.0 32.1 ± 7.4 27.2 ± 7.0 19.7 ± 6.2 8.6 ± 3.2 Note: a significant difference between the groups: * - p <0.05; ** - p <0.01, *** - p <0.001.

During treatment, we observe a positive dynamics in the psychological state of patients with psoriasis in both groups, more pronounced in the group of patients who received complex treatment. After 7 days, the level of attention increases, the number of somatic complaints decreases; after treatment, the level of depression and the number of somatic complaints are reduced. Moreover, in the group of patients who received standard therapy, after treatment, a reduced level of confidence remained compared with the group of healthy ones (p <0.05), increased level of depression and the number of complaints (Tables 2, 3).

table 2 The dynamics of the psychological state of patients with psoriasis (group 1) during treatment (M ± m) Indicator Units rev. Patients with psoriasis (1 group) (n = 22) Healthy (n = 30) Before treatment 7 day of treatment After treatment Pep point 5.2 ± 0.2 5.2 ± 0.3 5.3 ± 0.3 5.3 ± 0.2 Interest point 4.0 ± 0.3 * 4.9 ± 0.2 5.2 ± 0.2 5.2 ± 0.3 Mindfulness point 5.1 ± 0.2 * 5.8 ± 0.2 6.1 ± 0.2 6.1 ± 0.2 Mood point 5.7 ± 0.2 5.7 ± 0.1 5.8 ± 0.2 5.8 ± 0.1 Feeling well point 5.1 ± 0.2 * 5.9 ± 0.2 6.3 ± 0.3 6.3 ± 0.2 Calm point 5.5 ± 0.1 5.7 ± 0.3 5.7 ± 0.2 5.7 ± 0.1 Confidence point 2.1 ± 0.2 ** 5.9 ± 0.2 6.3 ± 0.3 6.3 ± 0.2 Psychological comfort point 36.5 ± 0.7 * 38.2 ± 1.3 40.6 ± 1.2 40.7 ± 0.6 Complaints qty 2.2 ± 0.3 # * 1.8 ± 0.4 1.4 ± 0.3 1.4 ± 0.2 Situational anxiety point 41.2 ± 3.2 40.9 ± 1.2 40.5 ± 1.3 40.5 ± 0.7 Personal anxiety point 43.4 ± 3.3 42.9 ± 1.1 42.5 ± 1.2 42.5 ± 0.5 Depression scale point 44.6 ± 1.6 42.2 ± 1.2 41.3 ± 1.2 41.2 ± 1.5

Table 3 The dynamics of the psychological state of patients with psoriasis (group 2) during treatment (M ± m) Indicator Units rev. Patients with psoriasis (group 2) (n = 30) Healthy (n = 30) Before treatment 7 day of treatment After treatment Pep point 5.1 ± 0.2 5.1 ± 0.3 5.2 ± 0.3 5.3 ± 0.2 Interest point 4.1 ± 0.3 * 4.2 ± 0.2 5.0 ± 0.2 5.2 ± 0.3 Mindfulness point 5.0 ± 0.2 * 5.3 ± 0.2 * 5.8 ± 0.2 6.1 ± 0.2 Mood point 5.8 ± 0.3 5.7 ± 0.1 5.8 ± 0.1 5.8 ± 0.1 Feeling well point 5.0 ± 0.3 * 5.0 ± 0.2 * 6.0 ± 0.2 6.3 ± 0.2 Calm point 5.5 ± 0.1 5.5 ± 0.3 5.6 ± 0.3 5.7 ± 0.1 Confidence point 2.2 ± 0.2 ** 2.4 ± 0.2 ** 4.0 ± 0.2 * 6.3 ± 0.2 Psychological comfort point 36.7 ± 0.7 * 36.8 ± 1.2 * 38.3 ± 1.4 40.7 ± 0.6 Complaints qty 2.2 ± 0.4 # * 2.0 ± 0.4 # * 1.9 ± 0.4 1.4 ± 0.2 Situational anxiety point 41.0 ± 3.3 41.1 ± 1.3 40.9 ± 1.2 40.5 ± 0.7 Personal anxiety point 43.5 ± 3.2 43.3 ± 1.2 43.0 ± 1.1 42.5 ± 0.5 Depression scale point 44.5 ± 1.6 44.0 ± 1.2 43.2 ± 1.3 41.2 ± 1.5 Note: a significant difference between the groups: * - p <0.05; ** - p <0.01, *** - p <0.001

During treatment, there was a positive dynamics of the state of the autonomic nervous system of patients with psoriasis in both groups, more pronounced in the group of patients receiving complex treatment. Already after 7 days and after treatment, the indicators of variational pulsometry, spectral analysis of the heart rhythm caused by the skin autonomic potential significantly change. The nature of these changes indicates the normalization of the state of the autonomic nervous system - a decrease in increased central ergotropic and humoral influences and parasympathetic activity (Table 4 and Table 5).

Table 4 Dynamics of physiological parameters of patients with psoriasis (group 1) during treatment (M ± m) Indicator Units rev. Patients with psoriasis (1 group) (n = 22) Healthy (7 group) (n = 30) Before treatment 7 day of treatment After treatment Sdnn ms 53.6 ± 5.2 * 56.7 ± 3.1 58.7 ± 3.2 59.8 ± 5.3 AMo % 35.2 ± 4.1 # * 37.9 ± 4.0 * 44.9 ± 4.3 46.0 ± 4.0 IWR cu 86.2 ± 7.7 ** 114.3 ± 6.4 * 143.4 ± 6.3 148.2 ± 29.1 IN cu 50.8 ± 4.8 *** 104.2 ± 4.1 * 127.3 ± 4.2 131.0 ± 10.0 NF. not. 58.3 ± 5.8 # *** 44.6 ± 3.6 # * 33.4 ± 3.6 * 29.0 ± 3.0 Heart rate. beats / m 89.2 ± 2.3 ** 86.4 ± 2.4 * 83.4 ± 2.2 * 75.2 ± 2.5 GARDEN Hg 106.5 ± 4.1 * 104.5 ± 2.3 * 101.3 ± 2.4 97.8 ± 1.6 TRO. ms 1338.2 ± 330.5 * 1547.3 ± 169.7 1747.3 ± 158.7 1897.2 ± 167.3 TRK. ms 3527.4 ± 817.5 * 3006.7 ± 462.7 2716.1 ± 432.1 2304.1 ± 371.4 VLFo. % 51.2 ± 4.1 * 47.2 ± 1.3 * 42.3 ± 1.2 40.9 ± 1.5 Lfo. % 41.5 ± 3.6 * 43.7 ± 3.1 * 48.7 ± 3.2 50.5 ± 3.2 S1 p. from 0.77 ± 0.05 * 0.73 ± 0.05 * 0.69 ± 0.05 0.63 ± 0.06 A2 p. mV 1.62 ± 0.18 *** 1.98 ± 0.06 * 2.57 ± 0.07 * 3.16 ± 0.24 S2 p. from 0.97 ± 0.05 * 1.19 ± 0.15 * 1.35 ± 0.14 1.41 ± 0.10

Table 5 Dynamics of physiological parameters of patients with psoriasis (group 2) during treatment (M ± m) Indicator Units rev. Patients with psoriasis (group 2) (n = 30) Healthy (7 group) (n = 30) Before treatment 7 day of treatment After treatment Sdnn ms 53.8 ± 5.1 * 54.3 ± 2.2 * 55.6 ± 3.2 59.8 ± 5.3 AMo % 35.1 ± 4.2 # ** 36.2 ± 4.3 # * 37.1 ± 4.1 # * 46.0 ± 4.0 IWR cu 86.0 ± 7.8 ** 98.2 ± 7.7 ** 116.2 ± 6.8 * 148.2 ± 29.1 IN cu 50.7 ± 4.8 *** 65.1 ± 4.3 # *** 99.2 ± 4.2 # ** 131.0 ± 10.0 NF. not. 58.2 ± 5.9 # *** 49.1 ± 3.2 # ** 39.5 ± 3.4 # * 29.0 ± 3.0 Heart rate. beats / m 89.3 ± 2.4 ** 89.4 ± 2.5 ** 88.5 ± 2.3 * 75.2 ± 2.5 GARDEN. Hg 106.6 ± 4.2 * 105.7 ± 2.3 ** 103.8 ± 2.3 * 97.8 ± 1.6 TRO. ms 1340.4 ± 321.4 * 1365.6 ± 178.3 * 1565.6 ± 164.9 1897.2 ± 167.3 TRK. ms 3547.7 ± 837.4 * 3345.4 ± 474.5 * 3108.7 ± 472.6 * 2304.1 ± 371.4 VLFo. % 51.3 ± 4.2 * 50.8 ± 1.4 * 47.3 ± 1.4 * 40.9 ± 1.5 Lfo. % 41.5 ± 3.6 * 41.8 ± 3.2 * 42.4 ± 3.1 * 50.5 ± 3.2 S1 p. from 0.76 ± 0.04 * 0.76 ± 0.05 * 0.74 ± 0.05 * 0.63 ± 0.06 A2 p. mV 1.61 ± 0.19 *** 1.77 ± 0.05 * 2.17 ± 0.06 * 3.16 ± 0.24 S2 p. from 0.98 ± 0.06 * 1.02 ± 0.15 * 1.12 ± 0.14 * 1.41 ± 0.10 Note: a significant difference between the groups: * - p <0.05; ** - p <0.01, *** - p <0.001.

Thus, as a result of complex treatment of patients with psoriasis using phenibut and trittiko, the treatment time is reduced by 7 days, the normalization of the psychological state and autonomic imbalance is reduced by 14 days. In the long-term period, remission for more than a year in the group receiving complex treatment was observed in 72.4% of patients, with the standard treatment regimen - in 41.3% (p <0.05). In addition to the indicated advantages of the proposed treatment method in the form of increasing effectiveness, eliminating treatment complications, reducing treatment duration and reducing the recurrence rate of the disease, it is necessary to take into account the improvement in the quality of life of patients due to recovery, psychophysiological state.

Claims (1)

The use of a “daytime” phenibut tranquilizer and antidepressant, a selective trittico serotonin reuptake inhibitor, in the treatment of psoriasis.