[Teraligen in the complex treatment of anxiety-phobic, behavioral and depressive syndromes in children and adolescents with schizotypal disorder]. / Teralidzhen v kompleksnoi terapii trevozhno-fobicheskikh, povedencheskikh i depressivnykh narushenii u detei i podrostkov s shizotipicheskim rasstroistvom.

OBJECTIVE: To determine the frequency of prescribing and the main therapeutic targets of Teraligen in the treatment of Schizotypal disorder (STD) in childhood and adolescence. MATERIAL AND METHODS: The sample consisted of 151 patients aged 7 to 16 years with a diagnosis of STD (F 21), of which 31.1% (n=47) of female patients and 68.9% (n=104) of male patients who received inpatient or outpatient treatment at the FSBI NCPZ from 2008 to 2020. The study was conducted by clinical-psychopathological, clinical-catamnestic, and statistical methods. RESULTS: Teraligen was prescribed by psychiatrists to patients with STD in 74.2% of cases, of which in 46.4% of cases patients received Teraligen even before the diagnosis of STD in connection with complaints of neurotic disorders (anxiety, fears and sleep disorders) (n=30), as well as in connection with autistic-like behavior (n=22). At the time of follow-up, 55% (n=83) of patients received Teraligen, of which 63.9% (n=53) of patients were prescribed it for the first time. The applied schemes of prescribing Teraligen for the treatment of anxiety-phobic, depressive and behavioral syndromes within the framework of the STD in a relatively age-related aspect are presented. CONCLUSION: The high frequency of prescribing Teraligen by psychiatrists and neurologists to children and adolescents with STD at different stages of observation is shown, which reflects the confidence of specialists in this drug. Teraligen has demonstrated a multidimensional pharmacological effect, including a mild antipsychotic effect, providing reduction of a wide range of psychopathological symptoms, with good tolerability and drug interaction. The study of the possibilities of Teraligen, both for monotherapy and for augmentation of the treatment of mental pathology in childhood, remains relevant.

[Efficacy and safety studies review of Teraligen usage in psychiatric practice and general medicine]. / Obzor issledovanii effektivnosti i bezopasnosti primeneniya preparata Teralidzhen v psikhiatricheskoi praktike i obshchei meditsine.

OBJECTIVE: Determination of the dose-dependent effect of the Teraligen for various nosological forms of disorders in psychiatric practice and general medicine. MATERIAL AND METHODS: Analysis of 98 publications included in the database of the RISC (2012-2021) with the identification of disorders (according to ICD-10) in which Teraligen is prescribed or can be used (in adults and children from the age of 7). RESULTS: Despite a rather long and successful history use, research work on the study drug Teraligen continues. Currently Teraligen is widely and actively used by doctors of various specialties in the psychiatry, neurology, pediatrics, gerontology, internal medicine, gastroenterology, gynecology, cardiology, endocrinology and other disciplines. The drug is presented in several release forms: Teraligen 5 mg tablets; Teraligen retard 20 mg; Teraligen solution for intravenous injections. Teraligen is characterized by the following psychotropic effects: anxiolytic (++ - a distinct, moderately pronounced effect); sedative (++); hypnotic (++); antidepressant (+ - the effect is distinct, but expressed slightly and does not determine the drug main prescriptions spectrum); antipsychotic (± - the effect is weakly expressed and clinically insignificant when using conventional (5-80 mg/day) drug dosages). CONCLUSION: According to the authors, the main effect of the «small¼ neuroleptic/antipsychotic Alimemazine (Teraligen ) is primarily aimed at pathological anxiety and affective instability. Its use is possible in various age groups, as it has a fairly high safety. In addition, like other «small¼ neuroleptics/antipsychotics with a predominantly sedative effect, the drug can be used to correct neuroleptics-prolongs side effects with dominant manifestations in the form of anxiety, irritability and insomnia.

[Alimemazine in treatment of agitation in schizophrenia]. / Primenenie Alimemazina pri kupirovanii vozbuzhdeniya u bol'nykh shizofreniei.

OBJECTIVE: An analysis of the efficacy and safety of additional therapy of excitement with the injectable form of alimemazine during exacerbations of schizophrenia with psychomotor agitation, impulsivity, including dangerous behavior, irritability, conflict, hostility, aggressiveness, anxiety, sleep disturbances (insomnia). MATERIAL AND METHODS: Thirty patients, aged 18 to 65 years, with a diagnosis of «paranoid schizophrenia¼, established in accordance with the ICD-10 criteria, were studied. The patients received treatment with a second-generation antipsychotic and alimemazine (intramuscular injection solution) in daily dose from 25 mg to 150 mg during no more than 9 days. The patients were assessed with psychometric scales (PANSS, ABS, HARS and VAS) four times during the observation period. RESULTS AND CONCLUSION: During therapy with a combination of second-generation antipsychotics and alimemazine solution for intramuscular injection, a reliable (p<0.001) reduction in the severity of psychotic symptoms assessed with PANSS was achieved by 8-9 days (the average total score decreased by 30% relative to the initial level) that indicated the improvement in all manifestations of schizophrenia exacerbation. A decrease of 34.8% (p=0.007) in the risk of aggression (PANSS points S1-S3) was established. The level of excitation on the agitation scale (ABS) decreased by 3.6% (p<0.001). In 50% of patients, manifestations of anxiety disappeared, and the average HARS score decreased by 2.2 times compared with the initial level (p<0.001). Almost half of the patients noted the normalization of sleep, and the average value of sleep disturbance on a visual analogue scale decreased threefold compared with the initial level (p<0.001). The observed adverse events were moderate or mild. Alimemazine shows the highest efficacy in the treatment of anxiety arousal in patients with schizophrenia with affective-delusional attacks.

[The safety and efficacy of alimemazine (teraligen) in relieving anxiety in patients with alcohol addiction]. / Éffektivnost' i bezopasnost' primeneniia preparata alimemazin (teralidzhen) dlia kupirovaniia trevogi u patsientov s sindromom zavisimosti ot alkogolia.

AIM: To assess the efficacy of monotherapy of anxiety in alcoholism with alimemazine (teraligen). MATERIAL AND METHODS: Thirty-six patients with alcohol addiction were treated with alimemazine in dose 15 mg during 9 month. In control group (11 patients) teraligen was no used. RESULTS AND CONCLUSION: A significant positive effect of treatment with teraligen was observed. There were the improvement in alcohol addiction course, decrease in scores on the Addiction Severity Index (ASI) from severe to mild level and decrease in trait and state anxiety measured with the Spielberger-Khanin scale from high to low levels. The reduction on symptoms of depression from moderate (at baseline) to subdepressive levels on the Beck Depression Inventory was noted in the end of treatment.

Are antihistamines effective in children? A review of the evidence.

BACKGROUND AND AIMS: During the last decades, much attention has been paid to off-label and unlicensed prescriptions in paediatrics. However, on-label prescribing can also cause health issues. In this paper, the case of first-generation H1-antihistamines is investigated, notably the range of indications for which products are licensed in different European countries and the evidence base (or lack thereof) for each indication, as well as reported adverse drug reactions. METHODS: Review of the Summary of Product Characteristics of first-generation H1-antihistamines with a focus on paediatric use. This is plotted against the evidence available in the literature. RESULTS: This investigation shows a large variability in labelled indications and licensing ages when compared in five different European countries. Moreover, most of the indications are not based on clinical trials evaluating efficacy and safety of these drugs in children. CONCLUSIONS: Many of the licensed indications of first-generation antihistamines do not appear to be evidence based.

[The multicenter non-interventional, prospective observational program on the study of practical use of teraligen in patients diagnosed with autonomic disorder (START2): a local Russian experience with the use of the Russian version of The Four-Dimensional Symptom Questionnaire (4DSQ). An intermediate analysis].

AIM: To develop a new instrument able to identify pathological states and assess their changes during medication treatment. We aimed to study the typical practice of using alimemazine (teraligen) in patients with the diagnosis of autonomic nervous system disorder and to test the Russian version of @The Four-Dimensional Symptom Questionnaire@ (4DSQ) for measuring distress, depression, anxiety and somatization. MATERIAL AND METHODS: We examined 3053 patients (mean age 42.09 ± 11.71 years) who received teraligen in doses gradually increasing from 5 to 15 mg per day. The observational program was carried out in over 600 outpatient clinics of the Russian Federation. The 4DSQ was administered before treatment and 4 weeks after treatment. The Clinical Global Impression (CGI) scale was used before, during (after 2 weeks) and after (4 weeks) treatment with teraligen. RESULTS AND CONCLUSION: There was a significant improvement of patient's state assessed both by physicians (CGI scale) and by patients (96 and 98%, respectively). The 4DSQ was sensitive to the parameters of response to treatment with teraligen: parameters obtained at baseline and 4 weeks after the beginning of treatment differed significantly demonstrating a significant decrease in distress, anxiety and somatization.

[The efficacy and safety of teraligen in patients with brain ischemia, stages I and II, and psychoautonomic syndrome].

OBJECTIVE: To assess the efficacy and safety of teraligen in patients with psychoautonomic syndrome comorbid to brain ischemia. MATERIAL AND METHODS: Forty-five patients, aged from 42 to 65 years (mean age 56 years), diagnosed with brain ischemia, stages I and II, with the signs of psychoautonomic syndrome were examined. Thirty-five patients received teraligen in the daily dose of 15 mg. The control group comprised 10 patients who were not treated with this drug. The duration of treatment was 60 days. Neurological status, autonomic changes, cognitive functions and mental state were assessed during the treatment. Neurophysiological examination (EEG and P300 event-related potential) were performed in the first and last visits. RESULTS AND CONCLUSION: The distinct positive dynamics of the decrease of psychoautonomic symptoms, cephalgic syndrome, sleep normalization as well as the improvement of cognitive function were noted. Good tolerability and no side-effects, in particular, those related to vascular disorders, were demonstrated. Clinical results were supported by the results of neurophysiological examinations. The drug can be recommended for treatment of psychoautonomic syndrome in elderly patients with brain ischemia, stages I and II.

Case report of atopic dermatitis with refractory pruritus markedly improved with the novel use of clonidine and trimeprazine.

We report a 6-year-old boy with severe atopic dermatitis and refractory pruritus. The novel use of clonidine, an adrenergic agonist, along with trimeprazine, led to dramatic improvement. This represents the first case report of clonidine's effect in relieving pruritus in atopic dermatitis.

Guía de práctica clínica sobre trastornos del sueño en la infancia y adolescencia en atención primaria / Clinical practice guide on sleep disorders in childhood and adolescence in primary care

Orientar a los profesionales sanitarios del ámbito de Atencion Primaria (AP) en el reconocimiento de los problemas y trastornos del sueño en la infancia y adolescencia, y sobre todo, en la selección de recomendaciones basadas en la evidencia científica disponible, de las intervenciones terapéuticas para el manejo de los pacientes.

Influence of comedication on serum concentrations of aripiprazole and dehydroaripiprazole.

Aripiprazole, a relatively new antipsychotic drug, is metabolized by cytochrome P450 3A4 (CYP3A4) and CYP2D6 to an active metabolite, dehydroaripiprazole. As studies on pharmacokinetic drug interactions with aripiprazole are so far limited, the aim of the present study was to investigate the impact of comedication on serum concentrations of aripiprazole and dehydroaripiprazole in psychiatric patients in a clinical setting. A therapeutic drug monitoring database was screened for patients receiving aripiprazole tablets as part of their treatment. Of the 361 samples included, 78% were from patients receiving comedication. The remaining 79 samples constituted the control group. Steady-state dose-adjusted serum concentrations (concentration to dose ratios, C:D ratios) of aripiprazole, dehydroaripiprazole and the sum of aripiprazole and dehydroaripiprazole, and the metabolic ratio (dehydroaripiprazole/aripiprazole) in the different comedication groups were compared with controls. Coadministration of a CYP3A4 inducer resulted in approximately 60% lower mean C:D ratios of aripiprazole, dehydroaripiprazole, and the sum of aripiprazole and dehydroaripiprazole (P < 0.05, P < 0.01, and P < 0.01, respectively). Combination with a CYP2D6 inhibitor resulted in a 45% higher mean C:D ratio of aripiprazole (P < 0.05), with no effect on the C:D ratio of dehydroaripiprazole. When aripiprazole was coadministered with alimemazine or lithium, a 56% (P < 0.01) and 43% (P = 0.05) higher mean C:D ratio of aripiprazole, respectively, was observed. Olanzapine, risperidone injections, escitalopram, or lamotrigine also had statistically significant effects on aripiprazole disposition but to a lesser extent. In conclusion, concurrent treatment with CYP3A4 inducers, CYP2D6 inhibitors, alimemazine, or lithium resulted in changes in the systemic exposure of aripiprazole between 40% and 60%. This is of such a magnitude that dose adjustments of aripiprazole may be required.

Behavioral treatment of bedtime problems and night wakings in infants and young children.

This paper reviews the evidence regarding the efficacy of behavioral treatments for bedtime problems and night wakings in young children. It is based on a review of 52 treatment studies by a task force appointed by the American Academy of Sleep Medicine to develop practice parameters on behavioral treatments for the clinical management of bedtime problems and night wakings in young children. The findings indicate that behavioral therapies produce reliable and durable changes. Across all studies, 94% report that behavioral interventions were efficacious, with over 80% of children treated demonstrating clinically significant improvement that was maintained for 3 to 6 months. In particular, empirical evidence from controlled group studies utilizing Sackett criteria for evidence-based treatment provides strong support for unmodified extinction and preventive parent education. In addition, support is provided for graduated extinction, bedtime fading/positive routines, and scheduled awakenings. Additional research is needed to examine delivery methods of treatment, longer-term efficacy, and the role of pharmacological agents. Furthermore, pediatric sleep researchers are strongly encouraged to develop standardized diagnostic criteria and more objective measures, and to come to a consensus on critical outcome variables.

Effectiveness of alimemazine in controlling retching after Nissen fundoplication.

BACKGROUND: Retching, an early component of the emetic reflex, is a common and distressing symptom in children after Nissen fundoplication. Alimemazine (trimeprazine, Vallergan; Castlemead, Herts, UK) is a phenothiazine derivative histamine(1) antagonist, which anecdotally relieves the retching symptoms. MATERIAL AND METHODS: A prospective, double-blind, randomized, crossover, placebo-controlled study of 15 neurologically impaired children with retching after Nissen fundoplication over a period of 1 year (December 2002-December 2003). Patients were randomly allocated to receive 1 week each of alimemazine and placebo with crossover. A diary was maintained of retching episodes 1 week before, during, and 1 week after the trial. Dosage of alimemazine used was 0.25 mg/kg 3 times a day (maximum, 2.5 mg per dose). Statistical analysis was done using a paired Student's t test, where P value of less than .05 was considered significant. Results are presented as mean +/- SD. RESULTS: Twelve parents completed the diaries (9 open, 3 laparoscopic Nissen fundoplication). Median age of the child was 36 months (8-180 months), median duration of retching was 4.5 months (1-52 months), and mean number of retching episodes per week was 60 +/- 29.40. Mean number of retching episodes with alimemazine was 10.42 +/- 9.48 vs 47.67 +/- 27.79 with a placebo (P < .0001). No adverse effects were reported in those cases that completed the study. CONCLUSION: At low dose, alimemazine (Vallergan) is a safe and effective drug in the management of retching after Nissen fundoplication.

[Methadone and sleep apnea syndrome]. / Méthadone et syndrome d'apnées du sommeil.

BACKGROUND: Sleep apnea syndrome occurs when, during sleep, breathing stops for 10 seconds or longer, with an index of 5 times or more an hour. It is clinically characterized by loud snoring at night, continuous or interrupted by pauses followed by loud breathing. Sleep is fitful, broken by arousals, and yields little rest. There is daytime excessive sleepiness with repeated involuntary falling asleep, often unknown by the subject. CLINICAL DESCRIPTION: In this article, we describe an observation of central sleep apnea syndrome in a female patient receiving an opiate replacement therapy. METHOD: An analysis of the before and after methadone withdrawal polysomnograhic tracing was done for this patient. RESULTS: This diagnosis etiology and physiopathology are critically approached. Clinicians should be careful in treating induced sleep disorders in such patients. CONCLUSION: Prescribing benzodiazepines during an opiate withdrawal of the methadone type is not recommended when central apnea occurs.

A new powerful antibacterial synergistic combination of trimethoprim and trimeprazine.

The antihistaminic phenothiazine trimeprazine (Tz) was found to exhibit significant antibacterial activity on the basis of in vitro and in vivo tests. For the study of synergism due to a combination between Tz and trimethoprim (Tm), drug soaked filter paper discs were placed on young culture lawns of sensitive bacteria on nutrient agar plates. Calculation of the area of inhibition zones for determining the degree of synergism between Tz and Tm showed the increase to be statistically significant (p<0.01) when compared with their individual effects. By the checkerboard assessment procedure, the fractional inhibitory concentration (FIC) index was found to be 0.18, confirming synergism. The protective capacity of this combination was then assessed in Swiss white mice using S. typhimurium as the challenge bacterium, and the level of bacterial load was determined from infected autopsied animals. Statistical analysis of the data by students 't' test finally proved that a combination of Tz+Tm was highly synergistic.

[Value of trimeprazine among hypnotics in a psychiatric facility]. / Place de l'alimémazine parmi les hypnotiques dans un établissement de soins psychiatriques.

Trimeprazine (TPZ) has been marketed in France since 1959, as tablets and solution containing respectively 5 mg and 40 mg/ml. TPZ is a phenothiazine derivative with known antihistaminic and sedative effects. The first approved indication for TPZ is in the treatment of allergy. However, its frequent sedative effects are undesirable in this indication. The second approved indication is in the treatment of insomnia (5-20 mg/day) and TPZ is an alternative to conventional hypnotics as diazepam, flunitrazepam, zolpidem, butobarbital... Due to the prescription frequency of this medicine in our hospital, we analyzed the naturalistic prescriptions mode and the clinical end point in patients hospitalized for mental illness. On the one hand, using the hospital prescription software, we analyzed: prescriptions frequency, dose regimen and drug associations with hypnotics, anxiolytics and sedative antipsychotics. On the other hand, we came into contact with physicians in order to know their opinion on TPZ and the whole point of that indication. The results showed a very high prescription frequency (139/400 patients; 35%), a marked increase in dose compared to those approved by the French Drug Administration (5-20 mg/day: 5%; 20-200 mg/day: 95%) and main drug association with hypnotics, tranquilizers or antipsychotics, respectively 38%, 65% and 91%. Clinical end points are: non addictive properties and an easily adequation of posology for the drinkable drop form in contrast with tablets. Thus, TPZ appears as a first-line hypnotic in spite of its adverse effects common to phenothiazine (atropinic and antidopaminergic effects) and is a usefull medicine for the treatment of insomnia in psychotic patients.

A multiple-baseline, double-blind evaluation of the effects of trimeprazine tartrate on infant sleep disturbance.

Infant sleep disturbance involving chronic night waking and resistance to settling to sleep or returning to sleep is a common problem for families with children 6-27 months old. Prescription and nonprescription sedatives are frequently administered without clear evidence that they are effective as either long-term or short-term palliatives. Trimeprazine tartrate, administered either 15 mg/5 mL or 30 mg/5 mL, was compared with both baseline and placebo in a multiple-baseline-across participants, double-blind study. No clinically significant effects of the low dose were detected, whereas the effects of the high dose were not consistently replicated across nor within participants. During active drug treatment, only 2 of 12 children achieved Sleep Behaviour Scale scores indicative of nonproblem sleep. Trimeprazine tartrate is not recommended as a pharmacological treatment for infant sleep disturbance unless as an adjunct to a behavioral therapy program.