Клиническая эффективность смеси на основе козьего молока у детей первого года жизни с аллергией к белкам коровьего молока (Пособие для врачей)

Purpose/background A recent years' increase in both prescribing and availability of second-generation antipsychotics (SGAs) has been observed. According to the literature, typically made up by case studies/series, quetiapine seems to be the most commonly misused SGA, with both intranasal and intravenous intake modalities having been described. Another SGA that has been anecdotally reported to be misused is olanzapine. For these molecules, both a previous history of drug misuse and being an inmate have been described as factors associated with misuse. Hence, while providing here an updated literature review of the topic, we aimed at assessing all cases of quetiapine misuse/abuse/dependence/withdrawal as reported to the European Medicines Agency's EudraVigilance (EV) database; this was carried out in comparison with the reference drug olanzapine. Methods All spontaneous, European Medicines Agency database reports relating to both quetiapine (2005-2016) and olanzapine (2004-2016) misuse/abuse/dependence/withdrawal issues were retrieved, and a descriptive analysis was performed. Results From the EV database, 18,112 (8.64% of 209,571) and 4178 (7.58% of 55,100) adverse drug reaction reports of misuse/abuse/dependence/withdrawal were associated with quetiapine and olanzapine, respectively. The resulting proportional reporting ratio values suggested that the misuse/abuse-, dependence-, and withdrawal-related adverse drug reactions were more frequently reported for quetiapine (1.07, 1.01, and 5.25, respectively) in comparison with olanzapine. Conclusions Despite data collection limitations, present EV data may suggest that, at least in comparison with olanzapine, quetiapine misuse may be a cause for concern.

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Is There a Potential of Misuse for Quetiapine?: Literature Review and Analysis of the European Medicines Agency/European Medicines Agency Adverse Drug Reactions' Database

Opioid agonist therapy using methadone, an effective treatment of opioid use disorders (OUD) for people who inject drugs (PWID), is recommended by the World Health Organization as essential to curtail the growing HIV epidemic. Yet, despite increasing prevalence of OUD and HIV, methadone therapy has not yet been implemented in Russia. The aim of this modeling study was to estimate the cost-effectiveness of methadone therapy for Russian adults with a diagnosed OUD. We modeled the projected program implementation costs and estimated disability-adjusted life years (DALYs) averted over a 10-year period, associated with the provision of methadone therapy for a hypothetical, unreplenished cohort of Russian adults with an OUD (n = 249,000), in comparison to the current therapies at existing addiction treatment facilities. Our model compared four distinct scenarios of treatment coverage in the cohort ranging from 3.1 to 55%. Providing methadone therapy to as few as 3.1% of adults with an OUD amounted to an estimated almost 50,000 DALYs averted over 10 years at a cost of just over USD 17 million. Further expanding service coverage to 55% resulted in an estimated almost 900,000 DALYs averted, at a cost of about USD 308 million. Our study indicated that implementing opioid agonist therapy with methadone to treat OUD at existing facilities in Russia is highly cost-effective.

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Implementation of methadone therapy for opioid use disorder in Russia – a modeled cost-effectiveness analysis

Engaging people who drink alcohol or inject drugs in HIV care can be challenging, particularly in Eastern Europe. Healthcare facilities in Russia are organized by specialty; therefore linking patients from addiction care to HIV hospitals has been difficult. The HIV care cascade outlines stages of HIV care (e.g., linkage to care, prescribed antiretroviral therapy [ART], and achieving HIV viral suppression). We hypothesized that unhealthy alcohol use, injection drug use, and opioid craving are associated with unfavorable HIV care cascade outcomes. We analyzed data from a cohort (n = 249) of HIV-positive Russians who have been in addiction hospital treatment in the past year and had a lifetime history of injection drug use (IDU). We evaluated the association between unhealthy alcohol use (AUDIT score > 7 [both hazardous drinking and dependence]), past-month injection drug use (IDU), and opioid craving (visual analogue scale from 1 to 100) with HIV care cascade outcomes. The primary outcome was linkage to HIV care within 12 months. Other outcomes were prescription of ART (secondary) and achievement of undetectable HIV viral load (HVL < 500 copies/mL) within 12 months (exploratory); the latter was analyzed on a subset in which HVL was measured (n = 48). We assessed outcomes via medical record review (linkage, ART) and serum tests (HVL). To examine the primary outcome, we used multiple logistic regression models controlling for potential confounders. Among 249 study participants, unhealthy alcohol use (n = 148 [59%]) and past-month IDU (n = 130 [52%]) were common. The mean opioid craving score was 49 (SD: 38). We were unable to detect significant associations between the independent variables (i.e., unhealthy alcohol use, IDU and opioid craving) and any HIV care cascade outcomes in unadjusted and adjusted analyses. In this cohort of HIV-positive Russians with a history of IDU, individual substance use factors were not significantly associated with achieving HIV care cascade milestones (i.e., linkage to HIV care; prescription for ART; or suppressed viral load). Given no detection of an association of cascade outcomes with recent unhealthy use of alcohol or injection drugs in this cohort, examining systemic factors to understand determinants of HIV care engagement for people with drug use would be important.

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Role of substance use in HIV care cascade outcomes among people who inject drugs in Russia

Что такое доказательная медицина? Определение понятия и исторические перс­ пективы Единого определения термина "доказатель­ ная медицина" не существует, и в литературе его можно встретить более чем в 10 вариантах. Наи­ более употребляемым и официальным опреде­ лением является формулировка, предложенная рабочей группой экспертов Evidence Based Me­ dicine Working Group в 1993 году: доказательная медицина (evidence based medicine) это раздел медицины, основанный на доказательствах, предполагающий поиск, сравнение, обобщение и широкое распространение полученных доказа­ тельств для использования в интересах больных. Также существуют более узкие и альтерна­ тивные подходы к определению данного терми­ на, например у Триши Гринхальх: доказательная медицина это усиление традиционных навыков клинициста в диагностике, лечении, профилак­ тике и других областях путем систематического формулирования вопросов и применения мате­ матических оценок вероятности и риска. Однако, несмотря на отсутствие единого определения понятия "доказательная медицина", разные авторы под этим термином понимают: • добросовестное, точное и осмысленное ис­ пользование результатов наиболее доказатель­ ных из существующих клинических исследо­ ваний для выбора методов лечения конкретных больных • гарантирование наиболее эффективного, безопасного и экономичного лечения, основан­ ного на самых надежных из доступных доказа­ тельств • сбор, интерпретацию и интеграцию надеж­ ных клинических данных, полученных в резуль­ тате сообщений пациентов, наблюдений специа­ листов и при проведении испытаний • технологию поиска, анализа, обобщения и применения медицинской информации, позволя­ ющую принимать оптимальные клинические ре­ шения • процесс непрерывного самоуправляемого обучения, позволяющий интегрировать наибо­ лее надежные из существующих доказательств с индивидуальным опытом • набор эволюционирующих принципов, стратегий и тактик в лечении • новую парадигму клинической медицины, отличающуюся от прежней меньшим воздейст­ вием субъективного фактора на выбор критериев диагностики и терапии и требующую от врача критической оценки мнений различных экспер­ тов и результатов клинических исследований • технологию получения достоверной и до­ казательной информации при осуществлении ис­ следований, начиная от доклинического уровня, заканчивая организацией и администрированием в здравоохранении. Таким образом, различные формулировки содержат общий конструктивный момент: по­ тенциальные возможности доказательной меди­ цины позволяют дополнить интуицию и квали­ фикацию врача, мнения авторитетных экспертов и рекомендации популярных руководств и спра­ вочников новейшей и достоверной информацией о наиболее эффективных, безопасных и эконо­ мичных современных подходах к лечению на го­ сударственном, региональном, популяционном, субпопуляционном и индивидуальном уровнях, способствуя выбору оптимального варианта ре­ шения в каждом конкретном случае. Кроме того, доказательная медицина не ограничивается то­ лько клиническими исследованиями лекарствен­ ных средств, ее принципы применимы к любой области медицины и подразумевают комплекс­ ный анализ всех материалов, использующихся при создании и усовершенствовании любой ме­ дицинской технологии. Под, медицинской техно­ логией понимается совокупность методов (прие­ мов, способов) лечения, диагностики, профилак­ тики, реабилитации, средства (нескольких средств), с помощью которых данный метод осу­ ществляется, а в некоторых случаях и способ по­ лучения средства, применяемого в данной техно­ логии (приказ Минздравсоцразвития No 6317).

Основы доказательной медицины: опыт преподавания в Кыргызстане

Aim A clinical and phenomenological comparative evaluation of addictions (alcoholism, drug addiction, sexual and tobacco dependence, pathological gambling) to develop integrative methods for the assessment of comparative performance profiles of addictive disorders. Material and methods One hundred and forty-six patients were examined using clinical, psychometric and statistical methods. Results and conclusion Addiction profiles were described and addictive potentials were compared. The most pronounced addictive symptoms were found in groups where the participants were addicted to drugs or to pathological gambling. The least pronounced symptoms were found in patients addicted to tobacco. Participants addicted to alcohol were in the middle range.

Addictions profiles as a tool for comparison of chemical and nonchemical dependencies

Approaches of psychiatrists and neurologists to the diagnosis and therapy of sleep disorders are analyzed. On the basis of studying of 37 patients, the phenomenon of «somnic anhedonia» is described. Data on the relationship between insomnia and various mental disorders are presented. Scientifically based schemes of therapy, in particular, with the application of etifoxine (stresam) are described.

Sleep disorders (insomnia) as a psychoneurological dilemma in the diagnosis and treatment

BACKGROUND For many years, clinical protocols for treatment of drug abuse patients and treatment standards in Russian Federation were not grounded on the principles of evidence-based medicine [1]. Recommendations for use of certain drugs were not accompanied by any indication of the level of credibility of the evidence supporting it. The appearance in 2014 of such indications in clinical recommendations can be considered a significant step forward for the science of addiction medicine [2]. OBJECTIVE To compare Russian evidence and practice in addiction medicines with international standards. METHODS Situation and literature analysis. RESULTS The analysis shows that in the wording of recommendations on the use of medicines, some were subject of serious methodological errors. For some drugs globally there is high quality evidence supporting effects of certain drugs globally, but this is not recognized in Russia. As a result, Russian standards of clinical care for the treatment of dependency syndrome are radically different to the standards of therapy, presented in the WHO recommendations. This is due both to the disregard of the meta-analyses presented in the Cochrane reviews and also to the specific bioethical preferences in drug treatment in Russia.It is known that there is no convincing data on the effectiveness and safety of antipsychotics in the treatment of alcohol dependence syndrome [3]. 13 randomized trials with a double blind placebo-controlled design involving 1593 patients assessing effects of amisulpride, aripiprazole, flupentixolum dekonoat, olanzapine, quetiapine, tiapride showed that antipsychotics do not result in abstinence, do not reduce abuse and do not stop craving in alcoholic patients: "Antipsychotics should not be used in patients with a primary diagnosis of dependence. Appointment of antipsychotics for the treatment of substance abuse disorders are contraindicated, since not only does it not improve the condition of patients, but it can even worsen the course of the disease, leading to a reduction in the duration and quality of the remission, and is fraught with serious side effects that threaten the health of patients."SSRI antidepressants indirectly improve the results of treatment of comorbid alcoholism in depressed patients, without affecting alcohol dependence per se. Also, there is currently no convincing evidence of the efficacy of anticonvulsants in the treatment of dependence syndrome, particularly alcohol.Despite the fact that traditional psychotherapeutic interventions remain widespread in practice, and treatment of alcohol dependence syndrome showed high efficiency, there is no convincing evidence for long-term benefits as opposed to short-term benefits.The Cochrane Review with data based on 146 scientific studies involving 21,404 patients confirmed the effectiveness of opioid receptor agonists in treatment of opioid dependence. This therapy showed a statistically significant reduction in the use of illegal drugs, HIV transmission and risky sexual behavior, and was significantly more effective compared to the conventional maintenance therapy with opioid receptor antagonists. In countries, where law prohibits prescribing and use of opioid agonists for opioid dependence treatment, the drugs of choice are antagonists.A meta-analysis of thirteen randomized placebo-controlled trials of oral form of naltrexone (1158 subjects), did not show any advantages of this type of treatment both for management and prevention of relapse compared with placebo [4]. Special studies also showed no inclination to reduce the use of opiates in patients receiving naltrexone [5]. However, studies carried out in Russia, showed the best results for daily intake of naltrexone after detoxification, which increased the duration of remission [6]. It was noted that the effect is associated with higher levels of adherence and family support in the examined population.An overview based on controlled clinical studies on the use of antipsychotic drugs (neuroleptics) in patients dependent on opioids revealed no evidence of effectiveness of this approach. It was concluded that the use of antipsychotics is justified only in the presence of co-morbid psychiatric problems in patients [7]. In a recent meta-analytic review on the use of atypical antipsychotics for off-label indications (off-label), there was a lack of data to support the effectiveness of their use in substance abuse [8, 9]. The effectiveness of anticonvulsants in the treatment of opioid dependence syndrome has not been proven.In connection with the above puzzling fact, for Russian standards of treatment (clinical guidelines) the level of credibility of the effectiveness of antipsychotics and antidepressants in treatment of substance abuse is assessed as A or B. This paradox raises the question of the methodology for determining the level of credibility of evidence. It should be noted that Russian recommendations for inclusion of certain drugs and therapies are based on sufficient consensus of experts rather than on the results of meta-analyses [2]. CONCLUSIONS This fact casts doubt on credibility and validity of scientific recommendations. Thus, one may say that Russian addiction medicine is not based on evidence, which is, in our view, erroneous and may impair the quality of care.

Paradoxes of evidence in Russian addiction medicine.

Neuropsychiatric presentations are observed in a substantial number of patients with amyotrophic lateral sclerosis (ALS). Severe behavioral disorders develop in ALS combined with frontotemporal dementia, which are considered to be a disease continuum. Psychiatric disorders in ALS with predominantly motor symptoms are less prominent and mostly presented with apathy. Psychiatric disorders in ALS by their origin could be psychogenic, reflecting the patients' reactions on severe disease, and organic, developing as a result of degeneration of central motor neurons and disconnection between fronto-subcortical and frontotemporal loops. An important role in the development of psychiatric disorders in ALS belongs to genetic factors, in particular to hexanucleotide expansion in the C9orf72 gene. During the first months after establishing the diagnosis of ALS, there is the high risk of developing depressive disorders, which in severe cases can lead to suicide. More research is needed in this area.

[Neuropsychiatric presentations of amyotrophic lateral sclerosis].

Methodological mistakes and contradictions in the Federal clinical recommendations on therapy of addictive disorders are analyzed. It is noted that the recommendations aren't based on the principles of evidence-based medicine; ignore achievements of world addiction medicine and necessity of using drugs with the proved efficacy; are accepted in the conditions of refusal of scientific collegiality; contradict the instructions on the use of medicines and contain a large number of controversial theoretical issues.

V D Mendelevich

Papers

Addictions profiles as a tool for comparison of chemical and nonchemical dependencies

Sleep disorders (insomnia) as a psychoneurological dilemma in the diagnosis and treatment

Paradoxes of evidence in Russian addiction medicine.

[Neuropsychiatric presentations of amyotrophic lateral sclerosis].

Methodological mistakes and contradictions in the ederal clinical recommendations on addiction medicine