For many reasons randomized clinical trials today can»t cope with the tasks set by modern health care, which was clearly demonstrated by the COVID-19 pandemic. This gave new impetus to the development of the RWD / RWE. It became obviously that in cases of impossibility, unethical and other reasons, new methods for obtaining high-quality evidence may be effectively used, and later can be used by decision-makers and organizations engaged in the assessment of health technologies.
Recently, the development of a methodology for obtaining evidence of clinical efficacy and safety of medical technologies based on the collection and analysis of real clinical practice data (real-world data; RWD; real-world evidence; RWE) has become extremely relevant. Different types of research are used in RWD/RWE. It must develop a unified methodology for conducting and approach the reliability of the results of such studies. One of these approaches is the ranking of the reliability of research results based on an assessment of the quality of the original data: patient populations, exposures, outcomes and confounding factors (interfering factors). Simultaneously, for an optimal assessment of reliability, the following should be considered: a description of the data sources implemented during the study; techniques used to transform them; the techniques used to make up for missing information in the collection of these data.
Аннотация. Нестероидные противовоспалительные средства широко применяются пациентами и медицинскими работниками, как на территории Российской Федерации, так и за рубежом. Несмотря на устоявшееся общественное мнение о безопасности данной группы лекарственных средств, их применение ассоциировано с токсическими реакциями. В настоящем исследовании проанализирована выгрузка национальной базы данных «Фармаконадзор» за 11 лет (за период с 2010 по 2020 г.) с определением основных представителей данного класса медикаментов, вызывающих нежелательные реакции. Для сравнения нескольких независимых выборок пациентов, получавших разные МНН группы НПВС, применялся ранговый анализ вариаций по Краскелу -Уоллису (Kruskel-Wallis ANOVA) с применением пакетов Microsoft Excel 2013, STATISTICA 10.0. На основании полученных результатов можно заключить, что основная доля нежелательных реакций (НР) ассоциирована с женским полом и применением метамизола натрия. Кроме того, зарегистрированы НР, окончившиеся летальным исходом, большая часть которых связана с применением парацетамола.
Aim -to investigate the role of the detoxification-associated stress on cognitive functions during early remission among HIV-positive patients with opioid use disorder.Material and methods. Prospective cohort study among HIV-positive patients with opioid use disorder (n=41) who admitted at the hospital for detoxification due to opioid withdrawal syndrome. Participants were assessed at four visits: Visit 0 -at hospital admission (Day 0); Visit 1 -the peak of withdrawal (Days 3-5); Visit 2 -at the end of detoxification therapy (Day 10-14) and Visit 3 -early remission (Days 21-40). We applied experimental psychological and clinical psychopathological methods, also laboratory assessment of plasma cortisol, dehydroepiandrosterone (DHEA) and dehydroepiandrosterone-sulfate (DHEA-S) levels was conducted.Results. The level of cortisol in plasma was elevated while DHEA-S level was decreased during whole period of observation. The intensity of cognitive impairment were gradually decreased over 3 weeks after detoxification compared to withdrawal treatment period (p<0.05). In regression model we found that increased ratio of cortisol to DHEA during withdrawal was associated with severe cognitive deficits during remission [regression coefficient (95% CI) = -1.2 (-2; -0.4)].
Conclusion.Our funding shown that cognitive impairment, including decreased information proceeding speed, learning and memory in HIV-positive patients remain during several weeks after opioid detoxification treatment. The study results suggested the hypothalamic pituitary adrenal system dysfunction which activated by the cessation of opioid use and withdrawal. We conclude that the neuroendocrine system was involved in the development of cognitive impairment in HIV-positive patients during opioid withdrawal syndrome.
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