To assess the bioequivalence of two zolpidem hemitartrate formulations in 30 healthy volunteers. Plasma samples were obtained over a 24 h period. Plasma concentrations of zolpidem were analyzed by liquid chromatography coupled to tandem mass spectrometry with positive ion electrospray ionization using multiple reaction monitoring. Values of peak concentration (Cmax), area under curve (AUC), half‐life, elimination constant, volume of distribution and clearance showed statistically significant differences when comparing women (604.34 ng h/ml, 127.36 ng/ml, 4.4 h, 0.18 1/h, 50.56 L and 8.55 L/h, respectively) and men (276.1 ng h/ml, 70.9 ng/ml, 3.3 h, 0.26 1/h, 91.42 L and 24.34 L/h, respectively), receiving the same dose (5 mg), respectively. The geometric means with corresponding 90% confidence interval for Test/Reference percentage ratios were 99.73% (CI 93.69–106.16) for Cmax, 97.44% (90% CI = 91.85–103.37%) for area under curve of plasma concentration until the last concentration observed (AUClast) and 98.30% (90% CI = 92.48–104.49) for the area under curve between the first sample (pre‐dosage) and infinity (AUC0–inf). Since the 90% CI for AUClast, AUC0–inf and Cmax ratios were within the 80–125% interval proposed by the US Food and Drug Administration, it was concluded that zolpidem hemitartrate formulation (5 mg orodispersible tablet) is bioequivalent to the zolpidem hemitartrate formulation (Patz SL 5 mg sublingual tablet) with regard to both the rate and the extent of absorption. A new formulation of zolpidem 2.5 mg may be useful in women for the same clinical benefits as the 5 mg formulation in men.
ABSTRACT. Attention deficit hyperactivity disorder (ADHD) is one of the most frequent childhood psychiatric problems. Objective: The objective of this study was to identify, synthesize the results, and critically evaluate all Cochrane systematic reviews (SRs) on the pharmacological interventions for children and adolescents (up to age 18) diagnosed with ADHD. Methods: The search was performed in the Cochrane Database of Systematic Reviews (via Wiley) in July 2020. Results: The search strategy resulted in four SRs of high methodological quality, analyzing 51 randomized clinical trials (9,013 participants). Compared to placebo, treatment with tricyclic antidepressants (TCAs) (desipramine), amphetamine, and methylphenidate showed improvement in symptoms such as difficulty concentrating, impulsivity, and hyperactivity in the short term (up to 6 months). There was an increase in the occurrence of adverse events, such as reduced appetite, difficulty sleeping, and abdominal pain. Insufficient evidence was found to support the effects of supplementation with polyunsaturated fatty acids. Conclusions: The use of TCAs, amphetamine, and methylphenidate in children and adolescents with ADHD seems to present positive effects and higher rates of minor adverse events when compared to placebo.
Ao longo dos anos foram implantados diversos programas odontológicos para atendimento a bebês em vários municípios no Brasil. A efetividade desses programas precisa ser mensurada por meio da avaliação do impacto na saúde bucal das crianças que passaram por essa experiência. Objetivo: Verificar a presença de lesões de cárie na dentição mista em crianças de 6 a 12 anos, que tiveram atendimento precoce no Programa de Atenção Odontológica de Bebês (PAOB), quando tinham a faixa etária de 0 – 3 anos, comparando os resultados com um grupo controle não exposto ao tratamento preventivo, no serviço de Saúde Bucal da Unidade de Estratégia de Saúde da Família (ESF) São Bento, na cidade de Santos. Método: Estudo de Coorte Retrospectivo, onde foram coletados dados de 100 prontuários odontológicos das crianças, 50 de cada grupo. Foram realizados os procedimentos de estatística descritiva e análise estatística usando o teste de Fisher, para medir a correlação entre as variáveis. Resultados: Em relação aos dentes decíduos, 26% das crianças que participaram do PAOB, apresentaram lesões de cárie, enquanto no grupo não exposto, 60% das crianças apresentaram lesões de cárie. Já na avaliação da presença de lesões de cárie nos dentes permanentes, quase não houve diferença estatisticamente significante entre os dois grupos, 10% no grupo exposto ao tratamento precoce e 14% no grupo não exposto. Conclusão: Observou-se influência positiva do Programa de Atenção Odontológica de Bebês nas condições de saúde oral das crianças.
Objective: The objective of this research was to evaluate stress in teachers in the five areas of Education (Early Childhood Education, Elementary School I and II, High School and University). Methods: A total of 125 teachers from Baixada Santista, SP, Brazil, were included. Physical and psychological stress in the their lives were evaluated, using the Marilda Lipp Stress Symptom Inventory (lSSI) test. Symptoms were assessed in the first 24 hours, 1 week and after 1 month. It was applied remotely, in a single application, from April to June 2021. Results: Out of the total of 125 teachers, 92 had stress and 33 had no stress. Out of the 111 female participants, 84 had stress and 27 had no stress, whereas out of the 14 male participants, 8 had stress and 6 had no stress. Of the 92 participants that showed stress, 5 participants were in the Alert Phase, 49 participants were in the Resistance Phase and 38 participants were in the Exhaustion Phase. 39 participants had Physical symptoms, 5 participants had Psychological symptoms and 48 participants had both symptoms. Conclusion: It is important to reflect on the importance of stress prevention within educational institutions, aiming to provide a better quality of life for teachers.
The results from the present study do not confirm findings from other authors who had observed high levels of aggressive behavior in patients with MS. The authors are aware that exclusion of patients with moderate or severe disability, anxiety, or depression might have influenced the results.
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