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1.
Contemp Clin Trials ; 123: 106970, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36280033

RESUMO

INTRODUCTION: Imaging-confirmed uncomplicated acute appendicitis can be effectively and safely treated with antibiotics in most adults and children. Symptomatic treatment may have similar efficacy and safety. METHODS AND ANALYSIS: The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. INCLUSION CRITERIA: 1) age ≥ 7 and < 16 years, 2) imaging-confirmed uncomplicated acute appendicitis and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency laparoscopic appendectomy or symptomatic treatment. To ensure patient safety, symptomatically treated patients are hospitalized for at least 24 h receiving standard practice intravenous fluids and analgesics according to standard clinical practice. Primary outcome is 30-day treatment success defined by the absence of any treatment failure criteria. In appendectomy, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In symptomatic treatment, treatment failure is defined as 1) inability for hospital discharge without appendectomy within 48 h after randomization with a finding of histopathologically inflamed appendix, 2) appendectomy during the initial hospital stay due to clinical progression of appendicitis with complicated acute appendicitis both histopathologically and surgically, 3) appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or 4) any complication of appendicitis requiring general anesthesia. Detailed predefined secondary outcomes will be analyzed. ETHICS AND DISSEMINATION: Study was approved by Ethics Committee of Helsinki University Hospital (ID:HUS/1993/2021), conducted in compliance with the declaration of Helsinki with results disseminated in peer-reviewed scientific journals. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05289713).


Assuntos
Apendicectomia , Apendicite , Adulto , Humanos , Criança , Adolescente , Apendicectomia/efeitos adversos , Apendicectomia/métodos , Apendicite/diagnóstico por imagem , Apendicite/cirurgia , Projetos Piloto , Estudos de Viabilidade , Doença Aguda , Antibacterianos/uso terapêutico , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
2.
Children (Basel) ; 10(1)2022 Dec 29.
Artigo em Inglês | MEDLINE | ID: mdl-36670622

RESUMO

Symptomatic congenital pulmonary malformations (CPMs) are a group of anomalies involving the lungs. The long-term outcomes of these patients are not well known. The present research aimed to study the pulmonary function, respiratory morbidity, and health-related quality of life (QoL) of patients treated for CPMs. All children (<16 years of age) treated for CPMs in 2002−2012 (in Oulu University Hospital) were invited to the follow-up visit. Altogether, there were 22 patients, out of which 17 (77%) participated. The mean follow-up time was 6.6 (ranged from 3 to 16) years. Pulmonary function tests, diffusing capacity, respiratory morbidity, and QoL were determined as the primary outcomes. Potential residual malformations and lung anatomy were investigated using computer tomography (CT) imaging. The outcomes were compared to the age- and sex-matched healthy controls. The forced expiratory volume at 1 s (FEV1, Z-score) remained lower in operated patients compared to the healthy controls (−1.57 ± SD 1.35 vs. −0.39 ± SD −0.86, p-value 0.005). There were no differences in respiratory morbidity or QoL between the patients and the controls. The surgical approach (lobectomy vs. partial resection) did not affect lung function. A younger age (<1 year of age) at the time of the surgery seemed to result in a higher lung capacity, but the finding was not statistically significant. Patients with CPMs treated with surgery were satisfied with their wellbeing in the long-term. A lower lung function did not have an impact on their wellbeing. However, there was a slight decrease in lung function compared to the healthy controls, and a clinical follow-up of the patients was recommended.

3.
Arch Environ Contam Toxicol ; 44(4): 467-75, 2003 May.
Artigo em Inglês | MEDLINE | ID: mdl-12712277

RESUMO

Uptake, biotransformation, and elimination rates were determined for pentachlorophenol (PCP), methyl parathion (MP), fluoranthene (FU), and 2,2',4,4',5,5'-hexachlorobiphenyl (HCBP) using juvenile Hyalella azteca under water-only exposures. A two-compartment model that included biotransformation described the kinetics for each chemical. The uptake clearance coefficients (k(u)) were 25.7 +/- 2.9, 11.5 +/- 1.1, 184.4 +/- 9.3, and 251.7 +/- 9.0 (ml g(-1) h(-1)) for PCP, MP, FU, and HCBP, respectively. The elimination rate constant of the parent compound (k(ep)) for MP was almost an order of magnitude faster (0.403 +/- 0.070 h(-1)) than for PCP and FU (0.061 +/- 0.034 and 0.040 +/- 0.008 h(-1)). The elimination rate constants for FU and PCP metabolites (k(em)) were similar to the parent compound elimination 0.040 +/- 0.005 h(-1) and 0.076 +/- 0.012 h(-1), respectively. For MP, the metabolites were excreted much more slowly than the parent compound (0.021 +/- 0.001 h(-1)). For PCP, FU, and MP whose metabolites were measured, the biological half-life (t(1/2p)) of the parent compound was shorter than the half-life for metabolites (t(1/2m)) because the rate is driven both by elimination and biotransformation processes. Thus, H. azteca is capable of metabolizing compounds with varying chemical structures and modes of toxic action, which may complicate interpretation of toxicity and bioaccumulation results. This finding improves our understanding of H. azteca as a test organism, because most biomonitoring activities do not account for biotransformation and some metabolites can contribute significantly to the noted toxicity.


Assuntos
Crustáceos/efeitos dos fármacos , Monitoramento Ambiental/métodos , Poluentes Químicos da Água/toxicidade , Animais , Biotransformação , Crustáceos/metabolismo , Monitoramento Ambiental/normas , Fluorenos/farmacocinética , Fluorenos/toxicidade , Metil Paration/farmacocinética , Metil Paration/toxicidade , Modelos Biológicos , Pentaclorofenol/farmacocinética , Pentaclorofenol/toxicidade , Bifenilos Policlorados/farmacocinética , Bifenilos Policlorados/toxicidade , Poluentes Químicos da Água/farmacocinética
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