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PURPOSE: Patients with primary open-angle glaucoma (POAG) are required to take long-term treatments with topical medications to halt disease progression. This cross-sectional survey aimed to describe the level of acceptance of Brazilian patients toward the long-term treatment with eyedrops and to find possible correlates of high acceptance. METHODS: POAG patients were recruited from the Glaucoma Service-Santa Casa of Sao Paulo, Sao Paulo, Brazil. Clinical and demographic data were retrieved from participants' electronic records. All patients answered the ACCEPT© questionnaire. This is a generic patient-reported outcome questionnaire specifically developed to assess patients' acceptance of long-term medications and not adherence. Summed scores and those for each domain were calculated to range from 0 to 100 with a higher score indicating greater acceptance. RESULTS: The sample comprised 96 patients with POAG. The mean age was 63.2 ± 8.9 years; 48 were male and 48 female; 55 (57.3%) were white, 36 (37.5%) African-Brazilian, and 5 (5.2%) were of mixed color; most patients (97.9%) had less than high school degree and all had a family income Assuntos
Glaucoma de Ângulo Aberto
, Glaucoma
, Humanos
, Masculino
, Feminino
, Pessoa de Meia-Idade
, Idoso
, Glaucoma de Ângulo Aberto/tratamento farmacológico
, Estudos Transversais
, Pressão Intraocular
, Brasil
, Glaucoma/tratamento farmacológico
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The aim of this work was to assess the tolerability, safety, and efficacy of an ophthalmic topical formulation containing helenalin from Arnica montana and hyaluronic acid 0.4% (HA) in patients with mild-to-moderate Dry Eye Disease (DED) exhibiting positive Matrix Metalloproteinase 9 (MMP-9) test results. Tolerability and safety were evaluated in 24 healthy subjects. Participants were instructed to apply one drop of the formulation three times a day in the study eye, for 2 weeks, followed by a clinical follow-up of 21 days. Efficacy was studied in 48 DED patients randomized into Study (Group 1/receiving the studied formulation) or Control (Group 2/Receiving HA 0.4% eye lubricant) groups for 1 month. Assessments included an MMP-9 positivity test, conjunctival impression cytology (CIC), Ocular Surface Disease Index (OSDI), non-invasive film tear breakup time (NIBUT), non-invasive average breakup time (NIAvg-BUT), ocular surface staining, Schirmer's test, and meibomiography. A crossover design with an additional 1-month follow-up was applied to both groups. Healthy subjects receiving the studied formulation exhibited good tolerability and no adverse events. Regarding the efficacy study, Group 1 exhibited a statistically significant reduction in the MMP-9 positivity rate compared to Group 2 (p < 0.001). Both Group 1 and Group 2 exhibited substantial improvements in OSDI and NIBUT scores (p < 0.001). However, Group 1 demonstrated a significant improvement in NI-Avg-BUT and Schirmer's test scores (p < 0.001), whereas Group 2 did not (p > 0.05). Finally, after the crossover, the proportion of MMP-9-positive subjects in Group 1 increased from 25% to 91.6%, while Group 2 showed a significant decrease from 87.5% to 20.8%. Overall, the topical formulation containing sesquiterpene helenalin from Arnica montana and hyaluronic acid was well tolerated and exhibited a favorable safety profile. Our formulation reduces DED symptomatology and modulates the ocular surface inflammatory process; this is evidenced by the enhancement of CIC, the improvement of DED-related tear film status, and the reduction of the MMP-9 positivity rate.
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Endometriosis is a chronic inflammatory disease that occurs in women of reproductive age. Much of the treatment involves hormone therapy that suppresses the proliferation of endometriosis lesions.Objective To compare discontinuation rates of pharmacological treatment with estrogen-progestins and progestins medications. The secondary objective is to evaluate the main side effects of these drugs in patients with endometriosis.Methods This retrospective study analyzed data from 330 patients who attended the Hospital of the State Public Servant of São Paulo from August 1999 to September 2020 and received pharmacological treatment for endometriosis. The data were obtained by review of the files of medical appointments with specialized staff.Results The median treatment time was 18 months, ranging from 1 to 168 months, and 177 patients interrupted the proposed treatment. The combined contraceptives with estrogens and progestins were significantly linked to treatment interruption, with a relative risk of 1,99 (p = 0,005). The most important side effects that resulted in treatment interruption were pain persistence (p = 0,043), weight gain (p = 0,017) and spotting (p < 0,001).
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Endometriose , Humanos , Feminino , Progestinas/uso terapêutico , Anticoncepcionais , Endometriose/tratamento farmacológico , Estudos Retrospectivos , BrasilRESUMO
Introduction: Paroxetine is an older "selective" serotonin reuptake inhibitor (SSRI) that is notable for its lack of selectivity, resulting in a cholinergic adverse-effect profile, especially among older adults (65+). Methods: Paroxetine prescription rates and costs per state were ascertained from the Medicare Specialty Utilization and Payment Data. States' annual prescription rate, corrected per thousand Part D enrollees, outside 95% confidence interval were considered significantly different from the average. Results: There was a steady decrease in paroxetine prescriptions (-34.52%) and spending (-16.69%) from 2015-2020 but a consistent, five-fold state-level difference. From 2015-2020, Kentucky (194.9, 195.3, 182.7, 165.1, 143.3, 132.5) showed significantly higher prescriptions rates relative to the national average, and Hawaii (42.1, 37.9, 34.3, 31.7, 27.7, 26.6) showed significantly lower prescription rates. North Dakota was often a frequent elevated prescriber of paroxetine (2016: 170.7, 2018: 143.3), relative to the average. Neuropsychiatry and geriatric medicine frequently prescribed the largest amount of paroxetine prescriptions, relative to the number of providers in that specialty, from 2015-2020. Discussion: Despite the American Geriatrics Society prohibition against paroxetine use in the older adults and many effective treatment alternatives, paroxetine was still commonly used in this population, especially in Kentucky and North Dakota and by neuropsychiatry and geriatric medicine. These findings provide information on the specialty types and states where education and policy reform would likely have the greatest impact on improving adherence to the paroxetine prescription recommendations.
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INTRODUCTION AND AIM: Transnasal endoscopy (TNE) has proven its diagnostic utility, but it has not been widely accepted given that it is performed without sedation. There are no previous studies on the use of methods to improve its tolerability. Our aim was to evaluate the tolerability of TNE, when simultaneously performed with an audiovisual device as a distractor. METHODS: We evaluated 50 patients, 10 of whom did not agree to participate. The performance of the procedure was explained, using an audiovisual device. Before randomization, we applied anxiety and depression scores. Patients were divided into 2 groups: Group I (using an audiovisual device during the procedure) and Group II (without a device). Anxiety and numeric pain rating scales were used, and vital signs were monitored and recorded before, during, and after the endoscopy. An overall procedure satisfaction score was applied at the end of the study and 24â¯h later. RESULTS: Mean age was 41.6 years and 35 of the patients were women (87.5%). The most frequent indication for TNE was refractory gastroesophageal reflux disease. There were no severe comorbidities, and none of the patients had a significant anxiety or depression score. One patient in Group II did not tolerate TNE due to nasal pain. There was no statistically significant difference between groups, regarding anxiety, pain, vital signs, and satisfaction scale. CONCLUSION: Our study showed that TNE was well tolerated and had a high acceptance rate in our patients. The use of distracting audiovisual devices did not increase tolerance to the endoscopic procedure.
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Refluxo Gastroesofágico , Satisfação do Paciente , Humanos , Feminino , Adulto , Masculino , Estudos Prospectivos , Endoscopia Gastrointestinal/métodos , Dor/etiologia , Dor/prevenção & controle , Refluxo Gastroesofágico/etiologiaRESUMO
INTRODUCTION: In SERAPHIN, a long-term, event-driven, double-blind randomised controlled trial in pulmonary arterial hypertension (PAH), macitentan 10 mg significantly reduced the risk of morbidity/mortality compared with placebo. Its open-label extension study (SERAPHIN OL) further assessed long-term safety and tolerability of macitentan 10 mg in PAH patients. METHODS: Patients in SERAPHIN who completed the double-blind treatment period or experienced a morbidity event during the study could enter SERAPHIN OL. Patients received macitentan 10 mg once daily, and safety and survival were assessed until end of treatment (+ 28 days). Two overlapping sets were analysed for safety: (1) all patients in SERAPHIN OL (OL safety set); (2) patients randomised to macitentan 10 mg in SERAPHIN (long-term safety/survival set). Survival was evaluated as an exploratory endpoint in the latter set. RESULTS: Of 742 patients randomised in SERAPHIN, 550 (74.1%) entered SERAPHIN OL (OL safety set); 242 patients were randomised to macitentan 10 mg in SERAPHIN (long-term safety/survival set). Median (min, max) exposure to macitentan 10 mg was 40.1 (0.1, 130.5) months (2074.7 patient-years; OL safety set) and 54.7 (0.1, 141.3) months (1151.0 patient-years; long-term safety/survival set). Safety in both analysis sets was comparable to the known safety profile of macitentan. Kaplan-Meier survival estimates (95% CI) at 1, 5, 7 and 9 years were 95.0% (91.3, 97.1), 73.3% (66.6, 78.9), 62.6% (54.6, 69.6) and 52.7% (43.6, 61.0), respectively (long-term safety/survival set; median follow-up: 5.9 years). CONCLUSIONS: This analysis provides the longest follow-up for safety and survival published to date for any PAH therapy. The safety profile of macitentan 10 mg over this extensive treatment period was in line with that observed in SERAPHIN. As the majority of patients were receiving other PAH therapy at macitentan initiation, our study provides additional insight into the long-term safety of macitentan, including as part of combination therapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT00660179 and NCT00667823.
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Hipertensão Arterial Pulmonar , Hipertensão Pulmonar Primária Familiar/tratamento farmacológico , Humanos , Hipertensão Arterial Pulmonar/tratamento farmacológico , Pirimidinas/efeitos adversos , Sulfonamidas/efeitos adversos , Resultado do TratamentoRESUMO
Resumen Objetivo: Describir la efectividad del tratamiento antiparasitario intestinal brindado a niños de cuatro a nueve años atendidos en el centro de Salud de la Universidad del Quindío entre Julio de 2017 a marzo de 2018. Materiales y métodos: Estudio observacional prospectivo. Se extrajeron datos de historias clínicas de pacientes con rango de edad de 4 a 9 años, quienes consultaron en el Centro de Salud de la Universidad del Quindío y se diagnosticaron mediante coprológico con blastocistosis o giardiasis. Se seleccionaron las historias cuyo tratamiento fuese Nitazoxanida y tuviesen un coprológico control postratamiento. Se presentan estadísticas descriptivas; porcentaje de eficacia y tolerabilidad. Resultados: De 15 niños tratados con Nitazoxanida, respondieron al tratamiento 10, en quienes no se hallaron parásitos en el coprológico control. Con una eficacia del 83,3% (IC95% 60 - 100) en blastocistosis, 57,1% (IC95% 32 - 82%) en giardiasis. Conclusión: Se evidenciaron resultados porcentuales similares a los reportados en la literatura, siendo más eficaz en blastocisotisis que en giardiasis.
Abstract Objective: To describe the effectiveness of the intestinal antiparasitic treatment given to children ranging between 4 and 9 years old that were attended in the Health Center of the University of Quindío in the period of July 2017 and March 2018. Materials and methods: Prospective observational study. Data were extracted from medical records of patients with an age range of 4 to 9 years, who consulted at the Health Center of the University of Quindío and were diagnosed through coprological tests with Blastocystis and Giardiasis. The clinical records were selected by whose treatment was done with Nitazoxanide or Albendazole with coprological results of post-treatment check-up. Descriptive statistics are presented along with percentage of efficacy and tolerability. Results: From 15 children treated with Nitazoxanide, 10 responded to the treatment, who presented no parasites in the coprological check-up. The remaining population presented some type of parasitic infection (n = 5). With an efficiency of 83,3% (IC95% 32 - 82%) in blastocystis, and 57,1% (IC95% 32 - 82%) in giardiasis. Conclusion: Percentage results similar to those reported in the literature were evidenced, being more effective in blastocystis than in giardiasis.
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Agavins are prebiotics and functional fiber that modulated the gut microbiota and metabolic status in obese mice. Here, we designed a placebo-controlled, double-blind, exploratory study to assess fluctuations in gastrointestinal (GI) tolerability-related symptoms to increasing doses of agavins in 38 lean and obese Mexican adults for five weeks and their impact on subjective appetite, satiety, metabolic markers, and body composition. All GI symptoms showed higher scores than placebo at almost every dose for both lean and obese groups. Flatulence caused an intense discomfort in the lean-agavins group at 7 g/day, while obese-agavins reported a mild-to-moderate effect for all five symptoms: no significant differences among 7, 10, and 12 g/day for flatulence, bloating, and diarrhea. Ratings for any GI symptom differed between 10 and 12 g/day in neither group. The inter-group comparison demonstrated a steady trend in GI symptoms scores in obese participants not seen for lean volunteers that could improve their adherence to larger trials. Only body weight after 10 g/day reduced from baseline conditions in obese-agavins, with changes in triglycerides and very-low-density lipoproteins compared to placebo at 5 g/day, and in total cholesterol for 10 g/day. Altogether, these results would help design future trials to evaluate agavins impact on obese adults.
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Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled on the ocular surface. To evaluate the safety, tolerability, and biological activity of TALF, an animal study and a phase I clinical assay were performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biological activity of the formulation. No inflammation, lens opacity, swelling, or increase in intraocular pressure were recorded after the instillation of TALF in any of the animal or clinical studies. Mainly, mild and transient adverse events such as dry eye and burning were reported. TALF significantly improves visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biological activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroid IVTs and their associated hazards.
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O foco deste estudo é investigar a segurança e tolerabilidade da ETCC anódica em crianças e adolescentes com paralisia cerebral (PC). Participaram desse estudo dez crianças e adolescentes com PC do tipo hemiplégica e diplégica, com idade entre oito e 17 anos (média = 11,40, dp = 2,83). Os sujeitos participaram de cinco sessões de ETCC anódica no córtex parietal posterior (CPP) direito, com o cátodo posicionado no músculo deltoide esquerdo. Após cada sessão de estimulação foi aplicado um questionário padronizado para avaliação de efeitos adversos. Os resultados revelaram os seguintes efeitos adversos: as taxas de prurido (62%), sensação de queimação (16%) e formigamento (23%). A maior parte dos efeitos foi classificada como de intensidade leve pelos participantes, demonstrando a alta tolerabilidade e segurança da ETCC em crianças e adolescentes com PC.
The focus of this study is to investigate the safety and tolerability of anodic tDCS in children and adolescents with cerebral palsy (CP). Ten children and adolescents with hemiplegic and diplegic PCs, aged eight to 17 years (mean = 11.40, dp = 2.83) participated in this study. The subjects participated in five sessions of anodic tDCS in the right posterior parietal córtex (PPC), with the cathode positioned in the left deltoid muscle. After each stimulation session, a standardized questionnaire was used to assess adverse effects. Results: the results showed the following adverse effects: pruritus rates (62%), burning sensation (16%) and tingling (23%). Most of the effects were classified as mild intensity by the participants, thus demonstrating the high tolerability and safety of tDCS in children and adolescents with CP.
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Introduced in the late 1950s, polyenes represent the oldest family of antifungal drugs. The discovery of amphotericin B and its therapeutic uses is considered one of the most important scientific milestones of the twentieth century . Despite its toxic potential, it remains useful in the treatment of invasive fungal diseases owing to its broad spectrum of activity, low resistance rate, and excellent clinical and pharmacological action. The well-reported and defined toxicity of the conventional drug has meant that much attention has been paid to the development of new products that could minimize this effect. As a result, lipid-based formulations of amphotericin B have emerged and, even keeping the active principle in common, present distinct characteristics that may influence therapeutic results. This study presents an overview of the pharmacological properties of the different formulations for systemic use of amphotericin B available for the treatment of invasive fungal infections, highlighting the characteristics related to their chemical, pharmacokinetic structures, drug-target interactions, stability, and others, and points out the most relevant aspects for clinical practice.
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BACKGROUND: Colonoscopy is the gold standard exam for evaluation of colonic abnormalities and for screening and surveillance for colorectal cancer. However, the efficacy of colonoscopy is dependent on the quality of the pre-colonoscopy bowel preparation. Polyethylene glycol (PEG) and sodium picosulfate/magnesium citrate (SPMC) have emerged as two of the most commonly used bowel preparation agents. We conducted an evidence-based review of current evidence to further investigate the efficacy and patient tolerability of split-dose SPMC oral solution compared to PEG solution for colonoscopy bowel preparation. METHODS: A systematic search was performed using Pubmed (MEDLINE), Web of Science, EMBASE, and Cochran Central Register of Controlled Trials databases. All studies on split-dose bowel preparation with SPMC and PEG were reviewed. Relevant studies regarding colonoscopy and bowel preparations were also included. Randomized controlled trials were prioritized due to the high quality of evidence. RESULTS: Eight randomized controlled trials were included. Split-dose SPMC and PEG were associated with similar results for adequacy of bowel preparation. Split-dose SPMC was associated with increased patient tolerability and compliance. CONCLUSION: Split-dose SPMC and PEG are both adequate and safe for bowel preparation for outpatient colonoscopy, with split-dose SPMC being more tolerable for patients. Additional RCTs comparing these and other bowel preparation solutions are necessary to further investigate quality of bowel preparation, patient preference, and cost-effectiveness of the various options.
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PURPOSE: Natalizumab (NTZ) is a monoclonal antibody with confirmed efficacy in white populations with recurrent-remitting multiple sclerosis (RRMS); there are few studies, however, in mixed-race populations. Real-world studies of NTZ are needed to better understand the drug's effectiveness. This study evaluated the effectiveness and adverse events of NTZ in a cohort of Brazilian patients with MS, as well as the impact of clinical and demographic factors on patient response to treatment. METHODS: This multicenter, Brazilian observational study was conducted from January 2011 until December 2016 and included patients with RRMS (McDonald criteria 2005 and 2010) aged ≥18 years treated with NTZ for at least 3 months. Demographic, clinical, and radiologic data were obtained from medical records and during follow-up visits. The primary outcomes investigated were the absolute number of relapses and annualized rate of relapses, change in Expanded Disability Status Scale value, and presence of new lesions on magnetic resonance imaging after starting NTZ treatment; the occurrence and type of adverse events were also analyzed. In addition, the impact of demographic and clinical prognostic factors and radiologic activity on the effectiveness of NTZ was measured. Descriptive and univariate statistical analyses used a significance level of P < 0.05. RESULTS: The study enrolled 56 patients; 64% were women, and 36% were of African descent. There was a significant reduction in the mean absolute number (P = 0.001) and in the annualized rate (P = 0.001) of relapses and in the radiologic activity of the disease (P = 0.001). Furthermore, 71% of patients showed no increase in Expanded Disability Status Scale score after 1 year of treatment. The effectiveness of NTZ was not associated with the presence of clinical and demographic prognostic factors, and the most frequent adverse events during the use of NTZ were gastrointestinal symptoms; there were no cases of progressive multifocal leukoencephalopathy. IMPLICATIONS: According to patients' reports and clinicians' observations regarding clinical and radiologic benefits and tolerability to adverse events, the use of NTZ was favorable in this Brazilian MS cohort, regardless of the presence of unfavorable prognostic factors.
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Fatores Imunológicos/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Natalizumab/uso terapêutico , Adulto , Brasil , Estudos de Coortes , Feminino , Humanos , Fatores Imunológicos/efeitos adversos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/diagnóstico por imagem , Natalizumab/efeitos adversos , Resultado do Tratamento , Adulto JovemRESUMO
Abstract Aim: To verify the acute effect of sodium bicarbonate (NaHCO3) supplementation on performance during CrossFit® workout. Methods: Nine experienced males (30.8 ± 3.5 years; 84.4 ± 9.5 kg; 177.5 ± 4.03 cm; 2.2 ± 1.0 years) in CrossFit® participated in this study. They were allocated to two conditions: a) supplementation with 0.3 g.kg-1 of body weight of NaHCO3 and b) supplementation with 0.045 g.kg-1 of body weight of sodium chloride (NaCl). Blood lactate was analyzed at two different moments: before (lac-pre) and after the training protocol (lac-post). The heart rate (HR) and the rating of perceived exertion (RPE) were also collected every two minutes during the execution of the training protocol, and the RPE was also collected after it was finished. At the end of the training protocol, a questionnaire to measure gastrointestinal side effects (GSE) was answered by the participants. Repetitions performed in the training protocol was computed to evaluate the performance during the workout. Results: The results showed that there were no differences found when comparing the conditions for all parameters. HR and RPE were different in the first few minutes (< 4-6 minutes) when compared to the final minutes (> 14 minutes) of the workout. The area under the curve of HR and RPE was significantly lower in the NaHCO3 condition. Conclusion: Acute NaHCO3 supplementation did not improve performance during workout 'Cindy' in experienced men. Supplementation also did not alter hemodynamic and perceptual parameters, nor did it cause any GSE. However, responses as a function of time were reduced with NaHCO3 supplementation.
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Humanos , Exercício Físico/fisiologia , Bicarbonato de Sódio/administração & dosagem , Fadiga Muscular/fisiologia , Ácido Láctico/sangue , Inquéritos e QuestionáriosRESUMO
T0001 is the first mutant of etanercept with a higher affinity to tumor necrosis factor α (TNF-α) than etanercept. In order to investigate the safety and tolerability of T0001, a study was carried out in healthy Chinese subjects. A first-in-human, dose escalation study was conducted in healthy Chinese subjects. Fifty-six subjects were divided into six dose cohorts (10 mg, 20 mg, 35 mg, 50 mg, 65 mg and 75 mg) to receive a single subcutaneous injection of T0001. Safety and tolerability assessment were based on the records of vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms and adverse events (AEs). All subjects were in good compliance and none withdraw due to AEs. No serious AEs occurred. A total of twenty-three AEs in sixteen subjects were recorded, and eighteen of these AEs were believed to be related to T0001. The most frequently reported AEs were injection site reactions and white blood cell count increase. All these AEs were of mild to moderate intensity and most of them recovered spontaneously within 14 days. In this study, no dose-limiting toxicity was observed, and the maximum tolerated dose was identified as 75 mg. T0001 was considered safe and generally well tolerated at doses up to 75 mg in healthy Chinese volunteers
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Humanos , Masculino , Feminino , Adolescente , Adulto , Segurança , Voluntários , Dose Única/efeitos dos fármacos , Etanercepte/análogos & derivados , Exame Físico , Artrite Reumatoide/patologia , Fator de Necrose Tumoral alfa/classificação , Técnicas de Laboratório Clínico , Povo Asiático/classificação , Eletrocardiografia , Reação no Local da Injeção , Injeções Subcutâneas/classificaçãoRESUMO
Background: The World Health Organization (WHO) ethanol-based handrub (EBHR) formulation contains 1.45% glycerol as an emollient to protect healthcare workers' (HCWs) skin against dryness and dermatitis. However, glycerol seems to negatively affect the antimicrobial efficacy of alcohols. In addition, the minimal concentration of glycerol required to protect hands remain unknown. We aim to evaluate the tolerance of HCWs to the WHO EBHR formulation using different concentrations of glycerol in a tropical climate healthcare setting. Methods: We conducted a cluster-randomized, double-blind, crossover study among 40 HCWs from an intensive care unit of a tertiary-care hospital in Brazil, from June 1st to September 30, 2017. We tested the WHO EBHR original formulation containing 1.45% glycerol against three other concentrations (0, 0.5, and 0.75%). HCWs used one formulation at a time for seven working days during their routine practice and then had their hands evaluated by an external observer using the WHO scale for visual inspection. Participants also used a WHO self-evaluation tool to rate their own skin condition. We used a generalized estimating equations of the logit type to compare differences between the tolerability to different formulations. Results: According to the independent observation, participants had 2.4 times (95%CI: 1.12-5.15) more chance of having a skin condition considered good when they used the 0.5% compared to the 1.45% glycerol formulation. For the self-evaluation scale, participants were likely to have a worst evaluation (OR: 0.23, 95%CI: 0.11-0.49) when they used the preparation without glycerol compared to the WHO standard formulation (1.45%), and there were no differences between the other formulations used. Conclusion: In a tropical climate setting, the WHO-modified EBHR formulation containing 0.5% glycerol led to better ratings of skin tolerance than the original formulation, and, therefore, may offer the best balance between skin tolerance and antimicrobial efficacy.
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Etanol/efeitos adversos , Glicerol/análise , Desinfecção das Mãos/métodos , Pele/efeitos dos fármacos , Adulto , Estudos Cross-Over , Método Duplo-Cego , Etanol/química , Feminino , Pessoal de Saúde , Humanos , Unidades de Terapia Intensiva , Masculino , Atenção Terciária à Saúde , Clima Tropical , Organização Mundial da SaúdeRESUMO
OBJECTIVES: To evaluate the intermediate-term efficacy and tolerance of statins in children and adolescents with familial hypercholesterolemia. STUDY DESIGN: A total of 131 children or adolescents treated with statins for familial hypercholesterolemia were prospectively included. The efficacy of treatment was established by the percentage of children who achieved low density lipoprotein-cholesterol (LDL-C) levels <160 mg/dL during treatment. Treatment tolerance was evaluated by the occurrence of clinical or laboratory side effects, regularity of increases in height and weight, and pubertal development. RESULTS: The median duration of treatment with statins was 4 years. A median decrease of 32% in LDL-C levels was observed (P < .0001). The therapeutic target (LDL-C <160 mg/dL) was achieved in 67% of cases. Increases in height and weight and sexual maturation were not affected by the treatment. Minor side effects were reported for 24 (18.4%) patients including 3 cases of a clinically asymptomatic increase in creatine phosphokinase (CPK) levels, 2 cases of an increase in CPK levels with muscular symptoms, 14 cases of myalgia without an increase in CPK levels, 3 cases of abdominal pain, 1 case of dysuria, and 1 case of diffuse pain. None of these side effects led to the discontinuation of statin therapy, although a change of statin was required in 7 cases. This new statin was tolerated in all cases. No patients had abnormal liver function during treatment. CONCLUSIONS: The results of this large cohort confirm the intermediate-term safety and efficacy of statin therapy in children with familial hypercholesterolemia.
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Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hiperlipoproteinemia Tipo II/tratamento farmacológico , Dor Abdominal/induzido quimicamente , Adolescente , Criança , LDL-Colesterol/sangue , Creatina Quinase/sangue , Disuria/induzido quimicamente , Feminino , Humanos , Masculino , Mialgia/induzido quimicamente , Dor/induzido quimicamente , Estudos ProspectivosRESUMO
INTRODUCTION AND AIM: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks' treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics. Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. MATERIALS AND METHODS: 106 consecutive cirrhotics (70.8% males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2%) based expected tolerability, at a mean dose of 964±202mg/day. Baseline Child-Pugh class was A 91.5%, B 6.6%, C 1.9%; mean baseline MELD was 8.5±2.7. RESULTS: All patients completed 12-week follow-up post-treatment, and 104 (98.1%) obtained sustained virological response (100% in ribavirin -treated patients vs. 90.4% without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). CONCLUSION: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100% efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.
Assuntos
Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Imidazóis/administração & dosagem , Cirrose Hepática/virologia , Ribavirina/administração & dosagem , Sofosbuvir/administração & dosagem , Adulto , Idoso , Antivirais/uso terapêutico , Carbamatos , Estudos de Coortes , Intervalos de Confiança , Esquema de Medicação , Quimioterapia Combinada , Feminino , Seguimentos , Perfil Genético , Hepacivirus/efeitos dos fármacos , Hepatite C Crônica/diagnóstico , Hepatite C Crônica/genética , Humanos , Itália , Cirrose Hepática/epidemiologia , Cirrose Hepática/patologia , Testes de Função Hepática , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Pirrolidinas , Medição de Risco , Índice de Gravidade de Doença , Resposta Viral Sustentada , Fatores de Tempo , Resultado do Tratamento , Valina/análogos & derivadosRESUMO
BACKGROUND: The enteric string test can be used to obtain a specimen for microbiological confirmation of tuberculosis in children, but it is not widely used for this. The aim of this analysis to evaluate this approach in children with tuberculosis symptoms. METHODS: We conducted a cross-sectional study to assess children's ability to complete the test (feasibility), and self-reported pain (tolerability). We examined caregivers' and children's willingness to repeat the procedure (acceptability) and described the diagnostic yield of cultures for diagnostic tools. We stratified estimates by age and compared metrics to those derived for gastric aspirate (GA). RESULTS: Among 148 children who attempted the string test, 34% successfully swallowed the capsule. Feasibility was higher among children aged 11-14 than in children 4-10 years (83% vs 22% respectively, p < 0.0001). The string test was better tolerated than GA in both age groups; however, guardians and older children reported higher rates of willingness to repeat GA than the string test (86% vs. 58% in children; 100% vs. 83% in guardians). In 9 children with a positive sputum culture, 6 had a positive string culture. The one children with a positive gastric aspirate culture also had a positive string culture. CONCLUSION: Although the string test was generally tolerable and accepted by children and caregivers; feasibility in young children was low. Reducing the capsule size may improve test success rates in younger children.