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1.
BMC Infect Dis ; 22(1): 1, 2022 Jan 04.
Artigo em Inglês | MEDLINE | ID: mdl-34983406

RESUMO

BACKGROUND: Real-world data on safety and clinical outcomes of remdesivir in COVID-19 management is scant. We present findings of data analysis conducted for assessing the safety and clinical outcomes of remdesivir treatment for COVID-19 in India. METHODS: This retrospective analysis used data from an active surveillance programme database of hospitalised patients with COVID-19 who were receiving remdesivir. RESULTS: Of the 2329 patients included, 67.40% were men. Diabetes (29.69%) and hypertension (20.33%) were the most common comorbidities. At remdesivir initiation, 2272 (97.55%) patients were receiving oxygen therapy. Remdesivir was administered for 5 days in 65.38% of patients. Antibiotics (64.90%) and steroids (47.90%) were the most common concomitant medications. Remdesivir was overall well tolerated, and total 119 adverse events were reported; most common were nausea and vomiting in 45.40% and increased liver enzymes in 14.28% patients. 84% of patients were cured/improved, 6.77% died and 9.16% showed no improvement in their clinical status at data collection. Subgroup analyses showed that the mortality rate was significantly lower in patients < 60 years old than in those > 60 years old. Amongst patients on oxygen therapy, the cure/improvement rate was significantly higher in those receiving standard low-flow oxygen than in those receiving mechanical ventilation, non-invasive ventilation, or high-flow oxygen. Factors that were associated with higher mortality were age > 60 years, cardiac disease, diabetes high flow oxygen, non-invasive ventilation and mechanical ventilation. CONCLUSION: Our analysis showed that remdesivir is well tolerated and has an acceptable safety profile. The clinical outcome of cure/improvement was 84%, with a higher improvement in patients < 60 years old and on standard low-flow oxygen.


Assuntos
COVID-19 , Monofosfato de Adenosina/análogos & derivados , Alanina/análogos & derivados , Antivirais/uso terapêutico , COVID-19/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , SARS-CoV-2 , Resultado do Tratamento , Conduta Expectante
3.
Eur Radiol ; 32(1): 680-689, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34255161

RESUMO

OBJECTIVES: To compare the performance of the PRECISE scoring system against several MRI-derived delta-radiomics models for predicting histopathological prostate cancer (PCa) progression in patients on active surveillance (AS). METHODS: The study included AS patients with biopsy-proven PCa with a minimum follow-up of 2 years and at least one repeat targeted biopsy. Histopathological progression was defined as grade group progression from diagnostic biopsy. The control group included patients with both radiologically and histopathologically stable disease. PRECISE scores were applied prospectively by four uro-radiologists with 5-16 years' experience. T2WI- and ADC-derived delta-radiomics features were computed using baseline and latest available MRI scans, with the predictive modelling performed using the parenclitic networks (PN), least absolute shrinkage and selection operator (LASSO) logistic regression, and random forests (RF) algorithms. Standard measures of discrimination and areas under the ROC curve (AUCs) were calculated, with AUCs compared using DeLong's test. RESULTS: The study included 64 patients (27 progressors and 37 non-progressors) with a median follow-up of 46 months. PRECISE scores had the highest specificity (94.7%) and positive predictive value (90.9%), whilst RF had the highest sensitivity (92.6%) and negative predictive value (92.6%) for predicting disease progression. The AUC for PRECISE (84.4%) was non-significantly higher than AUCs of 81.5%, 78.0%, and 80.9% for PN, LASSO regression, and RF, respectively (p = 0.64, 0.43, and 0.57, respectively). No significant differences were observed between AUCs of the three delta-radiomics models (p-value range 0.34-0.77). CONCLUSIONS: PRECISE and delta-radiomics models achieved comparably good performance for predicting PCa progression in AS patients. KEY POINTS: • The observed high specificity and PPV of PRECISE are complemented by the high sensitivity and NPV of delta-radiomics, suggesting a possible synergy between the two image assessment approaches. • The comparable performance of delta-radiomics to PRECISE scores applied by expert readers highlights the prospective use of the former as an objective and standardisable quantitative tool for MRI-guided AS follow-up. • The marginally superior performance of parenclitic networks compared to conventional machine learning algorithms warrants its further use in radiomics research.


Assuntos
Neoplasias da Próstata , Conduta Expectante , Humanos , Imageamento por Ressonância Magnética , Masculino , Estudos Prospectivos , Neoplasias da Próstata/diagnóstico por imagem , Estudos Retrospectivos
6.
Arch Ital Urol Androl ; 93(4): 385-388, 2021 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-34933522

RESUMO

BACKGROUND: The aim of our study was to evaluate the outcome of active surveillance (AS) for prostate cancer for a cohort of patients at our institution. METHODS: A total of 43 patients with low risk prostate cancer were enrolled in an active surveillance pilot program at our institution between 2008 and 2018. Follow up protocols included: periodic prostate specific antigen (PSA), digital rectal examination (DRE), multiparametric MRI, and prostate biopsy at one year. Pertinent parameters were collected, and descriptive statistics were reported along with a subset analysis of patients that dropped out of the protocol to receive active treatment for disease progression. RESULTS: Out of 43 eligible patients, 46.5% had a significant rise in follow up PSA. DRE was initially suspicious in 27.9% of patients, and none had any change in DRE on follow up. Initially, prostate MRIs showed PIRADS 3, 4, and 5 in 14%, 37.2%, and 11.6% respectively, while 23.2% had a negative initial MRI. 14% did not have an MRI. Upon follow up, 18.6% of patients had progression on MRI. Initial biopsies revealed that 86% were classified as WHO group 1, while 14% as WHO group 2. With regards to the follow up biopsies, 11.6% were upgraded. 20.9% of our patients had active treatment; 44.4% due to upgraded biopsy results, 22.2% due to PSA progression, 22.2% due to strong patient preference, and 11.1% due to radiologic progression. CONCLUSIONS: For selected men with low risk prostate cancer, AS is a reasonable alternative. The decision for active treatment should be tailored upon changes in PSA, DRE, MRI, and biopsy results.


Assuntos
Neoplasias da Próstata , Conduta Expectante , Biópsia , Exame Retal Digital , Humanos , Masculino , Antígeno Prostático Específico , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/epidemiologia , Centros de Atenção Terciária
7.
Medicina (Kaunas) ; 57(11)2021 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-34833425

RESUMO

Heterotopic pregnancy is a rare, difficult to diagnose and life-threatening pathology, which requires timely decisions made by an experienced multidisciplinary team. In this type of multiple pregnancy there are both intrauterine and ectopic pregnancies present. Its incidence increases in pregnancies conceived by assisted reproductive technology or in pregnancies with ovulation induction. This article presents an angular heterotopic pregnancy case in a 34-year-old multigravida. The patient was admitted on the 14th week of gestation due to abdominal pain on the left side with suspicion of heterotopic pregnancy. Transabdominal ultrasound and magnetic resonance imaging (MRI) were performed to confirm the diagnosis of heterotopic angular pregnancy in the left cornu of the uterus. Multidisciplinary team made a decision to keep monitoring the growth of both pregnancies by ultrasound while maternal vitals were stable. Due to intensifying abdominal pain, diagnostic laparoscopy was performed. No signs of uterine rupture were observed, and no additional surgical procedures were performed. Maternal status and ultrasonographic findings were closely monitored. The mass in the left cornu of the uterus did not change significantly and the fetal growth of the intrauterine pregnancy matched its gestational age throughout pregnancy. At the 41st week of gestation, a healthy female neonate was born via spontaneous vaginal delivery. The incidence rate of heterotopic pregnancy tends to grow due to an increased number of pregnancies after assisted reproductive technology and ovulation induction. It is important to always assess the risk factors. The main methods for diagnosing heterotopic pregnancies are ultrasonography and MRI. The main management tactics for heterotopic pregnancy include expectant management as well as surgical or medical termination of the ectopic pregnancy. Expectant management may be chosen as an option only in a limited number of cases, if the clinical situation meets the specific criteria. When applicable, expectant management may reduce the frequency of unnecessary interventions and help to prevent patients from its complications.


Assuntos
Gravidez Angular , Gravidez Heterotópica , Adulto , Diagnóstico Diferencial , Feminino , Humanos , Recém-Nascido , Cuidado Pós-Natal , Gravidez , Gravidez Heterotópica/diagnóstico por imagem , Gravidez Heterotópica/cirurgia , Conduta Expectante
8.
Surg Clin North Am ; 101(6): 1067-1079, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34774269

RESUMO

Inguinal hernias represent one of the most common pathologic conditions presenting to the general surgeon. In surgical practice, several controversies persist: when to operate, the utility of a laparoscopic versus open approach, the applicability of robotic surgery, the approach to bilateral hernias, management of athletic-related groin pain ("sports hernia"), and the role of tissue-based repairs in modern hernia surgery. Ideally, surgeons should approach each patient individually and tailor their approach based on patient factors and preferences. The informed consent process is critical, especially given increasing recognition of the risk of long-term chronic pain following hernia repair.


Assuntos
Hérnia Inguinal/cirurgia , Herniorrafia , Virilha , Hérnia Inguinal/complicações , Hérnia Inguinal/terapia , Herniorrafia/efeitos adversos , Herniorrafia/métodos , Humanos , Laparoscopia , Dor/etiologia , Procedimentos Cirúrgicos Robóticos , Telas Cirúrgicas , Conduta Expectante
11.
World J Surg Oncol ; 19(1): 305, 2021 Oct 18.
Artigo em Inglês | MEDLINE | ID: mdl-34663341

RESUMO

BACKGROUND: Some clinical researchers have reported that patients with cCR (clinical complete response) status after neoadjuvant chemoradiotherapy (nCRT) could adopt the watch-and-wait (W&W) strategy. Compared with total mesorectal excision (TME) surgery, the W&W strategy could achieve a similar overall survival. Could the W&W strategy replace TME surgery as the main treatment option for the cCR patients? By using the meta-analysis method, we evaluated the safety and efficacy of the W&W strategy and TME surgery for rectal cancer exhibiting cCR after nCRT. METHODS: We evaluated two treatment strategies for rectal cancer with cCR after nCRT up to July 2021 by searching the Cochrane Library, PubMed, Wanfang, and China National Knowledge Infrastructure (CNKI) databases. Clinical data for primary outcomes (local recurrence, cancer-related death and distant metastasis), and secondary outcomes (disease-free survival (DFS) and overall survival (OS)) were collected to evaluate the efficacy and safety in the two groups. RESULTS: We included nine studies with 818 patients in the meta-analysis, and there were five moderate-quality studies and four high-quality studies. A total of 339 patients were in the W&W group and 479 patients were in the TME group. The local recurrence rate in the W&W group was greater than that in the TME group in the fixed-effects model (OR 8.54, 95% CI 3.52 to 20.71, P < 0.001). The results of other outcomes were similar in the two groups. CONCLUSION: The local recurrence rate of the W&W group was greater than that in the TME group, but other results were similar in the two groups. With the help of physical examination and salvage therapy, the W&W strategy could achieve similar treatment effects with the TME approach. TRIAL REGISTRATION: Protocol registration number: CRD42021244032 .


Assuntos
Terapia Neoadjuvante , Neoplasias Retais , Humanos , Recidiva Local de Neoplasia/terapia , Prognóstico , Neoplasias Retais/terapia , Conduta Expectante
12.
BMJ Open ; 11(10): e044347, 2021 10 18.
Artigo em Inglês | MEDLINE | ID: mdl-34663648

RESUMO

INTRODUCTION: Leiomyoma recurrence is a major concern for long-term myomectomy management, especially for multiple leiomyomas. Gonadotropin-releasing hormone agonist (GnRHa) is one of the most effective medications to reduce the volume of fibroids and the uterus. However, its role in preventing recurrence after conservative surgery remains unclear. At present, there is no randomised clinical trial determining the efficacy of GnRHa treatment for preventing multiple leiomyomas recurrence after myomectomy. METHODS AND ANALYSIS: We are conducting a phase IV randomised controlled trial in women aged 18-45 undergoing myomectomy for multiple leiomyomas. After surgery, women whose pathological result confirms multiple leiomyomas are randomised in a 1:1 ratio into an observation or GnRHa group. The primary outcome is the recurrence of either clinical symptoms or fibroids on imaging. Patients will be assessed for adverse events during the follow-up. ETHICS AND DISSEMINATION: The study was approved by the Medical Ethics Committee of the Tongji Hospital Affiliated with the Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20180311) according to the submitted study protocol (V.1.0, 10 November 2017) and informed consent (V.1.0, 10 November 2017). The results will be presented at domestic and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR-IPR-17012992.


Assuntos
Leiomioma , Miomectomia Uterina , Neoplasias Uterinas , Feminino , Hormônio Liberador de Gonadotropina , Humanos , Leiomioma/tratamento farmacológico , Leiomioma/cirurgia , Estudos Multicêntricos como Assunto , Recidiva Local de Neoplasia/prevenção & controle , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias Uterinas/tratamento farmacológico , Neoplasias Uterinas/cirurgia , Conduta Expectante
14.
J Urol ; 206(5): 1147-1156, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34503355

RESUMO

PURPOSE: We examined the demographic and clinicopathological parameters associated with the time to convert from active surveillance to treatment among men with prostate cancer. MATERIALS AND METHODS: A multi-institutional cohort of 7,279 patients managed with active surveillance had data and biospecimens collected for germline genetic analyses. RESULTS: Of 6,775 men included in the analysis, 2,260 (33.4%) converted to treatment at a median followup of 6.7 years. Earlier conversion was associated with higher Gleason grade groups (GG2 vs GG1 adjusted hazard ratio [aHR] 1.57, 95% CI 1.36-1.82; ≥GG3 vs GG1 aHR 1.77, 95% CI 1.29-2.43), serum prostate specific antigen concentrations (aHR per 5 ng/ml increment 1.18, 95% CI 1.11-1.25), tumor stages (cT2 vs cT1 aHR 1.58, 95% CI 1.41-1.77; ≥cT3 vs cT1 aHR 4.36, 95% CI 3.19-5.96) and number of cancerous biopsy cores (3 vs 1-2 cores aHR 1.59, 95% CI 1.37-1.84; ≥4 vs 1-2 cores aHR 3.29, 95% CI 2.94-3.69), and younger age (age continuous per 5-year increase aHR 0.96, 95% CI 0.93-0.99). Patients with high-volume GG1 tumors had a shorter interval to conversion than those with low-volume GG1 tumors and behaved like the higher-risk patients. We found no significant association between the time to conversion and self-reported race or genetic ancestry. CONCLUSIONS: A shorter time to conversion from active surveillance to treatment was associated with higher-risk clinicopathological tumor features. Furthermore, patients with high-volume GG1 tumors behaved similarly to those with intermediate and high-risk tumors. An exploratory analysis of self-reported race and genetic ancestry revealed no association with the time to conversion.


Assuntos
Prostatectomia/estatística & dados numéricos , Neoplasias da Próstata/terapia , Conduta Expectante/estatística & dados numéricos , Idoso , Biópsia com Agulha de Grande Calibre/estatística & dados numéricos , Progressão da Doença , Seguimentos , Humanos , Calicreínas/sangue , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Próstata/patologia , Próstata/cirurgia , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Medição de Risco/estatística & dados numéricos , Fatores de Risco , Fatores de Tempo , Carga Tumoral
15.
Pan Afr Med J ; 39(Suppl 1): 2, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548894

RESUMO

Introduction: intussusception is a condition in which one segment of the bowel prolapses into another causing obstruction. Information on the epidemiology of intussusception in sub-Saharan Africa is limited. We describe the sociodemographic and clinical characteristics of children with intussusception in Ethiopia. Methods: active surveillance for children < 12 months of age with intussusception was conducted at six sentinel hospitals in Ethiopia. Limited socio-economic and clinical data were collected from enrolled children. Characteristics among children who died and children who survived were compared using the Wilcoxon rank sum test for continuous variables and Chi-square tests for categorical variables. Results: total of 164 children < 12 months of age with intussusception were enrolled; 62% were male. The median age at symptom onset was 6 months with only 12 (7%) of cases occurring in the first 3 months of life. Intussusception was reduced by surgery in 90% of cases and 10% were reduced by enema; 13% of cases died. Compared to survivors, children who died had a significantly longer time to presentation to the first health care facility and to the treating health care facility (median 3 days versus 2 days, p = 0.02, respectively). Conclusion: the high mortality rate, late presentation of intussusception cases, and lack of modalities for non-surgical management at some facilities highlight the need for better management of intussusception cases in Ethiopia.


Assuntos
Enema/métodos , Intussuscepção/epidemiologia , Distribuição por Idade , Etiópia/epidemiologia , Feminino , Humanos , Lactente , Recém-Nascido , Intussuscepção/mortalidade , Intussuscepção/terapia , Masculino , Fatores Socioeconômicos , Estatísticas não Paramétricas , Taxa de Sobrevida , Fatores de Tempo , Tempo para o Tratamento , Conduta Expectante
16.
BMJ ; 374: n2103, 2021 09 22.
Artigo em Inglês | MEDLINE | ID: mdl-34551918

RESUMO

OBJECTIVE: To evaluate whether extended release metformin could be used to prolong gestation in women being expectantly managed for preterm pre-eclampsia. DESIGN: Randomised, double blind, placebo controlled trial. SETTING: Referral hospital in Cape Town, South Africa. PARTICIPANTS: 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. INTERVENTION: 3 g of oral extended release metformin or placebo daily, in divided doses, until delivery. MAIN OUTCOME MEASURE: The primary outcome was prolongation of gestation. RESULTS: Of 180 participants, one woman delivered before taking any trial drug. The median time from randomisation to delivery was 17.7 days (interquartile range 5.4-29.4 days; n=89) in the metformin arm and 10.1 (3.7-24.1; n=90) days in the placebo arm, a median difference of 7.6 days (geometric mean ratio 1.39, 95% confidence interval 0.99 to 1.95; P=0.057). Among those who continued to take the trial drug at any dose, the median prolongation of gestation in the metformin arm was 17.5 (interquartile range 5.4-28.7; n=76) days compared with 7.9 (3.0-22.2; n=74) days in the placebo arm, a median difference of 9.6 days (geometric mean ratio 1.67, 95% confidence interval 1.16 to 2.42). Among those who took the full dosage, the median prolongation of gestation in the metformin arm was 16.3 (interquartile range 4.8-28.8; n=40) days compared with 4.8 (2.5-15.4; n=61) days in the placebo arm, a median difference of 11.5 days (geometric mean ratio 1.85, 95% confidence interval 1.14 to 2.88). Composite maternal, fetal, and neonatal outcomes and circulating concentrations of soluble fms-like tyrosine kinase-1, placental growth factor, and soluble endoglin did not differ. In the metformin arm, birth weight increased non-significantly and length of stay decreased in the neonatal nursery. No serious adverse events related to trial drugs were observed, although diarrhoea was more common in the metformin arm. CONCLUSIONS: This trial suggests that extended release metformin can prolong gestation in women with preterm pre-eclampsia, although further trials are needed. It provides proof of concept that treatment of preterm pre-eclampsia is possible. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR201608001752102 https://pactr.samrc.ac.za/.


Assuntos
Metformina/administração & dosagem , Pré-Eclâmpsia/tratamento farmacológico , Nascimento Prematuro/prevenção & controle , Adulto , Preparações de Ação Retardada , Método Duplo-Cego , Endoglina/sangue , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Fator de Crescimento Placentário/sangue , Gravidez , Nascimento Prematuro/etiologia , Estudo de Prova de Conceito , Fatores de Tempo , Resultado do Tratamento , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/sangue , Conduta Expectante
17.
MMWR Morb Mortal Wkly Rep ; 70(38): 1332-1336, 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34555002

RESUMO

Foodborne illnesses are a substantial and largely preventable public health problem; before 2020 the incidence of most infections transmitted commonly through food had not declined for many years. To evaluate progress toward prevention of foodborne illnesses in the United States, the Foodborne Diseases Active Surveillance Network (FoodNet) of CDC's Emerging Infections Program monitors the incidence of laboratory-diagnosed infections caused by eight pathogens transmitted commonly through food reported by 10 U.S. sites.* FoodNet is a collaboration among CDC, 10 state health departments, the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS), and the Food and Drug Administration. This report summarizes preliminary 2020 data and describes changes in incidence with those during 2017-2019. During 2020, observed incidences of infections caused by enteric pathogens decreased 26% compared with 2017-2019; infections associated with international travel decreased markedly. The extent to which these reductions reflect actual decreases in illness or decreases in case detection is unknown. On March 13, 2020, the United States declared a national emergency in response to the COVID-19 pandemic. After the declaration, state and local officials implemented stay-at-home orders, restaurant closures, school and child care center closures, and other public health interventions to slow the spread of SARS-CoV-2, the virus that causes COVID-19 (1). Federal travel restrictions were declared (1). These widespread interventions as well as other changes to daily life and hygiene behaviors, including increased handwashing, have likely changed exposures to foodborne pathogens. Other factors, such as changes in health care delivery, health care-seeking behaviors, and laboratory testing practices, might have decreased the detection of enteric infections. As the pandemic continues, surveillance of illness combined with data from other sources might help to elucidate the factors that led to the large changes in 2020; this understanding could lead to improved strategies to prevent illness. To reduce the incidence of these infections concerted efforts are needed, from farm to processing plant to restaurants and homes. Consumers can reduce their risk of foodborne illness by following safe food-handling and preparation recommendations.


Assuntos
COVID-19/epidemiologia , Microbiologia de Alimentos/estatística & dados numéricos , Parasitologia de Alimentos/estatística & dados numéricos , Doenças Transmitidas por Alimentos/epidemiologia , Pandemias , Conduta Expectante , Adolescente , Criança , Pré-Escolar , Doenças Transmitidas por Alimentos/microbiologia , Doenças Transmitidas por Alimentos/parasitologia , Humanos , Incidência , Lactente , Estados Unidos/epidemiologia
18.
Trials ; 22(1): 627, 2021 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-34526095

RESUMO

BACKGROUND: Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. METHODS/DESIGN: The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24-72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. TRIAL REGISTRATION: ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.


Assuntos
Permeabilidade do Canal Arterial , Pré-Escolar , Permeabilidade do Canal Arterial/diagnóstico por imagem , Permeabilidade do Canal Arterial/terapia , Humanos , Ibuprofeno/efeitos adversos , Lactente , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Conduta Expectante
19.
Pan Afr Med J ; 39(Suppl 1): 4, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548896

RESUMO

Introduction: intussusception surveillance was initiated in Tanzania in 2013 after monovalent rotavirus vaccine was introduced, as part of the 7-country African evaluation to assess whether the vaccine was associated with an increased risk of intussusception. An increased risk from vaccine was not identified. Published data on intussusception in Tanzanian infants are limited. Methods: prospective intussusception surveillance was conducted at 7 referral hospitals during 2013-2016 to identify all infants with intussusception meeting Brighton Level 1 criteria. Demographic, household and clinical data were collected by hospital clinicians and analyzed. Results: a total of 207 intussusception cases were identified. The median age of cases was 5.8 months and nearly three-quarters were aged 4-7 months. Median number of days from symptom onset to admission at treatment hospital was 3 (IQR 2-5). Seventy-eight percent (152/195) of cases had been admitted at another hospital before transfer to the treating hospital. Enema reduction was not available; all infants were treated surgically and 55% (114/207) had intestinal resection. The overall case-fatality rate was 30% (62/206). Compared with infants who survived, those who died had longer duration of symptoms before admission to treatment hospital (median 4 vs 3 days; p < 0.01), higher rate of intestinal resection (81% [60/82] vs 44% [64/144], p < 0.001), and from families with lower incomes (i.e., less likely to own a television [p < 0.01] and refrigerator [p < 0.05). Conclusion: Tanzanian infants who develop intussusception have a high case-fatality rate. Raising the index of suspicion among healthcare providers, allocating resources to allow wider availability of abdominal ultrasound for earlier diagnosis, and training teams in ultrasound-guided enema reduction techniques used in other African countries could reduce the fatality rate.


Assuntos
Hospitalização/estatística & dados numéricos , Intussuscepção/epidemiologia , Feminino , Humanos , Lactente , Recém-Nascido , Intussuscepção/mortalidade , Intussuscepção/terapia , Masculino , Estudos Prospectivos , Vacinas contra Rotavirus/administração & dosagem , Vacinas contra Rotavirus/efeitos adversos , Taxa de Sobrevida , Tanzânia/epidemiologia , Fatores de Tempo , Tempo para o Tratamento , Conduta Expectante
20.
Pan Afr Med J ; 39(Suppl 1): 6, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548898

RESUMO

Introduction: recipients of monovalent rotavirus vaccine have a low risk of developing intussusception (IS) in high- to medium-high-income countries. In sub-Saharan Africa, Zambia included, this risk of IS has not been assessed. Two-dose monovalent rotavirus vaccine, introduced in Zambia in 2012 in the capital of Lusaka, and rolled out countrywide in 2013, is administered at 6 and 10 weeks of age with no catch-up dose. Active IS surveillance monitoring in children < 2 years has been ongoing in Zambia since July 2009 and additional retrospective review was conducted from 2007- June 2009. Methods: retrospective review (January 2007-June 2009) and prospective (July 2009-December 2018) IS surveillance was conducted at nine hospitals and four large paediatric hospital departments in Zambia, respectively. Demographic and clinical data were collected from medical folder abstraction and supplemented by parental interview during prospective surveillance. Results: a total of 248 children < 2 years with IS were identified; 57.3% were male. Most cases with IS were infants (85.5%). IS admissions remained stable during the surveillance period with no seasonality pattern although an increase in cases occurred between August and October, hot dry season. The median time from symptom onset to presentation for treatment was 2 days and 63.6% (154/242) of IS diagnoses were made during surgery. The bowel resection rate was 46.6%. A high CFR of 23.3% was observed. Conclusion: the number of intussusception cases in Zambia was relatively small and remained stable over the 12-year study period. However, a high CFR was observed among cases.


Assuntos
Hospitalização/estatística & dados numéricos , Intussuscepção/epidemiologia , Vacinas contra Rotavirus/administração & dosagem , Distribuição por Idade , Estudos Transversais , Feminino , Humanos , Lactente , Recém-Nascido , Intussuscepção/mortalidade , Intussuscepção/terapia , Masculino , Estudos Prospectivos , Estudos Retrospectivos , Vigilância de Evento Sentinela , Tempo para o Tratamento , Conduta Expectante , Zâmbia/epidemiologia
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