SUMMARY: Background Nonacog beta pegol is a recombinant glycoPEGylated factor IX with an extended half-life, developed to improve care for patients with hemophilia B. Objectives To investigate the safety, efficacy and pharmacokinetics of nonacog beta pegol for the prophylaxis and treatment of bleeds in previously treated children with hemophilia B. Patients/Methods This phase 3 trial, paradigm(™) 5, enrolled and treated 25 children (aged ≤ 12 years) with hemophilia B (FIX ≤ 2%). Patients were stratified by age (0-6 years and 7-12 years), and received once-weekly prophylaxis with 40 IU kg(-1) nonacog beta pegol for 50 exposure days. Results No patient developed inhibitors, and no safety concerns were identified. Forty-two bleeds in 15 patients were reported to have been treated; the overall success rate was 92.9%, and most bleeds (85.7%) resolved after one dose. The median annualized bleeding rates (ABRs; bleeds per patient per year) were 1.0 in the total population, 0.0 in the 0-6-year group, and 2.0 in the 7-12-year group; the estimated mean ABRs were 1.44 in the total population, 0.87 in the 0-6-year group, and 1.88 in the 7-12-year group. For 22 patients who had previously been receiving prophylaxis, the estimated mean ABR was 1.38 versus a historical ABR of 2.51. Estimated mean steady-state FIX trough levels were 0.153 IU mL(-1) (0-6 years) and 0.190 IU mL(-1) (7-12 years). Conclusion Nonacog beta pegol was well tolerated in previously treated children with hemophilia B; a 40 IU kg(-1) dose provided effective once-weekly prophylaxis and hemostasis when bleeds were treated.
METHOD: A literature survey of published kratom studies among humans was conducted. Forty published studies relevant to the objective were reviewed.
RESULTS: Apart from the differences in the sources of supply, patterns of use and social acceptability of kratom within these two regions, the most interesting finding is its evolution to a recreational drug in both settings and the severity of the adverse effects of kratom use reported in the West. While several cases of toxicity and death have emerged in the West, such reports have been non-existent in South East Asia where kratom has had a longer history of use. We highlight the possible reasons for this as discussed in the literature. More importantly, it should be borne in mind that the individual clinical case-reports emerging from the West that link kratom use to adverse reactions or fatalities frequently pertained to kratom used together with other substances. Therefore, there is a danger of these reports being used to strengthen the case for legal sanction against kratom. This would be unfortunate since the experiences from South East Asia suggest considerable potential for therapeutic use among people who use drugs.
CONCLUSION: Despite its addictive properties, reported side-effects and its tendency to be used a recreational drug, more scientific clinical human studies are necessary to determine its potential therapeutic value.
METHODS: This is a cross-sectional study of seatbelt compliance of patients aged over 18 years, attending the emergency departments of five public hospitals in Singapore after road collisions from 2011-2014. Seatbelt data was obtained from paramedic and patient history.
RESULTS: There were 4,576 patients studied. Most were Singapore citizens (83.4 %) or permanent residents (2.4 %), with the largest non-resident groups from Malaysia, India, and China. Overall seatbelt compliance was 82.1 %. On univariate analysis, seatbelt compliance was higher in older patients (OR 1.02, 95 % CI 1.001-1.021, p
AIMS: To evaluate the evidence relating to attitudes towards PEG feeding and to determine potential barriers to the acceptance of PEG tube feeding.
METHODS: We searched Ovid MEDLINE, EMBASE, the Cochrane Library, Web of Science and CINAHL databases. The search for the studies was performed without restrictions by using the terms "PEG", "percutaneous endoscopic gastrostomy", "enteral feeding", "attitude", "perception" and "opinion". Qualitative and quantitative studies were included. Quality of studies was assessed with the Alberta checklists.
RESULTS: From 981 articles, 17 articles were included in the final analysis. Twelve qualitative and four quantitative studies were considered of good quality. Seven of the 14 studies reported positive attitudes towards PEG. Three major themes were identified in terms of barriers to PEG feeding: lack of choice (poor knowledge, inadequate competency and skills, insufficient time given, not enough information given, lack of guidelines or protocol, resource constraints), confronting mortality (choosing life or death, risk of procedure) and weighing alternatives (adapting lifestyle, family influences, attitudes of healthcare professionals (HCPs), fear and anxiety).
CONCLUSIONS: Only half of the reviewed studies reported positive perceptions towards PEG feeding. The themes identified in our systematic review will guide the development of interventions to alter the current attitudes and barriers towards PEG tube feeding.