ABSTRACTObjectives: Intravenous thrombolysis and thrombectomy are recommended for patients whose stroke onsets are within first 6 h, and very few options are available for patients whose stroke onset is more than 6 h, which includes most ischemic stroke patients. Human urinary kallidinogenase (HUK) showed potential clinical benefits in acute ischemic stroke patients. This study aims to investigate the safety and clinical benefits of HUK in ischemic stroke patients.Patients and methods: Patients were recruited for a multicenter double-blind, placebo-controlled phase II b and phase III trial. Neurophysiological outcomes were assessed by the European Stroke Scale (ESS) and the functional outcomes were assessed by the activity of daily living scale (ADL). Safety was monitored by recording adverse events.Results: The improvements in ESS scores and ADL scores in the HUK group were significantly greater than that in patients receiving placebo. Furthermore, HUK treatment was also associated with a lower rate of disable, according to ADL. HUK-related adverse events occurred at a low rate, in 1.73% of HUK-treated patients.Conclusion: HUK is safe and provides potential clinical benefits as a treatment for acute ischemic stroke. Further large post-marketing observational studies are needed. 相似文献
Frailty and disability from arthritis are closely intertwined and little is known about the impact of frailty on total hip arthroplasty (THA) outcomes. We hypothesized that higher preoperative frailty is associated with more adverse events following THA.
Methods
All patients (≥50 years) undergoing unilateral primary or revision THA at a single institution from 2005 through 2016 were included. We analyzed the association of frailty (measured by a frailty deficit index) with postoperative outcomes in hospital, within 90 days, and within 1 year using multivariable logistic and Cox regression, adjusting for age.
Results
Among 8640 patients undergoing THA (6502 primary and 2138 revisions; median age 68 years), 22.7%, 32.9%, and 44.4% were classified as frail, vulnerable, and nonfrail, respectively. Frail patients tended to be female, older, sicker (American Society of Anesthesiologists ≥3), and received general anesthesia more frequently. Relative to nonfrail patients, frail patients had significantly increased odds of wound complications/hematoma (odds ratio 2.01) and reoperation (odds ratio 2.74) while in hospital, and increased risks for mortality (1-year hazards ratio [HR] 5.65), infection (1-year HR 3.63), dislocation (1-year HR 2.10), wound complications/hematoma (1-year HR 2.61), and reoperation (1-year HR 2.22) within 90 days and 1 year. Frailty was also associated with >5.5-fold increased mortality risk 1 year following THA. No significant associations with aseptic loosening, periprosthetic fracture, or heterotopic ossification were observed.
Conclusion
A higher preoperative frailty index is associated with increased mortality and perioperative complications following primary and revision THA. The proposed frailty deficit index provides clinically important information for healthcare providers to use when counseling patients prior to decision for surgery. 相似文献
Background:Since the outbreak of coronavirus disease 2019 (COVID-19), with the improvement of diagnosis and treatment level in various countries, more and more patients have been discharged after systematic treatment. In order to effectively promote the overall recovery of patients’ physical and mental function and quality of life (QOL), the focus of clinical work should be gradually shifted to rehabilitation treatment. Dance-based mind-motor activities were defined as coordinated upright mind-motor movements that emphasize dynamic balance, structured through music or an inner rhythm (e.g., breathing) and distinctive instructions or choreography, and that involve social interaction. It has positive effects on motor function, lung function, psychological mood and other aspects, so it can be used as a safe alternative therapy for patients recovering from COVID-19. At present, there are no relevant articles for systematic review.Methods:From its inception until March 2021, we will conduct a comprehensive electronic search, including Cochrane Library, MEDLINE, PubMed, Springer, EMBASE, Chinese Science Citation Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, Wan-fang database. Two independent researchers will conduct article retrieval, screening, quality assessment, and data analysis through the Review Manager (V. 5.3.5).Results:The results of this study will evaluate the effectiveness and safety of dance-based mind-motor activities for the improvement of QOL in COVID-19 patients during the recovery period.Conclusion:The conclusion of the study will provide an evidence to judge whether dance-based mind-motor activities is effective and safe for COVID-19 in recovery period.Ethics and dissemination:This protocol will not evaluate individual patient information or infringe patient rights and therefore does not require ethical approval.PROSPERO registration number:CRD42021232995. 相似文献
Introduction: In the past eight years, the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has been intensively involved in a European Commission led process to develop EU legislation on the information of hazardous products that companies have to notify to EU Poisons Centres (or equivalent “appointed bodies”). As a result of this process, the Commission adopted Regulation (EU) No 2017/542, amending the CLP Regulation by adding an Annex on harmonised product submission requirements.
Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC). The information will be submitted by companies to PCs (or equivalent “appointed bodies”) using a web-based software application or in-house software. Two new important features are introduced. Firstly, to be able to rapidly identify the product formula, a Unique Formula Identifier (UFI) on the product label links to the submitted information. Secondly, for better comparability of reports on poisonings between EU member states, a harmonised Product Categorisation System will specify the intended use of a product. Rapid product identification and availability of detailed composition information will lead to timely and adequate medical intervention. This may lead to considerable reduction in healthcare costs.
Additionally, for companies trading across the EU, costs of submission of this information will be reduced significantly.
Next steps: From 2017, an implementation period has started, consisting of a three-year period for stakeholders to implement the new requirements, followed by a gradual applicability for consumer products (2020), professional products (2021) and industrial use-only products (2024). Technical tools to generate the electronic format and the UFI together with guidance documents are expected to be made available by the end of 2017 by the European Chemicals Agency (ECHA). Guidance on interpretation of legal text and ECHA helpdesk support are planned to be ready at the end of 2018. 相似文献