BackgroundInfluenza is a global public health problem. However, severe influenza only recently has been addressed in routine surveillance.ObjectivesThe Global Influenza Hospital Surveillance Network (GIHSN) was established to study the epidemiology of severe influenza in consecutive seasons in different countries. Our objective is to describe the GIHSN approach and methods.MethodsThe GIHSN uses prospective active surveillance to identify consecutive influenza admissions in permanent residents of well-defined geographic areas in sites around the world. A core common protocol is followed. After consent, data are collected on patient characteristics and clinical outcomes, respiratory swabs are obtained, and the presence of influenza virus and subtype or lineage is ascertained by polymerase chain reaction. Data are collated and analyzed at the GIHSN coordination center.ResultsThe GIHSN has run its activities for two consecutive influenza seasons, 2012–2013 and 2013–2014, and hospitals in Brazil, China, France, Russian Federation, Turkey, and Spain have been involved in one or both seasons. Consistency on the application of the protocol and heterogeneity for the first season have been addressed in two previous publications. During both seasons, 19 677 eligible admissions were recorded; 11 843 (60%) were included and tested, and 2713 (23%) were positive for influenza: 991 (37%) A(H1N1); 807 (30%) A(H3N2); 583 (21%) B/Yamagata; 56 (2%) B/Victoria and 151 (6%) influenza A; and 125 (5%) influenza B were not characterized.ConclusionsThe GIHSN is a platform that provides information on severe influenza worldwide, applying a common core protocol and a consistent case definition.
RDP seems to be a safe and effective alternative to LDP. Large randomized controlled trials are needed to verify the results of this meta-analysis.
Background: Xingnaojing injection (XNJ) is the only Chinese herbal injection approved for both intracerebral hemorrhage and ischemic stroke (IS) first-aid on ambulances in China; many systematic reviews (SRs) and meta-analyses (MAs) of XNJ on stroke have been published. The purpose of this research was to evaluate and summarize the current evidence on XNJ for IS.Methods: A comprehensive search was conducted for SRs and MAs of XNJ on IS in seven databases up to January 1, 2021. Two authors independently identified SRs and MAs, extracted data, assessed the quality of the included SRs and MAs using the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2), and assessed quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE).Results: A total of 10 SRs met the inclusion criteria. The quality of included SRs using AMSTAR 2 was critically low as the critical items were poorly reported. Only 10% of SRs reported 50% of the 16 items, while the remaining 90% SRs reported just less than half of the items on AMSTAR 2. For GRADE, 7 (35%) of outcomes had low-quality evidence, 10 (50%) with very low, and 3 (15%) with moderate quality evidence. Very low to low quality of evidence indicated XNJ plus conventional therapy (CT) alleviated the neurological deficits of acute IS. Moderate-quality evidence showed XNJ plus CT reduced mortality when compared to Danshen injection plus CT, and very low-quality evidence showed XNJ plus CT could not improve the degree of coma, while low-quality evidence indicated the opposite. Mild adverse events in the CT group were less than those in the XNJ plus CT group, and there were no serious adverse events, but there was no statistical difference between the two groups. The included 10 SRs indicated that XNJ was used for acute IS, but only four SRs (40%) reported the course of disease.Conclusion: XNJ appears to be effective and safe for acute IS in improving the neurological deficits, but the evidence is not robust enough. However, whether administering XNJ immediately after or within 24 h of IS is best remains unknown due to the lack of data. Well-designed large-scale randomized controlled trials with measurable outcomes are required in future studies.
IntroductionWith the threat of a worldwide pandemic of COVID-19, it is important to identify the prognostic factors for critical conditions among patients with non-critical COVID-19. Prognostic factors and models may assist front-line clinicians in rapid identification of high-risk patients, early management of modifiable factors, appropriate triaging and optimising the use of limited healthcare resources. We aim to systematically assess the clinical, laboratory and imaging predictors as well as prediction models for severe or critical illness and mortality in patients with COVID-19.Methods and analysisAll peer-reviewed and preprint primary articles with a longitudinal design that focused on prognostic factors or models for critical illness and mortality related to COVID-19 will be eligible for inclusion. A systematic search of 11 databases including PubMed, EMBASE, Web of Science, Cochrane Library, CNKI, VIP, Wanfang Data, SinoMed, bioRxiv, Arxiv and MedRxiv will be conducted. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data extraction will be performed using the modified version of the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies checklist and quality will be evaluated using the Newcastle-Ottawa Scale and the Quality In Prognosis Studies tool. The association between prognostic factors and outcomes of interest will be synthesised and a meta-analysis will be conducted with three or more studies reporting a particular factor in a consistent manner.Ethics and disseminationEthical approval was not required for this systematic review. We will disseminate our findings through publication in a peer-reviewed journal.PROSPERO registration numberCRD 42020178798.
Background: BuqiTongluo (BQTL) granules are herbal phenotypic drugs for Qi deficiency and blood stasis (QDBS) syndrome. Its discovery relied primarily on knowledge of observable phenotypic changes associated with diseases. Although BQTL granules have been widely advocated by Chinese Medicine (CM) practitioners, its use lacks empirical support.Aim of the study: In this basket trial, the efficacy of BQTL granules in multiple diseases that have the QDBS syndrome in common will be compared with placebo.Materials and Methods: The BuqiTongluo granule for Qi deficiency and blood stasis syndrome (BOSS) study is a basket herbal trial (ClinicalTrials.gov, NCT04408261). It will be a double-blinded, randomized, placebo-controlled, parallel, multicenter, clinical trial. In total, 432 patients (1:1:1 ischemic stroke, stable angina pectoris, and diabetic peripheral neuropathy), who meet the operationalized diagnostic criteria for QDBS syndrome, have been recruited and randomized in a ratio of 1:1 to receive 6 weeks’ treatment with BQTL granules or placebo. The primary outcome is the change in the QDBS syndrome score at week 6 from baseline. Secondary outcomes include objective outcome measures for the three diseases and adverse events. Omics will help to understand these responses by molecular events.Conclusion: QDBS syndrome is a common phenotypic marker that was hypothesized to predict whether patients with multiple diseases would respond to this targeted therapy. No previous basket trial has assessed the potential efficacy of an herbal intervention for multiple diseases. The unique promise of the trial is its ability to exploit a disease phenotype to discover novel treatments for three diseases for which the root cause is unknown, complex, or multifactorial, and for which scientific understanding is insufficient to provide valid molecular targets.
Background: Although revascularization treatment is recommended as the first-line therapy for patients with non-minor acute ischemic stroke (AIS), it only benefits a minority of patients. Previous studies have reported the positive effects of Panax notoginseng saponins (PNS) (Xueshuantong lyophilized powder) on AIS, however, there have been no rigorous trials. This study aims to assess the efficacy and safety of PNS therapy for patients with AIS.Methods: The Evaluation of Xueshuantong in Patients with acutE ischemiC sTroke (EXPECT) trial is a multicenter, randomized, placebo-controlled, double-blind study aiming to enroll 480 patients in China. Eligible patients with AIS within 72 h of symptom onset will randomly receive either PNS or PNS placebo for 10 days and subsequently be followed up to 90 days. The primary outcome will be a change in the National Institute of Health Stroke Scale (NIHSS) score from baseline to 10 post-randomization days. The secondary outcomes include early neurological improvement (proportion of patients with NIHSS score 0–1), and Patient-Reported Outcomes Scale for Stroke score at 10 post-randomization days, the proportion of patients with life independence (modified Rankin Scale score of 0–1), the proportion of patients with a favorable outcome (Barthel Index ≥90), and Stroke-Specific Quality of Life score at 90 days. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of PNS.Conclusions: To our knowledge, this study is the first double-blind trial to assess the efficacy and safety of PNS in patients with AIS. Findings of the EXPECT trial will be valuable in improving evidence regarding the clinical application of PNS therapy in patients with AIS ineligible for revascularization treatment in the reperfusion era.
Background: Given the complexity of stroke treatment and the current widespread use of traditional Chinese medicine (TCM) in the absence of robust, large, long-term effectiveness and safety studies, and the lack of nationwide epidemiology and clinical characteristics of patients with stroke receiving TCM treatment, the acquisition of data from longitudinal cohorts is essential. We intend to generate the major clinical characteristics of patients with stroke who receive TCM treatment and to investigate the effectiveness and safety of TCM in the Chinese population.Methods: The China Stroke Registry for Patients with Traditional Chinese Medicine (CASES-TCM) study is a prospective, multicenter, observational disease registry aiming to register 20,000 hospitalized patients. Eligible adult patients with clearly diagnosed acute ischemic stroke or intracerebral hemorrhage within 7 days of symptom onset will be consecutively registered from 126 participating sites across China. Baseline data will be recorded, and all patients will be regularly followed up at 3, 6, 12, and 24 months after stroke onset. Collected data will be entered into a web-based system with high-level data security. The primary outcomes include the distribution of scores on the modified Rankin Scale at the 3-months follow-up, and recurrent stroke events within the 12-months follow-up.Conclusion: To our knowledge, the CASES-TCM study is the first and largest nationwide registry to document comprehensive data on TCM treatment in patients with acute stroke. The findings of this study will be valuable to improve our knowledge about TCM treatment for patients with stroke and its subsequent outcomes in the actual clinical setting, consequently facilitating and standardizing the optimization of individualized interventions with TCM for stroke prevention and treatment in China.Study registration: This study was registered with Clinicaltrials.gov (URL: https://clinicaltrials.gov/, Unique identifier: NCT04921397).
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