Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 5.845
Filter
2.
Interact Cardiovasc Thorac Surg ; 35(5)2022 10 10.
Article in English | MEDLINE | ID: covidwho-20233824

ABSTRACT

Aortic wrapping is a controversial repair in patients presenting with acute type A aortic dissection or intramural haematoma, but this method may be a potential alternative to medical treatment or conventional repair in patients aged >80 years and in those presenting with prohibitive co-morbidities such as stroke, circulatory collapse, full oral anticoagulation with the last generation drugs. We report on 5 high-risk and/or patients over 80 years who received external aortic wrapping with or without cardiopulmonary bypass during the last 18 months. All survived the procedure and could be extubated early postoperatively. No patient remained on the intensive care longer than 2 days and all were discharged without additional complications. Postoperative radiological control was acceptable and no patient had any new aortic event up to 18 months postoperatively.


Subject(s)
Aortic Aneurysm, Thoracic , Aortic Dissection , Humans , Aortic Dissection/complications , Aortic Dissection/diagnostic imaging , Aortic Dissection/surgery , Hematoma/diagnostic imaging , Hematoma/etiology , Hematoma/surgery , Aorta , Cardiopulmonary Bypass , Anticoagulants/therapeutic use , Treatment Outcome , Aortic Aneurysm, Thoracic/surgery
3.
Medicine (Baltimore) ; 99(41): e22697, 2020 Oct 09.
Article in English | MEDLINE | ID: covidwho-20237005

ABSTRACT

BACKGROUND: The study aims to evaluate the effectiveness and safety of acupuncture therapy for asymptomatic infection of COVID-19. METHODS: The following electronic databases will be searched from December 2019 to December 2020: MEDLINE, PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), Wan-fang database, Chinese Scientific Journal Database (VIP), Chinese Biomedical Literature Databases (CBM), and other databases. All published randomized controlled trials (RCTs) about this topic will be included. Two independent researchers will operate article retrieval, duplication removing, screening, quality evaluation, and data analyses by Review Manager (V.5.3.5). Meta-analyses, subgroup analysis, and/or descriptive analysis will be performed based on the included data conditions. RESULTS: High-quality synthesis and/or descriptive analysis of current evidence will be provided from the time of negative nucleic acid detection for 2 consecutive times (not on the same day), cure rate, converting to clinical diagnosis rate, and side effects of acupuncture. CONCLUSION: This study will provide the evidence of whether acupuncture is an effective and safe intervention for asymptomatic infection of COVID-19. PROSPERO REGISTRATION NUMBER: CRD 42020179729.


Subject(s)
Acupuncture Therapy , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Asymptomatic Diseases , COVID-19 , Humans , Meta-Analysis as Topic , Pandemics , Systematic Reviews as Topic , Treatment Outcome
5.
Lancet ; 401(10388): 1584-1594, 2023 05 13.
Article in English | MEDLINE | ID: covidwho-20236681

ABSTRACT

BACKGROUND: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. METHODS: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to <60 mL/min per 1·73 m2 and ≥60 mL/min per 1·73 m2) and urine protein excretion at screening (≤1·75 g/day and >1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. FINDINGS: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. INTERPRETATION: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. FUNDING: Travere Therapeutics.


Subject(s)
Glomerulonephritis, IGA , Adult , Humans , Adolescent , Irbesartan/therapeutic use , Glomerulonephritis, IGA/drug therapy , Creatinine/urine , Proteinuria/drug therapy , Double-Blind Method , Treatment Outcome
6.
Int Braz J Urol ; 49(4): 462-468, 2023.
Article in English | MEDLINE | ID: covidwho-20236176

ABSTRACT

PURPOSE: To evaluate the effect of the standardized laparoscopic simulation training program in pyeloplasty, following its implementation and during the COVID-19 pandemic. MATERIAL AND METHODS: A retrospective chart review was performed at Hospital de Clínicas de Porto Alegre, a tertiary referral center in south Brazil, in which 151 patients underwent laparoscopic pyeloplasty performed by residents between 2006-2021. They were divided into three groups: before and after adoption of a standardized laparoscopic simulation training program and during the COVID-19 pandemic. The main outcome was a combined negative outcome of conversion to open surgery, major postoperative complications (Clavien-Dindo III or higher) or unsuccessful procedure, defined as need for redo pyeloplasty. RESULTS: There was a significant reduction in the combined negative outcome (21.1% vs 6.3%), surgical time (mean 200.0 min vs 177.4 min) and length of stay (median 5 days vs 3 days) after the adoption of simulation training program. These results were maintained during the COVID-19 pandemic (combined negative outcome of 6.3%, mean surgical time of 160.1 min and median length of stay of 3 days) despite a reduction in 55.4% of the surgical volume. CONCLUSION: A structured laparoscopic simulation program can improve outcomes of laparoscopic pyeloplasty during the learning curve.


Subject(s)
COVID-19 , Internship and Residency , Laparoscopy , Simulation Training , Ureteral Obstruction , Humans , Kidney Pelvis/surgery , Pandemics , Ureteral Obstruction/surgery , Retrospective Studies , Urologic Surgical Procedures/methods , Treatment Outcome , COVID-19/complications , Laparoscopy/methods , Tertiary Care Centers
7.
J Clin Nurs ; 32(13-14): 4116-4127, 2023 Jul.
Article in English | MEDLINE | ID: covidwho-20235883

ABSTRACT

AIM: To design a protocol based on the experiences of long-term survivors to facilitate resilience for oesophageal cancer patients in rural China. BACKGROUND: According to the latest Global Cancer Statistics Report, 604,000 new cases of oesophageal cancer were reported, of which over 60% of the disease burden is distributed in China. The incidence of oesophageal cancer in rural China (15.95/100,000) is twice as high as those in urban areas (7.59/100,000). To be sure, resilience can help patients better adapt to post-cancer life. But universal interventions involving improving the resilience of oesophageal cancer patients have much less been explored, especially for rural patients. METHODS: The two-arm, parallel design, non-blinded, randomised controlled trial will be implemented in 86 adults diagnosed with oesophageal cancer and will be randomly assigned to the control group or the intervention group via the blocked randomisation. The intervention group will undergo an intervention with one-on-one guidance from a nurse while viewing a CD of the experiences of long-term survivors with oesophageal cancer in rural areas. Every 2 weeks, a theme session will be introduced, and the entire intervention will continue for 12 weeks. Psychosocial variables (resilience, self-efficacy, coping mode and family support) will be surveyed at baseline, post-intervention and 3 months after the intervention. The paper complies with the Standard Protocol Items: Recommendations for Intervention Trials 2013 and Consolidated Standards of Reporting Trials guidelines for study protocols adapted for designing and reporting parallel group randomised trials. CONCLUSION: The intervention programme transitions from hospitalisation to discharge, which includes one-on-one interventions by medical personnel and a portable CD describing the experiences of long-term survivors with rural oesophageal cancer. Once the intervention's effectiveness is proven, this protocol will provide psychological support for massive oesophageal cancer patients. RELEVANCE TO CLINICAL PRACTICE: The intervention programme may be used as an auxiliary therapy to promote patients' postoperative psychological rehabilitation. This programme has the advantages of being cost-effective, flexible, accessible, and convenient and can be implemented without the limitation of time, place and clinical medical staff. TRIAL REGISTRATION: The Chinese Clinical Trial Registration number is ChiCTR2100050047. Registered on 16 August 2021.


Subject(s)
COVID-19 , Esophageal Neoplasms , Adult , Humans , SARS-CoV-2 , Survivors , Cost of Illness , Treatment Outcome , Randomized Controlled Trials as Topic
8.
Addict Sci Clin Pract ; 18(1): 39, 2023 06 02.
Article in English | MEDLINE | ID: covidwho-20235217

ABSTRACT

BACKGROUND: Breaking Free Online (BFO), a computer-assisted therapy (CAT) program for substance use disorders (SUD), has been available across UK treatment services for the past decade and has demonstrated efficacy. The Covid-19 pandemic has contributed to digital and 'telehealth' approaches to healthcare delivery becoming more common and accepted, and has in parallel, increased numbers of referrals to SUD services because of the impact pandemic-related stress has had on substance using habits in the general population. Digital and telehealth approaches, such as BFO, have the potential to support the treatment system to meet this increased demand for SUD services. METHODS: Parallel-group randomized controlled trial of eight-week BFO as an adjunct to standard treatment for SUD, in comparison to standard treatment only, at a National Health Service (NHS) Mental Health Trust in North-West England. Participants will be service users aged 18 years and over with demonstrable SUD for at least 12-months. Interventional and control groups will be compared on multiple measures from baseline to post-treatment assessment at eight-weeks, and then three and six-months follow-up. Primary outcome will be self-reported substance use, with secondary outcomes being standardized assessments of substance dependence, mental health, biopsychosocial functioning and quality of life. DISCUSSION: This study will examine whether BFO and telehealth support, when delivered as an adjunct to standard SUD interventions, improves outcomes for services users receiving NHS SUD treatment. Findings from the study will be used to inform both developments to the BFO program and guidance around augmenting the delivery of CAT programs via telehealth. Trial registration registered with ISRCTN on 25th May 2021-registration number: 13694016. PROTOCOL VERSION: 3.0 05th April 2022. TRIAL STATUS: This trial is currently open to recruitment-estimated to be completed in May 2023.


Subject(s)
COVID-19 , Substance-Related Disorders , Therapy, Computer-Assisted , Humans , Pandemics , Quality of Life , State Medicine , Therapy, Computer-Assisted/methods , Substance-Related Disorders/therapy , Substance-Related Disorders/psychology , Treatment Outcome , Randomized Controlled Trials as Topic
9.
BMJ Open ; 13(5): e064058, 2023 05 25.
Article in English | MEDLINE | ID: covidwho-20235059

ABSTRACT

INTRODUCTION: In the COVID-19 pandemic, healthcare workers (HCWs) were at high risk of infection due to their exposure to COVID infections. HCWs were the backbone of our healthcare response to this pandemic; every HCW withdrawn or lost due to infection had a substantial impact on our capacity to deliver care. Primary prevention was a key approach to reduce infection. Vitamin D insufficiency is highly prevalent in Canadians and worldwide. Vitamin D supplementation has been shown to significantly decrease the risk of respiratory infections. Whether this risk reduction would apply to COVID-19 infections remained to be determined. This study aimed to determine the impact of high-dose vitamin D supplementation on incidence of laboratory-confirmed COVID-19 infection rate and severity in HCWs working in high COVID incidence areas. METHODS AND ANALYSIS: PROTECT was a triple-blind, placebo-controlled, parallel-group multicentre trial of vitamin D supplementation in HCWs. Participants were randomly allocated in a 1:1 ratio in variable block size to intervention (one oral loading dose of 100 000 IU vitamin D3+10 000 IU weekly vitamin D3) or control (identical placebo loading dose+weekly placebo). The primary outcome was the incidence of laboratory-confirmed COVID-19 infection, documented by RT-qPCR on salivary (or nasopharyngeal) specimens obtained for screening or diagnostic purposes, as well as self-obtained salivary specimens and COVID-19 seroconversion at endpoint. Secondary outcomes included disease severity; duration of COVID-19-related symptoms; COVID-19 seroconversion documented at endpoint; duration of work absenteeism; duration of unemployment support; and adverse health events. The trial was terminated prematurely, due to recruitment difficulty. ETHICS AND DISSEMINATION: This study involves human participants and was approved by the Research Ethics Board (REB) of the Centre hospitalier universitaire (CHU) Sainte-Justine serving as central committee for participating institutions (#MP-21-2021-3044). Participants provided written informed consent to participate in the study before taking part. Results are being disseminated to the medical community via national/international conferences and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: https://clinicaltrials.gov/ct2/show/NCT04483635.


Subject(s)
COVID-19 , Humans , SARS-CoV-2 , Pandemics/prevention & control , Canada/epidemiology , Vitamin D/therapeutic use , Vitamins/therapeutic use , Treatment Outcome , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
10.
BMJ Open ; 13(6): e072622, 2023 06 01.
Article in English | MEDLINE | ID: covidwho-20233676

ABSTRACT

INTRODUCTION: Children with bone and joint infections are traditionally treated with intravenous antibiotics for 3-10 days, followed by oral antibiotics. Oral-only treatment has not been tested in randomised trials. METHODS AND ANALYSIS: Children (3 months to 18 years) will be randomised 1:1 with the experimental group receiving high-dose oral antibiotics and the control group receiving intravenous antibiotics with a shift in both groups to standard oral antibiotics after clinical and paraclinical improvement. Children in need of acute surgery or systemic features requiring intravenous therapy, including septic shock, are excluded. The primary outcome is defined as a normal blinded standardised clinical assessment 6 months after end of treatment. Secondary outcomes are non-acute treatment failure and recurrent infection. Outcomes will be compared by a non-inferiority assumption with an inferiority margin of 5%. ETHICS AND DISSEMINATION: The trial has the potential to reduce unnecessary hospitalisation and use of intravenous antibiotics in children with bone or joint infections. Due to the close follow-up, exclusion of severely ill children and predefined criteria for discontinuation of the allocated therapy, we expect the risk of treatment failure to be minimal. TRIAL REGISTRATION NUMBER: NCT04563325.


Subject(s)
COVID-19 , Humans , Child , Anti-Bacterial Agents/therapeutic use , SARS-CoV-2 , Treatment Outcome , Administration, Intravenous , Randomized Controlled Trials as Topic
11.
Psychol Med ; 53(7): 2808-2819, 2023 May.
Article in English | MEDLINE | ID: covidwho-20233596

ABSTRACT

BACKGROUND: To determine: whether young adults (aged 18-24) not in education, employment or training (NEET) have different psychological treatment outcomes to other young adults; any socio-demographic or treatment-related moderators of differential outcomes; and whether service-level changes are associated with better outcomes for those who are NEET. METHODS: A cohort was formed of 20 293 young adults treated with psychological therapies in eight Improving Access to Psychological Therapies services. Pre-treatment characteristics, outcomes, and moderators of differential outcomes were compared for those who were and were not NEET. Associations between outcomes and the following were assessed for those that were NEET: missing fewer sessions, attending more sessions, having a recorded diagnosis, and waiting fewer days between referral and starting treatment. RESULTS: Those who were NEET had worse outcomes: odds ratio (OR) [95% confidence interval (CI)] for reliable recovery = 0.68 (0.63-0.74), for deterioration = 1.41 (1.25-1.60), and for attrition = 1.31 (1.19-1.43). Ethnic minority participants that were NEET had better outcomes than those that were White and NEET. Living in deprived areas was associated with worse outcomes. The intensity of treatment (high or low) did not moderate outcomes, but having more sessions was associated with improved outcomes for those that were NEET: odds (per one-session increase) of reliable recovery = 1.10 (1.08-1.12), deterioration = 0.94 (0.91-0.98), and attrition = 0.68 (0.66-0.71). CONCLUSIONS: Earlier treatment, supporting those that are NEET to attend sessions, and in particular, offering them more sessions before ending treatment might be effective in improving clinical outcomes. Additional support when working with White young adults that are NEET and those in more deprived areas may also be important.


Subject(s)
Ethnicity , Unemployment , Humans , Young Adult , Minority Groups , Employment , Treatment Outcome
12.
Wounds ; 35(6): 109-116, 2023 Jun.
Article in English | MEDLINE | ID: covidwho-20233446

ABSTRACT

INTRODUCTION: COVID-19 illness is associated with increased operative risks, ranging from delayed wound healing and coagulopathy to increased risk of mortality. OBJECTIVE: This article describes the authors' recent experience of the implications of COVID-19 on limb salvage procedures. MATERIALS AND METHODS: Patients who underwent LE limb salvage procedures within 30 days of a positive COVID-19 diagnosis were retrospectively reviewed. Patient demographics, comorbidities, surgical factors, postoperative complications, and management were collected. RESULTS: Of 597 patients screened from February 2020 to March 2022, a total of 67 (11.2%) were diagnosed with COVID-19, of which 17 received the diagnosis within 30 days of surgery and were thus included. Average follow-up was 43 ± 3.2 months, at which point 6 (35.3%) were fully healed. The mortality rate at the most recent follow-up visit was 29.4% of patients (n = 5). Two patients required admission to the SICU following index procedure, and 1 necessitated a return to the operating room. CONCLUSION: COVID-19 may negatively affect the wound healing process while increasing the mortality rate amongst patients with multiple or severe comorbidities undergoing limb salvage procedures. Medical providers need to be aware of the complexity of these patients and apply a multi-disciplinary protocol to obtain successful outcomes.


Subject(s)
COVID-19 , Limb Salvage , Humans , Limb Salvage/methods , Retrospective Studies , COVID-19 Testing , Tertiary Healthcare , Treatment Outcome , Ischemia/surgery , COVID-19/epidemiology , Risk Factors
13.
J Am Pharm Assoc (2003) ; 63(3): 742-750.e3, 2023.
Article in English | MEDLINE | ID: covidwho-20233304

ABSTRACT

BACKGROUND: Long-acting injectable antipsychotic (LAIA) medications offer an effective treatment option for patients with serious mental illness. Despite demonstrated clinical safety and efficacy as well as increased adherence and less frequent administration compared with daily oral regimens, LAIAs remain underutilized in clinical practice. With legislation allowing pharmacists to administer injectable medications in 48 U.S. states, community pharmacies are uniquely positioned to serve as an access point for patients with serious mental illnesses to receive LAIA injections. OBJECTIVE: This study aimed to conduct a systematic review of the health and economic benefits and costs of community pharmacist administration of LAIA medications. METHODS: A systematic search of the literature published from January 1996 to April 2022 was conducted across 3 databases (Embase, PubMed, and Scopus Plus). Publications describing pharmacist administration of LAIA medications in outpatient settings were included. Publications that examined the use of LAIAs but did not involve a pharmacist administering the medication were excluded. RESULTS: Of 2261 publications reviewed, we identified 8 publications (4 articles and 4 abstracts) that met our inclusion criteria, of which only 7 included results. Four studies reported high medication adherence achieved by patients receiving pharmacist-administered LAIAs. Two publications surveyed patient satisfaction with pharmacist administration of LAIAs in community pharmacy settings. One study found pharmacists' mixed attitudes regarding LAIA administration and time and safety barriers to offering the service. CONCLUSION: We found very little evidence on the impact of pharmacist administration of LAIAs on patient outcomes. This review highlights the need to generate greater evidence on the health and economic benefits as well as financial models for pharmacists to administer LAIA medications in outpatient and community pharmacy settings. Such evidence could support more community pharmacists to offer LAIA medications and contribute to the shift toward value-based care.


Subject(s)
Antipsychotic Agents , Community Pharmacy Services , Humans , Pharmacists , Injections , Treatment Outcome , Patient Satisfaction
14.
BMC Psychiatry ; 23(1): 406, 2023 06 06.
Article in English | MEDLINE | ID: covidwho-20233301

ABSTRACT

BACKGROUND: Activity and participation are critical to health and wellbeing. Limited evidence exists on how to support people with mental illness in participating in everyday activities. AIM: To investigate the effectiveness of Meaningful Activities and Recovery (MA&R), a co-led peer occupational therapy intervention focusing on activity engagement, functioning, quality of life, and personal recovery. METHODS: In a statistician blinded, multicenter RCT including 139 participants from seven community and municipal mental health services in Denmark, participants were randomly assigned to 1) MA&R and standard mental health care or 2) standard mental health care. The MA&R intervention lasted 8 months and consisted of 11 group sessions, 11 individual sessions, and support to engage in activities. The primary outcome, activity engagement, was measured using Profile of Occupational Engagement in People with Severe Mental Illness (POES-S). Outcomes were measured at baseline and post-intervention follow-up. RESULTS: Meaningful Activities and Recovery was delivered with high fidelity and 83% completed the intervention. It did not demonstrate superiority to standard mental health care, as intention-to treat analysis revealed no significant differences between the groups in activity engagement or any of the secondary outcomes. CONCLUSION: We did not find positive effects of MA&R, possibly because of COVID-19 and related restrictions. Fidelity assessments and adherence rates suggest that MA&R is feasible and acceptable. However, future studies should focus on refining the intervention before investigating its effectiveness. TRIAL REGISTRATION: The trial was registered 24/05/2019 at ClinicalTrials.gov NCT03963245.


Subject(s)
COVID-19 , Mental Disorders , Occupational Therapy , Humans , Quality of Life , Treatment Outcome , Mental Disorders/therapy , Mental Disorders/psychology
15.
BJS Open ; 7(3)2023 05 05.
Article in English | MEDLINE | ID: covidwho-20233205

ABSTRACT

BACKGROUND: A major shift in treatment of appendicitis occurred early in the SARS-CoV-2 pandemic with non-operative management used commonly outside research protocols and in units with limited previous experience. This study aims to compare real-world outcomes of surgery versus non-operative management of uncomplicated appendicitis in children with 1-year follow-up. METHOD: A prospective multicentre observational study of children treated for uncomplicated appendicitis at 74 hospitals in the UK and Ireland from 1 April to 31 July 2020 was performed. Propensity-score matched analysis was conducted using age, sex, C-reactive protein at diagnosis and duration of symptoms as covariates. Primary outcomes were success of non-operative management defined as achieving 1-year follow-up without undergoing appendicectomy due to recurrent appendicitis or ongoing symptoms, and occurrence of any predefined complication (intra-abdominal collection, wound infection, bowel obstruction or reintervention). RESULTS: Of 1464 children with presumed uncomplicated appendicitis, 1027 (70.2 per cent) underwent surgery and 437 (29.9 per cent) underwent non-operative management. Ninety-four children (21.5 per cent) treated by initial non-operative management required appendicectomy during the index hospital admission while recurrent appendicitis after discharge occurred in 25 (10.4 per cent) children within 1 year. The overall success rate of non-operative management at 1 year was 63.1 per cent (95 per cent c.i. 58.0 to 68.3 per cent). For propensity-score matched analyses, 688 children undergoing surgery and 307 undergoing non-operative management were included. Any predefined complication occurred in 50 (7.3 per cent) children undergoing surgery and in four (1.3 per cent) children undergoing non-operative management (OR 5.9 (95 per cent c.i. 2.1 to 16.6)) in the propensity-score matched cohort. There was no mortality or stoma formation. CONCLUSION: Non-operative management is a safe and valid alternative to appendicectomy in children with uncomplicated appendicitis.


Subject(s)
Appendicitis , COVID-19 , Child , Humans , Anti-Bacterial Agents/therapeutic use , Appendicitis/surgery , Appendicitis/complications , Pandemics , Prospective Studies , SARS-CoV-2 , Treatment Outcome , Male , Female
16.
Ter Arkh ; 94(11): 1268-1277, 2022 Dec 26.
Article in Russian | MEDLINE | ID: covidwho-20232702

ABSTRACT

BACKGROUND: A multicenter, double-blind, placebo-controlled, randomized clinical trial (RCT) of the phase III efficacy and safety of Ergoferon® for the non-specific prevention of COVID-19 during vaccination against a new coronavirus infection was conducted (permission of the Ministry of Health of the Russian Federation №559 dated 22.09.2021; ClinicalTrials.gov Identifier: NCT05069649). AIM: To evaluate the efficacy and safety of the use of Ergoferon for the non-specific prevention of COVID-19 during vaccination against a new coronavirus infection. MATERIALS AND METHODS: From October 2021 to April 2022, 1,057 patients aged 18 to 92 years who received component I of the "Gam-COVID-Vac" vaccine were included. After screening, 1,050 patients were randomized into 2 groups: 526 people received Ergoferon according to the prophylactic scheme - 1 tablet per administration 2 times a day for 3 weeks, the drug is not allowed during the meal and should be kept in the mouth without swallowing, until completely dissolved; 524 patients received a placebo according to the Ergoferon® scheme. The total duration of participation in the study was 5 weeks + 3 days. The primary endpoint is the number of RT-PCR - confirmed cases of SARS-CoV-2 infection, regardless of the presence of symptoms during participation in the study. An additional criterion of effectiveness is the proportion of those hospitalized with COVID-19. The safety assessment included consideration of the presence and nature of adverse events (AEs), their severity, relationship with the drug intake, and outcome. Statistical data processing was carried out using SAS 9.4 with the calculation of the exact Fisher test, χ2 test, Cochrane-Mantel-Hensel test, Wilcoxon test and other parameters. RESULTS: The ITT (Intention-to-treat) and PP [Per Protocol] efficacy analysis included data from 1,050 [970] patients: 526 [489] people - Ergoferon® group and 524 [481] people - Placebo group. The primary endpoint - the number of laboratory-confirmed cases of SARS-CoV-2 infections was 3 times less compared to placebo - 7 (1.43%) vs 22 (4.57%), respectively (p=0.0046; [p=0.0041]). Taking Ergoferon® reduces the risk of SARS-CoV-2 infection by more than 3 times in vaccinated patients during 5 weeks of the vaccination and post-vaccination periods (p=0.0046 [p=0.0041]). Of the COVID-19 patients in the Ergoferon® group (1.33%) nobody was hospitalized. According to the Post hoc analysis, Ergoferon® reduces the risk of COVID-19 disease by 4 times in the period between the components I and II of the "Gam-COVID-Vac" vaccine (p=0.0066 [p=0.006]). The frequency of AEs in both groups did not differ. There were no registered AEs associated with the drug with a reliable degree. There was a high level of patient compliance and good tolerability. CONCLUSION: Ergoferon is an effective and safe drug for the prevention of COVID-19 in people vaccinated against a new coronavirus infection.


Subject(s)
COVID-19 , Vaccines , Humans , COVID-19/epidemiology , COVID-19/prevention & control , SARS-CoV-2 , Vaccination , Double-Blind Method , Treatment Outcome
17.
J Fr Ophtalmol ; 46(6): 596-604, 2023 Jun.
Article in French | MEDLINE | ID: covidwho-20232688

ABSTRACT

PURPOSE: To assess the impact of the measures taken during the lockdown period from March 17 to May 11, 2020 on the management of patients with exudative age related macular degeneration treated by intravitreal anti-VEGF injections at the University Hospital of Tours. METHODS: In this retrospective study, patients were included after analysis of the computerized medical records of patients with age related macular degeneration. Those who were treated for exudative age related macular degeneration who received at least 1 intravitreal injection in the 12 months prior and at least one consultation in the 6 months prior to the lockdown period, were included. The initial and final mean visual acuity were compared with a 5 letter non-inferiority margin. A subgroup analysis was performed according to outcomes. The visual acuities immediately after this period were also recorded. RESULTS: In all, 595 eyes of 493 patients were included. The mean initial visual acuity was 59.6 letters, vs. 58.5 for the final visual acuity, i.e. a difference of -1.13 letters with a lower limit of the confidence interval of less than 5. The visual acuity on release from lockdown was comparable to the other 2 measurements. Initial visual acuity and the number of missed treatments were the main factors associated with functional loss. CONCLUSION: Patients' visual acuity during the lockdown period was able to be maintained despite the restrictive measures and limitation of care access in France. The most common cause of substantial visual decline was missed intravitreal injections.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Humans , Infant , Angiogenesis Inhibitors/therapeutic use , Ranibizumab , Follow-Up Studies , Retrospective Studies , COVID-19/epidemiology , COVID-19/prevention & control , Communicable Disease Control , Macular Degeneration/drug therapy , Macular Degeneration/epidemiology , Intravitreal Injections , Treatment Outcome , Wet Macular Degeneration/drug therapy , Wet Macular Degeneration/epidemiology
18.
Cephalalgia ; 43(4): 3331024231161745, 2023 04.
Article in English | MEDLINE | ID: covidwho-20232627

ABSTRACT

BACKGROUND: Following the CENTURION phase 3 randomized controlled trial's four-month double-blind phase, this 12-month open-label extension collected data for up to one year about dose optimization, patterns of use, migraine-related disability, and quality of life during lasmiditan treatment. METHODS: Migraine patients ≥18 years completing the double-blind phase and treating ≥3 migraine attacks could continue into the 12-month open-label extension. The initial oral lasmiditan dose was 100 mg; the dose could subsequently be adjusted to 50 mg or 200 mg at the investigator's discretion. RESULTS: 477 patients entered and 321 (72.1%) completed the extension; 445 (93.3%) treated ≥1 attack with lasmiditan. Of 11,327 attacks, 8654 (76.4%) were lasmiditan-treated (84.9% of these involved moderate or severe pain). By study end, 17.8%, 58.7%, and 23.4% of patients were taking lasmiditan 50, 100, and 200 mg, respectively. Mean improvements were observed in disability and quality of life. The most common treatment-emergent adverse event was dizziness (35.7% of patients, 9.5% of attacks). CONCLUSIONS: During this 12-month extension, lasmiditan was associated with a high rate of study completion, most attacks were treated with lasmiditan, and patients reported improvements in migraine-related disability and quality of life. No new safety findings were observed with longer exposure.Trial registration: ClinicalTrials.gov (NCT03670810); European Union Drug Regulating Authorities Clinical Trials Database (EUDRA CT: 2018-001661-17).


Subject(s)
Migraine Disorders , Quality of Life , Humans , Treatment Outcome , Serotonin Receptor Agonists , Migraine Disorders/drug therapy , Migraine Disorders/chemically induced , Double-Blind Method
20.
Sci Rep ; 13(1): 8439, 2023 05 25.
Article in English | MEDLINE | ID: covidwho-20238800

ABSTRACT

To describe the epidemiology, clinical and social characteristics, management, and outcomes of patients with secondary glaucoma in Central China, a total of 1,129 cases (1,158 eyes) among 710 males (62.89%) and 419 females (37.11%) were analyzed. The mean age was 53.75 ± 17.11 years. The New Rural Cooperative Medical System (NCMS) played the most important role in reimbursement (60.32%) for secondary glaucoma-related medical expenses. The predominant occupation was "farmer" (53.41%). Neovascularization and trauma were the leading causes of secondary glaucoma. Cases of trauma-induced glaucoma decreased substantially during the coronavirus disease 2019 (COVID-19) pandemic. An education level of senior high school or above was uncommon. Ahmed glaucoma valve implantation was the most commonly performed surgery. At the final follow-up, the overall intraocular pressure (IOP) in patients with vascular disease- and trauma-related secondary glaucoma was 19.53 ± 10.20 mmHg, 20.26 ± 11.75 mmHg, and 16.90 ± 6.72 mmHg, while the mean visual acuity (VA) was 0.33 ± 0.32, 0.34 ± 0.36, and 0.43 ± 0.36. In 814 (70.29%) eyes, the VA was < 0.01. Effective preventive measures for at-risk populations, increased NCMS coverage and the promotion of higher education are necessary. These findings will help ophthalmologists detect secondary glaucoma early and manage it in a timely manner.


Subject(s)
COVID-19 , Glaucoma Drainage Implants , Glaucoma , Male , Female , Humans , Adult , Middle Aged , Aged , Treatment Outcome , Prosthesis Implantation , COVID-19/epidemiology , Glaucoma/epidemiology , Glaucoma/surgery , Intraocular Pressure , Retrospective Studies , Follow-Up Studies
SELECTION OF CITATIONS
SEARCH DETAIL