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1.
Medicine (Baltimore) ; 100(4): e24339, 2021 Jan 29.
Artículo en Inglés | MEDLINE | ID: mdl-33530227

RESUMEN

BACKGROUND: In recent years, a number of clinical trials for antibody drugs targeting programmed cell death protein 1 (PD1)/programmed cell death 1 ligand 1 (PD-L1) have been carried out on recurrent or metastatic head and neck squamous cell carcinoma (R/M SCCHN) and reported promising prospects. To further evaluate and understand the effects and risk of anti-PD1/PD-L1 monotherapy vs standard of care (SoC) in R/M SCCHN, we conducted this meta-analysis of published randomized controlled trials. METHOD: The potential eligible trials were searched from Cochrane library and Pubmed and Embase databases. Randomized controlled trials evaluating the effects and risk of anti-PD1/PD-L1 monotherapy vs SoC in platinum refractory R/M SCCHN were selected. The outcomes, including objective response rate, disease control rate, progression-free survival, overall survival, and treatment-related adverse events, were extracted and pooled. RESULTS: 1345 patients with R/M SCCHN from three randomized controlled trials were enrolled in this analysis. Compared with SoC, anti-PD1/PD-L1 monotherapy could provide statistically significant overall survival benefit, hazard ratio (95% confidence interval ) = 0.79 [0.70-0.90]. However, we observed no significant difference between 2 treatments in progression-free survival (hazard ratio [95% confidence interval] = 0.96 [0.85-1.09]). Furthermore, anti-PD1/PD-L1 monotherapy caused less treatment-related adverse events than standard of care. CONCLUSION: Anti-PD1/PD-L1 monotherapy could indeed reduce the risk of death in R/M SCCHN patients, and provide higher safety vs SoC. Expression level of PD-L1 may be a useful biomarker for selecting patients with better response to anti-PD1/PD-L1 monotherapy.


Asunto(s)
Antineoplásicos Inmunológicos/uso terapéutico , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Carcinoma de Células Escamosas de Cabeza y Cuello/tratamiento farmacológico , Nivel de Atención/estadística & datos numéricos , Adulto , Antígeno B7-H1/inmunología , Biomarcadores de Tumor/inmunología , Femenino , Neoplasias de Cabeza y Cuello/inmunología , Neoplasias de Cabeza y Cuello/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/inmunología , Recurrencia Local de Neoplasia/mortalidad , Selección de Paciente , Receptor de Muerte Celular Programada 1/inmunología , Ensayos Clínicos Controlados Aleatorios como Asunto , Carcinoma de Células Escamosas de Cabeza y Cuello/inmunología , Carcinoma de Células Escamosas de Cabeza y Cuello/mortalidad , Resultado del Tratamiento
2.
Trials ; 22(1): 126, 2021 Feb 09.
Artículo en Inglés | MEDLINE | ID: mdl-33563325

RESUMEN

BACKGROUND: The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. METHODS: DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician's discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. DISCUSSION: The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. TRIAL REGISTRATION: EU Clinical trials register EudraCT Nb 2020-001614-38 . Registered on 22 April 2020.


Asunto(s)
Antivirales/efectos adversos , Azitromicina/efectos adversos , /genética , Nivel de Atención , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antivirales/administración & dosificación , Azitromicina/administración & dosificación , Bélgica/epidemiología , /virología , Femenino , Humanos , Hidroxicloroquina/uso terapéutico , Tiempo de Internación , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Reacción en Cadena de la Polimerasa , Prueba de Estudio Conceptual , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Adulto Joven
3.
JAMA Netw Open ; 4(2): e210369, 2021 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-33576820

RESUMEN

Importance: There is limited evidence regarding early treatment of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to mitigate symptom progression. Objective: To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection. Design, Setting, and Participants: This multicenter, single health system randomized clinical factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020. Intervention: Patients were randomized in a 1:1:1:1 allocation ratio to receive either 10 days of zinc gluconate (50 mg), ascorbic acid (8000 mg), both agents, or standard of care. Outcomes: The primary end point was the number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary end points included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements. Results: A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups. Conclusions and Relevance: In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care. Trial Registration: ClinicalTrials.gov Identifier: NCT04342728.


Asunto(s)
Ácido Ascórbico/uso terapéutico , Suplementos Dietéticos , Zinc/uso terapéutico , Adulto , Atención Ambulatoria , Antioxidantes/uso terapéutico , Tos/tratamiento farmacológico , Tos/etiología , Disnea/tratamiento farmacológico , Disnea/etiología , Fatiga/tratamiento farmacológico , Fatiga/etiología , Femenino , Fiebre/tratamiento farmacológico , Fiebre/etiología , Gluconatos/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Nivel de Atención , Oligoelementos/uso terapéutico , Resultado del Tratamiento
4.
Artículo en Inglés | MEDLINE | ID: mdl-33572669

RESUMEN

Currently, SARS-CoV-2 is the primary pathogen worldwide, disrupting most of our everyday activities. The study aim was to evaluate its impact on the Polish dental community, standards of care, health, and welfare. METHODS: A Google Forms survey was conducted among 303 dental practitioners. RESULTS: Of respondents, 54.93% curbed the number of patients in the last six months, 34.21% declared no changes, and 10.86% reported an increase; whereas 70.7% of the respondents reported a treatment price increase within the same period (27.96% and 1.32% reported no changes and a decrease, respectively). Of the respondents, 15.5% did not close their businesses during the first wave of the pandemic. Most declared 1 or 2 month break, 30.7% and 34.7%, respectively. Some reported 3, 4, or 5 month breaks (15.84%, 1.32%, and 0.99%, respectively), and only two respondents (0.66%) did not admit patients at all. Headache episodes were more frequent among female dentists before the pandemic; after the pandemic, headache frequency increased among both sexes. Temporomandibular disorders (TMDs) were more frequent among women (p = 0.017). CONCLUSIONS: Most Polish dentists followed SARS-CoV-2 recommendations and restricted their practices to admitting only patients with pain or incomplete treatment. Decreased sleep parameters, head, back, and neck pain, were observed. This situation may affect dental health conditions in Polish society over time.


Asunto(s)
Odontología/tendencias , Odontólogos , Nivel de Atención , Odontología/normas , Femenino , Cefalea/epidemiología , Humanos , Masculino , Polonia/epidemiología , Rol Profesional , Estudios Retrospectivos , Encuestas y Cuestionarios , Trastornos de la Articulación Temporomandibular/epidemiología
5.
Trials ; 22(1): 3, 2021 Jan 04.
Artículo en Inglés | MEDLINE | ID: mdl-33397457

RESUMEN

OBJECTIVES: To investigate the efficacy and safety of repurposed antiprotozoal and antiretroviral drugs, nitazoxanide and atazanavir/ritonavir, in shortening the time to clinical improvement and achievement of SARS-CoV-2 polymerase chain reaction (PCR) negativity in patients diagnosed with moderate to severe COVID-19. TRIAL DESIGN: This is a pilot phase 2, multicentre 2-arm (1:1 ratio) open-label randomised controlled trial. PARTICIPANTS: Patients with confirmed COVID-19 diagnosis (defined as SARS-CoV-2 PCR positive nasopharyngeal swab) will be recruited from four participating isolation and treatment centres in Nigeria: two secondary care facilities (Infectious Diseases Hospital, Olodo, Ibadan, Oyo State and Specialist State Hospital, Asubiaro, Osogbo, Osun State) and two tertiary care facilities (Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State and Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State). These facilities have a combined capacity of 146-bed COVID-19 isolation and treatment ward. INCLUSION CRITERIA: Confirmation of SARS-CoV-2 infection by PCR test within two days before randomisation and initiation of treatment, age bracket of 18 and 75 years, symptomatic, able to understand study information and willingness to participate. Exclusion criteria include the inability to take orally administered medication or food, known hypersensitivity to any of the study drugs, pregnant or lactating, current or recent (within 24 hours of enrolment) treatment with agents with actual or likely antiviral activity against SARS-CoV-2, concurrent use of agents with known or suspected interaction with study drugs, and requiring mechanical ventilation at screening. INTERVENTION AND COMPARATOR: Participants in the intervention group will receive 1000 mg of nitazoxanide twice daily orally and 300/100 mg of atazanvir/ritonavir once daily orally in addition to standard of care while participants in the control group will receive only standard of care. Standard of care will be determined by the physician at the treatment centre in line with the current guidelines for clinical management of COVID-19 in Nigeria. MAIN OUTCOME MEASURES: Main outcome measures are: (1) Time to clinical improvement (defined as time from randomisation to either an improvement of two points on a 10-category ordinal scale (developed by the WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection) or discharge from the hospital, whichever came first); (2) Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at days 2, 4, 6, 7, 14 and 28; (3) Temporal patterns of SARS-CoV-2 viral load on days 2, 4, 6, 7, 14 and 28 quantified by RT-PCR from saliva of patients receiving standard of care alone versus standard of care plus study drugs. RANDOMISATION: Allocation of participants to study arm is randomised within each site with a ratio 1:1 based on randomisation sequences generated centrally at Obafemi Awolowo University. The model was implemented in REDCap and includes stratification by age, gender, viral load at diagnosis and presence of relevant comorbidities. BLINDING: None, this is an open-label trial. NUMBER TO BE RANDOMISED (SAMPLE SIZE): 98 patients (49 per arm). TRIAL STATUS: Regulatory approval was issued by the National Agency for Food and Drug Administration and Control on 06 October 2020 (protocol version number is 2.1 dated 06 August 2020). Recruitment started on 9 October 2020 and is anticipated to end before April 2021. TRIAL REGISTRATION: The trial has been registered on ClinicalTrials.gov (July 7, 2020), with identifier number NCT04459286 and on Pan African Clinical Trials Registry (August 13, 2020), with identifier number PACTR202008855701534 . FULL PROTOCOL: The full protocol is attached as an additional file which will be made available on the trial website. In the interest of expediting dissemination of this material, the traditional formatting has been eliminated, and this letter serves as a summary of the key elements in the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).


Asunto(s)
Antivirales/administración & dosificación , Sulfato de Atazanavir/administración & dosificación , Ritonavir/administración & dosificación , Tiazoles/administración & dosificación , Administración Oral , Adolescente , Adulto , Anciano , Antivirales/efectos adversos , Sulfato de Atazanavir/efectos adversos , /virología , Ensayos Clínicos Fase II como Asunto , Esquema de Medicación , Combinación de Medicamentos , Reposicionamiento de Medicamentos , Quimioterapia Combinada/efectos adversos , Quimioterapia Combinada/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Nigeria , Proyectos Piloto , ARN Viral/aislamiento & purificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Ritonavir/efectos adversos , /aislamiento & purificación , Índice de Severidad de la Enfermedad , Nivel de Atención , Tiazoles/efectos adversos , Resultado del Tratamiento , Carga Viral/efectos de los fármacos , Adulto Joven
6.
Trials ; 22(1): 9, 2021 Jan 06.
Artículo en Inglés | MEDLINE | ID: mdl-33407777

RESUMEN

OBJECTIVES: 1. To assess the efficacy of Mesenchymal Stromal Cells (MSC) versus a control arm as described in the primary endpoint. 2. To evaluate the effects of MSC on the secondary efficacy endpoints. 3. To evaluate the safety and tolerability profiles of MSC. 4. To study soluble and cellular biomarkers that might be involved in the course of the disease and the response to the investigational product. TRIAL DESIGN: A double-blind, randomized, controlled, trial to evaluate the efficacy and safety of MSC intravenous administration in patients with COVID-induced Acute Respiratory Distress Syndrome (ARDS) compared to a control arm. PARTICIPANTS: The trial is being conducted at a third level hospital, Hospital Universitario Puerta de Hierro, in Majadahonda, Madrid (Spain). Inclusion criteria 1. Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling). Written consent by patient or representatives will be obtained whenever possible. 2. Adult patients ≥18 years of age at the time of enrolment. 3. Laboratory-confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction (PCR), in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease. Alternative tests (e.g., rapid antigen tests) are also acceptable as laboratory confirmation if their specificity has been accepted by the Sponsor. 4. Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization. 5. Patients requiring invasive ventilation are eligible within 72 hours from intubation. 6. Eligible for ICU admission, according to the clinical team. Exclusion criteria 1. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team). 2. "Do Not Attempt Resuscitation" order in place. 3. Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment. 4. History of a moderate/severe lung disorder requiring home-based oxygen therapy. 5. Patient requiring Extracorporeal Membrane Oxygenation (ECMO), haemodialysis or hemofiltration at the time of treatment administration. 6. Current diagnosis of pulmonary embolism. 7. Active neoplasm, except carcinoma in situ or basalioma. 8. Known allergy to the products involved in the allogeneic MSC production process. 9. Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrolment). 10. Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria). 11. Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial. INTERVENTION AND COMPARATOR: - Experimental treatment arm: Allogeneic MSC (approximately 1 x 106 cells/kg). - Control arm: placebo solution (same composition as the experimental treatment, without the MSC). One single intravenous dose of the assigned treatment will be administered on Day 0 of the study. All trial participants will receive standard of care (SOC). In the context of the current worldwide pandemic, SOC can include medicines that are being used in clinical practice (e.g. lopinavir/ritonavir; hydroxy/chloroquine, tocilizumab, etc.), as well as those authorised for COVID (e.g., remdesivir). MAIN OUTCOMES: Primary endpoint: Change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7. Secondary endpoints: - All-cause mortality on days 7, 14, and 28 after treatment. - PaO2/FiO2 ratio at baseline and days 2, 4, 7, 14 and 28 after treatment. - Oxygen saturation (by standardized measurement) at baseline, daily until day 14, and on day 28 after treatment. - Time to PaO2/FiO2 ratio greater than 200 mmHg. - Subjects' clinical status on the WHO 7-point ordinal scale at baseline, daily until day 14, and on day 28 after treatment. - Time to an improvement of one category from admission on the WHO 7-point ordinal scale. - Percentage of patients that worsen at least one category on the WHO 7-point ordinal scale. - Percentage of patients that improve at least one category (maintained 48h) on the WHO 7-point ordinal scale. - Sequential Organ Failure Assessment (SOFA) scale at baseline and days 2, 4, 7, 14 and 28 after treatment. - Duration of hospitalization (days). - Duration of ICU stay (days). - Oxygen therapy-free days in the first 28 days after treatment. - Duration of supplemental oxygen. - Incidence of and duration of non-invasive and invasive mechanical ventilation in the first 28 days after treatment. - Mechanical ventilation-free days in the first 28 days after treatment. - Ventilation parameters. - Incidence of new onset pulmonary fibrosis at 3 and 12 months after treatment, based on CT scan and pulmonary function tests. - Survival at 3 and 12 months. - Cumulative incidence of Serious Adverse events (SAEs) and Grade 3 and 4 Adverse Events (AEs). - Cumulative incidence of Adverse Drug Reactions (ADR) in the experimental treatment arm. - Cumulative incidence of AEs of special interest. - Levels of analytical markers (C-Reactive Protein, lymphocyte and neutrophil counts, lymphocyte subpopulations, LDH, ferritin, D-dimer, coagulation tests and cytokines...) at baseline and days 2, 4, 7, 14 and 28 after treatment. - Other soluble and cellular biomarkers that might be involved in the course of the disease and the response to MSC. RANDOMISATION: The assignment to treatment will be carried out randomly and blinded, with a 1:1 allocation. Randomization will be done through a centralized system embedded in the electronic Case Report Form (CRF). BLINDING (MASKING): To ensure blinding, treatments will be prepared for administration at the Cell Production Unit and the administration of the treatment will be masked, not allowing the identification of the Investigational Medicinal Product (IMP). NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 20 participants are planned to be randomized, 10 to each treatment group. TRIAL STATUS: Protocol version: 1.2, dated October 14th, 2020 Start of recruitment: 01/10/2020 End of recruitment (estimated): December 2020. TRIAL REGISTRATION: EudraCT Number: 2020-002193-27 , registered on July 14th, 2020. NCT number: NCT04615429 , registered on November 4th, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Antivirales/administración & dosificación , Trasplante de Células Madre Mesenquimatosas/métodos , /terapia , Administración Intravenosa , Adulto , Biomarcadores/sangre , /diagnóstico , Ensayos Clínicos Fase II como Asunto , Terapia Combinada/efectos adversos , Terapia Combinada/métodos , Método Doble Ciego , Femenino , Humanos , Masculino , Trasplante de Células Madre Mesenquimatosas/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Respiración Artificial , /diagnóstico , /aislamiento & purificación , Índice de Severidad de la Enfermedad , España , Nivel de Atención , Trasplante Homólogo/efectos adversos , Trasplante Homólogo/métodos
8.
Trials ; 22(1): 70, 2021 Jan 20.
Artículo en Inglés | MEDLINE | ID: mdl-33472681

RESUMEN

BACKGROUND: COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. METHODS/DESIGN: The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. DISCUSSION: This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04345523 . Registered on 30 March, 2020. First posted date: April 14, 2020.


Asunto(s)
/terapia , /aislamiento & purificación , Adulto , Ensayos Clínicos Fase II como Asunto , Femenino , Hospitalización , Humanos , Inmunización Pasiva/efectos adversos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Nivel de Atención , Resultado del Tratamiento
12.
Asia Pac J Clin Oncol ; 17 Suppl 1: 3-14, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33506626

RESUMEN

Patients presenting with hormone receptor-positive (HR+ ), human epidermal growth factor receptor 2-negative (HER2- ) metastatic breast cancer (MBC) are usually treated with endocrine therapy (ET), except if there is a concern about endocrine resistance or a need to achieve rapid disease control due to visceral crisis. The combination of CDK4/6 inhibitor + ET has now replaced single-agent ET as the standard first-line treatment; and it can also be considered a standard option in the second-line setting. This review briefly summarizes recently reported efficacy findings from the key phase III clinical trials of CDK4/6 inhibitor + ET in patients with HR+ /HER2- MBC, including evidence that adding a CDK4/6 inhibitor to ET improves overall survival and does so without reducing patients' quality of life. There is still much to learn regarding the use of CDK4/6 inhibitors and how they may be optimally integrated into clinical practice. In particular, there is a need for specific biomarkers that help predict the likelihood of response or resistance to CDK4/6 inhibitor therapy; and for data to guide treatment decisions when a patient's disease progresses on a CDK4/6 inhibitor.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Quinasa 4 Dependiente de la Ciclina/antagonistas & inhibidores , Quinasa 6 Dependiente de la Ciclina/antagonistas & inhibidores , Neoplasias de la Mama/enzimología , Neoplasias de la Mama/metabolismo , Ensayos Clínicos Fase III como Asunto , Femenino , Fulvestrant/administración & dosificación , Humanos , Medición de Resultados Informados por el Paciente , Supervivencia sin Progresión , Inhibidores de Proteínas Quinasas/administración & dosificación , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Nivel de Atención
13.
Int Immunopharmacol ; 91: 107301, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33421928

RESUMEN

INTRODUCTION: The Corona virus disease 19 (COVID-19) has accounted for multiple deaths and economic woes.While the entire medical fraternity and scientists are putting their best feet forward to find a solution to contain this deadly pandemic, there is a growing interest in integrating other known alternative therapies in to standard care. This study is aimed at evaluating the safety and efficacy of ozone therapy (OT), as an adjuvant to the standard of care (SOC). METHODS: In the current randomized control trial, 60 patients with mild to moderate score NEWS score were included in two parallel groups (n = 30/group). The interventional group (OZ) received ozonized rectal insufflation and minor auto haemotherapy, daily along with SOC, while the control group (ST) received SOC alone. The main outcome measures included changes in clinical features, oxygenation index (SpO2), NEWS score, Reverse transcription polymerase chain reaction(RT-PCR), inflammatory markers, requirement of advanced care, and metabolic profiles. RESULTS: The OZ group has shown clinically significant improvement in the mean values of all the parameters tested compared to ST Group. However, statistical significance were only observed in RT-PCR negative reaction (P = 0.01), changes in clinical symptoms (P < 0.05) and requirement for Intensive care (P < 0.05). No adverse events were reported in OZ group, as against 2 deaths reported in ST group. CONCLUSION: OT when integrated with SOC can improve the clinical status and rapidly reduce the viral load compared to SOC alone, which facilitate early recovery and check the need for advanced care and mortality as demonstrated in this study.


Asunto(s)
/terapia , Ozono/uso terapéutico , /efectos de los fármacos , Adulto , Cuidados Críticos/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias/prevención & control , Nivel de Atención , Resultado del Tratamiento
15.
Otolaryngol Clin North Am ; 54(1): 11-23, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33243372

RESUMEN

A new era of surgical visualization and magnification is poised to disrupt the field of otology and neurotology. The once revolutionary benefits of the binocular microscope now are shared with rigid endoscopes and exoscopes. These 2 modalities are complementary. The endoscope improves visualization of the hidden recesses through the external auditory canal or canal-up mastoidectomy. The exoscope provides an immersive visual experience and superior ergonomics compared with binocular microscopy. Endoscopes and exoscopes are poised to disrupt the standard of care for surgical visualization and magnification in otology and neurotology.


Asunto(s)
Endoscopios/normas , Endoscopía/instrumentación , Otoneurología/instrumentación , Otolaringología/instrumentación , Pandemias , Conducto Auditivo Externo/cirugía , Endoscopía/normas , Diseño de Equipo/normas , Humanos , Mastoidectomía/instrumentación , Microcirugia/instrumentación , Procedimientos Quirúrgicos Mínimamente Invasivos/instrumentación , Procedimientos Neuroquirúrgicos/instrumentación , Otoneurología/normas , Otolaringología/normas , Nivel de Atención/normas , Estados Unidos
16.
Bioethics ; 35(2): 125-134, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33325536

RESUMEN

In March 2020, the rapid increase in severe COVID-19 cases overwhelmed the healthcare systems in several European countries. The capacities for artificial ventilation in intensive care units were too scarce to care for patients with acute respiratory disorder connected to the disease. Several professional associations published COVID-19 triage recommendations in an extremely short time: in 21 days between March 6 and March 27. In this article, we compare recommendations from five European countries, which combine medical and ethical reflections on this situation in some detail. Our aim is to provide a detailed overview on the ethical elements of the recommendations, the differences between them and their coherence. In more general terms we want to identify shortcomings in regard to a common European response to the current situation.


Asunto(s)
/terapia , Asignación de Recursos para la Atención de Salud , Nivel de Atención/ética , Triaje/ética , Factores de Edad , Europa (Continente)/epidemiología , Personal de Salud/ética , Personal de Salud/psicología , Prioridades en Salud , Hospitalización , Derechos Humanos , Humanos , Unidades de Cuidados Intensivos/ética , Guías de Práctica Clínica como Asunto , Resultado del Tratamiento , Ventiladores Mecánicos/provisión & distribución , Privación de Tratamiento/ética
17.
JAMA Netw Open ; 3(12): e2029917, 2020 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-33315114

RESUMEN

Importance: Patients with autoimmune disease and lung cancer pose a multidisciplinary treatment challenge, particularly with the advent of immunotherapy. However, the association between autoimmune disease and lung cancer survival is largely unknown. Objective: To determine the association between autoimmune disease and lung cancer survival. Design, Setting, and Participants: Retrospective cohort study between 2003 and 2019 at a single academic medical center (Northwestern University). A query of the Northwestern Medicine Enterprise Data Warehouse identified 349 patients with lung cancer and several autoimmune diseases. Types of lung cancers included small cell, adenocarcinoma, squamous cell carcinoma, non-small cell not otherwise specified, and large cell carcinoma. Autoimmune diseases included rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, myositis, and Sjögren syndrome. Inclusion criteria were biopsy-confirmed lung cancer, autoimmune diagnosis confirmed by a rheumatologist, and death or an encounter listed in the electronic medical record within 2 years of study end. A control group of patients with biopsy-proven lung cancer but without autoimmune disease was identified. Data analysis was conducted from March to July 2020. Exposure: Presence of autoimmune disease. Main Outcomes and Measures: Overall survival and progression-free survival in patients with autoimmune disease. The hypothesis was that patients with autoimmune disease would have worse progression-free survival and overall survival compared with patients in the control group. Results: Of the original 349 patients, 177 met inclusion criteria. Mean (SD) age at lung cancer diagnosis was 67.0 (10.0) years and 136 (76.8%) were women. Most common autoimmune diseases were rheumatoid arthritis (97 [54.8%]), systemic sclerosis (43 [24.3%]), and systemic lupus erythematous (15 [8.5%]). Most common lung cancers were adenocarcinoma (99 [55.9%]), squamous cell carcinoma (29 [16.4%]), and small cell lung cancer (17 [9.6%]). A total of 219 patients (mean [SD] age at diagnosis, 65.9 [4.1] years; 173 [79.0%]) were identified as having lung cancer without autoimmune disease and included in the control cohort. Compared with patients in the control group, patients with autoimmune disease experienced no difference in overall survival (log-rank P = .69). A total of 126 patients (69.5%) with autoimmune disease received standard of care vs 213 patients (97.3%) in the control group (P < .001). No individual autoimmune disease was associated with worse prognosis, even among patients with underlying interstitial lung disease. Conclusions and Relevance: Compared with institutional controls, patients with autoimmune disease experienced no difference in survival despite the fact that fewer patients in this group received standard-of-care treatment. No individual autoimmune disease was associated with worse prognosis. Future multicenter prospective trials are needed to further evaluate autoimmune disease and lung cancer survival.


Asunto(s)
Neoplasias Pulmonares , Pulmón/patología , Anciano , Artritis Reumatoide/epidemiología , Artritis Reumatoide/fisiopatología , Artritis Reumatoide/terapia , Autoinmunidad , Biopsia/métodos , Biopsia/estadística & datos numéricos , Comorbilidad , Registros Electrónicos de Salud/estadística & datos numéricos , Femenino , Humanos , Investigación Interdisciplinaria , Neoplasias Pulmonares/inmunología , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/terapia , Lupus Eritematoso Sistémico/epidemiología , Lupus Eritematoso Sistémico/fisiopatología , Masculino , Estadificación de Neoplasias , Noroeste de Estados Unidos/epidemiología , Pronóstico , Estudios Retrospectivos , Esclerodermia Sistémica/epidemiología , Esclerodermia Sistémica/fisiopatología , Esclerodermia Sistémica/terapia , Nivel de Atención/organización & administración , Nivel de Atención/estadística & datos numéricos , Análisis de Supervivencia
19.
Can J Surg ; 63(5): E460-E467, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33107814

RESUMEN

BACKGROUND: Enhanced Recovery After Surgery (ERAS) protocols use evidence-based perioperative practices that reduce morbidity and length of stay and improve patient satisfaction. ERAS is considered standard of care; however, utilization remains low and substantial practice variation exists. The aim of this study was to pragmatically characterize variation in colorectal surgery practice and identify predictors of ERAS utilization. METHODS: A survey of general surgeons identified using the Ontario College of Physicians and Surgeons database was conducted. Information on basic demographic characteristics, utilization of ERAS and predictors of ERAS implementation was collected. Nine ERAS behaviours were analyzed. Multivariable analysis was used to determine effects of demographic, hospital and surgeon covariates on ERAS utilization. RESULTS: Seven hundred and ninety-seven general surgeons were invited to participate in the survey, and 235 general surgeons representing 84 Ontario hospitals responded (30% response rate). Surgeons practising in academic settings and in large community hospitals represented 30% and 47% of the respondents, respectively. A total of 20% of the respondents used all 9 ERAS behaviours consistently. Rates of diet advancement on postoperative day 0, intravenous fluid restriction and having catheter and line procedures were significantly higher among respondents who adhered to ERAS protocols than among those who did not (74% v. 54%, p = 0.004; 92% v. 80%, p = 0.01; and 91% v. 41%, p < 0.001, respectively). Respondents from academic settings reported practising nearly 1 more ERAS behaviour than those from small community hospitals (odds ratio [OR] 0.86, 95% confidence interval [CI] 0.42 to 1.31, p < 0.001). Multivariable analysis demonstrated that colorectal fellowship training or exposure to ERAS during training did not significantly affect ERAS behaviour utilization (OR 0.32, 95% CI -0.31 to 0.94, p = 0.16; OR 0.28, 95% CI -0.26 to 0.82, p = 0.16, respectively). CONCLUSION: Substantial practice variation in colorectal surgery still exists. Individual ERAS principles are commonly followed; however, ERAS behaviours are not widely formalized into hospital protocols.


Asunto(s)
Colon/cirugía , Procedimientos Quirúrgicos Electivos/efectos adversos , Recuperación Mejorada Después de la Cirugía/normas , Complicaciones Posoperatorias/prevención & control , Pautas de la Práctica en Medicina/estadística & datos numéricos , Recto/cirugía , Centros Médicos Académicos/normas , Centros Médicos Académicos/estadística & datos numéricos , Adulto , Protocolos Clínicos/normas , Femenino , Adhesión a Directriz/normas , Adhesión a Directriz/estadística & datos numéricos , Hospitales Comunitarios/normas , Hospitales Comunitarios/estadística & datos numéricos , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Ontario , Satisfacción del Paciente , Complicaciones Posoperatorias/etiología , Pautas de la Práctica en Medicina/normas , Nivel de Atención , Cirujanos/normas , Encuestas y Cuestionarios/estadística & datos numéricos
20.
PLoS One ; 15(10): e0239811, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33031426

RESUMEN

INTRODUCTION: Cancer Survivorship is a growing public health challenge. Effective responses from health care and social services depend on appropriate identification of survivors and their families´ specific needs. There are few studies on survivorship in low and middle-income countries, therefore, more evidence-based studies are necessary to develop a comprehensive approach to cancer survivorship. OBJECTIVES: Identify the needs of cancer survivors and their relatives, specifically those of individuals with breast, cervical or prostate cancer, and with acute lymphocytic leukemia (ALL). METHODS: A qualitative, exploratory study conducted in two referral institutions in Brazil, located in Rio de Janeiro (Southeast region) and Fortaleza (Northeast region). The study included 47 patients of public and private health services and 12 family members. We used script-based semi-structured interviews. The discursive material obtained was categorized and analyzed using the Thematic Analysis approach. RESULTS: The analysis identified three central themes: 1) consequences of cancer treatment; 2) Changes in daily life associated with cancer survivorship; and 3) Unmet structural needs in cancer survivorship. CONCLUSION: Social and cancer control policies in Brazil should provide resources, specific care standards and clinical, psychological and social support. Cancer survivors should also receive rehabilitation and work reintegration guidelines. This matter requires broader access to qualified cancer information, development of an integrated patient-centered care and care model, and more research resources for the country's post-treatment cancer period.


Asunto(s)
Supervivientes de Cáncer , Necesidades y Demandas de Servicios de Salud , Atención Dirigida al Paciente , Sistemas de Apoyo Psicosocial , Nivel de Atención , Supervivencia , Adulto , Anciano , Brasil , Familia , Femenino , Accesibilidad a los Servicios de Salud , Humanos , Masculino , Persona de Mediana Edad , Investigación Cualitativa , Calidad de Vida/psicología , Grupos de Autoayuda , Encuestas y Cuestionarios , Adulto Joven
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