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1.
Trials ; 24(1): 720, 2023 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-37951972

RESUMO

BACKGROUND: In the severe forms of COVID-19 and many other infectious diseases, the patients develop a cytokine storm syndrome (CSS) where pro-inflammatory cytokines such as IL-6 and TNF-α play a key role in the development of this serious process. Selenium and iron are two important trace minerals, and their metabolism is tightly connected to immune system function. Numerous studies highlight the role of selenium and iron metabolism changes in the procedure of COVID-19 inflammation. The immunomodulator effect of nanomedicines that are synthesized based on nanochelating technology has been proved in previous studies. In the present study, the effects of the combination of BCc1(with iron-chelating property) and Hep-S (containing selenium) nanomedicines on mentioned cytokines levels in hospitalized moderate COVID-19 patients were evaluated. METHODS: Laboratory-confirmed moderate COVID-19 patients were enrolled to participate in a randomized, double-blind, placebo-controlled study in two separate groups: combination of BCc1 and Hep-S (N = 62) (treatment) or placebo (N = 60) (placebo). The blood samples were taken before medications on day zero, at discharge, and 28 days after consumption to measure hematological and biochemical parameters and cytokine levels. The clinical symptoms of all the patients were recorded according to an assessment questionnaire before the start of the treatment and on days 3 and discharge day. RESULTS: The results revealed that consumption of the nanomedicines led to a significant decrease in the mean level of IL-6 cytokine, and at the end of the study, there was a 77% downward trend in IL-6 in the nanomedicine group, while an 18% increase in the placebo group (p < 0.05). In addition, the patients in the nanomedicines group had lower TNF-α levels; accordingly, there was a 21% decrease in TNF-α level in the treatment group, while a 31% increase in this cytokine level in the placebo was observed (p > 0.05). On the other hand, in nanomedicines treated groups, clinical scores of coughing, fatigue, and need for oxygen therapy improved. CONCLUSIONS: In conclusion, the combination of BCc1 and Hep-S inhibits IL-6 as a highly important and well-known cytokine in COVID-19 pathophysiology and presents a promising view for immunomodulation that can manage CSS. TRIAL REGISTRATION: Iranian Registry of Clinical Trials RCT20170731035423N2 . Registered on June 12, 2020.


Assuntos
COVID-19 , Selênio , Humanos , Adulto , Interleucina-6 , SARS-CoV-2 , Fator de Necrose Tumoral alfa , Irã (Geográfico) , Resultado do Tratamento , Citocinas , Ferro , Método Duplo-Cego
2.
Thromb Haemost ; 123(7): 723-733, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36944357

RESUMO

BACKGROUND: In the INSPIRATION-S trial, atorvastatin versus placebo was associated with a nonsignificant 16% reduction in 30-day composite of venous/arterial thrombosis or death in intensive care unit (ICU) patients with COVID-19. Thrombo-inflammatory response in coronavirus disease 2019 (COVID-19) may last beyond the first 30 days. METHODS: This article reports the effects of atorvastatin 20 mg daily versus placebo on 90-day clinical and functional outcomes from INSPIRATION-S, a double-blind multicenter randomized trial of adult ICU patients with COVID-19. The main outcome for this prespecified study was a composite of adjudicated venous/arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause mortality. Functional status was assessed with the Post-COVID-19 Functional Scale. RESULTS: In the primary analysis, 587 patients were included (age: 57 [Q1-Q3: 45-68] years; 44% women). By 90-day follow-up, the main outcome occurred in 96 (33.1%) patients assigned to atorvastatin and 113 (38.0%) assigned to placebo (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.60-1.05, p = 0.11). Atorvastatin in patients who presented within 7 days of symptom onset was associated with reduced 90-day hazard for the main outcome (HR: 0.60, 95% CI: 0.42-0.86, p interaction = 0.02). Atorvastatin use was associated with improved 90-day functional status, although the upper bound CI crossed 1.0 (ORordinal: 0.64, 95% CI: 0.41-1.01, p = 0.05). CONCLUSION: Atorvastatin 20 mg compared with placebo did not significantly reduce the 90-day composite of death, treatment with ECMO, or venous/arterial thrombosis. However, the point estimates do not exclude a potential clinically meaningful treatment effect, especially among patients who presented within 7 days of symptom onset (NCT04486508).


Assuntos
COVID-19 , Trombose , Adulto , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Atorvastatina/uso terapêutico , Resultado do Tratamento , Trombose/tratamento farmacológico , Unidades de Terapia Intensiva , Método Duplo-Cego
3.
Iran J Pharm Res ; 21(1): e123947, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35765502

RESUMO

More than a year after the onset of the coronavirus disease pandemic in 2019, the disease remains a major global health issue. During this time, health organizations worldwide have tried to provide integrated treatment guidelines to control coronavirus disease 2019 (COVID-19) at different levels. However, due to the novel nature of the disease and the emergence of new variants, medical teams' updating medical information and drug prescribing guidelines should be given special attention. This version is an updated instruction of the National Research Institute of Tuberculosis and Lung Disease (NRITLD) in collaboration with a group of specialists from Masih Daneshvari Hospital in Tehran, Iran, which is provided to update the information of caring clinicians for the treatment and care of COVID-19 hospitalized patients.

4.
Respir Physiol Neurobiol ; 300: 103870, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35176500

RESUMO

Asthma is a chronic inflammatory disease associated with a high prevalence of psychiatric disorders. There are specific brain networks responsible for emotional processes, including two important networks associated with psychiatric problems: the default mode network (DMN), which is more active in the resting state, and the salience network (SN), which is structurally connected to DMN. Although previous studies suggested that neuro-phenotypes of asthma may be recognizable by the neural activity of brain circuits, an association between the brain's functional alterations and psychiatric impairments induced by asthma remains unknown. We aimed to assess DMN and SN activity and its association with psychiatric indices and clinical parameters in asthmatic patients. Electroencephalography was recorded during the resting state with an awake and eyes-open condition in thirty-eight sex and age-matched subjects (19 atopic asthma patients and 19 healthy participants). Power spectrum and functional connectivity were computed for DMN and SN. We examined psychiatric disorders (including depression, anxiety, and stress) and pulmonary function using the DASS questionnaire and spirometry test, respectively. The results showed that DASS scores were significantly higher in asthmatic patients compared to healthy subjects. Asthmatic patients also demonstrate a significant enhancement in power and functional connectivity in the two networks. Notably, these power enhancements of the networks were correlated with psychiatric problems scores, pulmonary function, asthma duration, and poor asthma control. These results introduce new evidence for the association between altered brain activity, the existence of psychiatric disorders, and asthma-related features, including pulmonary function. Also, we provide new insights into asthma-induced inflammatory response and the importance of developing novel interventions and therapeutic strategies for managing allergic inflammation patients who suffer from concurrent psychiatric disorders.


Assuntos
Asma , Mapeamento Encefálico , Asma/complicações , Asma/diagnóstico por imagem , Encéfalo/diagnóstico por imagem , Mapeamento Encefálico/métodos , Eletroencefalografia , Humanos , Imageamento por Ressonância Magnética/métodos , Vias Neurais/diagnóstico por imagem
5.
Heliyon ; 8(2): e08957, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35187271

RESUMO

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). Circulating soluble angiotensin-converting enzyme (sACE2)2, the main receptor for SARS-CoV-2, together with components of the renin-angiotensin system promote infection and disease severity. OBJECTIVE: This pilot study followed the time-course of sACE2 levels in relation to systemic cytokines in severe and moderate COVID-19 patients treated with remdesivir/dexamethasone in combination. METHODS: Peripheral blood was obtained upon admission from 30 patients (12 with moderate disease and 18 with severe disease) and 14 patients with PCR-confirmed mild COVID-19. Severe and moderate patients were treated with remdesivir (200mg/first day and 100mg/day for the remaining days) and dexamethasone (100mg/day). 6 healthy control subjects (HC) were also enrolled. Serum interleukin (IL)-6 and IL-8 and sACE2 levels were measured by ELISA at baseline and during treatment in severe and moderate patients and at baseline in mild and HCs. RESULTS: Baseline sACE2 levels were lower in severe (p = 0.0005) and moderate (p = 0.0022) patients than in patients with mild COVID-19 and in HC (p = 0.0023 and p = 0.0012 respectively). Treatment significantly increased sACE2 levels in patients with moderate disease (p = 0.0156) but only 50% of patients with severe disease showed enhanced levels compared to baseline. Systemic IL-6 and IL-8 levels were higher in all patient groups compared with HC and were not significantly affected over time or by remdesivir/dexamethasone treatment for 5 days. CONCLUSION: Serum sACE2 levels increase in severe COVID-19 patients as they recover over time whilst circulating cytokines are unaffected. Future studies should link these results to clinical outcomes.

6.
Thromb Haemost ; 122(1): 131-141, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-33865239

RESUMO

BACKGROUND: Thrombotic complications are considered among the main extrapulmonary manifestations of coronavirus disease 2019 (COVID-19). The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. METHODS: This article reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. RESULTS: Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]: 62 [50, 71] years; 237 [42.2%] women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, p = 0.11). Findings were similar for other efficacy outcomes, and in the landmark analysis from days 31 to 90 (HR: 1.59, 95% CI: 0.45-5.06). There were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24). CONCLUSION: Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.


Assuntos
Anticoagulantes/administração & dosagem , Tratamento Farmacológico da COVID-19 , Enoxaparina/administração & dosagem , SARS-CoV-2 , Trombose/prevenção & controle , Idoso , Anticoagulantes/efeitos adversos , COVID-19/complicações , COVID-19/mortalidade , Estudos de Coortes , Cuidados Críticos , Relação Dose-Resposta a Droga , Enoxaparina/efeitos adversos , Oxigenação por Membrana Extracorpórea , Feminino , Hemorragia/induzido quimicamente , Humanos , Unidades de Terapia Intensiva , Irã (Geográfico)/epidemiologia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Pandemias , Trombose/etiologia , Trombose/mortalidade
7.
Tanaffos ; 21(4): 512-515, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37583778

RESUMO

Hydatidosis is one of the most important parasitic and zoonotic endemic infections caused by the larvae of cestode Echinococcus granulosus. Co-infection of hydatid cyst with the coronavirus disease 2019 (COVID-19), which is caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), has been previously reported. The mortality rate of hydatidosis is reported to be 2-4% and the liver and lungs are the two most commonly involved organs, respectively. In the present study, we have reported two recovered pulmonary hydatidosis patients who were infected with SARS-CoV-2 after thoracotomy in the hospital. In general, current cases suggest that patients with thoracic surgery are more likely to develop severe infection with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). The patients presented COVID-19 symptoms shortly after thoracotomy and their viral tests were confirmed with the positive result of SARS-CoV-2 RT-PCR. In conclusion, possible differential diagnoses should be considered in similar cases and adequate attention should be paid to intraoperative and postoperative care.

8.
Tanaffos ; 21(2): 201-206, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36879740

RESUMO

Background: Cancer is one of the leading causes of morbidity and mortality around the world. Caregivers of these patients are affected by various physical, emotional, social, spiritual, and financial factors that can affect their quality of life (QoL). This study aimed to compare the QoL and general health status of thoracic cancer patients with their family caregivers in Iranian population. Materials and Methods: Using the City of Hope-Quality of Life (COH-QOL) questionnaire and the General Health Status (GHQ) questionnaire, this cross-sectional study compared the QoL and general health status in 71 thoracic cancer patients with their family members as the primary caregivers. The study was conducted in Masih Daneshvari Hospital of Tehran, Iran from 2017 to 2018. Demographic data and results of the questionnaires were analyzed using the Statistical Package for the Social Sciences (SPSS v.20). Student's t-test, Chi square test, and Pearson's correlation were used to compare the results. Results: In patients and their caregivers, 53.5% (N=38) and 36.6% (N=26) were male, respectively (P=0.043). While the average score of physical wellbeing was 6.12 ± 1.95 in caregivers, it was 5.32 ± 2.08 in patients (P=0.021). In case of psychological wellbeing, the average score in caregivers was 4.14 ± 1.50 and in patients was 5.7 ± 1.54 (P=0.000). We observed no significant difference between caregivers and patients regarding social concerns (4.62 ± 1.50 vs. 4.90 ± 1.74) and spiritual wellbeing (7.03 ± 1.17 vs. 7.2 ± 1.53). Also, the mean scores of GHQ-12 were 5.06 ± 2.5 and 4.17 ± 2.53 in caregivers and patients, respectively (P=0.04). A significant negative correlation was observed between GHQ-12 and QoL scores (r=-0.593, P<0.001). The probability of acquiring mental disorders in female caregivers was two times higher than male caregivers (P=0.05). Conclusion: Our findings demonstrated that family caregivers of thoracic cancer patients suffer from physical and psychological distress, sometimes even more than the patients. This highlights the important role of family caregivers in the process of approaching a patient with thoracic cancer.

9.
Front Pharmacol ; 13: 1107198, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36733376

RESUMO

Background: Remdesivir is effective against SARS-Cov-2 with little evidence of its adverse effect on the cardiac system. The aim of the present study is investigating the incidence of bradycardia in COVID-19 patients treated with Remdesivir. Methods: This prospective longitudinal study was conducted in a tertiary center on COVID-19 patients for Remdesivir therapy. The objectives were to investigate the incidence of sinus bradycardia, and also the association between their demographics, underlying diseases, and the disease severity with developing bradycardia in COVID-19 patients treated with Remdesivir. Results: Of 177 patients, 44% were male. The mean (±standard deviation) age of patients was 49.79 ± 15.16 years old. Also, 33% were hospitalized due to more severe symptoms. Oxygen support was required for all hospitalized subjects. A total of 40% of the patients had comorbidities, with the most common comorbidity being hypertension. The overall incidence of bradycardia (heart rate<60 bpm) in patients receiving Remdesivir was 27%, of whom 70% had extreme bradycardia (heart rate <50 bpm). There was also a statistically significant reduction in heart rate after five doses of Remdesivir compared to the baseline heart rates. In the multivariable model, none of the covariates including age above 60 years, female sex, CRP>50 mg/L, O2 saturation<90%, underlying cardiovascular disease, hypertension and diabetes mellitus, and beta-blockers were associated with Remdesivir-induced bradycardia. No association was found between the COVID-19 severity indicators and bradycardia. Conclusion: As sinus bradycardia is a prevalent adverse cardiac effect of Remdesivir, it is recommended that all COVID-19 patients receiving Remdesivir, be evaluated for heart rate based on examination; and in the case of bradyarrhythmia, cardiac monitoring should be performed during administration to prevent adverse drug reactions.

10.
JAMA ; 325(16): 1620-1630, 2021 04 27.
Artigo em Inglês | MEDLINE | ID: mdl-33734299

RESUMO

Importance: Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis. Objective: To evaluate the effects of intermediate-dose vs standard-dose prophylactic anticoagulation among patients with COVID-19 admitted to the intensive care unit (ICU). Design, Setting, and Participants: Multicenter randomized trial with a 2 × 2 factorial design performed in 10 academic centers in Iran comparing intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo (second hypothesis; not reported in this article) among adult patients admitted to the ICU with COVID-19. Patients were recruited between July 29, 2020, and November 19, 2020. The final follow-up date for the 30-day primary outcome was December 19, 2020. Interventions: Intermediate-dose (enoxaparin, 1 mg/kg daily) (n = 276) vs standard prophylactic anticoagulation (enoxaparin, 40 mg daily) (n = 286), with modification according to body weight and creatinine clearance. The assigned treatments were planned to be continued until completion of 30-day follow-up. Main Outcomes and Measures: The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment. Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition), powered for noninferiority (a noninferiority margin of 1.8 based on odds ratio), and severe thrombocytopenia (platelet count <20 ×103/µL). All outcomes were blindly adjudicated. Results: Among 600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). The primary efficacy outcome occurred in 126 patients (45.7%) in the intermediate-dose group and 126 patients (44.1%) in the standard-dose prophylaxis group (absolute risk difference, 1.5% [95% CI, -6.6% to 9.8%]; odds ratio, 1.06 [95% CI, 0.76-1.48]; P = .70). Major bleeding occurred in 7 patients (2.5%) in the intermediate-dose group and 4 patients (1.4%) in the standard-dose prophylaxis group (risk difference, 1.1% [1-sided 97.5% CI, -∞ to 3.4%]; odds ratio, 1.83 [1-sided 97.5% CI, 0.00-5.93]), not meeting the noninferiority criteria (P for noninferiority >.99). Severe thrombocytopenia occurred only in patients assigned to the intermediate-dose group (6 vs 0 patients; risk difference, 2.2% [95% CI, 0.4%-3.8%]; P = .01). Conclusions and Relevance: Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome of a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days. These results do not support the routine empirical use of intermediate-dose prophylactic anticoagulation in unselected patients admitted to the ICU with COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04486508.


Assuntos
Anticoagulantes/administração & dosagem , COVID-19/complicações , Enoxaparina/administração & dosagem , Oxigenação por Membrana Extracorpórea , Oxigenoterapia/métodos , Trombose/prevenção & controle , Idoso , Anticoagulantes/efeitos adversos , COVID-19/mortalidade , Esquema de Medicação , Enoxaparina/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Hospitalização , Humanos , Unidades de Terapia Intensiva , Irã (Geográfico) , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Avaliação de Resultados em Cuidados de Saúde , Embolia Pulmonar/epidemiologia , Trombocitopenia/induzido quimicamente , Trombose/etiologia , Trombose/mortalidade , Resultado do Tratamento , Trombose Venosa/epidemiologia , Trombose Venosa/mortalidade
12.
Tanaffos ; 19(2): 122-128, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33262799

RESUMO

BACKGROUND: Following the recent epidemic of coronavirus disease 2019 (COVID-19) in Wuhan, China, a novel betacoronavirus was isolated from two patients in Iran on February 19, 2020. In this study, we aimed to determine the clinical manifestations and outcomes of the first confirmed cases of COVID-19 infection (n=127). MATERIALS AND METHODS: This prospective study was conducted on all COVID-19-suspected cases, admitted to Masih Daneshvari Hospital (a designated hospital for COVID-19), Tehran, Iran, since February 19, 2020. All patients were tested for COVID-19, using reverse transcription-polymerase chain reaction (RT-PCR) assay. Data of confirmed cases, including demographic characteristics, clinical features, and outcomes, were collected and compared between three groups of patients, requiring different types of admission (requiring ICU admission, admission to the general ward, and transfer to ICU). RESULTS: Of 412 suspected cases, with the mean age of 54.1 years (SD=13.4), 127 (31%) were positive for COVID-19. Following the patients' first visit to the clinic, 115 cases were admitted to the general ward, while ten patients required ICU admission. Due to clinical deterioration in the condition of 25 patients (out of 115 patients), ICU admission was essential. Based on the results, the baseline characteristics of the groups were similar. Patients requiring ICU admission were more likely to have multiorgan involvement (liver involvement, P<0.001; renal involvement, P<0.001; and cardiac involvement, P=0.02), low O2 saturation (P<0.001), and lymphopenia (P=0.05). During hospital admission, 21 (16.5%) patients died, while the rest (83.5%) were discharged and followed-up until March 26, 2020. Also, the survival rate of patients, who received immunoglobulin, was higher than other patients (60.87% vs. 39.13%). CONCLUSION: The mortality rate of COVID-19 patients was considerable in our study. Based on the present results, this infection can cause multiorgan damage. Therefore, intensive monitoring of these patients needs to be considered.

13.
Tanaffos ; 19(1): 74-78, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33101435

RESUMO

Extra-nasal types of Extra-nodal natural killer cell lymphoma (ENKL) have been known with poorer prognoses than nasal type with the worst responses to treatment. The current work introduces a case of ENKL with GI involvement with no nasal manifestations. We report a 56-year male farmer with fever, productive cough, dyspnea, anorexia, vomiting and chill in addition to malaise and cachexia of three months duration referred to a hospital with acute abdominal pain, and was diagnosed as peritonitis due to perforated terminal ileum ulcer before experiencing surgery as a case of acute abdomen. The pathologic study of the relevant biopsy showed "ulceration and necrosis with dense fibrinoleukocytic exudation and granulation tissue formation. CT scan determined a bilateral mass like haziness which was more likely to be metastatic. The review of the previous pathologic specimens raised Natural Killer/T cell Lymphoma (NKTL), the reason for which we focused on the patient's sinuses and nasal area as well as nasopharynx. There was no finding in examination and endoscopy of sinuses. Pathology also found malignant high grade non-Hodgkin T cell lymphoma in specimens obtained from debridement of ulcer at terminal ileum. It also showed that most of the tumor cells were positive for CD3, CD56, CD8, and LCA but negative for CD19, CD20 and AE1/AE3. Positive reactions for CD30 were shown by some cells. CD56, CD3, and CD8 were expressed by neoplastic cells and CD30 were positive in few cells. Proliferative activity (Ki67 index) was high (60-70%). This was the main base to diagnose an extra-nodal extra-nasal NK/T cell lymphoma. In conclusion, Intestinal changes at middle age, especially in men with nonspecific clinical manifestations is highly advised to be studied pathologically and genetically for T cell types like CD30 positive T cells which are usually engaged in ENKTL.

14.
Thromb Res ; 196: 382-394, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32992075

RESUMO

BACKGROUND: Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown. METHODS: The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts. CONCLUSIONS: INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.


Assuntos
Anticoagulantes/administração & dosagem , Atorvastatina/administração & dosagem , Tratamento Farmacológico da COVID-19 , Enoxaparina/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Trombose/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Anticoagulantes/efeitos adversos , Atorvastatina/efeitos adversos , COVID-19/complicações , COVID-19/diagnóstico , Estado Terminal , Método Duplo-Cego , Enoxaparina/efeitos adversos , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Irã (Geográfico) , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombose/diagnóstico , Trombose/etiologia , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiologia
15.
Adv Respir Med ; 87(3): 146-151, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31282555

RESUMO

INTRODUCTION: With a 5-10% global prevalence, asthma, as a chronic condition which can strongly affect the quality of life of patients and care givers, needs comprehensive approach, including medications and psychological techniques, to get the optimal control. This is why the current study aimed to assess the effectiveness of the Papworth method relaxation training among patients with asthma, considering reduced anxiety and improved quality of life. MATERIAL AND METHODS: Through a randomized controlled trial, 30 patients with asthma 20-45 years of age referring to a tertiary university hospital in Tehran enrolled two study groups, including disease cases and controls. The Papworth method of relaxation was used and was finally assessed for its effectiveness by two questionnaires, namely STAI for anxiety and SF-36 for the quality of life. Pre-test and post-test were done for both groups. RESULTS: The scores of the anxiety questionnaire (STAI) before and after the intervention were significantly different, and the mean scores obviously reduced after relaxation training among cases from 102.6 to 79.5. The scores of the QOL grew clearly after relaxation training in the case group from 308.07 to 546.6. CONCLUSIONS: As an accessory helpful treatment, relaxation training Papworth method sounds to be perfectly able to control stressful conditions in patients with asthma to prevent disease attacks and improve the quality of life. So, psychological teams can be advised to referral centers for asthma in the relevant clinics to help people get training in this regard.


Assuntos
Ansiedade/terapia , Asma/terapia , Qualidade de Vida/psicologia , Terapia de Relaxamento/métodos , Adulto , Ansiedade/etiologia , Ansiedade/psicologia , Asma/complicações , Asma/psicologia , Feminino , Humanos , Irã (Geográfico) , Masculino , Pessoa de Meia-Idade , Relaxamento Muscular , Adulto Jovem
16.
Open Access Maced J Med Sci ; 6(7): 1310-1314, 2018 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-30087743

RESUMO

INTRODUCTION: Fatigue is one of the common symptoms of sarcoidosis, which occurs in about 50-70% of patients. AIM: Considering that there are no valid Iranian questionnaires for evaluating fatigue in sarcoidosis, in the present study, for the first time, we translated Fatigue Questionnaire into Persean and evaluated its validity and reliability among Iranian patients with sarcoidosis. MATERIAL AND METHODS: In methodological research, English version of Fatigue assessment scale (FAS) 10 items questionnaire which is designed to assess physical or mental fatigue in chronic disease patients, was translated into Persian and back-translated into English. Its validity and reliability were studied on the one hundred and thirteen confirmed sarcoidosis patients are referring to respiratory referral hospital of Iran. Reliability analysis was performed by estimation of Cronbach`s alpha test. RESULTS: According to the cut-off point of 22.84 (74%) of the studied patients were suffering from fatigue. The internal consistency calculation revealed that the alpha value of the physical fatigue and mental fatigue was 0.945 and 0.896, respectively. CONCLUSION: We concluded that the existence of questions number 4 and 10 in the questionnaire reduces the continuity of the questions, and therefore we suggest applying the FAS questionnaire without the two questions 4 and 10. This study showed that FAS questionnaire was very practical and can routinely be applied to assess the fatigue scale in sarcoidosis patients.

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