RESUMO
The angiotensin-converting enzyme (ACE) has been shown to play a role as a receptor for the COVID-19 virus. This virus usually gets into cells and infects them by attaching to their glycoprotein receptors, which are found on the ACE2 receptor. The aim of this study was to evaluate the frequency and inheritance of ACE1 I/D and ACE2 rs2285666 polymorphisms in COVID-19 patients with varying severity of lung involvement and its effect on serum cytokines levels of interleukin (IL)-1 and IL-6 and laboratory parameters. One hundred eighty-five COVID-19 patients were grouped according to the severity of lung involvement. (I/D) polymorphism of the ACE1 gene and rs2285666 polymorphism of the ACE2 gene were determined by single specific primer-polymerase chain reaction and restriction fragment length reaction-polymerase chain reaction methods, respectively. Serum levels of IL-1 and IL-6 were also measured by the enzyme linked immunosorbent assay technique. No statistically significant association of ACE2 rs2285666 polymorphism genotypes and ACE1 I/D with the severity of lung involvement was noted. However, there was a statistically significant association between I/D ACE1 polymorphism genotypes and IL-6, white blood cells (WBC), and neutrophil-to-lymphocyte ratio (NLR) levels. Also, there was no statistically significant association between rs2285666 polymorphism genotypes and patients' blood oxygen saturation level, IL-6, IL-1ß, lactate dehydrogenase activity, WBC count, and NLR. In patients with COVID-19, the rs2285666 polymorphism of the ACE2 gene and the I/D polymorphism of the ACE1 gene were not significantly associated with the severity of COVID-19 disease and serum IL-6 and IL-1 cytokine levels.
Assuntos
Enzima de Conversão de Angiotensina 2 , COVID-19 , Humanos , Enzima de Conversão de Angiotensina 2/genética , COVID-19/genética , COVID-19/patologia , COVID-19/virologia , Citocinas , Interleucina-1 , Interleucina-6 , PulmãoRESUMO
BACKGROUND: Chronic hepatitis B (CHB) is a significant risk factor for liver-related disorders. Hepatic fibrosis staging by liver biopsy in these patients can lead to complications. This study aimed to compare aspartate aminotransferase/alanine aminotransferase (AST/ALT) ratio, AST to platelet ratio index (APRI), and fibrosis-4 (FIB-4) with FibroScan results for the evaluation of hepatic fibrosis in CHB patients. METHODS: This cross-sectional study included patients with CHB referred to the outpatient clinics of Bandar Abbas, Hormozgan, Iran, in 2021. The age and sex of the participants were noted. FibroScan evaluation was done for all subjects. Moreover, AST, ALT, and platelet counts were measured in their blood samples within one month of the FibroScan evaluation. RESULTS: Of the 267 CHB patients evaluated in the present study (mean age: 45.45 ± 18.16 years), 173 (64.8%) were male. According to FibroScan results, 65 CHB patients (24.3%) had F1, 53 (19.9%) F2, 38 (14.2%) F3, and 20 (7.5%) F4 liver fibrosis. There was a significant correlation between FibroScan results and the three indices of AST/ALT ratio, APRI, and FIB-4 (P < 0.001), with the strongest correlation between FibroScan results and APRI (r = 0.682). With an area under the receiver operating characteristic (AUROC) curve of 0.852 (95% confidence interval [CI] 0.807; 0.897, P < 0.001), APRI ≥ 0.527 had the best diagnostic accuracy (77.15%) for the detection of any grade of liver fibrosis. Although the AUROC curve of APRI and FIB-4 was similar (0.864) for distinguishing between F3/F4 and F0-F2 of liver fibrosis, FIB-4 had the best diagnostic accuracy (82.02%). CONCLUSIONS: APRI can rule out 95.4% of F3/F4 of liver fibrosis and rule in any grade of liver fibrosis in CHB patients by 90.78%. Therefore, APRI appears to be the best substitute for FibroScan in the assessment of liver fibrosis in patients with CHB.
Assuntos
Hepatite B Crônica , Humanos , Masculino , Adulto , Pessoa de Meia-Idade , Feminino , Hepatite B Crônica/patologia , Irã (Geográfico) , Estudos Transversais , Biomarcadores , Cirrose Hepática/diagnóstico por imagem , Cirrose Hepática/etiologia , Curva ROC , Aspartato Aminotransferases , Biópsia , Alanina TransaminaseRESUMO
Licorice extract (glycyrrhizin), a potent antiviral, anti-inflammatory, and antioxidant remedy, is a potential therapeutic option for COVID-19. We evaluated the efficacy and safety of licorice in patients with moderate COVID-19. In this study, 60 patients with confirmed COVID-19 were randomly assigned in a 1:1 ratio to receive licorice (at a dose of 760 mg three times a day for seven days) or control groups. The primary outcomes were SPO2, body temperature, and respiratory rate (RR) after the end of the intervention. The findings indicated that SPO2, body temperature, and RR had no significant difference between the groups at the end of the intervention. However, CRP and ALT improved in the licorice group toward the baseline. The number of patients with worse prognoses, LOS, mortality, and the incidence of adverse events were not different between the groups at the end of the study. Licorice had no beneficial effect on the clinical symptoms of COVID-19. Moreover, this intervention demonstrated a safe profile of adverse events. The confirmation of the results of this preparatory trial requires more detailed multiple-center trials with a larger sample size.
Assuntos
COVID-19 , Glycyrrhiza , Humanos , Extratos Vegetais/efeitos adversos , Extratos Vegetais/uso terapêutico , SARS-CoV-2RESUMO
OBJECTIVES: It has been generally believed that women who exposed to Toxoplasma gondii before pregnancy and have anti-T. gondii IgG antibody are immunized and their newborns will be protected from congenital infection. This study is aimed to investigate the role of T. gondii infection in spontaneous abortion through serological and molecular methods in southern Iran. STUDY DESIGN: Blood samples were taken from 50 spontaneously aborted mothers and anti-T. gondii antibodies were assessed using conventional enzyme-linked immunosorbent assay (ELISA) and avidity ELISA methods. The placenta and blood samples of aborted women were used for detection of the parasite's DNA by polymerase chain reaction (PCR) method targeting the RE gene. The parasite genotypes were determined by PCR-restriction fragment length polymorphism (RFLP) method using SAG3 and GRA6 genes. RESULTS: IgG antibody was detected in 28% (14/50) of mothers, but all samples were negative for IgM antibody. In the avidity ELISA test, 26% (13/50) of the samples had a high avidity index, suggesting chronic infection, while a low avidity index was detected in one case (2%), which suggests acute infection. The parasite's DNA was detected in 18% (9/50) and 14% (7/50) of blood and placenta samples, respectively. All DNA positive samples were IgG positive. All isolates were belonged to the T. gondii type III genotype. CONCLUSION: The results suggest that T. gondii seropositive women are not protected from congenital transmission. However, the results should be interpreted cautiously until further studies will be confirmed these results.
Assuntos
Aborto Espontâneo , Toxoplasma , Toxoplasmose , Anticorpos Antiprotozoários , Ensaio de Imunoadsorção Enzimática/métodos , Feminino , Genótipo , Humanos , Imunoglobulina G , Imunoglobulina M , Recém-Nascido , Gravidez , Toxoplasma/genética , Toxoplasmose/diagnósticoRESUMO
BACKGROUND: Diarrheagenic Escherichia coli (DEC) is a common enteric pathogen that causes a wide spectrum of gastrointestinal infections, particularly in developing countries. This is a systematic review and meta-analysis to determine the prevalence of DEC in various geographical regions in Iran. MATERIALS AND METHODS: English (PubMed, Web of Science, Scopus, Embase, Cochrane Library, and Google Scholar) and Persian (IranMedex, SID, Magiran, and Iran Doc) databases were comprehensively searched from January 1990 to April 2017. Study selection and data extraction were performed by two independent reviewers. After assessing heterogeneity among studies, a random effects model was applied to estimate pooled prevalence. Data analyses were done with the Stata software (version 12.0). This meta-analysis was registered with PROSPERO, number CRD42017070411. RESULTS: A total of 73 studies with 18068 isolates were eligible for inclusion within the meta-analysis. The results of random effects model showed that the most prevalent DEC pathotypes were enterotoxigenic E. coli (ETEC) (16%; 95% confidence interval [CI]: 11%-23%), enteroaggregative E. coli (11%; 95% CI: 8%-15%), atypical enteropathogenic E. coli (EPEC) (11%; 95% CI: 8%-14%), Shiga toxin-producing E. coli (9%; 95% CI: 6%-13%), diffuse adherent E. coli (6%; 95% CI: 6%-12%), enteroinvasive E. coli (4%; 95% CI: 2%-6%), and typical EPEC (3%; 95% CI: 1%-5%). CONCLUSION: This study showed that DEC infections in the Iranian population have low frequency. Our data suggest that the ETEC pathotype can be regarded as one of the most important etiological agents of diarrhea in this country. However, the prevalence of DEC pathotypes is diverse in different regions of Iran.
RESUMO
Hepatitis C virus (HCV) infection is considered one of the most important causes of chronic liver diseases. Many reports have shown that the proteins of the HCV via interactions with gene expression regulatory networks such as cellular pathways and microRNAs can contribute to the development of chronic liver diseases. The present study aimed to investigate the effects of the HCV NS3 protein on the expression of miR-150 miR-199a, miR-335, miR-194, miR-27a in a cell culture model. Plasmids expressing the full length of the HCV NS3 protein were transfected into the LX-2 cell line, while at the same time a plasmid expressing empty GFP (green fluorescent protein) was used as a negative control group. Subsequently, total RNA was extracted and real-time PCR was performed to measure microRNA expression levels. Additionally, the trypan blue exclusion test was performed to examine the effect of the expressing NS3 protein plasmid on cellular viability. The analysis of microRNA gene expression in LX-2 cells indicated that the NS3 protein, which is endogenous to HCV, can significantly upregulate the expression of miR-27a and downregulate the expression of miR-335 and miR-150 in comparison with the control plasmid expressing GFP and normal cells (p < 0.01). These results suggest that the HCV NS3 protein may play a role in the pathogenesis of chronic hepatic diseases such as liver fibrosis via interaction with cellular microRNAs and modulation of microRNA gene expressions.
Assuntos
Hepacivirus/fisiologia , Interações Hospedeiro-Patógeno , MicroRNAs/biossíntese , Proteínas não Estruturais Virais/metabolismo , Linhagem Celular , Sobrevivência Celular , Perfilação da Expressão Gênica , Hepatócitos/virologia , Humanos , Plasmídeos , Reação em Cadeia da Polimerase em Tempo Real , Proteínas não Estruturais Virais/genéticaRESUMO
BACKGROUND AND OBJECTIVES: Approximately one-third of hepatitis C virus (HCV) infected patients who complete antiviral therapy with undetectable serum HCV RNA at the end of therapy (ETR), will experience relapse. The reasons for the failure of treatment have not been elucidated. It was showed that HCV RNA can persist and replicate in extra hepatic sites, e.g. in peripheral blood mononuclear cells (PBMCs), but the relevance of its presence with relapse over time is still unknown. Moreover, interferon-gamma (IFN-γ) and IFN-lambdas [IFN-λ1, interleukin-29 (IL-29)], possess potent antiviral activity. We studied if the presence of plus-/minus strand RNA in PBMCs of patients and the serum level of IFN-γ and IL-29, which is the most abundant IFN-lambdas in serum, can be considered as predictive factors in relapse outcomes. METHODS: Patients were screened for plus-/minus strand RNA at ETR and after 6 months. Also, we measured the serum level of IFN-γ and IL-29 and compared the result with those who developed a sustained virological response (SVR). RESULTS: Levels of IL-29 and IFN-? serum were significantly higher in SVR at ETR and 6 months later compared to those of the relapsed patients, but there was no difference between the two groups regarding the presence or absence of plus-/minus HCV strand in PBMCs. CONCLUSIONS: Our novel findings showed that the serum level of IL-29 and IFN-γ are predictive of relapse outcomes to HCV treatment, but there was no association between the presence of plus-γminus HCV RNA in PBMCs of patients with an outcome of therapy at ETR and later.
Assuntos
Antivirais/uso terapêutico , Hepacivirus/efeitos dos fármacos , Hepatite C/tratamento farmacológico , Interferon gama/sangue , Interleucinas/sangue , Leucócitos Mononucleares/virologia , RNA Viral/genética , Adulto , Idoso , Biomarcadores/sangue , Feminino , Hepacivirus/genética , Hepacivirus/imunologia , Hepatite C/sangue , Hepatite C/imunologia , Hepatite C/virologia , Interações Hospedeiro-Patógeno , Humanos , Leucócitos Mononucleares/imunologia , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Recidiva , Fatores de Tempo , Falha de TratamentoRESUMO
BACKGROUND: Deferoxamine is a potent iron chelator that could remove iron from the virus, and severe acute respiratory syndrome coronavirus 2 requires iron to replication. Also, deferoxamine has antioxidant and cytokine-modulating effects. Therefore, we evaluated the efficacy and safety of deferoxamine in patients with moderate coronavirus disease 2019 (COVID-19). METHODS: In this randomized controlled trial, patients with moderate COVID-19 were randomly assigned in a 1:1 ratio to the deferoxamine group (received a solution of 500 mg deferoxamine divided into 4 doses a day through a nebulizer for 7 days) and the control group. The main outcomes were viral clearance, oxygen saturation (SPO2), body temperature, and respiratory rate (RR). Intensive care unit admission, hospital length of stay, and hospital mortality were also assessed. RESULTS: A total of 62 patients, with 30 in the deferoxamine group and 32 in the control group, were randomly assigned. There was no statistically significant improvement in viral clearance after the intervention ended in the deferoxamine group (36.7%) compared to the control group (34.4%). The results showed there was no significant difference between the analyzed groups in terms of SPO2, body temperature, RR, and the number of patients with a worse prognosis (SPO2â <â 96%, temperatureâ ≥â 37.5 °C, or RRâ ≥â 16/min) at the end of the study. There were no significant differences seen between the groups in terms of intensive care unit admission, hospital length of stay, hospital mortality, and the occurrence of adverse medication events during the follow-up period. CONCLUSION: Deferoxamine had no significant impact on improving moderately ill patients with COVID-19. However, it was well-tolerated in the patients, and this intervention demonstrated a safe profile of adverse events.
Assuntos
Tratamento Farmacológico da COVID-19 , Desferroxamina , SARS-CoV-2 , Humanos , Desferroxamina/uso terapêutico , Desferroxamina/administração & dosagem , Masculino , Feminino , Pessoa de Meia-Idade , COVID-19/mortalidade , Idoso , Tempo de Internação/estatística & dados numéricos , Resultado do Tratamento , Mortalidade Hospitalar , Adulto , Saturação de Oxigênio , Temperatura Corporal/efeitos dos fármacosRESUMO
OBJECTIVES: This study aims to evaluate the effect of vitamin D and magnesium supplementation on clinical symptoms and serum inflammatory and oxidative stress markers in patients with COVID-19. TRIAL DESIGN: This study is a 4-arm randomized, double-blind, placebo-controlled clinical trial with a factorial design and the intervention period is 3 weeks. PARTICIPANTS: This study is conducted on COVID-19 patients admitted to the Shahid Mohammadi hospital in Bandar Abbas, Iran, who are eligible for inclusion in the study. Patients are included only if they meet all of the following criteria: (1) aged from 18 to 65 years old; (2) confirmation of COVID-19 by RT-PCR test; (3) completing informed consent; (4) passing less than 48 h since the patient's hospitalization; (5) no skin or gastrointestinal allergies due to taking multivitamin supplements, vitamin D, and magnesium; and (6) having more than 30 breaths per minute and less than 93% oxygen saturation in room air and sea level. Patients are excluded if they have any of the following conditions: (1) pregnancy or lactation; (2) taking a daily multivitamin or take a vitamin D or magnesium supplement in the last month; (3) participating in other clinical trials; (4) renal failure or dialysis, severe liver disease or cirrhosis; (5) known diagnosis of hypercalcemia; (6) discharging from the hospital less than 24 h after the start of the intervention; (7) history of kidney stones in the last year; (8) transfer the patient to the ICU; (9) baseline vitamin D levels above 80 ng/ml; (10) baseline magnesium levels above 2.6 mg/dl; and (11) unwillingness of the patient to continue the study. INTERVENTION AND COMPARATOR: Participants will be randomly allocated to one of the four following groups: (A) vitamin D (two 50,000 IU capsules at the beginning of the study, two 50,000 IU capsules on the 4th day, one 50,000 IU capsule on the 11th day, and one 50,000 IU capsule on the 17th day) and magnesium supplement (300 mg/day); (B) vitamin D capsule and magnesium placebo; (C) magnesium supplement and vitamin D placebo; and (D) vitamin D placebo and magnesium placebo. MAIN OUTCOMES: The resolution of clinical symptoms (fever, dry cough, shortness of breath, headache, myalgia, oxygen saturation, and mortality rate) and interpretation of laboratory assays (CRP, MDA, TAC, WBC, neutrophils count, lymphocytes count, ratio of neutrophils to lymphocytes, levels of 25 hydroxyvitamin D and magnesium) will be assessed in the study groups. RANDOMIZATION: A computer-generated block randomization list is used for randomization. BLINDING (MASKING): Investigators and patients are blinded to group allocation and treatment. A double-blind design is achieved using matched placebos. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 104 eligible patients are randomized into four groups of 26 subjects (1:1:1:1 allocation ratio). DISCUSSION: With the rapid prevalence of COVID-19 in recent years, more attention has been paid to effective dietary supplementation to improve clinical symptoms and biochemical parameters in these patients. To our knowledge, this is the first study to evaluate the effects of vitamin D supplementation in combination with magnesium or alone with respect to this infectious disease. The findings of the current RCT will provide evidence regarding the effectiveness of dietary supplementation strategies to improve COVID-19 outcomes. TRIAL STATUS: Ethical approval of the first version of the study protocol was obtained from the medical ethics committee of Hormozgan University of Medical Sciences, Bandar Abbas, Iran on May 30, 2021 (IR.HUMS.REC.1400.085). Currently, the recruitment phase is ongoing since August 23, 2021, and is anticipated to be complete by the end of August 2022. TRIAL REGISTRATION: The study protocol was registered in the Iranian Registry of Clinical Trials ( https://www.irct.ir ; IRCT20210702051763N1) on August 14, 2021. https://www.irct.ir/trial/57413 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.
Assuntos
COVID-19 , Complexo Vitamínico B , Feminino , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Magnésio , SARS-CoV-2 , Irã (Geográfico)/epidemiologia , Vitamina D , Suplementos Nutricionais , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND AND AIMS: We aimed to compare the effect of topical olive oil dressing plus standard care with standard care alone on the treatment of grade 1 and 2 diabetic foot ulcers (DFUs) in type 2 diabetes mellitus (T2DM) patients. METHODS: This assessor-blind randomized controlled trial included 60 T2DM patients with DFU referred to the Diabetes Clinic of Shahid Mohammadi Hospital, Bandar Abbas, Iran, from February 21 to August 22, 2017. Patients were randomly assigned to intervention (n = 30) and control (n = 30) groups. The intervention group received standard care, including wound irrigation with normal saline and oral antibiotics plus daily topical olive oil dressing for four weeks, and the control group only received standard care. The wound healing assessment scale (wound degree, color, drainage, and surrounding tissue healing) was recorded weekly and the total wound status was determined at the end of the study. RESULTS: Treatment with olive oil led to significantly higher scores of ulcer degree, color, drainage, and surrounding tissue healing at weeks one, two, three and four in the olive oil group than in the control group (P < 0.001). Also, the total wound status score was higher in the olive oil group compared to the control group (P < 0.001). The proportions of completely healed, partially healed, and unhealed wounds were 76.6%, 23.3% and 0% in the intervention group, and 0%, 93.3% and 6.7% in the control group, respectively. CONCLUSIONS: Topical olive oil dressing promoted the healing of DFU and it can be recommended as a safe and effective treatment in this regard. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT), IRCT20150607022585N4. Registered 05/12/2018. Retrospectively registered, https://www.irct.ir/trial/19460.
Assuntos
Diabetes Mellitus Tipo 2 , Pé Diabético , Olea , Humanos , Pé Diabético/tratamento farmacológico , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/terapia , Azeite de Oliva/uso terapêutico , Azeite de Oliva/farmacologia , Irã (Geográfico)/epidemiologia , Bandagens , CicatrizaçãoRESUMO
To develop a suitable and effective vaccine against Staphylococcus aureus (S. aureus), we selected the Hla-MntC-SACOL0723 (HMS) recombinant protein with two different formulations of alum and Monophosphoryl lipid A (MPL) adjuvants. In this study, we aimed to evaluate the potentials of alum and MPL adjuvants in stimulating the immune response of HMS vaccine candidate against S. aureus. To evaluate the type of induced immune response, anti-HMS total IgG, IgG1, IgG2a, and IFN-γ, IL-2, IL-4, and IL-17 cytokines were determined after vaccination of mice with HMS-alum, HMS-MPL candidates. Mice were challenged with Methicillin-resistant Staphylococcus aureus (MRSA) was isolated from pressure sores and evaluated for bacterial load in the kidney homogenates and survival rate. It was observed that total IgG and isotypes (IgG1 and IgG2a), IL-4, and IL-17 were significantly increased in the group that received HMS-alum vaccine compared with the group that received HMS-MPL formulation. On the other hand, the levels of IFN-γ and IL-2 cytokines in the group that received HMS-MPL were higher than the group that received HMS-alum formulation. Bacterial load in the mice who received HMS protein formulated with alum adjuvant was reduced more than the mice who received HMS protein formulated with MPL adjuvant. Histopathological analysis showed more pathological changes in kidney tissues of the group received of HMS-MPL compared with the HMS-alum formulation. The survival rate was equal in both groups of immunized with HMS-alum and HMS-MPL formulations. Finally, it could be concluded that both adjuvants of alum and MPL are suitable immune response enhancers to HMS vaccine candidate.
Assuntos
Rim/patologia , Staphylococcus aureus Resistente à Meticilina/fisiologia , Proteínas Periplásmicas de Ligação/genética , Sepse/imunologia , Infecções Estafilocócicas/imunologia , Vacinas Antiestafilocócicas/imunologia , Staphylococcus aureus/fisiologia , Compostos de Alúmen , Animais , Feminino , Antígenos HLA/genética , Imunoglobulina G/metabolismo , Interleucina-17/metabolismo , Interleucina-4/metabolismo , Lipídeo A/análogos & derivados , Lipídeo A/imunologia , Camundongos , Camundongos Endogâmicos BALB C , Proteínas Recombinantes de Fusão/genética , Sepse/prevenção & controle , Regulação para CimaRESUMO
At present, novel Coronavirus (2019-nCoV, the causative agent of COVID-19) has caused worldwide social and economic disruption. The disturbing statistics of this infection promoted us to develop an effective vaccine candidate against the COVID-19. In this study, bioinformatics approaches were employed to design and introduce a novel multi-epitope vaccine against 2019-nCoV that can potentially trigger both CD4+ and CD8+ T-cell immune responses and investigated its biological activities by computational tools. Three known antigenic proteins (Nucleocapsid, ORF3a, and Membrane protein, hereafter called NOM) from the virus were selected and analyzed for prediction of the potential immunogenic B and T-cell epitopes and then validated using bioinformatics tools. Based on in silico analysis, we have constructed a multi-epitope vaccine candidate (NOM) with five rich-epitopes domain including highly scored T and B-cell epitopes. After predicting and evaluating of the third structure of the protein candidate, the best 3 D predicted model was applied for docking studies with Toll-like receptor 4 (TLR4) and HLA-A*11:01. In the next step, molecular dynamics (MD) simulation was used to evaluate the stability of the designed fusion protein with TLR4 and HLA-A*11:01 receptors. MD studies demonstrated that the NOM-TLR4 and NOM-HLA-A*11:01 docked models were stable during simulation time. In silico evaluation showed that the designed chimeric protein could simultaneously elicit humoral and cell-mediated immune responses. Communicated by Ramaswamy H. Sarma.
Assuntos
COVID-19 , Vacinologia , Biologia Computacional , Epitopos de Linfócito B , Epitopos de Linfócito T/genética , Humanos , Simulação de Acoplamento Molecular , SARS-CoV-2 , Vacinas de Subunidades AntigênicasRESUMO
OBJECTIVES: We will evaluate the efficacy and safety of Ivermectin in patients with mild and moderately severe COVID-19. TRIAL DESIGN: This is a phase 3, single-center, randomized, open-label, controlled trial with a 2-arm parallel-group design (1:1 ratio). PARTICIPANTS: The Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will screen for patients age ≥ 20 years and weight ≥35 kg for the following criteria: Inclusion criteria for patients with mild COVID-19 symptoms (outpatients) 1. Diagnosed mild pneumonia using computed tomography (CT) and/or chest X-ray (CX-R) imaging, not requiring hospitalization. 2. Signing informed consent. Inclusion criteria for patients with moderate COVID-19 symptoms (inpatients) 1. Confirmed infection using PCR. 2. Diagnosed moderate pneumonia using CT and/or CXR imaging, requiring hospitalization. 3. Hospitalized ≤ 48 hours. 4. Signing informed consent. Exclusion criteria 1. Severe and critical pneumonia due to COVID-19. 2. Underlying diseases, including AIDS, asthma, loiasis, and severe liver and kidney disease. 3. Use of anticoagulants (e.g., warfarin) and ACE inhibitors (e.g., captopril). 4. History of drug allergy to Ivermectin. 5. Pregnancy or breastfeeding. INTERVENTION AND COMPARATOR: Intervention groups: Outpatient and inpatient groups will receive the standard treatment regimen for mild and moderate COVID-19, based on the Iranian Ministry of Health and Medical Education's protocol, along with oral Ivermectin (MSD Company, France) at a single dose of 0.2 mg/kg. Control groups: The outpatient group will receive hydroxychloroquine sulfate (Amin Pharmaceutical Company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for seven subsequent days. The inpatient group will receive 200/50 mg Lopinavir/Ritonavir (Heterd Company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day. Other supportive and routine care will be the same in both outpatient and inpatient groups. MAIN OUTCOME: The primary outcomes are composite and include the improvement of clinical symptoms and need for hospitalization for outpatient groups, and the length of hospital stay until discharge, the need for ICU admission until discharge, and the need for mechanical ventilation for inpatient groups within seven days of randomization. The secondary outcome is the incidence of serious adverse drug reactions within seven days of randomization. RANDOMIZATION: Patients in both outpatient (mild) and inpatient (moderate) groups will be randomized into the treatment and control groups based on the following method. A simple randomization method and table of random numbers will be used. If the selected number is even, the patient is allocated to the treatment group, and if it is odd, the patient is allocated to the control group in a 1:1 ratio. BLINDING (MASKING): This is an open-label study, and there is not blinding. Numbers to be randomized (sample size) A total number of 120 patients (60 outpatients and 60 patients) will be randomized into two groups (30 patients in each of the intervention groups and 30 patients in each of the control groups). TRIAL STATUS: The protocol is Version 1.0, November 17, 2020. Recruitment began November 25, 2020, and is anticipated to be completed by February 25, 2021. TRIAL REGISTRATION: This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N6 ". The registration date is November 17, 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 the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.
Assuntos
Antivirais/administração & dosagem , Tratamento Farmacológico da COVID-19 , Ivermectina/administração & dosagem , SARS-CoV-2/isolamento & purificação , Administração Oral , Adulto , Antivirais/efeitos adversos , COVID-19/diagnóstico , COVID-19/virologia , Ensaios Clínicos Fase III como Assunto , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Feminino , Humanos , Hidroxicloroquina/administração & dosagem , Hidroxicloroquina/efeitos adversos , Unidades de Terapia Intensiva/estatística & dados numéricos , Interferon beta-1a/administração & dosagem , Interferon beta-1a/efeitos adversos , Irã (Geográfico) , Ivermectina/efeitos adversos , Tempo de Internação/estatística & dados numéricos , Lopinavir/administração & dosagem , Lopinavir/efeitos adversos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Ritonavir/administração & dosagem , Ritonavir/efeitos adversos , SARS-CoV-2/efeitos dos fármacos , Índice de Gravidade de DoençaRESUMO
OBJECTIVES: We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill. TRIAL DESIGN: This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design. PARTICIPANTS: Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days. CONTROL GROUP: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days. MAIN OUTCOMES: The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization. RANDOMIZATION: An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization. BLINDING (MASKING): All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 84 participants will be randomized into two groups of 42 patients. TRIAL STATUS: The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020. TRIAL REGISTRATION: This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N1 ". Registration date is 23 May 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.
Assuntos
Infecções por Coronavirus , Pandemias , Fitoterapia/métodos , Preparações de Plantas/farmacologia , Pneumonia Viral , Avaliação de Sintomas/métodos , Zingiber officinale , Administração Oral , Adulto , Betacoronavirus/isolamento & purificação , COVID-19 , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/terapia , Método Duplo-Cego , Monitoramento de Medicamentos/métodos , Feminino , Humanos , Irã (Geográfico) , Masculino , Pneumonia Viral/diagnóstico , Pneumonia Viral/fisiopatologia , Pneumonia Viral/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Índice de Gravidade de Doença , Comprimidos , Tratamento Farmacológico da COVID-19RESUMO
Diabetic foot infection is among the most common complications of diabetes mellitus which significantly causes hospitalization and is the most prevalent etiology of nontraumatic amputation worldwide. The current study aimed at assessing the frequency and antimicrobial susceptibility patterns of diabetic foot infection of patients from the Bandar Abbas area, in the south of Iran. In this study, a total of 83 diabetic patients with diabetic infected foot wounds referring to Shahid Mohammadi Hospital, Bandar Abbas, from 2017 to 2018 were assessed. Samples were obtained from wound sites and evaluated by aerobic culture and also an antibiogram test for antibiotic susceptibility. Factors including age, sex, type of diabetes, the medication used for diabetes, previous history of diabetic foot infection, duration of wound incidence, fever, and laboratory indices were recorded for each subject. The most prevalent detected bacteria were Escherichia coli (20.5%), Enterococcus sp. (16.9%), Klebsiella sp. (12%), Staphylococcus aureus (8.4%), Enterobacter sp. (7.2%), and Acinetobacter sp. (6%). The results of antibiogram tests revealed the most and the least antibiotic sensitivity for E. coli sp. as meropenem and ciprofloxacin, for Enterococcus sp. as gentamicin and ciprofloxacin, for Klebsiella sp. as amikacin and cotrimoxazole, and for Enterobacter sp. as cotrimoxazole and both amikacin and ciprofloxacin. Staphylococcus aureus was sensitive to vancomycin and doxycycline, and Acinetobacter sp. was 100% resistant to all antibiotics except amikacin and gentamycin. A significant statistical association was found between the C-reactive protein and the patients' diabetic foot infection organisms (P=0.019). Findings of the study revealed E. coli sp. as the most common bacteria which are infecting the foot lesions in the studied population. The highest antibiotic susceptibility was seen for vancomycin, linezolid, and carbapenem.
RESUMO
OBJECTIVES: We will evaluate the efficacy and safety of Melatonin, compared to the standard therapeutic regimen on clinical symptoms and serum inflammatory parameters in patients with confirmed COVID-19, who are moderately ill. TRIAL DESIGN: This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. PARTICIPANTS: All patients admitted to Severe Acute Respiratory Syndrome Departments of Shahid Mohammadi Hospital, Bandar Abbas, Iran will be screened for the following criteria. INCLUSION CRITERIA: 1. Age ≥20 years 2. Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction). 3. Moderate COVID-19 pneumonia (via computed tomography and or X-ray imaging), requiring hospitalization. 4. Hospitalized ≤48 hours. 5. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. EXCLUSION CRITERIA: 1. Underlying diseases, including chronic hypertension, diabetes mellitus, seizure, depression, chronic hepatitis, cirrhosis, and cholestatic liver diseases. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, corticosteroids, hormonal drugs, alcohol, other antiviral and investigational medicines, and illegal drugs (during the last 30 days). 4. History of known allergy to Melatonin. 5. Pregnancy and breastfeeding. INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin capsules at a dose of 50 mg daily for a period of seven days. CONTROL GROUP: The standard therapeutic regimen for COVID-19 along with Melatonin-like placebo capsules at a dose of one capsule daily for a period of seven days. Both Melatonin and placebo capsules were prepared at the Faculty of Pharmacy and Pharmaceutical Sciences, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. MAIN OUTCOMES: The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-É), interleukin-1ß (IL-1ß), and IL-6 within seven days of randomization. The secondary outcomes are the time to improve clinical and paraclinical features along with the incidence of serious adverse drug reactions within seven days of randomization. RANDOMIZATION: Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms. BLINDING (MASKING): All study participants, clinicians, nurses, research coordinators, and those analyzing the data are blinded to the group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 60 patients randomized into two groups (30 in each group). TRIAL STATUS: The trial protocol is Version 1.0, August 14, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by November 30, 2020. TRIAL REGISTRATION: The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N5 ". The registration date was 14 August 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 the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Assuntos
Betacoronavirus/efeitos dos fármacos , Depressores do Sistema Nervoso Central/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Melatonina/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Adulto , Betacoronavirus/genética , Biomarcadores/sangue , COVID-19 , Estudos de Casos e Controles , Depressores do Sistema Nervoso Central/administração & dosagem , Depressores do Sistema Nervoso Central/efeitos adversos , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Método Duplo-Cego , Hospitalização , Humanos , Irã (Geográfico)/epidemiologia , Melatonina/administração & dosagem , Melatonina/efeitos adversos , Oxigênio/sangue , Pandemias , Placebos/administração & dosagem , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , SARS-CoV-2 , Segurança , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients with confirmed COVID-19 that are moderately ill. TRIAL DESIGN: This is a single-center, open-label, randomized, clinical trial with parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. PARTICIPANTS: Both male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria. INCLUSION CRITERIA: 1. Confirmed diagnosis of SARS-CoV-2 infection (via polymerase chain reaction [PCR] and/or antibody test). 2. Presenting as moderate COVID-19 pneumonia (via chest computed tomography (CT) and/or X-ray) requiring hospitalization. 3. Hospitalized ≤48 hours. 4. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm. EXCLUSION CRITERIA: 1. Underlying diseases, including chronic heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs. 4. Treatment with Investigational and antiviral therapy in a clinical study within one month before randomization. 5. History of allergy to Licorice. 6. Pregnancy and breastfeeding. INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19 along with a Licorice-based herbal preparation (D-Reglis ®, Irandarouk Pharmaceutical Company, Iran) at a dose of 760 mg three times a day for a period of seven days. CONTROL GROUP: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol for a period of seven days. MAIN OUTCOMES: The recovery rate of clinical symptoms, including fever, dry cough, and tiredness, as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein, are evaluated as primary outcomes within seven days of randomization. Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization. RANDOMIZATION: An electronic table of random numbers will be used to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the simple randomization method. BLINDING (MASKING): This is an open-label trial without blinding and placebo control. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group). TRIAL STATUS: The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020. TRIAL REGISTRATION: This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is "IRCT20200506047323N2", https://www.irct.ir/trial/47990 . The registration date is 31 May 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.
Assuntos
Infecções por Coronavirus , Glycyrrhiza , Pandemias , Extratos Vegetais , Raízes de Plantas , Pneumonia Viral , Adulto , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/efeitos adversos , Betacoronavirus/efeitos dos fármacos , Betacoronavirus/isolamento & purificação , COVID-19 , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/fisiopatologia , Monitoramento de Medicamentos/métodos , Feminino , Hospitalização , Humanos , Masculino , Extratos Vegetais/administração & dosagem , Extratos Vegetais/efeitos adversos , Pneumonia Viral/diagnóstico , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/etiologia , Pneumonia Viral/fisiopatologia , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND: Toxoplasmosis can cause miscarriage or complications in the fetus. Diagnosis and treatment of this disease by anti-parasitic drugs especially in early pregnancy can help to prevent fetal infection and its complications. This study aimed to determine T. gondii infection in pregnant women, evaluate risk factors in the transmission of the disease and congenital toxoplasmosis. METHODS: Overall, 360 sera of pregnant women from 5 cities in the Hormozgan Province in southern Iran with different climate were evaluated from 2015-2016 for T. gondii infection by using ELISA method and positive cases of IgM and IgG were tested again using Avidity IgG ELISA. All cases were evaluated according to climate, acute and chronic of toxoplasmosis, number of pregnancy and abortion, epidemiological factors and food habits. RESULTS: Among 360 specimens T. gondii IgG + IgM antibodies were found positive in 0. 8% subjects and also 27% of samples had IgG seropositivity. A significant relationship was observed between age, sampling place, consumption of raw and half cooked meat, history of contact with cats, abortion history, number of children, and parity with IgG positive. In Avidity IgG ELISA test, 13 people with low avidity, 3 people with borderline avidity were reported. CONCLUSION: 72. 2% of the population had no antibody against the disease that this could be a warning to the people and requires education of preventive and prenatal care and routine screening of women at childbearing age.
RESUMO
Considering the crucial importance of hepatitis B and its high prevalence in the society, the present study was conducted to examine the demographic and paraclinical characteristics of patients with chronic hepatitis B. This descriptive cross-sectional study examined 180 patients with hepatitis B presenting to Shahid Mohammadi Hospital and Clinic and other private clinics in Bandar Abbas, Iran, in 2016-17. The patients were divided into three main groups: chronic hepatitis, liver cirrhosis, and healthy carriers. Parametric and nonparametric tests were used to analyze the relationship between the quantitative variables in terms of their normal or nonnormal distribution (P < 0.05). About 13.5% of the patients had cirrhosis, 35.4% were healthy carriers, and 51.12% had chronic hepatitis. The number of male patients in the cirrhosis group and the number of female participants in the healthy carrier group were higher. The difference in gender distribution between the three groups was statistically significant. According to the results of this study, male and married people constitute a high percentage of the population of patients with chronic hepatitis B. The clinical symptoms of chronic hepatitis B often do not occur until the patient's progress to advanced stages and cirrhosis, and most of the population is asymptomatic. Contact with a person suspected to have hepatitis B is one of the major risk factors of this disease.
RESUMO
BACKGROUND AND OBJECTIVE: The spread of carbapenem-resistant Klebsiella pneumoniae especially blaNDM-1-carrying isolates is a great concern worldwide. In this study we describe the molecular basis of carbapenem-resistant K. pneumoniae in three teaching hospitals at Bandar Abbas, south of Iran. MATERIALS AND METHODS: A total of 170 nonduplicate clinical isolates of K. pneumoniae were investigated. Antimicrobial susceptibility test was performed by disc diffusion method. PCR was carried out for detection of carbapenemase (blaKPC, blaIMP, blaVIM, blaNDM, blaSPM, blaOXA-48, and blaOXA-181) and extended-spectrum ß-lactamase (blaCTX-M, blaSHV, blaTEM, blaVEB, blaGES, and blaPER). Clonal relatedness of blaNDM-1-positive isolates was evaluated by multilocus sequence typing (MLST). RESULTS: Tigecycline was the most effective antimicrobial agent with 96.5% susceptibility. In addition, 6.5% of the isolates were carbapenem resistant. BlaNDM-1 was identified in four isolates (isolate A-D) and all of them were multidrug-resistant. MLST revealed that blaNDM-1-positive isolates were clonally related and belonged to two distinct clonal complexes, including sequence type (ST) 13 and ST 392. In addition to blaNDM-1, isolate A coharbored blaSHV-11, blaCTX-M-15, and blaTEM-1, isolate B harbored blaSHV-11 and blaCTX-M-15, and isolates C and D contained both blaSHV-1 and blaCTX-M-15. CONCLUSION: Our results indicate that NDM-1-producing K. pneumoniae ST 13 and ST 392 are disseminated in our region. Moreover, one of our major concerns is that these isolates may be more prevalent in the near future. Tracking and urgent intervention is necessary for control and prevention of these resistant isolates.