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BACKGROUND: Haemoperfusion (HP) is an innovative extracorporeal therapy that utilizes special cartridges to filter the blood, effectively removing pro-inflammatory cytokines, toxins, and pathogens in COVID-19 patients. This retrospective cohort study aimed to assess the clinical benefits of HP for severe COVID-19 cases using Shapley values for machine learning models. METHODS: The research involved 578 inpatients (≥ 20 years old) admitted to Baqiyatallah hospital (Tehran, Iran). The control group (359 patients) received standard treatment, including high doses of corticosteroids (a single 500 mg methylprednisolone pulse, followed by 250 mg for 2 days), categorized as regimen (I). On the other hand, the HP group (219 patients) received regimen II, consisting of the same corticosteroid treatment (regimen I) along with haemoperfusion using Cytosorb H300. The frequency of haemoperfusion sessions varied based on the type of lung involvement determined by chest CT scans. In addition, the value function v defines the Shapley value of the i th feature for the query point x , where the input matrix features represent individual characteristics, drugs, and history and clinical conditions of the patient. RESULTS: Our data showed a favorable clinical response in the HP group compared to the control group. Notably, one-to-three sessions of HP using the CytoSorb® 300 cartridge led to reduced ventilation requirements and mortality rates in severe COVID-19 patients. Shapley values were calculated to evaluate the contribution of haemoperfusion among other factors, such as side effects, medications, and individual characteristics, to COVID-19 patient outcomes. In addition, there is a significant difference between the two groups among the treatments and medications used remdesivir, adalimumab, tocilizumab, favipiravir, Interferon beta-1a, enoxaparin prophylaxis, enoxaparin full dose, heparin prophylaxis, and heparin full dose (P < 0.05). It seems that haemoperfusion has a positive impact on the reduction of inflammation markers and renal functional such as ferritin and creatinine, respectively, as well as D-dimer and WBC levels in the HP group were significantly lower than the control group. CONCLUSION: The findings indicated that haemoperfusion played a crucial role in predicting patient survival, making it a significant feature in classifying patients' prognoses.
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COVID-19 , Hemoperfusión , Aprendizaje Automático , Humanos , Hemoperfusión/métodos , Estudios Retrospectivos , Masculino , Femenino , Persona de Mediana Edad , Irán , Adulto , Anciano , Resultado del Tratamiento , Metilprednisolona/administración & dosificación , Metilprednisolona/uso terapéutico , Tratamiento Farmacológico de COVID-19 , Corticoesteroides/uso terapéutico , Corticoesteroides/administración & dosificaciónRESUMEN
BACKGROUND: Complementary ozone therapy has been identified as a revolutionary medical technique for a number of goals and ailments. At the present, it has been shown that ozone has medicinal qualities, such as antibacterial, antifungal, and antiparasitic properties. Coronavirus (SARS-CoV-2) is quickly spread over the globe. Cytokine storms and oxidative stress seem to play a substantial role in the most of acute attacks of the disease. The aim of this research was to assess the therapeutic advantages of complementary ozone therapy on the cytokine profile and antioxidant status in COVID-19 patients. METHODS: The statistical sample of this study included two hundred patients with COVID-19. One hundred COVID-19 patients (treatment group) received 240 ml of the patient's blood and an equal volume of O2/O3 gas at a concentration of 35-50 µg/ml daily, which gradually increased in concentration, and were kept for 5-10 days and one hundred patients (control group) received standard treatment. The secretion levels of IL-6, TNF-α, IL-1ß, IL-10 cytokines, SOD, CAT and GPx were compared between control patients (standard treatment) and standard treatment plus intervention (ozone) before and after treatment. RESULTS: The findings indicated a significant decrease in the level of IL-6, TNF-α, IL-1ß in group receiving complementary ozone therapy in compared with control group. Furthermore, a significant increase was found in the level of IL-10 cytokine. Moreover, SOD, CAT and GPx levels revealed a significant increase in complementary ozone therapy group compared to control group. CONCLUSIONS: Our results revealed that complementary ozone therapy can be used as a medicinal complementary therapy to reduce and control inflammatory cytokines and oxidative stress status in patients with COVID-19 as revealed its antioxidant and anti-inflammatory effects.
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COVID-19 , Ozono , Humanos , COVID-19/terapia , Antioxidantes/uso terapéutico , SARS-CoV-2 , Interleucina-10 , Factor de Necrosis Tumoral alfa , Interleucina-6 , Ozono/uso terapéutico , Citocinas , Superóxido DismutasaRESUMEN
Background: The present study was performed to investigate and compare renal functions of single-kidney patients after 12 h of percutaneous nephrolithotomy (PCNL) surgery through assessing major markers of renal function with focus on serum level of cystatin that performs a consistent accuracy in various conditions. Materials and Methods: This pilot quasi-experimental study was done on 92 patients with single kidney having staghorn calculus who had undergone PCNL and were referred to the Al-Zahra Hospital, Isfahan, Iran, during 2019-2021. Serum levels of cystatin C, creatinine, estimated glomerular filtration rate (eGFR), and neutrophil gelatinase-associated lipocalin (NGAL) urine level were evaluated before and 12 h after surgery. Results: The mean cystatin C decreased significantly 1.58 ± 0.55 versus mg/L 1.46 ± 0.52 after 12 h after surgery (P < 0.001). Furthermore, the mean levels of creatinine (2.04 ± 0.71 vs. 1.89 ± 0.60 mg/dL) and NGAL (39.72 ± 12.87 vs. 24.05 ± 10.89 µg/ml) were decreased significantly after 12 h of procedure (P < 0.05) while the mean eGFR (57.62 ± 27.59 vs. 64.68 ± 31.88 ml/min/1.73 m2) was increased significantly after 12 h (P < 0.001). Conclusion: Due to significant improvement in all markers of renal after PCNL, this procedure can be considered a potentially effective and safe approach for treating large stone in single-kidney patients.
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BACKGROUND: Pulmonary endarteritis is a rare clinical phenomenon with congenital heart that can potentially lead to major complications. CASE PRESENTATION: We report a 47-year-old man with pulmonary endarteritis. This patient presented with hypertension, chest pain and a previous history of pulmonary valve disease during childhood. Also, eight-months prior, he was hospitalized with dyspnea (Functional Class III), cough, phlegm, and night sweats without fever. Echocardiographic diagnosis in the first transtransthoracic echocardiography (TTE) was intense pulmonary valve stenosis (PVS) an, thus, the pulmonary valve vegetation and PVS, established by transesophageal echocardiography (TEE). He was referred for surgery after 1 weeks of intravenous antibiotic therapy for removal of the vegetation. CONCLUSIONS: Finally he was asymptomatic at 3-months of follow-up and was clinically in good condition. Therefore, the detection of infective endocarditis of the lung valve must not lengthy be prolonged.
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Endarteritis/diagnóstico , Endocarditis Bacteriana/diagnóstico , Embolia Pulmonar/diagnóstico , Sepsis/diagnóstico , Antibacterianos/uso terapéutico , Ecocardiografía Transesofágica , Endarteritis/diagnóstico por imagen , Endarteritis/terapia , Endocarditis Bacteriana/diagnóstico por imagen , Endocarditis Bacteriana/terapia , Humanos , Masculino , Persona de Mediana Edad , Embolia Pulmonar/terapia , Válvula Pulmonar/cirugía , Estenosis de la Válvula Pulmonar/diagnóstico por imagen , Sepsis/terapia , Tomografía Computarizada por Rayos XRESUMEN
We present a critically ill patient affected by COVID-19, whose chest computed tomography (CT) scan featured lung consolidations and severe patchy ground-glass opacitie. On day 3 since hospital admission the patient was placed on convalescent plasma treatment. A combined treatment with supportive care, hemoperfusion and convalescent plasma successfully managed to save the patient's life. Convalescent plasma probably contributed to heal this patient and should always be considered in the management of critically ill COVID-19 cases.
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COVID-19/terapia , Tomografía Computarizada por Rayos X , Adulto , COVID-19/diagnóstico por imagen , Enfermedad Crítica , Humanos , Inmunización Pasiva , Masculino , Sueroterapia para COVID-19RESUMEN
Since Dec. 2019 the new coronavirus (SARS-CoV-2) has infected millions and claimed life of several hundred thousand worldwide. However, so far no approved vaccine or drug therapy is available for treatment of virus infection. Convalescent plasma has been considered a potential modality for COVID-19 infection. One hundred eighty-nine COVID-19 positive patients including 115 patients in plasma therapy group and 74 patients in control group, registered in the hospitals with confirmed COVID-19 infection, entered this multi-center clinical study. Comparison of outcomes including all-cause mortality, total hospitalization days and patients' need for intubation between the two patient groups shows that total of 98 (98.2 %) of patients who received convalescent plasma were discharged from hospital which is substantially higher compared to 56 (78.7 %) patients in control group. Length of hospitalization days was significantly lower (9.54 days) in convalescent plasma group compared with that of control group (12.88 days). Only 8 patients (7%) in convalescent plasma group required intubation while that was 20 % in control group. This clinical study provides strong evidence to support the efficacy of convalescent plasma therapy in COVID-19 patients and recommends this treatment for management of these patients. Clinical efficacy, immediate availability and potential cost effectiveness could be considered as main advantages of convalescent plasma therapy.
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COVID-19/terapia , Adulto , Anciano , Anciano de 80 o más Años , COVID-19/inmunología , Femenino , Humanos , Inmunización Pasiva/efectos adversos , Masculino , Persona de Mediana Edad , SARS-CoV-2/inmunología , SARS-CoV-2/fisiología , Resultado del Tratamiento , Adulto Joven , Sueroterapia para COVID-19RESUMEN
BACKGROUND: Early detection of cancers improves patients' survival and decreases the treatment cost. Unfortunately, the current methods for diagnosis of bladder and prostate cancers, two most common urothelial malignancies, suffer from a low sensitivity and specificity. MicroRNAs, as a group of endogenously produced non-coding RNAs, regulate gene expression and their expression is observed to be altered in many cancers and cancer progression phenomena. The remarkable stability of microRNAs in biofluids and their unique expression pattern in different pathological conditions make them an appealing, noninvasive diagnostic method in cancer diagnosis. Our objective is to identify microRNAs as biomarkers in urine samples of bladder and prostate cancers to improve the existing diagnostic methods in this field. MATERIALS AND METHODS: In this study, urine samples from 110 men with either bladder (n = 45) or prostate (n = 23) cancer, benign prostatic hyperplasia (n = 22) and healthy controls (n = 20) were collected. qPCR was used to evaluate the expression level of miR-21-5p, miR-141-3p, and miR-205-5p in these samples. The sensitivity and specificity of these microRNAs were determined using ROC curve analysis. RESULTS: The analysis of the data revealed that miR-21-5p, miR-141-3p, and miR-205-5p are differentially expressed in urine of bladder and prostate cancer patients. All these three microRNAs were upregulated in these samples and they were also able to differentiate benign prostatic hyperplasia from malignant cases. The statistical analyses revealed a good specificity for each individual microRNA. CONCLUSION: The results show that these three urine-based microRNAs might be a good choice to implement a specific and non-invasive diagnostic tool for bladder and prostate cancer. The expression pattern of all three microRNAs was particularly useful to distinguish benign and invasive tumors in prostate cases. From the patients' perspective the improvement of the diagnostic situation is awaited eagerly.
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Biomarcadores de Tumor/orina , MicroARNs/orina , Neoplasias de la Próstata/orina , Neoplasias de la Vejiga Urinaria/orina , Anciano , Anciano de 80 o más Años , Biomarcadores de Tumor/genética , Regulación Neoplásica de la Expresión Génica , Humanos , Masculino , MicroARNs/genética , Persona de Mediana Edad , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/genética , Neoplasias de la Vejiga Urinaria/diagnóstico , Neoplasias de la Vejiga Urinaria/genéticaRESUMEN
BACKGROUND: Chronic kidney disease (CKD) is a progressive loss of kidney function and structure that affects approximately 13% of the population worldwide. A recent meta-analysis revealed that cell-based therapies improve impaired renal function and structure in preclinical models of CKD. We assessed the safety and tolerability of bone marrow-mesenchymal stromal cell (MSC) infusion in patients with CKD. METHODS: A single-arm study was carried out at one center with 18-month follow-up in seven eligible patients with CKD due to different etiologies such as hypertension, nephrotic syndrome (NS) and unknown etiology. We administered an intravenous infusion (1-2 × 106 cells/kg) of autologous cultured MSCs. The primary endpoint was safety, which was measured by number and severity of adverse events. The secondary endpoint was decrease in the rate of decrease in estimated glomerular filtration rate (eGFR). We compared kidney function during the follow-up visits to baseline and 18 months prior to the intervention. RESULTS: Follow-up visits of all seven patients were completed; however, we have not observed any cell-related adverse events during the trial. Changes in eGFR (P = 0.10) and serum creatinine (P = 0.24) from 18 months before cell infusion to baseline in comparison with baseline to 18 months were not statistically significant. CONCLUSIONS: We showed safety and tolerability of a single-dose infusion of autologous MSCs in patients with CKD.
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Células de la Médula Ósea/citología , Trasplante de Células Madre Mesenquimatosas/efectos adversos , Células Madre Mesenquimatosas/citología , Insuficiencia Renal Crónica/terapia , Adulto , Determinación de Punto Final , Femenino , Estudios de Seguimiento , Tasa de Filtración Glomerular , Humanos , Riñón/fisiopatología , Masculino , Persona de Mediana Edad , Insuficiencia Renal Crónica/fisiopatologíaRESUMEN
CONTEXT: Acute kidney injury (AKI) is a common complication after kidney transplantation (KT), especially in recipients from deceased donors. Urinary neutrophil gelatinase-associated lipocalin (u-NGAL) is an early and sensitive marker of AKI after transplantation. OBJECTIVES: We assessed the renoprotective effect of N-acetylcysteine (NAC) on u-NGAL levels as an early prognostic marker of graft function immediately after transplantation. MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled trial was conducted on 70 deceased-donor KT recipients ( www.irct.ir , trial registration number: IRCT2014090214693N4). Patients received 600 mg oral NAC or placebo twice daily from day 0 to 5 and urine samples were taken before, and on the first and fifth days after transplantation. U-NGAL and early graft function were compared between the two groups. RESULTS: NAC significantly reduced u-NGAL levels compared to placebo (p value = 0.02), while improvement in early graft function with NAC did not reach statistical significance. CONCLUSIONS: This study showed that NAC administration in deceased-donor KT recipients can reduce tubular kidney injury, evidenced by u-NGAL measurements. Improvement in early graft function needs a larger sample size to reach a statistical conclusion.
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Acetilcisteína/uso terapéutico , Biomarcadores/orina , Trasplante de Riñón/métodos , Lipocalina 2/orina , Acetilcisteína/administración & dosificación , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Lesión Renal Aguda/orina , Adulto , Funcionamiento Retardado del Injerto/fisiopatología , Funcionamiento Retardado del Injerto/prevención & control , Método Doble Ciego , Femenino , Depuradores de Radicales Libres/administración & dosificación , Depuradores de Radicales Libres/uso terapéutico , Humanos , Trasplante de Riñón/efectos adversos , Masculino , Persona de Mediana Edad , Donantes de TejidosRESUMEN
CONTEXT: As an alternative approach, administration of phytotherapeutic agents in management of benign prostate hyperplasia (BPH), is rapidly growing each day. Different authors have indicated effectiveness of Viola odorata L. (Violaceae), Echium amoenum Fisch. & C.A.Mey. (Boraginaceae) and Physalis alkekengi L. (Solanaceae) in treatment of BPH. However, none have reported the beneficial outcomes of the mixture yet. OBJECTIVE: This study evaluates the therapeutical effects of V. odorata, E. amoenum and P. alkekengi mixture on symptomatic BPH patients. MATERIALS AND METHODS: Eighty six symptomatic BPH patients with International Prostate Symptom Score (IPSS) of more than 13 and prostate volume of more than 30 cm3 were randomly allocated to receive a two-week course of placebo (control group) or 1 mL of mixed hydro-alcoholic solution of P. alkekengi, E. amoenum and V. odorata extracts (1.5, 1 and 1.5% respectively) (treatment group). RESULTS: IPSS score of incomplete urination (42.3 ± 2.04%), frequency of urination (20.08 ± 1.02%), intermittency (40.78 ± 2.16%), urgency (60.91 ± 3.14%), weak stream (50.58 ± 2.14%), straining (55.67 ± 2.53%) and nocturia (40.14 ± 1.89%) in treatment group were significantly decreased after treatment compare to placebo receiving group. Furthermore, the prostate volume (16.92 ± 0.89%) and extant urine volume (28.12 ± 1.36%) also significantly decreased in treatment group compared to control group. No significant side effects or abnormalities in biochemical tests and urinalysis were observed throughout the study. DISCUSSION AND CONCLUSIONS: Based on results, mentioned mixture is safe and effective in improving life quality of patients suffering from BPH.
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Echium/química , Extractos Vegetales/uso terapéutico , Hiperplasia Prostática/tratamiento farmacológico , Solanaceae/química , Viola/química , Adulto , Anciano , Método Doble Ciego , Humanos , Masculino , Persona de Mediana Edad , Fitoterapia , Extractos Vegetales/efectos adversos , Extractos Vegetales/aislamiento & purificación , Plantas Medicinales , Próstata/efectos de los fármacos , Próstata/patología , Hiperplasia Prostática/diagnóstico , Hiperplasia Prostática/fisiopatología , Calidad de Vida , Factores de Tiempo , Resultado del Tratamiento , Micción/efectos de los fármacosRESUMEN
BACKGROUND: The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients. OBJECTIVE: The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin(®)) and compare it with the innovator product Eprex(®), as a standard rHuEPO. METHODS: One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n = 50) or Eprex (n = 57). Each study group received rHuEPO at a dose of 80-120 IU/kg/week in 2-3 divided doses for a period of 3 months. Hematologic parameters including Hemoglobin, hematocrit, RBC, EBC, platelet, MCV, MCH and MCHC were checked every 2 weeks. Blood iron, ferritin, TIBC, creatinine, BUN and electrolytes (Na, K, Ca and P) were evaluated monthly over the 3 months. RESULTS: A significant increase in hemoglobin, hematocrit and RBC was observed by the end of study in both Pastopoitin and Eprex groups (p < 0.001). However, these factors were not significantly different between the groups, neither at baseline nor at the end of study (p > 0.05). Likewise, the groups were comparable regarding MCV, MCH, MCHC, iron, ferritin, TIBC, creatinine, BUN and electrolytes at baseline as well as at the end of trial. Adverse events were not serious and occurred with the same frequency in the study groups. CONCLUSION: Pastopoitin showed comparable efficacy and safety profile with Eprex in anemic patients on hemodialysis. Hence, Pastopoitin may be considered as a rHuEPO with a lower cost and wider availability compared with the innovator product Eprex.
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BACKGROUND: Solute carrier (SLC) transporters, a diverse family of membrane proteins, are instrumental in orchestrating the intake and efflux of nutrients including amino acids, vitamins, ions, nutrients, etc, across cell membranes. This dynamic process is critical for sustaining the metabolic demands of cancer cells, promoting their survival, proliferation, and adaptation to the tumor microenvironment (TME). Amino acids are fundamental building blocks of cells and play essential roles in protein synthesis, nutrient sensing, and oncogenic signaling pathways. As key transporters of amino acids, SLCs have emerged as crucial players in maintaining cellular amino acid homeostasis, and their dysregulation is implicated in various cancer types. Thus, understanding the intricate connections between amino acids, SLCs, and cancer is pivotal for unraveling novel therapeutic targets and strategies. SCOPE OF REVIEW: In this review, we delve into the significant impact of amino acid carriers of the SLCs family on the growth and progression of cancer and explore the current state of knowledge in this field, shedding light on the molecular mechanisms that underlie these relationships and highlighting potential avenues for future research and clinical interventions. MAJOR CONCLUSIONS: Amino acids transportation by SLCs plays a critical role in tumor progression. However, some studies revealed the tumor suppressor function of SLCs. Although several studies evaluated the function of SLC7A11 and SLC1A5, the role of some SLC proteins in cancer is not studied well. To exert their functions, SLCs mediate metabolic rewiring, regulate the maintenance of redox balance, affect main oncogenic pathways, regulate amino acids bioavailability within the TME, and alter the sensitivity of cancer cells to therapeutics. However, different therapeutic methods that prevent the function of SLCs were able to inhibit tumor progression. This comprehensive review provides insights into a rapidly evolving area of cancer biology by focusing on amino acids and their transporters within the SLC superfamily.
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Sistemas de Transporte de Aminoácidos , Aminoácidos , Neoplasias , Humanos , Neoplasias/metabolismo , Sistemas de Transporte de Aminoácidos/metabolismo , Sistemas de Transporte de Aminoácidos/genética , Aminoácidos/metabolismo , Animales , Microambiente Tumoral , Proteínas Transportadoras de Solutos/metabolismo , Proteínas Transportadoras de Solutos/genéticaRESUMEN
BACKGROUND: The involvement of the central nervous system is a frequent yet underestimated complication of diabetes mellitus. Visual evoked potentials (VEP) are a simple, sensitive, and noninvasive method for detecting early alterations in central optic pathways. The objective of this paralleled randomized controlled trial was to evaluate the impact of ozone therapy on visual pathways in diabetic patients. METHODS: Sixty patients with type 2 diabetes visiting clinics of Baqiyatallah university in Tehran (Iran) hospital were randomly assigned to two experimental groups: Group 1 (N = 30) undergoing a cycle of 20 sessions of systemic oxygen-ozone therapy in addition to standard therapy for metabolic control; Group 2 (N = 30)-serving as control-receiving only standard therapy against diabetes. The primary study endpoints were two VEP parameters; P100 wave latency and P100 amplitude at 3 months. Moreover, HbA1c levels were measured before the start of treatment and three months later as secondary study endpoint. RESULTS: All 60 patients completed the clinical trial. P100 latency significantly reduced at 3 months since baseline. No correlation was found between repeated measures of P100 wave latency and HbA1c (Pearson's r = 0.169, p = 0.291). There was no significant difference between baseline values and repeated measures of P100 wave amplitude over time in either group. No adverse effects were recorded. CONCLUSIONS: Ozone therapy improved the conduction of impulses in optic pathways of diabetic patients. The improved glycemic control following ozone therpay may not fully explain the reduction of P100 wave latency though; other mechanistic effects of ozone may be involved.
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BACKGROUND: Recombinant human erythropoietin is the cornerstone of therapy for anemia associated with chronic kidney disease or renal transplantation. However, it is not affordable and available for all patients. The present randomized double-blind trial compared the efficacy and safety of a biogeneric erythropoietin, Epolyrec, with the original product, Eprex, in correcting post-transplantation anemia (PTA). METHODS: Fifty patients who had undergone kidney transplantation surgery and had a hemoglobin level of < 11 g/L and a hematocrit of < 30% were recruited. These patients were randomly assigned to Epolyrec (n = 25) or Eprex (n = 25) at a dosage of 80 - 120 IU/kg body weight, three times/week. Patients were followed-up for two months unless they achieved the target levels for hemoglobin (1 g/L increase compared to baseline) and hematocrit (2 - 3% increase compared to baseline). Hemoglobin, hematocrit, and complete blood count with differential (CBC/DIFF) were evaluated at baseline and at months 1 and 2 of study. Other biochemical parameters were assessed at baseline and at the end of trial. RESULTS: Serum hemoglobin and hematocrit progressively increased from baseline to month 2 in both Epolyrec (p = 0.001) and Eprex (p < 0.001) groups, with no significant difference between the groups (p > 0.05). Mean corpuscular hemoglobin (MCH) and platelet count showed a significant increase during the course of the trial in both Epolyrec (p = 0.041 and 0.004 for MCH and platelet count, respectively) and Eprex (p = 0.036 and 0.003) groups. However, no significant change was observed between the groups regarding erythrocyte count, mean corpuscular volume, white blood cell count or reticulocyte count from baseline to the end of trial in any of the groups (p > 0.05). The incidence of adverse events were generally low in both groups and without any significant difference between Epolyrec and Eprex (p > 0.05). CONCLUSIONS: Epolyrec was equivalent to Eprex with respect to efficacy and safety. Hence, Epolyrec could represent a much more affordable and available biogeneric alternative to Eprex in correcting PTA.
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Anemia/tratamiento farmacológico , Medicamentos Genéricos , Eritropoyetina/uso terapéutico , Trasplante de Riñón/efectos adversos , Anemia/etiología , Creatina Quinasa/sangre , Método Doble Ciego , Eritropoyetina/efectos adversos , Hematócrito , Hemoglobinas/análisis , Humanos , Hierro/sangre , Pruebas de Función Renal , Pruebas de Función Hepática , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéuticoRESUMEN
BACKGROUND: Recombinant human erythropoietin (rHuEPO) is the cornerstone therapy for anemia associated with chronic kidney disease. However, not all patients with renal anemia receive sufficient doses of rHuEPO due to its high cost. The present trial aimed to evaluate the efficacy of Epolyrec, a biogeneric rHuEPO, in the management of renal anemia in patients on hemodialysis. METHODS: Seventy-two patients with end stage renal disease (ESRD) who were receiving hemodialysis were assigned to receive Epolyrec subcutaneously at a dose of 40-80 IU/Kg in 2-3 divided doses after each dialysis session for 12 weeks. Hemoglobin, hematocrit, and CBC/DIFF together with biomarkers of iron status, renal function, and trace elements were evaluated at baseline and during the course of trial. RESULTS: Hemoglobin concentrations and hematocrit progressively increased from baseline (8.45 +/- 1.42 mg/dL and 27.05 +/- 4.64% for hemoglobin and hematocrit, respectively) to the end of trial (10.56 +/- 1.93 and 34.06 +/- 6.70) (p < 0.001). RBC count (p = 0.026), reticulocyte count (p = 0.045), and MCV (p < 0.001) were also significantly increased at the end of trial (3.86 +/- 0.91x10(6)/microL, 0.78 +/- 0.31%, and 93.50 +/- 10.90 fL for RBC count, reticulocyte count, and MCV, respectively) compared to baseline (0.98 +/- 3.38, 0.18 +/- 0.63, and 89.75 +/- 9.35). Serum iron and ferritin were decreased while creatinine and phosphorous increased by the end of trial. No significant change was observed in WBC count, RDW, MCH, MCHC, BUN, PTH, Na, Ca, K, and Mg (p > 0.05). The frequencies of evaluated side effects were generally low and < 10%. CONCLUSIONS: Epolyrec is clinically efficacious in the elevation of hemoglobin and hematocrit in anemic ESRD patients receiving hemodialysis. Future comparative trials are warranted to compare the efficacy and safety of Epolyrec to those of innovator products.
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Anemia/tratamiento farmacológico , Eritropoyetina/uso terapéutico , Fallo Renal Crónico/terapia , Diálisis Renal , Anemia/etiología , Eritropoyetina/efectos adversos , Femenino , Humanos , Fallo Renal Crónico/complicaciones , Masculino , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéuticoRESUMEN
Background: There is a risk of novel mutations of SARS-CoV-2 that may render COVID-19 resistant to most of the therapies, including antiviral drugs and vaccines. The evidence around the application of therapeutic plasma exchange (TPE) for the management of critically ill patients with COVID-19 is still provisional, and further investigations are needed to confirm its eventual beneficial effects. Aims: To assess the effect of TPE on the risk of mortality in patients with COVID-19-associated pneumonia, using three statistical procedures to rule out any threats to validity. Methods: We therefore carried out a single-centered retrospective observational non-placebo-controlled trial enrolling 73 inpatients from Baqiyatallah Hospital in Tehran (Iran) with the diagnosis of COVID-19-associated pneumonia confirmed by real-time polymerase chain reaction (RT-qPCR) on nasopharyngeal swabs and high-resolution computerized tomography chest scan. These patients were broken down into two groups: Group 1 (30 patients) receiving standard care (corticosteroids, ceftriaxone, azithromycin, pantoprazole, hydroxychloroquine, lopinavir/ritonavir), and Group 2 (43 patients) receiving the above regimen plus TPE (replacing 2 l of patients' plasma by a solution, 50% of normal plasma, and 50% of albumin at 5%) administered according to various time schedules. The follow-up time was 30 days and all-cause mortality was the endpoint. Results: Deaths were 6 (14%) in Group 2 and 14 (47%) in Group 1. However, different harmful risk factors prevailed among patients not receiving TPE rather than being equally split between the intervention and control group. We used an algorithm of structural equation modeling (of STATA) to summarize a large pool of potential confounders into a single score (called with the descriptive name "severity"). Disease severity was lower (Wilkinson rank-sum test p < 0.001) among patients with COVID-19 undergoing TPE (median: -2.82; range: -5.18; 7.96) as compared to those not receiving TPE (median: -1.35; range: -3.89; 8.84), confirming that treatment assignment involved a selection bias of patients according to the severity of COVID-19 at hospital admission. The adjustment for confounding was carried out using severity as the covariate in Cox regression models. The univariate hazard ratio (HR) of 0.68 (95%CI: 0.26; 1.80; p = 0.441) for TPE turned to 1.19 (95%CI: 0.43; 3.29; p = 0.741) after adjusting for severity. Conclusions: In this study sample, the lower mortality observed among patients receiving TPE was due to a lower severity of COVID-19 rather than the TPE effects.
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We performed a review study according to recent COVID-19 vaccines' real-world data to provide comparisons between COVID-19 vaccines regarding their relative efficacy. Although most vaccine platforms showed comparable effectiveness and efficacy, we highlight critical points and recent developments generated in studies that might affect vaccine efficacy including population-dependent effects of the vaccine (transplantation, adiposity, and specific comorbidities, as well as older age, male sex, ethnicity, and prior infection), vaccine type, variants of concern (VOC), and an extended vaccine schedule. Owing to these factors, community-based trials can be of great importance in determining vaccine effectiveness in a systematic manner; thus, uncertainty remains regarding vaccine efficacy. Long immune protection of vaccination with BNT162b2 or ChAdOx1 nCoV-19 has been demonstrated to be up to 61 months and 5-12 months after the previous infection, and boosting infection-acquired immunity for both the first and second doses of the BNT162b2 and ChAdOx1 nCoV-19 vaccines was correlated with high and durable protection. However, large cohort and longitudinal studies are required for the evaluation of immunity dynamics and longevity in unvaccinated, vaccinated, and infected individuals, as well as vaccinated convalescent individuals in real-world settings. Regarding the likelihood of vaccine escape variants evolving, an ongoing examination of the protection conferred against an evolving virus (new variant) by an extended schedule can be crucial.
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COVID-19 , Vacunas , Masculino , Humanos , Vacunas contra la COVID-19 , Vacuna BNT162 , COVID-19/prevención & control , ChAdOx1 nCoV-19 , VacunaciónRESUMEN
BACKGROUND: The newly emerged pandemic of coronavirus disease-2019 (COVID-19) is the world's main health challenge because infected patients become vulnerable to a variety of opportunistic diseases. OBJECTIVE: This study aimed to assess clinical outcomes, diagnosis, utilized drug therapies, and ongoing COVID-19 practices in Iranian cases co-infected with COVID-19 and mucormycosis. PARTICIPANTS AND METHODS: A case-series analysis was conducted in the presence of 10 patients with COVID-19 and mucormycosis co-infection (two men and eight women; mean age of 48.8 years) from March to October 2020. Demographic variables, signs/symptoms, and comorbidities of all patients were recorded. COVID-19 was confirmed with reverse transcription polymerase chain reaction (RT-PCR) nasopharyngeal swab tests and high-resolution computed tomography (HR-CT)_ scans. RESULTS: All patients had a positive RT-PCR for SARS-CoV-2. Eight patients had a history of diabetes, while three of them exhibited a hypertension history. Remarkable laboratory findings were elevated fasting blood sugar in 6 cases and anaemia in four patients. A rhino-orbital-cerebral of mucormycosis in all patients was detected based on HR-CT scans and otorhinolaryngological or ophthalmological examinations. Neurological disorders including facial, trigeminal, optic, and oculomotor nerve involvement resulted in paraesthesia, pain, ptosis, no light perception, blurred vision, and papilledema in five cases. Maxillary and ethmoid sinuses were the most common sites of involvement. CONCLUSION: Vulnerable COVID-19 patients with comorbidities, any facial involvements, or treated by excessive doses of glucocorticoids and antibiotics should undergo precise examinations during the appearance of early signs and hospitalization to diagnose and treat mucormycosis using the standard care and antifungal treatments.
Asunto(s)
COVID-19 , Mucormicosis , Biomarcadores , Causalidad , Femenino , Humanos , Irán/epidemiología , Masculino , Persona de Mediana Edad , Mucormicosis/diagnóstico , Mucormicosis/tratamiento farmacológico , Mucormicosis/epidemiología , SARS-CoV-2RESUMEN
AIM: To evaluate the degree of CD3, CD20, Th17, and Tregs infiltration in kidney biopsy of the patients with acute cellular rejection and the possible relation with graft outcome. MATERIALS AND METHODS: In this retrospective study, fifty patients with Acute T Cell-Mediated Rejection (ATCMR) were enrolled. Previous and one year clinical follow-up data were collected. The kidney specimens were evaluated for infiltration of CD3, CD20, FOXP3, and Th17 with IHC. According to the serum creatinine level in one-year follow-up of the patients after rejection therapy and function of the transplanted organ from the day admitted into the hospital, they were respectively categorized in Stable graft function versus impaired graft function; appropriate response to treatment versus failure to response. RESULTS: Treg (P = 0.96) and Th17 (P = 0.24) cells were more in the unstable group than the stable group, but the difference wasn't significant. On the other hand, the FOXP3/Th17 ratio was higher in the stable group (P = 0.22). Moreover Treg (P = 0.1) and Th17 (P = 0.15) were higher in failure to response group, but FOXP3/Th17 was higher in proper response group (P = 0.8). CONCLUSION: From the results, it can be concluded that TH17 infiltration has a more significant effect on graft outcome and response to rejection therapy.