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1.
Expert Opin Drug Saf ; : 1-6, 2024 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-39076099

RESUMEN

BACKGROUND: Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). This post-marketing surveillance evaluates the safety of a trastuzumab biosimilar (AryoTrust), produced by AryoGen Co. Iran in Iranian women with HER2-positive non-metastatic breast cancer (BC). RESEARCH DESIGN AND METHODS: The patients who had undergone adjuvant chemotherapy regimens received trastuzumab every 3 weeks for nine cycles. The study started in February 2017 and finished in August 2022. Data regarding safety were collected using booklets and then analyzed. RESULTS: A total of 597 women with a mean ±SD age of 48.13 ± 10.18 years underwent 5,313 injection cycles. They received pre-study chemotherapies consisting of anthracyclines, taxanes, both, or other medications in 6.70, 7.20, 82.41, and 2.01% of the cases, respectively. One hundred and thirty-nine patients experienced at least one adverse event (AE). The most common AEs were decreased ejection fraction (EF, 5.7%), peripheral neuropathy (5.36%), and nausea (5.19%). Meningioma was the only life-threatening serious AE. Furthermore, bone pain and infusion-related reactions were the two most common grade three AEs. Nevertheless, the mean EF of patients did not change notably during the study. CONCLUSIONS: The results demonstrate that this trastuzumab biosimilar is a generally well tolerated and safe treatment for HER2-positive BC. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT06021379.

2.
Support Care Cancer ; 30(7): 5871-5879, 2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35359172

RESUMEN

The primary outcome was to assess the correlation between anxiety and pain, fatigue, nausea, and vomiting. The secondary outcome was to determine the predictive roles of pain, fatigue, nausea, and vomiting in anxiety among patients undergoing Hematopoietic Stem Cell Transplantation (HSCT). The present prospective cohort study was conducted on 200 patients treated by HSCT referred to the centers affiliated to Shiraz University of Medical Sciences. The data were collected using Spielberger Anxiety Questionnaire, Numerical Pain Scale, Brief Fatigue Inventory, and Rhodes Nausea and Vomiting Index. The data were analyzed using Spearman's test and multiple regression analysis. The means of state anxiety, trait anxiety, pain, fatigue, and nausea, vomiting, and retching were 41.67 (SD = 9.71), 43.78 (SD = 9.00), 3.79 (SD = 2.79), 4.23 (SD = 2.48), and 6.31 (SD = 7.53), respectively. The results showed that the participants with higher pain and fatigue scores had higher anxiety levels. Those with more nausea and vomiting had higher anxiety levels, as well. This indicated that fatigue, pain, severity and frequency of nausea, and type of HSCT were the predictors of trait anxiety. The results also showed the predictor role of pain, fatigue, and type of HSCT in state anxiety. The findings revealed a correlation between anxiety and pain, fatigue, nausea, and vomiting among the HSCT patients. The results also showed fatigue and pain as the predictors of anxiety among these patients. Yet, future studies are recommended to determine the other factors contributing to anxiety amongst HSCT patients.


Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Náusea , Ansiedad/epidemiología , Ansiedad/etiología , Ansiedad/terapia , Fatiga/epidemiología , Fatiga/etiología , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Humanos , Náusea/epidemiología , Náusea/etiología , Náusea/terapia , Dolor/epidemiología , Dolor/etiología , Estudios Prospectivos , Vómitos/epidemiología , Vómitos/etiología , Vómitos/terapia
3.
J Neurooncol ; 91(2): 233-6, 2009 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-18931888

RESUMEN

L -2-Hydroxyglutaric aciduria (L -2-OHGA) is a rare autosomal recessive inherited encephalopathy. This inborn error, characterized by psychomotor retardation, progressive ataxia and typical magnetic resonance imaging findings, presents in early infancy. To make a definitive diagnosis, an anomalous accumulation of L -2-hydroxyglutaric acid must be detected in body fluids. Here, we present a 17-year-old boy with L: -2-OHGA who developed an anaplastic ependymoma during the course of this disease. We also present a literature review including seven other patients who developed malignant brain tumors during the course of L -2-OHGA. This correlation may indicate a possible increased risk of brain tumors among patients with L -2-hydroxyglutaric aciduria.


Asunto(s)
Encefalopatías Metabólicas Innatas/complicaciones , Ependimoma/complicaciones , Lóbulo Frontal/patología , Hidroxiácidos/orina , Adolescente , Encefalopatías Metabólicas Innatas/orina , Ependimoma/orina , Humanos , Imagen por Resonancia Magnética/métodos , Masculino
4.
Iran J Allergy Asthma Immunol ; 7(3): 133-41, 2008 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-18780948

RESUMEN

Garlic is known as a potent spice and a medicinal herb with broad therapeutic properties ranging from antibacterial to anticancer and anticoagulant. Our previous studies have shown some immunoregulatory effects for aged garlic extract, suggesting a key role for 14-kD glycoprotein of garlic in shifting the cytokine pattern to T helper-1. In present study, we investigated the effect of 1, 2, and 3 times intraperitoneal injections of aged garlic extract on an established allergic airway inflammation in murine model (BALB/c mice). The garlic extract, isolated by biochemical method, includes proteins precipitation by ammonium sulfate. After injection of the aged garlic extract, IFN-, anti allergen specific IgE and IgG1 were measured in lavage and serum by ELISA and histological assessment was performed on the lung tissues. The results indicated that three-time intra peritoneal injections of the aged garlic extract caused a significant decrease in the hallmark criteria of allergic airway inflammation levels which included eosinophil percentage in lavage, peribronchial lung eosinophils, IgG1 level in lavage and serum, mucous producing goblet cells grade and peribronchial and perivascular inflammation. Our findings in the present research suggested that aged garlic extract has the potential of attenuation of inflammatory features of allergic airway inflammation in murine model.


Asunto(s)
Asma/tratamiento farmacológico , Asma/inmunología , Ajo , Células Caliciformes/inmunología , Inmunidad Celular/efectos de los fármacos , Fitoterapia , Extractos Vegetales/inmunología , Extractos Vegetales/farmacología , Células TH1/inmunología , Células Th2/inmunología , Animales , Asma/sangre , Eosinófilos/efectos de los fármacos , Eosinófilos/inmunología , Células Caliciformes/efectos de los fármacos , Inmunoglobulina E/sangre , Inmunoglobulina G/sangre , Inmunohistoquímica , Interferón gamma/inmunología , Interferón gamma/metabolismo , Recuento de Leucocitos , Masculino , Ratones , Ratones Endogámicos BALB C , Proteínas de Plantas/uso terapéutico
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