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1.
BMC Pulm Med ; 24(1): 87, 2024 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-38360614

RESUMEN

PURPOSE: Interstitial lung diseases (ILDs) are caused by inflammation and/or fibrosis of alveolar walls resulting in impaired gas exchange. Hypersensitivity pneumonitis (HP) is the third most common type of ILDs. Corticosteroids are the mainstay treatment for HP. The use of intramuscular (IM) betamethasone or intravenous (IV) dexamethasone as weekly pulse doses has shown higher benefit than daily oral prednisolone for HP patients. The aim of this study is to directly compare different corticosteroids in terms of effectiveness and in monetary values and perform an economic evaluation. METHODS: One hundred and seven patients were tested for pulmonary function tests (PFTs) and inflammatory markers to assess the treatment effectiveness. A cost-effectiveness analysis (CEA) was performed. ICERs between 3 treatment groups were calculated. RESULTS: Post treatment, Krebs von den Lungen-6 (KL-6) levels significantly improved in betamethasone group from 723.22 ± 218.18 U/ml to 554.48 ± 129.69 U/ml (p = 0.001). A significant improvement in erythrocyte sedimentation rate (ESR) occurred in the dexamethasone group from 56.12 ± 27.97 mm to 30.06 ± 16.04 mm (p = 0.048). A significant improvement in forced expiratory volume (FEV1), forced vital capacity (FVC) and six-minute walk distance (6MWD) was observed within the three treatment groups. A significant improvement in oxygen desaturation percentage (SpO2) occurred within dexamethasone and betamethasone groups. Betamethasone and dexamethasone were found more cost-effective than prednisolone as their ICERs fell in quadrant C. Furthermore, ICER between betamethasone and dexamethasone was performed; a small difference in cost was found compared to the higher benefit of betamethasone. CONCLUSION: Betamethasone and dexamethasone were found to be more effective than prednisolone in improving the inflammatory reaction and the clinical features of HP patients. Betamethasone was found to be the best intervention in terms of cost against the effect.


Asunto(s)
Alveolitis Alérgica Extrínseca , Enfermedades Pulmonares Intersticiales , Humanos , Economía Farmacéutica , Corticoesteroides/uso terapéutico , Alveolitis Alérgica Extrínseca/tratamiento farmacológico , Enfermedades Pulmonares Intersticiales/tratamiento farmacológico , Prednisolona/uso terapéutico , Betametasona/uso terapéutico , Dexametasona/uso terapéutico
2.
BMC Med Educ ; 24(1): 390, 2024 Apr 09.
Artículo en Inglés | MEDLINE | ID: mdl-38594659

RESUMEN

BACKGROUND: Diabetes recently has been identified as a growing epidemic. Although insulin's vital role in both types of diabetes, it is considered one of the harmful medications if used incorrectly. In Egypt, effective usage of insulin remains a challenge due to insufficient knowledge of insulin and diabetes management, leading to errors in insulin therapy. As pharmacists are experts in pharmacological knowledge, they are uniquely situated to assess adherence to treatment regimens, the effect of drug therapy, or potential alterations in drug therapy to meet patient goals. To provide effective patient education and counseling, community pharmacists in Egypt should be efficiently knowledgeable about diabetes and insulin. OBJECTIVE: To identify the knowledge, attitude, and practice of pharmacists and patients about insulin. To identify pharmacists' educational preparedness and confidence in counseling diabetic patients. METHODS: A descriptive, cross-sectional study was conducted with two knowledge, attitude, and practice surveys. This study was carried out from September 2016 to February 2023. Face-to-face interviews were conducted with patients, and a paper-based questionnaire was administered to pharmacists. The two questionnaires were adapted from previous studies. RESULTS: A total of 492 patients and 465 pharmacists participated in this study. The mean knowledge score of correct answers among patients and pharmacists was 10.67 ± 1.9 and 15 ± 3.6. Most of the patients and pharmacists had a positive attitude regarding insulin's role in improving health and to better control blood glucose. On the negative side, around half of the patients reported that they believe that regular use of insulin leads to addiction, while only 14.5% of the pharmacists believed that insulin could cause addiction. Self-confidence scores for pharmacists differed statistically with sex, years of experience, and pharmacist's direct exposure to diabetic patients. CONCLUSIONS: This study uncovers considerable deficiencies in patients' and pharmacists' knowledge about insulin therapy. This study also strongly recommends higher education and a more structured pharmacist training schedule.


Asunto(s)
Diabetes Mellitus , Farmacéuticos , Humanos , Farmacéuticos/psicología , Insulina/uso terapéutico , Estudios Transversales , Egipto , Conocimientos, Actitudes y Práctica en Salud , Actitud del Personal de Salud , Diabetes Mellitus/tratamiento farmacológico , Encuestas y Cuestionarios
3.
Eur J Nutr ; 62(8): 3241-3249, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37552330

RESUMEN

PURPOSE: The purpose of this study was to assess the possible clinical effects of vitamin K4 supplementation in individuals with type 2 diabetes namely insulin resistance, glycaemic control, and lipid profile. METHODS: This was a prospective randomised double-blind placebo-controlled clinical trial. A total of 106 patients were randomised to receive either 1 mg of vitamin K4 (menadiol diacetate) or placebo for 24 weeks. RESULTS: Ninety patients (n = 45 in each study group) were included in the final analysis. After 24 weeks, homeostatic model assessment of insulin resistance (HOMA-IR) (16.54 ± 7.81 vs. 29.09 ± 36.56, P = 0.027) and fasting serum insulin (FSI) (6.86 ± 3.45 vs. 11.13 ± 12.66 µU/ml, P = 0.032) were significantly lower in the vitamin K group compared to placebo. Additionally, triglycerides (TG) (144.94 ± 50.7 vs. 172.8 ± 101.5 mg/dl, P = 0.031) and very low-density lipoproteins (VLDL) levels (28.9 ± 9.88 vs. 34.6 ± 20.30 mg/dl, P = 0.027) decreased significantly in the vitamin K group after 24 weeks compared to baseline. Moreover, more patients in the vitamin K group (35.6%) had their antidiabetic medication doses reduced after 24 weeks compared to placebo (13.3%, P = 0.029). CONCLUSION: Vitamin K4 supplementation for 24 weeks is capable of improving insulin resistance and TG levels in individuals with type 2 diabetes. In addition, the improvement in insulin resistance was reflected in the decrease in antidiabetic medication doses. However, it did not affect fasting plasma glucose (FPG) or glycated haemoglobin (HbA1c). TRIAL REGISTRATION: The study was registered on clinicaltrials.gov with ID: NCT04285450.


Asunto(s)
Diabetes Mellitus Tipo 2 , Resistencia a la Insulina , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Glucemia , Estudios Prospectivos , Hipoglucemiantes/uso terapéutico , Vitamina K , Vitaminas/uso terapéutico , Suplementos Dietéticos , Método Doble Ciego , Insulina
4.
Lupus ; 31(4): 505-516, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35254887

RESUMEN

INTRODUCTION/OBJECTIVES: Lupus nephritis (LN) is a major and serious complication of systemic lupus erythematosus (SLE) and is associated with morbidity and mortality. The difference in drug cost between mycophenolate mofetil (MMF) and cyclophosphamide (CYC) inducing regimens becomes a relevant and realistic issue, especially in developing countries. Thus, this study aims to estimate and compare the costs and outcomes of CYC and MMF for better allocation of resources to reduce the burden on the Egyptian healthcare system. METHODS: A prospective, parallel observational study was conducted at Kasr Al-Aini Hospital between 2018 and 2020. One hundred and twenty-two LN patients were followed up monthly during the study period. Remission and maintenance of renal remission were assessed at 6 and 12 months from the start of therapy. Total direct medical costs associated with both regimens were examined. We applied the cost-minimization analysis method from governmental perspective. Besides, a prospective evaluation of reported changes in health-related quality of life using SF-36 was included in our study. RESULTS: There was no statistically significant difference in treatment response at 6 and 12 months (RR 0.6 [0.26;1.43] and 0.8 [0.27;2.33]), respectively, as well as the incidence of infection episodes between MMF and CYC group (71.4% versus 70.45%, p > 0.05). The average direct medical expenditures per patient in the MMF group were approximately one and half times more than the CYC group (2339.69 $ versus 1329.03 $, p <0.001). CONCLUSION: The CYC arm was associated with lower costs than the MMF arm, with equally effective outcomes indicating that CYC is an attractive treatment option.


Asunto(s)
Lupus Eritematoso Sistémico , Nefritis Lúpica , Ciclofosfamida/uso terapéutico , Egipto , Humanos , Inmunosupresores/uso terapéutico , Quimioterapia de Inducción , Lupus Eritematoso Sistémico/tratamiento farmacológico , Nefritis Lúpica/inducido químicamente , Nefritis Lúpica/tratamiento farmacológico , Ácido Micofenólico/uso terapéutico , Calidad de Vida , Inducción de Remisión , Resultado del Tratamiento
5.
Int J Clin Pract ; 75(6): e14104, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-33617679

RESUMEN

BACKGROUND: Iron overload-induced oxidative stress and transfusion-acquired hepatitis C virus (HCV) infection are the main reasons of liver damage in beta thalassemia major (ß-TM). OBJECTIVES: Based on metformin's hepatic benefits in nondiabetic populations, the study aims to investigate the safety and the potential hepatoprotective effect of metformin in HCV-infected ß-TM adolescent patients. METHODS: This was a prospective, randomised, parallel, controlled, open-label study in which 60 HCV-infected ß-TM adolescent patients aged 11 to 18 years and receiving no antiviral therapy were selected and randomly assigned to treatment or control group in 1:1 allocation. Both groups were receiving ß-TM standard-of-care regimen, whereas metformin (500 mg, twice daily) was added to the treatment group's regimen only. Patients were prospectively followed up for 6 months with assessment of liver biochemical profile, oxidative stress markers, liver fibrosis, clinical symptom improvement and metformin's adverse effects. RESULTS: Aspartate aminotransferase serum level decreased significantly over time in the treatment group only (P = .013). However, improvement was not clinically significant and did not attain normality. Change in total antioxidant capacity and malondialdehyde serum levels indicated significantly improved oxidative stress status in the treatment group versus significant deterioration in the control group (P < .001). Fibrosis grade improvement was observed in 14 patients in the treatment group versus one improved case in the control group. CONCLUSION: The use of metformin in HCV-infected ß-TM adolescent patients as an adjuvant antioxidant hepatoprotective agent is promising and can improve liver damage.


Asunto(s)
Hepatitis C , Metformina , Talasemia beta , Adolescente , Niño , Hepacivirus , Humanos , Metformina/uso terapéutico , Estudios Prospectivos , Talasemia beta/complicaciones , Talasemia beta/tratamiento farmacológico
6.
Telemed J E Health ; 25(6): 462-470, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-30048216

RESUMEN

Background:Adherence and safety challenges aroused with the use of oral chemotherapeutic agents, such as capecitabine, necessitated implementation of a more focused follow-up for patients receiving these agents.Patients and Methods:This prospective, randomized open-label study explored the usefulness of weekly telephone-based follow-up in Egyptian patients with metastatic colorectal or gastric cancer treated with capecitabine-based chemotherapy regimens at the National Cancer Institute, Egypt, compared with a standard care group. Patients' adherence, safety, efficacy, and health service utilization were assessed and compared in 82 eligible patients; control group (n = 38) and intervention group (n = 44).Results:The intervention group showed statistically better tolerability to certain adverse effects in certain cycles with nonsignificantly higher patients' adherence and overall survival (OS), along with statistically higher passive call duration.Conclusion:These results suggested that pharmacist-led telephone follow-up (TFU) could help in building a close trusting rapport between the patient and caregiving pharmacist. They also demonstrated the potential usefulness of the TFU on patients' tolerability, adherence, and OS; however, further trials with a larger sample size should be encouraged to explore more pronounced results. Otherwise, the provided standard care could be considered good enough for these patients.


Asunto(s)
Antineoplásicos/uso terapéutico , Capecitabina/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Cumplimiento de la Medicación/estadística & datos numéricos , Neoplasias Gástricas/tratamiento farmacológico , Teléfono , Adulto , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Capecitabina/administración & dosificación , Capecitabina/efectos adversos , Neoplasias Colorrectales/mortalidad , Neoplasias Colorrectales/patología , Egipto , Femenino , Servicios de Salud/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Aceptación de la Atención de Salud/estadística & datos numéricos , Farmacéuticos/organización & administración , Estudios Prospectivos , Neoplasias Gástricas/mortalidad , Neoplasias Gástricas/patología
7.
Crit Care Med ; 46(1): 45-52, 2018 01.
Artículo en Inglés | MEDLINE | ID: mdl-28857848

RESUMEN

OBJECTIVE: Nebulized antibiotics offer high efficacy due to significant local concentrations and safety with minimal blood levels. This study evaluates the efficacy and nephrotoxicity of nebulized versus IV amikacin in postcardiothoracic surgical patients with nosocomial pneumonia caused by multidrug-resistant Gram- negative bacilli. DESIGN: Prospective, randomized, controlled study on surgical patients divided into two groups. SETTING: Postcardiac surgery ICU. INTERVENTIONS: The first gtroup was administered IV amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered IV piperacillin/tazobactam empirically. PATIENTS: Recruited patients were diagnosed by either hospital-acquired pneumonia or ventilator-associated pneumonia where 56 (42.1%) patients were diagnosed with hospital-acquired pneumonia, 51 (38.34%) patients were diagnosed with early ventilator-associated pneumonia, and 26 (19.54%) patients with late ventilator-associated pneumonia. MEASUREMENTS AND MAIN RESULTS: Clinical cure in both groups assessed on day 7 of treatment was the primary outcome. Efficacy was additionally evaluated through assessing the length of hospital stay, ICU stay, days on amikacin, days on mechanical ventilator, mechanical ventilator-free days, days to reach clinical cure, and mortality rate. Lower nephrotoxicity in the nebulized group was observed through significant preservation of kidney function (p < 0.001). Although both groups were comparable regarding length of hospital stay, nebulizer group showed shorter ICU stay (p = 0.010), lower number of days to reach complete clinical cure (p = 0.001), fewer days on mechanical ventilator (p = 0.035), and fewer days on amikacin treatment (p = 0.022). CONCLUSION: Nebulized amikacin showed better clinical cure rates, less ICU stay, and fewer days to reach complete recovery compared to IV amikacin for surgical patients with nosocomial pneumonia. It is also a less nephrotoxic option associated with less deterioration in kidney function.


Asunto(s)
Amicacina/administración & dosificación , Infección Hospitalaria/tratamiento farmacológico , Resistencia a Múltiples Medicamentos , Infecciones por Bacterias Gramnegativas/tratamiento farmacológico , Cardiopatías/cirugía , Neumonía Bacteriana/tratamiento farmacológico , Neumonía Asociada al Ventilador/tratamiento farmacológico , Complicaciones Posoperatorias/tratamiento farmacológico , Administración por Inhalación , Adulto , Amicacina/efectos adversos , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Humanos , Infusiones Intravenosas , Tiempo de Internación , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento
8.
Ann Allergy Asthma Immunol ; 118(5): 557-563, 2017 05.
Artículo en Inglés | MEDLINE | ID: mdl-28377173

RESUMEN

BACKGROUND: Despite the use of alfacalcidol in the management of corticosteroid-induced osteoporosis, it has never been considered an adjunct treatment for asthma management. It can target vitamin D deficiency, a possible risk factor for asthma, and, hence, improve pulmonary function of patients with asthma. OBJECTIVE: To explore the effect of alfacalcidol administration on pulmonary function and study the pattern of vitamin D deficiency in adults with asthma in Egypt. METHODS: Serum 25-hydroxyvitamin D was measured in 115 adults: 33 healthy subjects and 82 patients with asthma. Then, patients with asthma were randomized to receive standard asthma treatment only (n = 39) or receive it in addition to 1 µg of alfacalcidol daily for 4 months (n = 43). Randomization was stratified by the stage of asthma severity. Spirometry and measurement of 25-hydroxyvitamin were performed at baseline and end of follow-up. RESULTS: Vitamin D deficiency was more common in patients with asthma (57.3%) than in healthy subjects (21.2%; P < .001). In patients with asthma, alfacalcidol significantly improved forced expiratory volume in the first second and forced vital capacity (P < .001 for the 2 tests). Moreover, more patients in the intervention arm showed improvement in asthma severity stage (P = .04). A nonsignificant difference was observed in improvement of forced expiratory volume in the first second between patients with vitamin D deficiency and those without deficiency in the intervention group (P > .05). CONCLUSION: Alfacalcidol supplementation improved the pulmonary function and severity stage of adult patients with asthma regardless of deficiency. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02747381.


Asunto(s)
Asma/complicaciones , Asma/fisiopatología , Conservadores de la Densidad Ósea/uso terapéutico , Hidroxicolecalciferoles/uso terapéutico , Deficiencia de Vitamina D/complicaciones , Deficiencia de Vitamina D/tratamiento farmacológico , Corticoesteroides/efectos adversos , Corticoesteroides/uso terapéutico , Adulto , Anciano , Antiasmáticos/efectos adversos , Antiasmáticos/uso terapéutico , Asma/diagnóstico , Asma/tratamiento farmacológico , Estudios de Casos y Controles , Egipto , Femenino , Volumen Espiratorio Forzado/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Espirometría , Resultado del Tratamiento , Vitamina D/análogos & derivados , Vitamina D/sangre , Deficiencia de Vitamina D/diagnóstico , Adulto Joven
9.
J Cardiothorac Vasc Anesth ; 30(4): 876-83, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-27236490

RESUMEN

OBJECTIVE: Because of the lack of data regarding the impact of obesity on propofol pharmacokinetics in patients undergoing cardiac surgery using hypothermic cardiopulmonary bypass (CPB), the authors sought to explore propofol pharmacokinetics and develop a predictive pharmacokinetic model that characterizes and predicts propofol pharmacokinetics in this population. DESIGN: A prospective, observational study. SETTING: A teaching hospital. PARTICIPANTS: The study comprised 17 obese and 17 control (nonobese) patients undergoing hypothermic CPB. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: Patients mainly underwent valve surgery. On initiation of hypothermic CPB (28°C-32°C), patients received a propofol (1%) bolus (1 mg/kg) immediately followed by a 2 mg/kg/h infusion. Blood samples were withdrawn at the following times: before dosing; 1, 3, 5, and 7 minutes after the propofol bolus dose; every 20 minutes during infusion; just before discontinuation of the infusion; and at 1, 3, 5, 7, 10, 20, 30, and 60 minutes after discontinuation of the infusion. The plasma propofol concentration was determined using high-performance liquid chromatography, and then data were imported into Monolix (Lixoft, Antony, France) for population pharmacokinetic modeling and pharmacokinetic parameters estimation. A 2-compartment pharmacokinetic model with age as a covariate on the peripheral volume of distribution (V2) best described the pooled data. The pooled data was internally evaluated successfully to describe and predict propofol pharmacokinetics in the addressed population. Propofol clearance, intercompartmental clearance, and central volume of distribution were 805 mL/min, 1140 mL/min and 18.8 L, respectively. V2 was calculated as 9.86×exp.(1.88×[age/40]) L. CONCLUSION: Propofol pharmacokinetic parameters were similar in obese and nonobese patients undergoing hypothermic CPB. Age was the major determinant of propofol V2 in the obese population.


Asunto(s)
Anestésicos Intravenosos/sangre , Puente Cardiopulmonar/métodos , Obesidad/sangre , Propofol/sangre , Adulto , Factores de Edad , Antropometría/métodos , Recolección de Muestras de Sangre/métodos , Procedimientos Quirúrgicos Cardíacos , Estudios de Casos y Controles , Cromatografía Líquida de Alta Presión/métodos , Femenino , Humanos , Hipotermia Inducida , Masculino , Persona de Mediana Edad , Modelos Biológicos , Estudios Prospectivos
10.
J Cardiothorac Vasc Anesth ; 30(6): 1461-1470, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27595528

RESUMEN

OBJECTIVES: Comparing different perioperative statin regimens for the prevention of post-coronary artery bypass grafting adverse events. DESIGN: A randomized, prospective study. SETTING: Cardiothoracic surgical units in a government hospital. PARTICIPANTS: The study comprised 94 patients scheduled for elective, isolated on- or off- pump coronary artery bypass grafting. INTERVENTIONS: Patients were assigned randomly to 1 of the following 3 treatment groups: group I (80 mg of atorvastatin/day for 2 days preoperatively), group II (40 mg of atorvastatin/day for 5-9 days preoperatively), or group III (80 mg of atorvastatin/day for 5-9 days preoperatively). The same preoperative doses were restarted postoperatively and continued for 1 month. MEASUREMENTS AND MAIN RESULTS: Cardiac troponin I, creatine kinase, and C-reactive protein (CRP) levels were assayed preoperatively; at 8, 24, and 48 hours postoperatively; and at discharge. CRP levels at 24 hours (p = 0.045) and 48 hours (p = 0.009) were significantly lower in group III compared with the other 2 groups. However, troponin I levels at 8 hours (p = 0.011) and 48 hours (p = 0.025) after surgery were significantly lower in group II compared with group III. The incidence of postoperative major adverse cardiac and cerebrovascular events was assessed, and there was no significant difference among the 3 groups. CONCLUSION: The 3 regimens did not result in any significant difference in outcomes, but only simple trends. The higher-dose regimen resulted in a significant reduction in the CRP level. Thus, more studies are needed to confirm the benefit of higher-dose statins for the protection from post-coronary artery bypass grafting adverse events.


Asunto(s)
Atorvastatina/administración & dosificación , Puente de Arteria Coronaria/efectos adversos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Atención Perioperativa/métodos , Anciano , Atorvastatina/uso terapéutico , Proteína C-Reactiva/metabolismo , Trastornos Cerebrovasculares/etiología , Trastornos Cerebrovasculares/prevención & control , Puente de Arteria Coronaria/métodos , Puente de Arteria Coronaria/rehabilitación , Puente de Arteria Coronaria Off-Pump/efectos adversos , Puente de Arteria Coronaria Off-Pump/rehabilitación , Creatina Quinasa/sangre , Relación Dosis-Respuesta a Droga , Femenino , Cardiopatías/etiología , Cardiopatías/prevención & control , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Troponina I/sangre
11.
Clin Transplant ; 29(12): 1112-8, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26363413

RESUMEN

BACKGROUND: Using fluoroquinolone prophylaxis in pediatric neutropenic patients is a controversial issue due to the concern about emergence of resistant strains in addition to the lack of pediatric studies. This study was performed to assess the effectiveness of levofloxacin prophylaxis in pediatric patients during autologous stem cell transplantation. METHODS: This was an observational study of pediatric patients who underwent autologous stem cell transplantation, comparing patients who received levofloxacin prophylaxis to historical controls. RESULTS: A total of 96 patients were included (46 patients in the control group and 50 patients received levofloxacin). The median duration till onset of first fever was 11 d in the control group as compared to 15 d in patients who received levofloxacin (p ≤ 0.001). The incidence of infectious complications was higher in patients without levofloxacin (4/46) than those with levofloxacin (1/50). The median duration of empirical antibiotic use was 10 d in the levofloxacin group compared with 14 d in the control group (p < 0.001). CONCLUSION: Levofloxacin prophylaxis delayed first spike of fever, decreased the incidence of septic complications, and shortened the duration of empiric antibiotic use, but its impact on emergence of resistant organisms should be closely monitored.


Asunto(s)
Profilaxis Antibiótica/estadística & datos numéricos , Bacteriemia/prevención & control , Neutropenia Febril/prevención & control , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Levofloxacino/uso terapéutico , Adolescente , Bacteriemia/epidemiología , Bacteriemia/microbiología , Niño , Preescolar , Neutropenia Febril/epidemiología , Neutropenia Febril/microbiología , Femenino , Estudios de Seguimiento , Rechazo de Injerto , Supervivencia de Injerto , Humanos , Lactante , Masculino , Pronóstico , Factores de Riesgo , Trasplante Autólogo
12.
Clin Ther ; 46(1): e12-e22, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-37925363

RESUMEN

PURPOSE: Children with hematological malignancies and chronic hepatitis C virus (HCV) infection are at a higher risk for rapid progression of liver disease and malignancy relapse due to multiple hepatitis flares and chemotherapy interruption. They are therefore potential candidates for microelimination of HCV infection. This study aimed to assess the effect of acute lymphoblastic leukemia (ALL) on the pharmacokinetic (PK) profile of direct-acting antivirals, namely ledipasvir/sofosbuvir (LDV/SOF) and the SOF major metabolite GS-331007. METHODS: This was a 24-week, prospective, controlled, open-label, 2-arm PK study of patients receiving 45/200 mg once-daily LDV/SOF orally for 12 weeks. Eligible patients were HCV-RNA-positive, treatment-naive children aged 6 to <12 years and/or weighing 17 to <35 kg with genotype 4 chronic HCV infection without cirrhosis. The primary efficacy and safety end points were the achievement of sustained virologic response for all patients with absence of any adverse events leading to permanent discontinuation of the study drug. Steady-state noncompartmental analysis was performed to determine the PK parameters of SOF, GS-331007, and LDV as the primary PK outcome. Dose suitability was based on the 90% CI of exposure geometric mean ratio percentage within 50% to 200% compared with adults. FINDINGS: Ten HCV-infected children with ALL (chemotherapy treatment group) and 12 eligible children with no malignancy (control group) were enrolled and completed the study period. All 22 patients achieved the sustained virologic response with no adverse events leading to interruption or permanent discontinuation of the study drug. Compared with the control group, the ALL group patients had similar SOF, GS-331007, and LDV exposure. Compared with adults, the AUCτ of GS-331007 was lower and the AUCτ and Cmax,ss of SOF and the Cmax,ss of LDV were modestly higher in the ALL group (acceptance limit, 50%-200%). However, the observed efficacy and favorable safety profile made these changes not clinically significant. IMPLICATIONS: Weight-based dosing of LDV/SOF (45/200 mg) is highly effective and safe among genotype 4 HCV-infected children weighing 17 to <35 kg and diagnosed with ALL undergoing maintenance chemotherapy. The similarity in the drug exposure, efficacy, and safety clinical end points between patients with and without hematological malignancy support their therapeutic equivalence. Further studies with a larger sample size may be required to confirm the safety of LDV/SOF in patients with ALL and to recommend appropriate dosing in children with hematological malignancies, if needed. CLINICALTRIALS: gov identifier: NCT03903185.


Asunto(s)
Neoplasias Hematológicas , Hepatitis C Crónica , Hepatitis C , Adulto , Niño , Humanos , Sofosbuvir/efectos adversos , Hepacivirus/genética , Antivirales/efectos adversos , Hepatitis C Crónica/tratamiento farmacológico , Estudios Prospectivos , Uridina Monofosfato/efectos adversos , Hepatitis C/tratamiento farmacológico , Quimioterapia Combinada , Neoplasias Hematológicas/tratamiento farmacológico , Genotipo , Resultado del Tratamiento
13.
J Infect Dev Ctries ; 17(9): 1188-1198, 2023 09 30.
Artículo en Inglés | MEDLINE | ID: mdl-37824346

RESUMEN

INTRODUCTION: Coronavirus disease 2019 (COVID-19) vaccine hesitancy is a major problem. This study aimed to determine the factors associated with COVID-19 vaccine acceptance. METHODOLOGY: A cross-sectional survey-based study was conducted on a sample of the Egyptian population using an online survey distributed through social media platforms, including Facebook, WhatsApp, and LinkedIn. The questionnaire was composed of five parts: part I describing the research questionnaire and its aim, part II assessing the demographic data, part III assessing knowledge and attitude towards COVID-19 infection, and part IV and V evaluating knowledge regarding COVID-19 vaccines, factors affecting vaccine acceptance and participants' attitude toward vaccination. Regression models were used to assess factors associated with vaccine acceptability. RESULTS: A total of 24376 responses were included in the statistical analysis. Females represented more than two-thirds of the study sample (70.5%,) and 18-24 years was the most commonly reported age group. Around one-third of the sample were healthcare professionals (HCPs). Only 14.3% of the participants received or registered to receive the vaccine, while 47% refused to be vaccinated. Regression analysis revealed that male gender, secondary education, older age, married or divorced status, presence of comorbidities, and higher level of knowledge regarding the vaccine were significantly associated with high vaccine acceptance. The most important vaccine attributes influencing vaccine selection in the current work were efficacy and safety. CONCLUSIONS: Vaccine hesitancy is currently a major challenge. Governments should design educational campaigns that provide trusted data related to vaccine efficacy and safety to encourage vaccination and enhance awareness.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Femenino , Humanos , Masculino , Estudios Transversales , Egipto/epidemiología , COVID-19/prevención & control , Vacunación
14.
Pharmacoeconomics ; 41(3): 329-338, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36434416

RESUMEN

OBJECTIVES: To investigate the effect of an extensive pilot phase in improving protocol compliance, face validity, reduction of interviewer effect and prediction errors in the composite time trade-off (cTTO) data elicited as part of the EQ-5D-5L valuation study in Egypt. METHODS: This study used the cTTO data and quality control (QC) reports from the Egyptian EQ-5D-5L valuation study. Three-level mixed models were estimated to test whether interviewer effects were reduced during the pilot phase and subsequent rounds of collected cTTO data. Ordinary least square (OLS) regression analysis was conducted for each interviewer separately to test whether the mean absolute error (MAE) improved as interviewers completed more interviews. Moreover, improvement in protocol compliance, face validity and reduction of prediction errors in the cTTO data were tested. RESULTS: 1180 interviews were conducted by nine interviewers and included in the final analysis, of which 206 interviews were pilot and 974 interviews were actual. There was substantial improvement in the face validity and reduction of prediction errors in the cTTO data where the MAE of the actual data was 0.37, which is much lower than that of the pilot data, which was 0.44. However, there was an initial high level of protocol compliance in terms of the four indicators of the QC tool and the variance attributed to the interviewers was small throughout the whole study. CONCLUSIONS: This study clarified the benefits of the pilot phase and the strict implementation of the QC tool in improving the face validity and the prediction accuracy of the cTTO data. However, a more extensive pilot phase may be more beneficial in EQ-5D-5L valuation studies that have issues initially with protocol compliance and interviewer effects.


Asunto(s)
Estado de Salud , Calidad de Vida , Humanos , Egipto , Proyectos Piloto , Encuestas y Cuestionarios
15.
Arch Dermatol Res ; 315(5): 1293-1304, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-36571611

RESUMEN

Androgenetic alopecia (AGA) is the most common cause of hair loss in both genders with a higher psychological impact on females. Currently, topical minoxidil is the only FDA-approved treatment for female AGA and it needs life-long application and causes side effects. Cetirizine is an antihistamine that may be effective in hair loss treatment. This study aimed to compare the efficacy and safety of topical cetirizine with minoxidil (group 1) versus topical minoxidil with placebo (group 2) in female patients with AGA. This was a double-blind, randomized, controlled, parallel study conducted at Dermatology Clinic, Cairo University Teaching Hospital (Kasr- Al- Ainy), Egypt. Sixty-six patients with female AGA, aged 20-50 years, Sinclair (II-IV), were randomly assigned to one of the 2 groups for 24 weeks. The trichoscopic parameters, patients' self-assessment, side effects and global photographic assessment were evaluated. There was a statistically significant change from baseline in frontal and vertex terminal and vellus hair density (P < 0.0005) with a significant increase in vertex hair shaft thickness and average number of hairs per follicular unit in group 1 (P < 0.05). Patients reported significantly better scores in patient self-assessment in group 1 (P < 0.05). Side effects were not significantly different between groups (P > 0.05). Topical cetirizine increases hair shaft thickness and results in a higher clinical improvement from patients' perspective with a good safety profile (NCT04481412, study start date: July 2020).


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Minoxidil , Femenino , Humanos , Masculino , Cetirizina/farmacología , Cetirizina/uso terapéutico , Administración Tópica , Alopecia/tratamiento farmacológico , Cabello
16.
Patient ; 15(5): 589-598, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35156181

RESUMEN

OBJECTIVE: The aim of this study was to explore the impact of sociodemographic characteristics and illness experience on time trade-off (TTO)-based utility scores using data from the EQ-5D-5L Egyptian valuation study. METHODS: Data were from the Egyptian valuation study that was conducted using the adapted translated version of the EQ-VT to develop the Egyptian Tariff for the EQ-5D-5L based on preferences of the Egyptian population. Data were analysed using a series of univariate and multivariable censored linear regression models adjusted for severity of health states where the dependent variable was the TTO scores and the independent variables included age, sex, education, geographical region, dwelling, marital status, number of people in the household, employment status, having health insurance, number of chronic conditions, previous experience with illness, and self-rated health. RESULTS: Age, sex, education, marital status, dwelling, region of residence, health insurance and multimorbidity were significantly associated with health state valuations, while employment status, number of people in a household, religion, and previous experience with illness had non-significant associations. CONCLUSION: Age, sex and marital status are the main determinants of health state valuation in the Egyptian population, a finding consistent with those from other countries. Knowing these factors will help tailor health services provided and improve patient-centered care.


Asunto(s)
Estado de Salud , Calidad de Vida , Egipto , Humanos , Modelos Lineales , Encuestas y Cuestionarios
17.
Pharmacoeconomics ; 40(4): 433-447, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34786590

RESUMEN

INTRODUCTION: No value sets exist for either the EQ-5D-3L or the EQ-5D-5L in Egypt, despite local pharmacoeconomic guidelines recommending the use of the EQ-5D to derive utility. Most published Egyptian economic evaluation studies have used utility values from other published studies and systematic reviews. OBJECTIVE: Our objective was to develop an Egyptian EQ-5D-5L value set using the international EuroQol standardized protocol (EQ-VT-2.1). This study is a revision of a previous EQ-5D-5L value set for Egypt retracted by the authors. METHODS: Adult Egyptian participants were recruited from public places using multi-stratified quota sampling based on age, sex, and geographical distribution. Two elicitation techniques were applied: the composite time trade-off (cTTO) and discrete-choice experiments (DCEs). Before actual data collection, interviewers' performance was assessed in a pilot phase. Data were modelled using generalized least squares, Tobit, heteroskedastic, logit, and hybrid models, and the best fitting model was selected based on logical consistency of the parameters, significance level, prediction accuracy, and model parsimony. RESULTS: A total of 1378 interviews were conducted, of which 188 were excluded because they were incomplete and did not comply with the protocol, 216 were pilot interviews, and 974 were included in the final analysis. The heteroskedastic model with constraints (model 4) based on the cTTO data was selected as the preferred model to generate the value set. Values ranged from - 0.964 for the worst health state (55555) to 1 for full health (11111) and 0.948 for 11211, with 1123 of all predicted health states (35.94%) being worse than dead. Mobility had the largest impact on health state preference values. CONCLUSION: This is the first value set for the EQ-5D-5L based on social preferences obtained from a nationally representative sample in Egypt or any Arabic-speaking country. The value set can be used as a scoring system for economic evaluation and to improve the quality of health technology assessment in the Egyptian healthcare system.


Asunto(s)
Estado de Salud , Calidad de Vida , Adulto , Análisis Costo-Beneficio , Egipto , Humanos , Encuestas y Cuestionarios
18.
BMJ Open ; 11(12): e051727, 2021 12 23.
Artículo en Inglés | MEDLINE | ID: mdl-34949616

RESUMEN

OBJECTIVES: To present the challenges and adaptations done to the EuroQol Valuation Technology (EQ-VT) protocol to fit the Egyptian culture during the extensive pilot phase of the Egyptian EuroQol 5 Dimension five level (EQ-5D-5L) valuation study DESIGN: This study was a cross-sectional, interviewer-administered face-to-face survey of representative Egyptians using the Arabic version of the EuroQol Group Valuation Technology (EQ-VT-2.1) and a country specific questionnaire pertaining to participants' demographics and opinions about health, life and death SETTING: Participants were recruited from workplaces, university campuses, sporting clubs, shopping malls and other public areas from different Egyptian governorates representing all geographical areas of the country. PARTICIPANTS: A total of 1378 participants were interviewed from July 2019 to March 2020 by 12 interviewers to select a representative sample in terms of: geographical distribution, age and gender, of which 75 participants did not complete the interview, 298 interviews were pilot and 1005 interviews were real of which 974 interviews were used for the valuation study. Two participants did not complete the country-specific questionnaire but completed the valuation protocol; therefore, 1301 interviews were included in the final analysis of country specific questions. RESULTS: Some modifications were applied to the protocol. The 'wheelchair example' was modified to 'migraine example' since most of the participants in the pilot interviews considered being in a wheelchair 'worse than dead'. There was some ambiguity in the Egyptian translated version for the EQ-5D-5L between levels 4 and 5 of the pain and depression dimensions. This was overcome by using colour coding to express the different levels of severity. A pictorial representation for the EQ-5D-5L health states was used to interview illiterate and less educated participants. CONCLUSION: In the Egyptian valuation study, the modifications made to the EQ-VT protocol made it feasible and culturally acceptable to the Egyptian participants.


Asunto(s)
Estado de Salud , Calidad de Vida , Estudios Transversales , Egipto , Humanos , Encuestas y Cuestionarios , Tecnología
19.
Inform Health Soc Care ; 46(3): 244-255, 2021 Sep 02.
Artículo en Inglés | MEDLINE | ID: mdl-33622157

RESUMEN

To survey the health-seeking behaviors and perspectives of the Egyptian population toward the COVID-19 pandemic. A descriptive survey was designed and disseminated via social media platforms. The survey consisted of 32 questions addressing respondent's demographics, knowledge, practice, and attitude toward the COVID-19 pandemic. A total of 25,994 Egyptians participated in the survey from the 29 Egyptian governorates. More than 99% of the respondents were aware of the COVID-19 pandemic. Responses showed split opinions regarding whether people should wear gloves or masks to prevent COVID-19 infection (47.7% and 49.5% replied with "False", respectively). Almost one-quarter (23.1%) of the respondents went to crowded places during the last 14 days. Calling the emergency hotline and self-isolation at home were the most frequent practices to deal with COVID-19 symptoms (34.1% and 44.5%, respectively). A total of 85% of respondents reported their confidence in the Egyptian healthcare system to win the battle against COVID-19 despite the challenges. A vast majority of this large population sample reported reasonable knowledge levels and potentially appropriate practices toward COVID-19.


Asunto(s)
Ansiedad/epidemiología , COVID-19/epidemiología , Alfabetización en Salud/estadística & datos numéricos , Conducta en la Búsqueda de Información , Ansiedad/psicología , COVID-19/psicología , Estudios Transversales , Egipto , Conductas Relacionadas con la Salud , Humanos
20.
Pharmacoeconomics ; 39(5): 549-561, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33709283

RESUMEN

INTRODUCTION: No value sets exist for either the EQ-5D-3L or the EQ-5D-5L in Egypt, despite local pharmacoeconomic guidelines recommending the use of the EQ-5D to derive utility. Most published Egyptian economic evaluation studies have used utility values from other published studies and systematic reviews. OBJECTIVE: Our objective was to develop an Egyptian EQ-5D-5L value set using the international EuroQol standardized protocol (EQ-VT-2.1). METHODS: Adult Egyptian participants were recruited from public places using multi-stratified quota sampling based on age, sex, and geographical distribution. Two elicitation techniques were applied: the composite time trade-off (cTTO) and discrete-choice experiments (DCEs). Before actual data collection, interviewers' performance was assessed in a pilot phase. Data were modelled using generalized least square, Tobit, heteroskedastic, logit, and hybrid models, and the best fitting model was selected based on the value range between observed and predicted values, logical consistency of the parameters, significance level, and prediction accuracy. RESULTS: A total of 1378 interviews were conducted, of which 188 were excluded because they were incomplete or did not comply with protocol, 216 were pilot interviews, and 974 were included in the final analysis. The heteroskedastic model (model 4) based on the cTTO data was selected as the preferred model to generate the value set. Values ranged from - 0.93 for the worst health state (55555) to 1 for full health (11111), with 1136 (36.3%) of all predicted health states being worse than dead. Mobility had the largest impact on health state preference values. CONCLUSION: This is the first value set for the EQ-5D-5L based on social preferences obtained from a nationally representative sample in Egypt or any Arabic-speaking country. The value set can be used as a scoring system for economic evaluations and to improve the quality of health technology assessment in the Egyptian healthcare system.

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