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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.
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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 CuestionariosRESUMEN
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.
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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 TratamientoRESUMEN
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.
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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 , InsulinaRESUMEN
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).
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Minoxidil , Femenino , Humanos , Masculino , Cetirizina/farmacología , Cetirizina/uso terapéutico , Administración Tópica , Alopecia/tratamiento farmacológico , CabelloRESUMEN
BACKGROUND: Hepatitis C virus (HCV) infected adolescents with beta-thalassemia major (BTM) are considered a potential population for HCV micro-elimination model development where BTM may negatively impact the pharmacokinetic exposure parameters of sofosbuvir/ledipasvir (SOF/LED). OBJECTIVES: The study aimed at studying the effect of BTM on SOF/LED and SOF metabolite (GS-331007) pharmacokinetics. METHODS: A prospective, controlled study recruiting BTM and control HCV infected adolescents (Clinicaltrials.gov identifier-NCT04353986). Pharmacokinetic exposure to GS-331007 and LED was the primary pharmacokinetic outcome. No-effect boundaries were set to 90% confidence interval (CI) of exposure geometric mean ratio (GMR) within 70-143%. Dose suitability was based on the 90% CI of exposure GMR within 50-200% compared to adults. The percentage of patients achieving sustained virologic response 12 weeks post-treatment (SVR12) was the primary efficacy endpoint. RESULTS: Thirteen patients were enrolled per study group. All patients were included in the pharmacokinetic analysis (n=26). BTM patients showed lower GS-331007 and LED exposure that could, respectively, be as low as 45.4% and 36.1% compared to their control group. GS-331007 exposure in BTM patients was nearly half (56.8%, 90% CI 45.3-71.2%) that observed in adults. Despite that low drug exposure in 46.2% of BTM patients may alert dose unsuitability, they achieved SVR12. Moreover, patients with total bilirubin ≥1.93 mg/dL were predicted to have low GS-331007 exposure (0.913 receiver operating characteristic area under the curve with sensitivity and specificity >80%). CONCLUSION AND RELEVANCE: The identified systematically lower drug exposure in BTM patients might partially explain relapses or treatment failures among BTM patients reported in other studies. BTM may be a hurdle towards implementing HCV micro-elimination model that may necessitate dose-adjustment.
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Antivirales/uso terapéutico , Bencimidazoles/uso terapéutico , Fluorenos/uso terapéutico , Hepatitis C Crónica , Hepatitis C , Preparaciones Farmacéuticas , Sofosbuvir/uso terapéutico , Talasemia beta , Adolescente , Adulto , Quimioterapia Combinada , Genotipo , Hepacivirus , Hepatitis C/tratamiento farmacológico , Hepatitis C Crónica/tratamiento farmacológico , Humanos , Estudios Prospectivos , Resultado del Tratamiento , Uridina Monofosfato/uso terapéutico , Talasemia beta/tratamiento farmacológicoRESUMEN
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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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.
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Hepatitis C , Metformina , Talasemia beta , Adolescente , Niño , Hepacivirus , Humanos , Metformina/uso terapéutico , Estudios Prospectivos , Talasemia beta/complicaciones , Talasemia beta/tratamiento farmacológicoRESUMEN
Acne vulgaris is one of the most common chronic inflammatory skin disorder affecting millions of people worldwide. Vitamin D deficiency has a role in various inflammatory skin diseases as acne. This study aimed to investigate the serum level of 25 hydroxy vitamin D in acne patients and to assess the efficacy and safety of active vitamin D in management of acne. This study was conducted on 100 patients with acne and 100 healthy controls, then the 100 acne patients were randomized to either the study group that received 0.25ug alfacalcidol daily or the placebo group that received oral placebo during the 3 months study period. Serum levels of 25-hydroxy-vitamin D were significantly lower in acne patients than in healthy control and were inversely correlated to the severity of acne. After alfacalcidol administration, the study group showed significant higher level of 25(OH) D levels (p < .05) compared to placebo group. In addition, median serum level of IL6 and TNFα significantly decreased (p < .05) in the study group in comparison to placebo group and as compared to their baseline results. Acne patients are more commonly to have vitamin D deficiency as compared to healthy people and hence, alfacalcidol might have a beneficial role in the acne management with no reported side effects.
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Acné Vulgar , Deficiencia de Vitamina D , Vitamina D/uso terapéutico , Acné Vulgar/tratamiento farmacológico , Humanos , Piel , Deficiencia de Vitamina D/complicaciones , Deficiencia de Vitamina D/tratamiento farmacológicoRESUMEN
BACKGROUND: Daclatasvir has potent antiviral activity against HCV infection when used in combination with sofosbuvir, however, its pharmacokinetics have not been described in adolescents. The aim is to determine the pharmacokinetic parameters of daclatasvir in adolescents, and to develop a population pharmacokinetic (PopPK) model. METHODS: Seventeen adolescent patients with genotype-4 chronic HCV infection received once daily oral daclatasvir 60 mg in combination with 400 mg sofosbuvir for 12 weeks. Steady state concentrations were determined. Non-compartmental and population PK were determined. RESULTS: The average PK parameters calculated by non-compartmental analysis (NCA): maximum plasma concentration (Cmax), area under the curve (AUC), apparent oral volume of distribution (V/F), apparent oral clearance (CL/F) and half-life (T1/2) were 1,092 ng/ml, 11,178 ng/mlâ¢h, 55 l, 4.5 l/h and 8.5 h, respectively. Daclatasvir was best described by one compartment structural PK model with zero order absorption and first-order elimination. The absorption rate constant (K0), V/F, and CL/F of the final PopPK model of daclatasvir were 1.5/h, 52 l and 4.7 l/h, respectively. Body weight and serum albumin had significant effect on the V/F parameter. CONCLUSIONS: Body weight and serum albumin were the major determinants of daclatasvir V/F in this population. PK parameters were comparable to those reported in adult HCV patients, demonstrating that 60 mg daclatasvir is an appropriate dose for adolescents. ClinicalTrials.gov NCT03540212.
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Antivirales/farmacocinética , Carbamatos/farmacocinética , Hepacivirus/efectos de los fármacos , Hepatitis C Crónica/tratamiento farmacológico , Imidazoles/farmacocinética , Pirrolidinas/farmacocinética , Valina/análogos & derivados , Adolescente , Antivirales/sangre , Antivirales/uso terapéutico , Peso Corporal , Carbamatos/sangre , Carbamatos/uso terapéutico , Egipto , Femenino , Genotipo , Hepacivirus/genética , Humanos , Imidazoles/sangre , Imidazoles/uso terapéutico , Masculino , Estudios Prospectivos , Pirrolidinas/sangre , Pirrolidinas/uso terapéutico , Albúmina Sérica/análisis , Valina/sangre , Valina/farmacocinética , Valina/uso terapéuticoRESUMEN
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.
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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/patologíaRESUMEN
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.
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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 TratamientoRESUMEN
AIM: Compare the safety and efficacy of intermittent fenofibrate versus simvastatin in chronic hemodialysis patients. PATIENTS & METHODS: Sixty patients received either fenofibrate 100 mg or simvastatin 20 mg after their dialysis session (parallel study). The safety and efficacy of drugs on lipid profile, oxidized low-density lipoprotein (Ox-LDL), glutathione peroxidase and C-reactive protein were compared before and after 16-week treatment. RESULTS: After treatment, significant increase in glutathione peroxidase, significant decrease in total cholesterol, triglycerides, low density lipoprotein (LDL) and ox-LDL (p < 0.05) and no significant changes in C-reactive protein (p > 0.05) were observed in both groups. Both drugs were well tolerated with no serious side effects reported by the patients. CONCLUSION: Both drugs have comparable efficacy and safety when used as intermittent low dose regimen in hemodialysis. Larger studies with longer follow-up periods are needed to confirm our new findings.
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Anticolesterolemiantes/administración & dosificación , Fenofibrato/administración & dosificación , Diálisis Renal/métodos , Simvastatina/administración & dosificación , Anticolesterolemiantes/efectos adversos , Presión Sanguínea/efectos de los fármacos , Esquema de Medicación , Femenino , Fenofibrato/efectos adversos , Glutatión Peroxidasa/metabolismo , Humanos , Lipoproteínas LDL/metabolismo , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Simvastatina/efectos adversos , Resultado del Tratamiento , Triglicéridos/metabolismoRESUMEN
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.
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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 JovenRESUMEN
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.
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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/sangreRESUMEN
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.
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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 ProspectivosRESUMEN
BACKGROUND AND AIMS: Zinc has been found to be low in chronic hepatitis patients. Its level was correlated with response to Interferon/ribavirin therapy in patients infected with hepatitis C genotype 1. In Egypt, inexpensive predictors to treatment response in Hepatitis C genotype 4 infected patients are desperately needed. We aim to explore if pretreatment zinc serum levels correlate with response to pegylated- interferon and ribavirin therapy in Egyptian patients. METHODS: This is an observational prospective study where 57 treatment naive hepatitis C genotype 4 infected patients that were Hepatitis B and Human Immunodeficiency virus negative were recruited in a hospital setting. The study was performed from October 2010 till June 2012. Patients had Liver biopsy and basic biochemical profiles were performed pretreatment for all patients. Treatment consisted of 48 weeks of pegylated-interferon-alpha2a and ribavirin therapy. Blood samples were withdrawn from 21 healthy subjects to compare zinc levels and other biochemical markers. Patients were followed up to 72 weeks. RESULTS: Pretreatment serum zinc levels were significantly lower in hepatitis C infected patients compared to healthy volunteers (p < 0.05). Moreover, zinc levels correlated to sustained virological response in treated patients (p = 0.00). CONCLUSION: Serum zinc levels can be used as an inexpensive predictor to effective Pegylated-interferon/ribavirin therapy in Egyptian patients infected with Hepatitic C genotype 4.
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Monitoreo de Drogas/métodos , Hepacivirus/efectos de los fármacos , Hepatitis C Crónica/tratamiento farmacológico , Interferón-alfa/administración & dosificación , Polietilenglicoles/administración & dosificación , Ribavirina/administración & dosificación , Zinc/sangre , Adulto , Antivirales/administración & dosificación , Quimioterapia Combinada , Egipto , Femenino , Genotipo , Hepacivirus/genética , Hepatitis C Crónica/sangre , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Proteínas Recombinantes/administración & dosificación , Adulto JovenRESUMEN
BACKGROUND: Vancomycin remains the gold standard for treatment of methicillin-resistant Staphylococcus aureus. Specially designed continuous infusion of vancomycin leads to better therapy. METHODOLOGY: A total of 40 critically ill patients who suffered from pneumonia susceptible to vancomycin, had serum creatinine >1.4 mg%, and oliguria <0.5 mL/kg/h for 6 h were included in the study with respiratory culture sensitivity to vancomycin ≤2 mg/L. Patients' clinical, microbiological, and biological data were obtained by retrospective analysis of the corresponding medical files before and after vancomycin treatment. Patients with serum creatinine level ≥4 mg% and patients who received renal replacement therapy during the treatment period were excluded. The patients were divided into two groups-group 1 (intermittent dosing) and group 2 (continuous infusion) based on the following formula: rate of vancomycin continuous infusion (g/day) = [0.0205 creatinine clearance (mL/min) + 3.47] × [target vancomycin concentration at steady state (µg/mL)] × (24/1000). Trough vancomycin serum levels were also assessed using high-performance liquid chromatographic technique. Patients' outcomes such as clinical improvement, adverse events, and 15-day mortality were reported. RESULTS: Group 2 showed significant reduction in blood urea nitrogen, creatinine serum levels, white blood cells, partial carbon dioxide pressure, body temperature, and Sequential Organ Failure Assessment score, while significant increase in partial oxygen pressure and saturated oxygen was also observed. A significantly shorter duration of treatment with a comparable vancomycin serum levels was also reported with group 2. CONCLUSION: After treatment, comparison in patients' criteria supports the superiority of using continuous infusion of vancomycin according to this equation in renally impaired patients.