Manal El-Hamamsy

ω-3 fatty acids as an adjuvant therapy ameliorates methotrexate-induced hepatotoxicity in children and adolescents with acute lymphoblastic leukemia: A randomized placebo-controlled study

OBJECTIVES Methotrexate (MTX)-induced hepatotoxicity is a significant clinical problem that may affect overall prognosis and disease outcome. Oxidative stress is a key player in its pathogenesis. The aim of this study was to investigate the role of ω-3 fatty acids as an adjuvant therapy in children and adolescents with acute lymphoblastic leukemia (ALL) during the maintenance phase of chemotherapy and the effect of ω-3 on MTX-induced hepatotoxicity. METHODS This randomized, double-blind, placebo-controlled trial included 70 patients with ALL who were in the maintenance phase. The participants were divided into two groups: group A received oral MTX and ω-3 fatty acids (1000 mg/d) and group B (received MTX and placebo). Both groups were followed-up for 6 mo with assessment of liver enzymes, total antioxidant capacity (TAC), uric acid, malondialdhyde, superoxide dismutase (SOD), and glutathione peroxidase. The trial was registered at ClinicalTrials.gov (NCT02373579). RESULTS Baseline clinical and laboratory parameters were consistent between the two groups (P > 0.05). After 6 mo, liver enzymes and malondialdhyde increased, whereas TAC, uric acid, SOD, and glutathione peroxidase decreased in group B (MTX and placebo) compared with baseline levels or with group A ALL patients receiving ω-3 fatty acids (P < 0.001). The addition of ω-3 to MTX maintained normal liver function and oxidant-antioxidant levels among group A patients at the end of treatment compared with pretherapy levels (P > 0.05). No adverse reactions due to ω-3 supplementation were reported. ALT was inversely correlated to TAC and SOD in the MTX group. CONCLUSIONS The study determined that ω-3 fatty acids ameliorated MTX-induced hepatotoxicity and could be safely used during the maintenance phase of ALL.

Identification of Suitable Endogenous Normalizers for qRT-PCR Analysis of Plasma microRNA Expression in Essential Hypertension

Circulating microRNAs (miRNAs) are promising biomarkers for many diseases. Quantitative reverse transcription polymerase chain reaction (qRT-PCR) is a gold standard for miRNA expression profiling that requires proper data normalization. Since there is no universal normalizer, it is recommended to evaluate normalizers under every experimental condition. This study describes the identification of suitable endogenous normalizer(s) (ENs) for plasma miRNA expression in essential hypertension. Expression levels of 5 candidate ENs and 2 plasma quality markers were determined by qRT-PCR in plasma samples from 18 hypertensive patients and 10 healthy controls. NormFinder, GeNorm, and DataAssist software programs were used to select the best EN(s). Expression levels of the 5 candidate ENs were also analyzed in urine samples from hypertensive patients and compared to the plasma samples of the hypertensive patients. Among the analyzed candidates, hsa-miR-92a-3p was identified as the best EN, and hsa-miR-21-5p and hsa-miR-16-5p as the next best. Moreover, hsa-miR-92a-3p showed the most consistent expression between plasma and urine. In conclusion, this study showed that hsa-miR-92a-3p, hsa-miR-21-5p, and hsa-miR-16-5p may be used as normalizers for plasma miRNA expression data in essential hypertension studies.

The effect of 12 weeks carnosine supplementation on renal functional integrity and oxidative stress in pediatric patients with diabetic nephropathy: a randomized placebo-controlled trial

Oxidative stress is a significant contributor to the pathogenesis of diabetic nephropathy. Carnosine is a natural radical oxygen species scavenger. We investigated the effect of carnosine as an adjuvant therapy on urinary albumin excretion (UAE), the tubular damage marker alpha 1‐microglobulin (A1M), and oxidative stress in pediatric patients with type 1 diabetes and nephropathy.

Clinical Pharmacist-Provided Services In Iron Overloaded Beta-Thalassemia Major Children; A New Insight To Patient Care.

Iron‐overloaded β‐thalassaemia major (BTM) children have high risk of delayed sexual/physical maturation, liver/heart diseases and reduced life expectancy. The lifelong need to use iron chelators, their unpleasant administration, side effects and lack of awareness regarding iron overload risks all hamper BTM patient compliance to iron chelators. This study evaluated the impact of clinical pharmacist‐provided services on the outcome of iron‐overloaded BTM children. Forty‐eight BTM children were randomly assigned to either control group, who received standard medical care, or intervention group, who received standard medical care plus clinical pharmacist‐provided services. Services included detection of drug‐related problems (DRPs) and their management, patient education regarding disease nature and iron chelators, as well as providing patient‐tailored medication charts. After six months of study implementation, there was a highly significant difference between the control and intervention groups in serum ferritin (SF) (mean: 3871 versus 2362, μg/l, p = 0.0042), patient healthcare satisfaction (median: 24.47 versus 90.29, p < 0.0001) and quality of life (QoL) (median: 49.84 versus 63.51, p = 0.0049). The intervention group showed a decline from baseline to the end of study in DRPs (64–4), the number of non‐compliant patients (24–3) and mean SF levels (3949–2362 μg/l, p < 0.0001). Clinical pharmacist‐provided services can positively impact the outcome of BTM children.

Cost-Effectiveness of the Combined Use of Warfarin and Low-Dose Aspirin versus Warfarin Alone in Egyptian Patients with Aortic Valve Replacements: A Markov Model

BACKGROUND The combination of antiplatelet and anticoagulant therapy significantly reduces the rate of thromboembolic events in patients with heart valves compared with anticoagulant therapy alone. Cost-effectiveness of this therapy in Egypt, however, has not yet been established. OBJECTIVE The aim of the present study was to evaluate the cost-effectiveness of the combined use of warfarin and low-dose aspirin (100 mg) versus warfarin alone in patients with mechanical aortic heart valve prostheses who began therapy at the age of 50 to 60 years over a 5-year period from the perspective of the medical providers. METHODS A cohort Markov process model with five health states (recovery, reoperation, bleeding, thromboembolism, and death) based on Egyptian clinical practice was derived from published sources. The clinical parameters were derived from meta-analyses of randomized controlled trials of patients with mechanical valve prostheses. The quality of life of the health states was derived using the available published data. Direct medical costs were obtained from four top-rated governmental cardiology hospitals in Egypt. All costs and effects were discounted at 3.5% annually. All costs were converted using the purchasing power parity rate and are reported in US

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases

for the financial year of 2013. RESULTS The total quality-adjusted life-years (QALYs) were estimated to be 1.1616 and 1.1199 for the warfarin plus aspirin group and the warfarin group, respectively, which resulted in a difference of 0.0416 QALYs. The total costs for the warfarin plus aspirin group and the warfarin group were US

FAS and FASL genetic polymorphisms impact on clinical outcome of malignant pleural mesothelioma

307.33 and US

L-Carnitine Supplementation Improves the Behavioral Symptoms in Autistic Children.

315.25, respectively (the difference was US

An open-label randomized controlled phase II study of clarithromycin (CL) plus CVP in patients (pts) with previously untreated stage III/IV indolent non Hodgkin lymphoma (NHL).

7.92), which yielded an incremental cost-effectiveness ratio of -190.38 for the warfarin plus aspirin group. Thus, the combined therapy was dominant. Various one-way sensitivity analyses indicated that probabilities of reoperation and bleeding in the recovery state had the greatest effects on incremental costs. The model parameters that had the greatest effects on incremental QALYs were the relative risk reduction of death and the utility value in the recovery state. CONCLUSIONS The present study is the first cost-utility analysis to conclude that, from the perspective of Egyptian medical providers, combined therapy is more effective and less costly than warfarin alone for patients with mechanical aortic valve prostheses. For clinicians and patients who choose to focus on minimizing thromboembolic risk, these results suggest that combined therapy offers the best protection. This study helps to inform decisions about the allocation of health care system resources and to achieve better health in the Egyptian population.

The Effect of Coadminstration of Nicotinamide and Calcium-based Phosphate Binder on Hyperphophatemia in Patients Undergoing Hemodialysis

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.