El-Tantawy, W. H., H. F. Salem, and N. A. S. Mohammed Safwat, "Effect of Fascioliasis on the pharmacokinetic parameters of triclabendazole in human subjects", Pharmacy World and Science, vol. 29, issue 3, pp. 190 - 198, 2007. AbstractWebsite

Objectives: To study the clinical efficacy of Triclabendazole (TCBZ) on Egyptian patients infected with Fasciola and understand the effect of Fascioliasis on the pharmacokinetics of TCBZ. Methods: The pharmacokinetics of TCBZ administered as a single oral dose (10 mg/kg) was investigated in both infected and parasite - free Egyptian subjects. After oral administration, TCBZ is metabolized to a sulphone and sulfoxide derivatives. The latter is responsible for the fasciolicidal activity of TCBZ, and it could be used as a marker of drug bioavailability. Blood samples were collected following the oral administration, and TCBZ sulfoxide plasma concentrations were determined by a sensitive and specific HPLC method. Results: Pharmacokinetic parameters (C max, AUC0-48, t 1/2 and t max) for TCBZ sulfoxide were calculated. In patients; the mean C max was 9.11 ± 1.3 μg/ml, the mean AUC (0-48) was 91 ± 10.5 μg h ml-1, the mean t 1/2 was 7.4 ± 0.6 h, and the t max was 3.0 ± 0.4 h. In normal subjects, the mean C max was 8.48 ± 0.92 μg/ml, the mean AUC(0-48) was 85 ± 6.55 μg h ml-1, the mean t 1/2 was 6.2 ± 0.357 h, and the t max was 3 ± 0.4 h. No significant difference could be detected in the patients as compared to normal subjects, which would suggest that Fascioliasis does not affect any of the studied parameters. No eggs in faeces could be detected following TCBZ treatment. Also, most of the clinical investigations showed significant decline back to the normal ranges post-treatment which indicates complete curing and high TCBZ efficacy. Conclusion: Fasioliasis as an infective condition widely spread in Egypt has no significant effect on the pharmacokinetic parameters of the orally administered TCBZ and at the same time it is very effective against the parasite which strongly and safely suggests the use of this medication for the treatment of this infection. © 2007 Springer Science+Business Media, LLC.

Farid, S. F., M. M. Abbassia, N. A. Sabrya, and S. A. Elkhaleq, "Evaluation of digoxin dosing in two Egyptian hospitals a pilot study", Australian Journal of Basic and Applied Sciences, vol. 3, issue 3, pp. 1838 - 1841, 2009. AbstractWebsite

Introduction: Digoxin is one of the digitalis cardiac glycosides indicated in heart failure and atrial fibrillation. Due to individual variability in digoxin pharmacokinetics, digoxin doses need to be calculated based on patient's weight, renal function and indication. Furthermore, therapeutic drug monitoring of digoxin is highly recommended. However, it is common practice among cardiologists in Egypt to prescribe one and the same dose and dosing regimen to all patients for both heart failure and atrial fibrillation. Objective: The objective of this study is to predict digoxin plasma concentrations at digoxin steady state to assess the appropriateness of digoxin dosing. Methods: Digoxin plasma concentrations were calculated for 14 patients using prescribed digoxin doses and patient specific data and compared to target digoxin concentrations. Results: Patients had generally digoxin levels within the recommended therapeutic levels not taking into consideration the interrupted dosing schedule followed in Egyptian hospitals which might lead to sub-therapeutic levels. However, patients with reduced renal function had predicted levels higher than the recommended dosing range. Conclusion: Prescribing policy for digoxin in Egypt needs to be re-evaluated. Correct doses can easily be calculated using simple pharmacokinetic equations or computer programs to achieve therapeutic digoxin levels for different indications. The role of therapeutic drug monitoring should also be emphasized to ensure optimum therapeutic outcome and safety. © 2009, INSInet Publication.

El-Attar, M., M. Said, G. El-Assal, N. A. Sabry, E. Omar, and L. Ashour, "Serum trace element levels in COPD patient: The relation between trace element supplementation and period of mechanical ventilation in a randomized controlled trial", Respirology, vol. 14, issue 8, pp. 1180 - 1187, 2009. AbstractWebsite

Background and objective: Many trace elements play important roles in activating or inhibiting enzymatic reactions, by competing with other elements and metalloproteins for binding sites, by affecting the permeability of cell membranes and by other mechanisms. They play important roles in the oxidant/antioxidant balance. As such, trace elements are thought to be involved directly or indirectly in the pathogenesis of several diseases. The aim of the present study is to investigate the effect trace elements (Se, Mn and Zn) intravenously administered on the period the COPD patients spend on mechanical ventilation. Methods: In a randomized double-blinded controlled trial a set of 120 subjects (40 normal volunteers and 80 COPD) were recruited. Serum concentration levels of Se, Mn and Zn were determined for all enrolled subjects with Inductively Coupled Plasma spectroscopy. COPD patients received intravenous supplementation of the above trace elements and the period the patients spent on mechanical ventilation was determined. Results: There was a significant reduction (P = 0.013) in the period the patients with COPD spent on the mechanical ventilation when received intravenous supplementation (9.4 ± 7.3 days) compared with the COPD patients who received placebo (17.8 ± 7.6 days). Conclusions: Trace element (Se, Mn and Zn) status is altered in critically ill patients with COPD. The supplementation achieved a reduction in the period those patients spent on the mechanical ventilation. A larger multi-centre trial is required to confirm this preventive effect and to explore its applicability to other critical care conditions. © 2009 Asian Pacific Society of Respirology.

El-Gendy, N. A., N. A. Sabry, M. El-Attar, E. Omar, and M. Mahmoud, "Transdermal delivery of salbutamol sulphate: Formulation and evaluation", Pharmaceutical Development and Technology, vol. 14, issue 2, pp. 216 - 225, 2009. AbstractWebsite

Salbutamol patches were prepared and evaluated. The effect of different Eudragits and various plasticizers on the properties of the patches were studied. Patches were prepared by casting method employing different plasticizers. These patches were evaluated for weight, thickness uniformity, swelling index, tensile strength, elongation percent and moisture absorption capacity. Release was studied. Tensile strength of the patches using Eudragit RS 100 as well as RS100 L100 and triacetin was the lowest. Formulae containing 10% oleic acid and 5% dimethyl formamide, respectively, showed the highest permeability. These two formulae were studied clinically, the first formula only showed a significant improvement. © 2009 Informa UK Ltd.

Abdel-Bari, A., M. S. Mokhtar, N. A. Sabry, S. A. El-Shafi, and N. S. Bazan, "Once versus individualized multiple daily dosing of aminoglycosides in critically ill patients", Saudi Pharmaceutical Journal, vol. 19, issue 1, pp. 9 - 17, 2011. AbstractWebsite

Background and objective: The purpose of this study was to evaluate the once daily dosing (ODD) program in critically ill Egyptian patients compared to individualized multiple daily dosing (MDD) in terms of clinical and bacteriological efficacy. In addition, the incidence of nephrotoxicity associated with both regimens in this specific group of patients was assessed. Methods: Fifty-two patients with suspected or confirmed bacterial infections admitted to the Critical Care Medicine Department, Kasr El-Aini-Cairo University Hospitals comprised the study population. The amikacin group (30 patients) was sub-divided into 14 patients receiving amikacin ODD (1. g i.v.) and 16 patients receiving amikacin in MDD (500. mg i.v./dose). The gentamicin group (22 patients) was sub-divided into 10 patients receiving the drug ODD (240. mg i.v.) and 12 patients receiving gentamicin MDD (80. mg i.v./dose). Amikacin or gentamicin serum levels were determined by the enzyme multiplied immunoassay technique using Emit 2000. MDD regimen was adjusted based on the individual pharmacokinetic parameters using the Sawchuk-Zaske method. Results: There was no significant difference between the two dosing regimens with regard to clinical and antibacterial efficacy or incidence of nephrotoxicity of both gentamicin and amikacin groups. In the ODD regimen, duration of treatment had no effect on increasing incidence of nephrotoxicity unlike the individualized MDD regimen. No dose adjustments were needed in the once daily dosing regimen since trough concentrations have never been above toxic level. Conclusions: The study showed that the ODD regimen is preferred in critically ill patients to individualized MDD as shown by comparable efficacy, nephrotoxicity and lesser need for therapeutic drug monitoring and frequent dose adjustments required in the individualized MDD regimen. © 2010.

Abdel-Aziz, D. H., N. A. Sabry, M. H. El-Sayed, and O. N. El-Gazayerly, "Efficacy and safety of pegylated interferon in children and adolescents infected with chronic Hepatitis C: A preliminary study", Journal of Pharmacy Practice, vol. 24, issue 2, pp. 203 - 210, 2011. AbstractWebsite

This study researches the efficacy and safety of pegylated interferon alpha-2a (pegIFNα-2a) in Egyptian children and adolescents diagnosed with hepatitis C virus. Thirty patients were enrolled to receive pegIFN once a week with ribavirin twice daily for 12 weeks; viral load and experienced adverse effects were then assessed. Of the 30 patients, 16 (53.33%) were cleared from the virus, showing early virologic response (EVR). Three patients (10%) showed a 2-log reduction by week 12, with an overall early response rate of 63.33%. Three patients who showed EVR after 4 weeks relapsed by week 12. Levels of serum alanine aminotransferase (ALT) normalized at week 12. Adverse events included fever, myalgia, headache, flu-like symptoms, fatigue, anemia, and leucopenia; 63.33% of the patients showed significant reduction in their body weight. Although the patients showed a reduction in average body mass index, this reduction was not significant. Hemoglobin values decreased within the first 2 weeks and then stabilized but not back to baseline. A significant reduction in the level of absolute neutrophil count (ANC) was observed by the 4th week and started to improve by the 12th week. Of the recruited patients, 29.4% were subjected to IFN dose reduction. None of the patients with neutropenia developed serious infection or sepsis. The authors concluded that pegIFN plus ribavirin therapy is promising when tested on Egyptian children. © The Author(s) 2011.

Sabry, N. A., and E. E. Habib, "Zoledronic acid and clodronate in the treatment of malignant bone metastases with hypercalcaemia; Efficacy and safety comparative study", Medical Oncology, vol. 28, issue 2, pp. 584 - 590, 2011. AbstractWebsite

The aim of this study is to conduct a comparison study between the efficacy and safety of zoledronic acid and clodronate in malignant hypercalcemia secondary to bone metastases in Egyptian adult patients. This is a prospective observational study conducted 80 patients (40 in each group), who were assigned to receive either zoledronic acid (4 mg over a 30 min infusion) every 3-4 weeks or clodronate (a single dose of 1,500 mg over a 4 h infusion) monthly for 3 months. The primary efficacy analysis was the proportion of patients with at least one skeletal-related event. The safety was assessed based on the frequencies of the reported adverse effects as nausea, vomiting, anemia, etc. The calcium level significantly decreased in both groups. At least one skeletal-related event occurred in 15 (37.5%) patients receiving zoledronic acid and 32 (80%) patients receiving clodronate. Radiotherapy and fractures represented the highest event observed in both groups. At least one adverse event was experienced by 20 (50%) patients treated with zoledronic acid, while 26 (65%) patients on clodronate recorded one or more adverse event. Pyrexia was the most commonly reported side effect and flare phenomena. Both treatment groups were comparable regarding the reported adverse events. Both medications did not show any significant nephrotoxicity detected by elevation in the creatinine level. Zoledronic acid and clodronate have demonstrated clinical utility in the treatment of hypercalcaemia in cancer patients. Zoledronic acid provides a more effective and convenient treatment than clodronate, while both maintaining a similar safety profile. © 2010 Springer Science+Business Media, LLC.

Sweed, N., N. Sabry, T. Azab, and S. Nour, "Regional versus IV analgesics in labor", Minerva Medica, vol. 102, issue 5, pp. 353 - 361, 2011. AbstractWebsite

Aim. The aim of this study was to compare combined spinal epidural (CSE), epidural (E) and IV pethidine analgesia and their effects on the mother, fetus, newborn and the labor course. Methods. This is a prospective parallel single blind study, where 60 women in active labor were recruited and were allocated to five subgroups to receive analgesia by different routes. The mother and the fetus were assessed. The results were recorded and compared using Visual Analogue Scale (VAS) and modified Bromage scale for motor block, in addition to other clinical findings. Results. The duration of first stage of labor was significantly longer in the E group, compared with the CSE and IV pethidine groups. When the pain control achieved by CSE bupivacaine and lidocaine was compared with the corresponding epidural, it was found that the first technique achieved better pain control. Women who received pethidine had higher incidence of nausea and vomiting compared to those received CSE or E analgesia. There was no significant difference between the five groups with respect to other side effects. Conclusion. Regional analgesia especially CSE using bupivacaine or lidocaine is a safe effective method for analgesia in labor with relative better efficacy of bupivacaine.

Mohammed Saif, M., S. F. Farid, S. A. Khaleel, N. A. Sabry, and M. H. El-Sayed, "Hepatoprotective efficacy of ursodeoxycholic acid in pediatrics acute lymphoblastic leukemia", Pediatric Hematology and Oncology, vol. 29, issue 7, pp. 627 - 632, 2012. AbstractWebsite

Ursodeoxycholic acid (UDCA) possesses a hepatoprotective effect in drug-induced hepatotoxicity. In a prospective randomized parallel study, 39 children with acute lymphoblastic leukemia (ALL) were randomized to receive UDCA with chemotherapy for 6 months, then discontinued UDCA and were followed up for 3 months, (UDCA group) (N = 19) or receive chemotherapy without UDCA and followed up for 9 months (control group) (N = 20). In this pilot study, UDCA treatment was associated with a trend toward decreased levels of hepatic transaminases when concomitantly administered with chemotherapy and, therefore, safer outcome in children with ALL. Future studies with a larger sample size are needed to confirm the efficacy and safety of UDCA in this setting. © 2012 Informa Healthcare USA, Inc.

Bazan, N. S., N. A. Sabry, A. Rizk, S. Mokhtar, and O. Badary, "Validation of pharmacogenetic algorithms and warfarin dosing table in Egyptian patients", International Journal of Clinical Pharmacy, vol. 34, issue 6, pp. 837 - 844, 2012. AbstractWebsite

Background Warfarin remains a difficult drug to use due to the large variability in dose response. Clear understanding of the accuracy of warfarin pharmacogenetic dosing methods might lead to appropriate control of anticoagulation. Objective This study aims to evaluate the accuracy of warfarin dosing table and two pharmacogenetic algorithms, namely the algorithms of Gage et al. (Clin Pharmacol Ther 84:326-331, 2008), and the International Warfarin Pharmacogenetics Consortium algorithm (IWPC) in a real Egyptian clinical setting. Additionally, three nonpharmacogenetic dosing methods (the Gage, IWPC clinical algorithms and the empiric 5 mg/day dosing) were evaluated. Setting Sixty-three Egyptian patients on a stable therapeutic warfarin dose were included. Patients were recruited from the outpatient clinic of the critical care medicine department. Methods CYP2C9 and VKORC1 polymorphisms were genotyped by real time PCR system. Predicted doses by all dosing methods were calculated and compared with the actual therapeutic warfarin doses. Results The Gage algorithm (adjusted R2 = 0.421, and mean absolute error (MAE) = 3.3), and IWPC algorithm (adjusted R2 = 0.419, MAE = 3.2) produced better accuracy than did the warfarin dosing table (adjusted R2 = 0.246, MAE = 3.5), the two clinical algorithms (R2 = 0.24, MAE = 3.7) and the fixed dose approach (MAE = 3.9). However, all dosing models produced comparable clinical accuracy with respect to proportion of patients within 1 mg/day of actual dose (ideal dose). Nonpharmacogenetic methods severely over-predicted dose (defined as ≥2 mg/day more than actual dose) compared to the three pharmacogenetic models. In comparison to nonpharmacogenetic methods, the three pharmacogenetic models performed better regarding the low dose group in terms of percentage of patients within ideal dose. In the high dose group, none of the dosing models predicted warfarin doses within ideal dose. Conclusion Our study showed that genotype-based dosing improved prediction of warfarin therapeutic dose beyond that available with the fixed-dose approach or the clinical algorithms, especially in the low-dose group. However, the two pharmacogenetic algorithms were the most accurate. © Springer Science+Business Media B.V. 2012.