Publications by authors named "Nirmeen A Sabry"

22 Publications

  • Page 1 of 1

Beta-Thalassemia Major alters Sofosbuvir/Ledipasvir exposure in Hepatitis-C virus Infected Adolescent Patients.

Clin Res Hepatol Gastroenterol 2021 Jun 26:101747. Epub 2021 Jun 26.

Department of Paediatrics and Paediatric Haematology/Oncology unit, Faculty of Medicine, Ain Shams University, Cairo, Egypt; Faculty of Medicine Ain-Shams University Research Institute-Clinical research Centre (MASRI-CRC).

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 operator 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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http://dx.doi.org/10.1016/j.clinre.2021.101747DOI Listing
June 2021

A prospective, randomised clinical study comparing triple therapy regimen to hydrocortisone monotherapy in reducing mortality in septic shock patients.

Int J Clin Pract 2021 May 18:e14376. Epub 2021 May 18.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Objectives: This prospective, comparative and randomised clinical study evaluated the effectiveness of triple therapy regimen (hydrocortisone, thiamine and vitamin C) versus hydrocortisone alone in reducing the mortality rate and preventing progressive organ dysfunction in septic shock patients.

Methods: A total of 94 patients were randomly assigned to one of two groups: the first group received hydrocortisone 50 mg/6-h IV for 7 days or till intensive care unit (ICU) discharge, if sooner, followed by tapering. The second group received hydrocortisone 50 mg/6-h IV for 7 days or ICU discharge followed by tapering, vitamin C 1.5 g/6-h IV for 4 days or till ICU discharge and thiamine 200 mg/12-h IV for 4 days or till ICU discharge.

Results: The triple therapy regimen showed a non-significant reduction in 28-day mortality compared to hydrocortisone alone (17 [36.2%] vs. 21 [44.7%]; P = .4005), but it was significantly lower than the control group regarding shock time and the duration of vasopressor use in days (4.000 [3.000-7.000]; 5.000 [4.000-8.000], [P = .0100]). The patients in the control group were likely to get 0.59 more in SCr level than those in the intervention group by a linear regression model which was significant (P < .05). Also, the number of patients who developed a fever after 216 hours was significantly higher in the control group (P value = .0299).

Conclusion: Vitamin C, thiamine, and hydrocortisone regimen for septic shock management showed non-significant efficacy in decreasing 28-day mortality when compared to hydrocortisone monotherapy. On the other hand, it showed significant efficacy in decreasing the shock time and duration on vasopressors.
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http://dx.doi.org/10.1111/ijcp.14376DOI Listing
May 2021

Antimicrobial stewardship solutions with a smart innovative tool.

J Am Pharm Assoc (2003) 2021 Apr 24. Epub 2021 Apr 24.

Background: Antimicrobial consumption has been increasing lately. Hence, effective strategies are required to control antimicrobial use and decrease the development of antimicrobial resistance.

Objective: To evaluate the impact of the use of a mobile app on the implementation of antimicrobial stewardship program (ASP) interventions.

Methods: This was a longitudinal study conducted at El-Nile Badrawi Hospital in Cairo, Egypt, on inpatients receiving antimicrobials from January 2018 to December 2019. The study included 2 phases: the preimplementation phase, which included a paper-based ASP developed according to the Centers for Disease Control and Prevention Core Elements of Hospital Antibiotic Stewardship Programs 2014, and the mobile app phase where the MEDIcare Pro mobile app was developed and used in ASP intervention implementation. The study outcomes were antimicrobial consumption and cost, length of hospital and intensive care unit (ICU) stay, 30-day mortality rate and readmission rate, and detection of drug-related problems (DRPs).

Results: The mobile app statistically significantly decreased antimicrobial consumption from 75.1 defined daily dose (DDD)/100 bed-days in the preimplementation phase to 64.65 DDD/100 bed-days in the mobile app phase, with a total cost savings of E£1,237,476. There was a significant reduction in the length of ICU stay, with a mean difference of 1.63 days between the 2 phases, but no significance was detected regarding length of hospital stay or readmission rate. There was a statistically significant decrease in mortality rate from 1.17% in the preimplementation phase to 0.83% in the mobile app phase (P = 0.02). The frequency of DRPs detected by pharmacists statistically significantly increased from 0.54/100 bed-days in the preimplementation phase to 3.23/100 bed-days in the mobile app phase.

Conclusion: The use of a mobile app was found to be effective, applicable, and usable in guiding health professionals on rational antimicrobial use.
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http://dx.doi.org/10.1016/j.japh.2021.04.013DOI Listing
April 2021

Combined effect of high-dose vitamin A, vitamin E supplementation, and zinc on adult patients with diabetes: A randomized trial.

J Adv Res 2021 Feb 21;28:27-33. Epub 2020 Jun 21.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt.

In type 2 diabetes mellitus (T2DM), hyperglycemia leads to oxidative insult. Vitamins A and E have antioxidant potentials and may help in managing diabetes. The combined effect of high-dose vitamin A plus E supplementation with and without zinc on T2DM, has never been examined. Thus, this study aimed to evaluate and compare the effect of high-dose vitamin A plus E supplementation (AE) versus high-dose vitamin A plus E with zinc (AEZ), on different diabetic parameters. Ninety-eight patients with T2DM were randomized to receive either: 50,000 IU vitamin A and 100 mg vitamin E (AE group, N = 36), an equivalent dose of vitamin A and E combined with 25 mg zinc (AEZ group, N = 35), or no supplements (control group, N = 27) for three months. Compared to control, AEZ group showed significant reductions in fasting blood glucose, 2 h postprandial blood glucose, and glycated hemoglobin (HbA1c) with significant increases in homeostasis model assessment of beta-cell function and difference value of fasting insulin. Two hair loss cases were recorded in both treated groups. Although vitamin A needs dose moderation, these results suggest that, high-dose vitamin A plus E supplementation combined with zinc may improve glycemic control, β-cell function, and insulin secretion in adults with T2DM.
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http://dx.doi.org/10.1016/j.jare.2020.06.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753230PMC
February 2021

Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial.

Clin Ther 2021 01 16;43(1):e1-e18. Epub 2020 Dec 16.

Department of Anesthesiology and Critical Care, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Purpose: Vitamin D deficiency is highly prevalent in critically ill patients, and has been associated with more prolonged length of hospital stay and poor prognosis. Patients undergoing open-heart surgery are at higher risk due to the associated life-threatening postoperative complications. This study investigated the effect of alfacalcidol treatment on the length of hospital stay in patients undergoing valve-replacement surgery.

Methods: This single-center, randomized, open-label, controlled trial was conducted at El-Demerdash Cardiac Academy Hospital (Cairo, Egypt), from April 2017 to January 2018. This study included adult patients undergoing valve-replacement surgery who were randomized to the intervention group (n = 47; alfacalcidol 2 μg/d started 48 h before surgery and continued throughout the hospital stay) or to the control group (n = 42). The primary end points were lengths of stay (LOS) in the intensive care unit (ICU) and in the hospital. Secondary end points were the prevalence of postoperative hospital-acquired infections, cardiac complications, and in-hospital mortality.

Findings: A total of 86 patients were included in the final analysis, with 51 (59.3%) being vitamin D deficient on hospital admission. Treatment with alfacalcidol was associated with a statistically significant decrease in ICU LOS (hazard ratio = 1.61; 95% CI, 1.77-2.81; P = 0.041) and hospital LOS (hazard ratio = 1.63; 95% CI, 1.04-2.55; P = 0.034). Treated patients had a significantly lower postoperative infection rate than did the control group (35.5% vs 56.1%; P = 0.017). The median epinephrine dose was lower in the intervention group compared to that in the control group (5.9 vs 8.2 mg; P = 0.019). The rate of in-hospital mortality was not significantly different between the 2 groups.

Implications: Early treatment with 2 μg of alfacalcidol in patients undergoing valve-replacement surgery is promising and well tolerated. This effect may be attributed to its immunomodulatory and cardioprotective mechanisms. ClinicalTrials.gov identifier: NCT04085770.
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http://dx.doi.org/10.1016/j.clinthera.2020.11.008DOI Listing
January 2021

The Effect of Telephone-Based Follow-Up on Adherence, Efficacy, and Toxicity of Oral Capecitabine-Based Chemotherapy.

Telemed J E Health 2019 06 26;25(6):462-470. Epub 2018 Jul 26.

1 Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

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http://dx.doi.org/10.1089/tmj.2018.0077DOI Listing
June 2019

Nebulized Versus IV Amikacin as Adjunctive Antibiotic for Hospital and Ventilator-Acquired Pneumonia Postcardiac Surgeries: A Randomized Controlled Trial.

Crit Care Med 2018 01;46(1):45-52

Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

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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http://dx.doi.org/10.1097/CCM.0000000000002695DOI Listing
January 2018

Effect of alfacalcidol on the pulmonary function of adult asthmatic patients: A randomized trial.

Ann Allergy Asthma Immunol 2017 05 1;118(5):557-563. Epub 2017 Apr 1.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

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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http://dx.doi.org/10.1016/j.anai.2017.02.014DOI Listing
May 2017

The effect of α-antitrypsin deficiency combined with increased bacterial loads on chronic obstructive pulmonary disease pharmacotherapy: A prospective, parallel, controlled pilot study.

J Adv Res 2016 Nov 11;7(6):1019-1028. Epub 2016 May 11.

Department of Microbiology and Immunology, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt.

Chronic obstructive pulmonary disease (COPD) is caused by α1-antitrypsin deficiency (AATD) genetic susceptibility and exacerbated by infection. The current pilot study aimed at studying the combined effect of AATD and bacterial loads on the efficacy of COPD conventional pharmacotherapy. Fifty-nine subjects (29 controls and 30 COPD patients) were tested for genetic AATD and respiratory function. The bacterial loads were determined to the patients' group who were then given a long acting beta-agonist and corticosteroid inhaler for 6 months. Nineteen percent of the studied group were Pi∗MZ (heterozygote deficiency variant), Pi∗S (5%) (milder deficiency variant), Pi∗ZZ (10%) (the most common deficiency variant), and Pi∗Mmalton (2%) (very rare deficiency variant). The patients' sputum contained from 0 to 8 × 10 CFU/mL pathogenic bacteria. The forced vital capacity (FVC) values of the AAT non-deficient group significantly improved after 3 and 6 months. Patients lacking AATD and pathogenic bacteria showed significant improvement in forced expiratory volume (FEV), FEV/FVC, FVC, and 6 min walk distance (6MWD) after 6 months. However, patients with AATD and pathogenic bacteria showed only significant improvement in FEV and FEV/FVC. The findings of this pilot study highlight for the first time the role of the combined AATD and pathogenic bacterial loads on the efficacy of COPD treatment.
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http://dx.doi.org/10.1016/j.jare.2016.05.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5106446PMC
November 2016

Development and validation of LC-MS/MS assay for the simultaneous determination of methotrexate, 6-mercaptopurine and its active metabolite 6-thioguanine in plasma of children with acute lymphoblastic leukemia: Correlation with genetic polymorphism.

J Chromatogr B Analyt Technol Biomed Life Sci 2016 Dec 28;1038:88-94. Epub 2016 Oct 28.

Department of Pediatrics, Hematology-Oncology Division, Faculty of Medicine, Ain-Shams University, Cairo, Egypt.

Individualized therapy is a recent approach aiming to specify dosage regimen for each patient according to its genetic state. Cancer chemotherapy requires continuous monitoring of the plasma concentration levels of active forms of cytotoxic drugs and subsequent dose adjustment. In order to attain optimum therapeutic efficacy, correlation to pharmacogenetics data is crucial. In this study, a specific, accurate and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) has been developed for determination of methotrexate (MTX), 6-mercaptopurine (MP) and its metabolite 6-thioguanine nucleotide (TG) in human plasma. Based on the basic character of the studied compounds, solid phase extraction using a strong cation exchanger was found the optimum approach to achieve good extraction recovery. Chromatographic separation was carried out using RP-HPLC and isocratic elution by acetonitrile: 0.1% aqueous formic acid (85:15v/v) with a flow rate of 0.8mL/min at 40°C. The detection was performed by tandem mass spectrometry in MRM mode via electrospray ionization source in positive ionization mode. Analysis was carried out within 1.0min over a concentration range of 6.25-200.00ng/mL for the studied analytes. Validation was carried out according to FDA guidelines for bioanalytical method validation and satisfactory results were obtained. The applicability of the assay for the monitoring of the MTX, MP and TG and subsequent application to personalized therapy was demonstrated in a clinical study on children with acute lymphoblastic leukemia (ALL). Results confirmed the need for implementation of reliable analysis tools for therapeutic dose adjustment.
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http://dx.doi.org/10.1016/j.jchromb.2016.10.035DOI Listing
December 2016

Efficacy of Different Perioperative Statin Regimens on Protection Against Post-Coronary Artery Bypass Grafting Major Adverse Cardiac and Cerebral Events.

J Cardiothorac Vasc Anesth 2016 Dec 31;30(6):1461-1470. Epub 2016 May 31.

Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

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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http://dx.doi.org/10.1053/j.jvca.2016.05.046DOI Listing
December 2016

Obesity Does Not Affect Propofol Pharmacokinetics During Hypothermic Cardiopulmonary Bypass.

J Cardiothorac Vasc Anesth 2016 Aug 11;30(4):876-83. Epub 2016 Feb 11.

Clinical Pharmacy Department, Faculty of Pharmacy.

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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http://dx.doi.org/10.1053/j.jvca.2016.02.003DOI Listing
August 2016

Association Between Combined Presence of Hepatitis C Virus and Polymorphisms in Different Genes With Toxicities of Methotrexate and 6-Mercaptopurine in Children With Acute Lymphoblastic Leukemia.

Pediatr Blood Cancer 2016 09 10;63(9):1539-45. Epub 2016 May 10.

Department of Pediatrics, Hematology-Oncology Division, Faculty of Medicine, Ain-Shams University, Cairo, Egypt.

Background: The aim of the present study is to determine the correlation of hepatitis C virus (HCV) infection and polymorphisms in different genes with toxicity of either methotrexate (MTX) or 6-mercaptopurine (6-MP) administered to children with acute lymphoblastic leukemia (ALL).

Procedure: One hundred children with low-risk ALL, who were treated according to the St. Jude Total therapy XV, were recruited. The recruited children were receiving MTX and 6-MP during maintenance phase. Patients were excluded from the study if they had other types of leukemia. Genotyping analyses for the thiopurine methyltransferase (TPMT), methylenetetrahydrofolate reductase (MTHFR), and glutathione S-transferase (GST) genes were performed using a combination of polymerase chain reaction (PCR) and PCR-RFLP (where RFLP is restriction fragment length polymorphism) protocols. Relevant clinical data on adverse drug reactions were collected objectively (blinded to genotypes) from the patient medical records.

Results: There was a significant correlation between the combined presence of HCV and TPMT*3B G460A gene polymorphisms and grades 2-4 hepatotoxicity as aspartate aminotransferase (AST) elevation (P < 0.04). The same observation was seen when comparing either the presence of HCV alone or the presence of the gene polymorphism alone. A significant association between the combined presence of HCV and MTHFR C677T polymorphism and grades 2-4 hepatotoxicity as alanine aminotransferase (ALT), AST, and alkaline phosphatase (ALP) elevation was observed (P values <0.001, 0.02, and 0.001, respectively). The presence of HCV infection had a significant negative effect on hepatic transaminases.

Conclusions: The present data support a role for combining analysis of genetic variation in drug-metabolizing enzymes and the presence of HCV in the assessment of specific drugs toxicities in multiagent chemotherapeutic treatment regimens.
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http://dx.doi.org/10.1002/pbc.26045DOI Listing
September 2016

Adverse drug reactions reporting: a questionnaire-based study on Egyptian pharmacists' attitudes following an awareness workshop.

J Eval Clin Pract 2016 Jun 7;22(3):349-55. Epub 2015 Dec 7.

Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Rationale, Aims And Objectives: Hospital pharmacists can promote medication safety through spontaneous reporting of adverse drug reactions (ADRs). However, different educational interventions and different factors (socio-demographic and professional) have been implicated to influence the reporting process. The aims of this study were to assess the impact of pharmacovigilance awareness workshop on knowledge of hospital pharmacists; and to identify the main factors and barriers that influence ADRs reporting.

Methods: Two validated self-administered questionnaires were distributed to pharmacists attending an awareness workshop (pre and post); and a telephone survey was completed three months after the workshop. ADR reports (yellow cards) received from participating pharmacists were monitored for six months, and analysed for quality (validity and seriousness) and reporter demographic and professional factors.

Results: Two hundred and eighty-one pharmacists (95.25%) and 270 pharmacists (91.52%) completed pre- and post-workshop questionnaires respectively. A comparison of their knowledge of ADRs to report before and after the workshop showed significant difference (Wilcoxon test P < 0.05). Two hundred and four pharmacists (72.6%) completed the follow-up questionnaire, with lack of time, administrative barriers and inability to complete patient details being the most frequent reasons for not reporting. A total of 163 yellow cards were received from 49 pharmacists (17.44%) over 6 months, of which 126 reports (77.3%) were serious ADRs. Demographics of reporting pharmacists showed significance for completion of post-graduate studies, ministry of health hospitals and pharmacist post in hospital.

Conclusion: Despite pharmacists' adequate knowledge after the workshop, they failed to maintain consistent reporting. Addressing the barriers to reporting and the personal factors influencing the process may be needed.
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http://dx.doi.org/10.1111/jep.12484DOI Listing
June 2016

The impact of a 600-mg loading dose of clopidogrel in diabetic and non-diabetic patients undergoing elective PCI.

Minerva Cardioangiol 2016 Aug 16;64(4):375-82. Epub 2014 Jul 16.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt -

Background: High platelet reactivity (HPR) and suboptimal response to dual antiplatelet therapy (DAPT) may explain high recurrent rates of ischemic events in type 1 and 2 diabetes mellitus (DM) patients undergoing percutaneous coronary intervention (PCI). The aim of this study was to determine the effect of diabetes mellitus on clopidogrel activity in cardiac patients undergoing PCI.

Methods: This is an observational study. Patients were categorized according to DM status into diabetic group (N.=30) and non-diabetic group (N.=33). All patients received clopidogrel in a loading dose of 600 mg before PCI. Platelet function was assessed using light transmittance aggregometry (LTA) technique at baseline (before clopidogrel administration), 24 hour after clopidogrel loading dose administration and 7-10 days after PCI. All patients were followed up for at least one year after PCI for recurrence of acute cardiac events.

Results: There was no statistically significant difference between the two groups with respect to 10 µm adenosine diphosphate (ADP)-induced platelet aggregation measured at baseline (P=0.64), 24 hours after PCI (P=0.874), and 7-10 days after PCI (0.643). Diabetics were not significantly different from non-diabetics in terms of post-PCI acute stent thrombosis (P=0.945), sub-acute stent thrombosis (P=0.945), unstable angina (P=0.29) and cardiac death (P=0.64). There was a statistically significant difference between patients with and without post-PCI acute events regarding ADP aggregation measured 24 hours and 7-10 days after PCI.

Conclusions: The use of a high loading dose of clopidogrel (600 mg) in patients undergoing elective PCI can overcome the significant increase in post-PCI platelet aggregation and rate of acute cardiac events induced by diabetes mellitus as co-morbidity in those patients.
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August 2016

The role of clinical pharmacists as perceived by Egyptian physicians.

Int J Pharm Pract 2014 Oct 27;22(5):354-9. Epub 2014 Jan 27.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Objectives: Clinical pharmacists play an important role in ensuring the safe and rational use of medicines; however, physicians in developing countries may not always recognize the wide scope of services that a pharmacist can provide to improve patient safety and achieve clinical outcomes. The aim of this study was to investigate the perceptions and experience of physicians regarding the role of the pharmacists, the pharmacists' ability to perform clinical services, their acceptance of new pharmacist roles and the extent of collaboration that can occur between the two disciplines.

Methods: In this cross-sectional survey, 583 randomly selected physicians from the Grand Cairo area were invited to complete a survey composed of 25 questions designed to determine their perceptions of the role of clinical pharmacists.

Key Findings: The response rate was 53%. Of the 312 physicians who completed the questionnaire, 50.5% reported direct contact with the pharmacists using the pharmacist as a source of information about the name of the medication, side effects, drug interactions or efficacy as the main role. About one-third believed that pharmacists could be a reliable source of clinical information, identify clinically related problems or advise the physicians about medication's cost effectiveness. More than 80% agreed that physicians and clinical pharmacists should have daily cooperation, and face-to-face contact was selected to be the best method of communication.

Conclusion: Although a wide proportion of the physicians were aware of the clinical pharmacy principle, the service itself is not well promoted or applied. Greater effort needs to be directed towards increasing physicians' awareness and knowledge of the importance of clinical pharmacist and promote the benefit of the clinical pharmacy service.
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http://dx.doi.org/10.1111/ijpp.12087DOI Listing
October 2014

Antibiotic dispensing in Egyptian community pharmacies: an observational study.

Res Social Adm Pharm 2014 Jan-Feb;10(1):168-84. Epub 2013 May 10.

Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Background: Antibiotics are commonly dispensed medications from community pharmacies, and they are frequently prescribed for inappropriate indications. In many countries, they are easily accessible without prescriptions. The inappropriate use of antibiotics results in the emergence of resistant bacterial strains, which represents a considerable public health problem, particularly in developing countries.

Objective: This study aimed to describe the pattern of antibiotics dispensing from Egyptian community pharmacies and to collect baseline descriptive data on the antibiotics dispensed and their appropriateness.

Methods: A cross-sectional, observational study of antibiotic dispensing encounters was conducted at 36 randomly selected pharmacies in Greater Cairo, Egypt. Data were collected during one shift at each pharmacy. Structured questionnaires recording patient demographics, antibiotics dispensed and reasons for dispensing were completed for each antibiotic dispensing encounter. The data were descriptively analysed.

Results: Overall, 1158 antibiotics were dispensed during the study period with a total cost of L.E. 24,487 (approximately 3,673 $USD). While self-medication and purchasing without medical prescriptions were common, representing around 23.3% of the antibiotics (n = 270), most antibiotics were prescribed by a doctor or dentist (n = 736, 63.6%). Pharmacist recommendations accounted for the remainder (n = 152, 13.1%). The main reasons for antibiotic use were respiratory tract ailments and gastroenteritis symptoms. The antibiotics most commonly dispensed were: penicillins, erythromycin, metronidazole, neomycin, clotrimoxazole and tetracyclines. Approximately 70% of the antibiotics dispensed on prescriptions were judged to be appropriate for the indications while this percentage was around 61% for antibiotics dispensed on pharmacist recommendation and patient's request.

Conclusions: The results of this study show that antibiotics are frequently dispensed from community pharmacies in Egypt without appropriate prescriptions and for inappropriate indications. These findings support the need for strict enforcement of pharmacy laws through improved inspection processes. They highlight the need for evidence-based guidelines and educational interventions to improve antibiotic prescribing and dispensing practices.
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http://dx.doi.org/10.1016/j.sapharm.2013.03.004DOI Listing
August 2014

A specially tailored vancomycin continuous infusion regimen for renally impaired critically ill patients.

SAGE Open Med 2013 8;1:2050312113507921. Epub 2013 Oct 8.

Faculty of Pharmacy, Cairo University, Cairo, Egypt.

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.
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http://dx.doi.org/10.1177/2050312113507921DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4687768PMC
January 2016

Hepatoprotective efficacy of ursodeoxycholic acid in pediatrics acute lymphoblastic leukemia.

Pediatr Hematol Oncol 2012 Oct 13;29(7):627-32. Epub 2012 Aug 13.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

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.
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http://dx.doi.org/10.3109/08880018.2012.713083DOI Listing
October 2012

Zoledronic acid and clodronate in the treatment of malignant bone metastases with hypercalcaemia; efficacy and safety comparative study.

Med Oncol 2011 Jun 5;28(2):584-90. Epub 2010 Mar 5.

Faculty of Pharmacy, Cairo University, Giza, Egypt.

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.
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http://dx.doi.org/10.1007/s12032-010-9461-zDOI Listing
June 2011

Serum trace element levels in COPD patient: the relation between trace element supplementation and period of mechanical ventilation in a randomized controlled trial.

Respirology 2009 Nov 16;14(8):1180-7. Epub 2009 Sep 16.

Chest Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

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.
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http://dx.doi.org/10.1111/j.1440-1843.2009.01622.xDOI Listing
November 2009

Transdermal delivery of salbutamol sulphate: formulation and evaluation.

Pharm Dev Technol 2009 ;14(2):216-25

Pharmaceutics Department, Faculty of Pharmacy, Beni-suef University, Beni-suef, Egypt.

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.
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http://dx.doi.org/10.1080/10837450802572383DOI Listing
August 2009
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