Naguib, S. N., N. A. Sabry, S. F. Farid, and A. M. Alansary, "Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial.", Clinical therapeutics, vol. 43, issue 1, pp. e1-e18, 2021. Abstract

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.

Said, E., S. Mousa, M. Fawzi, N. A. Sabry, and S. Farid, "Combined effect of high-dose vitamin A, vitamin E supplementation, and zinc on adult patients with diabetes: A randomized trial.", Journal of advanced research, vol. 28, pp. 27-33, 2021. Abstract

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.

Kamel, A. M., M. Sobhy, N. Magdy, N. Sabry, and S. Farid, "Anticoagulation outcomes in hospitalized Covid-19 patients: A systematic review and meta-analysis of case-control and cohort studies.", Reviews in medical virology, pp. e2180, 2020. Abstract

BACKGROUND: Coagulopathy and thromboembolic events are common in Covid-19 patients and are poor prognostic factors. Controversy exists regarding the potential of anticoagulation (AC) to reduce mortality and incidence of thromboembolic events in Covid-19 patients. The current systematic review and meta-analysis investigated the association between anticoagulants and mortality in adult hospitalized COVID-19 patients using the available published non-randomized studies.

METHODS: Google Scholar, PubMed, Scopus, the Cochrane Library and Clinical Trials.gov were searched for relevant studies. A meta-analysis of adjusted and unadjusted estimates was performed. The relative risk was used as a measure of effect. The random-effects model was used to pool estimates using the generic inverse variance method.

RESULTS: Sixteen studies were included in the quantitative data synthesis. Results showed a statistically significant association between AC and mortality (RR = 0.56, 95% CI 0.36; 0.92, p = 0.02). Both therapeutic (Relative risk [RR] = 0.4, 95% CI 0.27; 0.57) and prophylactic AC (RR = 0.54, 95% CI 0.41; 0.71) were associated with lower risk of mortality. Pre-admission AC was not associated with mortality (RR = 0.84, 95% CI 0.49; 1.43, p > 0.05) while prophylactic AC was associated with higher risk of mortality compared to therapeutic AC (RR = 1.58, 95% CI 1.34; 1.87, p < 0.001).

CONCLUSION: Findings support the association of AC with mortality in Covid-19 patients. The results, synthesized from mostly low-quality studies, show that prophylactic and therapeutic AC might reduce mortality in Covid-19 patients. Findings suggest that therapeutic doses might be associated with better survival compared to prophylactic doses.

Abdel Monem, M. S., S. F. Farid, M. M. Abbassi, I. Youssry, N. G. Andraues, M. Hassany, Y. M. M. Selim, and M. H. El-Sayed, "The Potential Hepatoprotective Effect of Metformin in Hepatitis C Virus-infected Adolescent Patients with Beta Thalassemia Major: Randomized Clinical Trial.", International journal of clinical practice, pp. e14104, 2021. Abstract

BACKGROUND: Iron overload-induced oxidative stress and transfusion-acquired hepatitis C viral (HCV) infection are the main reasons of liver damage in beta thalassemia major (β-TM).

OBJECTIVES: Based on metformin's hepatic benefits in non-diabetic populations, the study aims to investigate the safety and the potential hepatoprotective effect of metformin in HCV-infected β-TM adolescent patients.

METHODS: This was a prospective, randomized, parallel, controlled, open label study in which 60 HCV-infected β-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 β-TM standard of care regimen while metformin (500 mg, twice daily) was added to the treatment group's regimen only. Patients were prospectively followed-up for six months with assessment of liver biochemical profile, oxidative stress markers, liver fibrosis, clinical symptoms improvement and metformin's adverse effects.

RESULTS: Aspartate aminotransferase serum level decreased significantly over time in the treatment group only (P= 0.013). 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 ˂ 0.001). Fibrosis grade improvement was observed in 14 patients in the treatment group versus one improved case in the control group.

CONCLUSION: Use of metformin in HCV-infected β-TM adolescent patients as an adjuvant antioxidant hepatoprotective agent is promising and can improve liver damage.

Al-Nahari, M. M., M. M. Abbassi, F. S. Ebeid, M. Hassany, M. H. El-Sayed, and S. F. Farid, "Pharmacokinetics of daclatasvir in Egyptian adolescents with genotype-4 HCV infection.", Antiviral therapy, vol. 25, issue 2, pp. 101-110, 2020. Abstract

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 (C), area under the curve (AUC), apparent oral volume of distribution (V/F), apparent oral clearance (CL/F) and half-life (T) were 1,092 ng/ml, 11,178 ng/ml•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 (K), 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.

Farid, S., "Development of Therapeutic Giuidelines", Encyclopedia of Pharmacy Practice and Clinical Pharmacy: Elsevier, 2019.
Ali, A., S. Farid, M. Amin, M. Kassem, and N. Al-Garem, "Clinical study on the therapeutic role of midodrine in non azotemic cirrhotic patients with tense ascites: a double-blind, placebo-controlled, randomized trial.", Hepato-gastroenterology, vol. 61, issue 135, pp. 1915-24, 2014. Abstract

BACKGROUND: Midodrine is an α-agonist prodrug of desglymidodrine used for the management of hypotension. Midodrine has demonstrated usefulness in hepatorenal syndrome.

OBJECTIVE: The objective of the present work was to study the role of midodrine in patients with non-azotemic cirrhosis with tense ascites.

METHODS: This prospective randomized double blind placebo-controlled study was conducted on 67 non azotemic inpatients with liver cirrhosis and tense ascites (52 men and 15 women; age range, 45-72). One patient declined to participate in the study, 33 patients were randomly assigned to take midodrine hydrochloride, and 33 patients were randomly assigned to take placebo. Out of 67 enrolled patients, 60 patients (30: in midodrine group; 30: in placebo group) completed the study and 6 patients lost to follow up. Patients were assessed for patients’ characteristics, history of tapping their ascetic fluid, laboratory values, and Doppler parameters before and after the study. Average 24-h urine volume was assessed before and after the start of the study.

RESULTS: significant reduction in body weight and abdominal girth was observed after 2 weeks of midodrine therapy.

CONCLUSION: Midodrine appeared to be effective in lowering body weights and abdominal girths of non azotemic cirrhotic patients with tense ascites.

Sabry, N. A., and S. F. Farid, "The role of clinical pharmacists as perceived by Egyptian physicians.", The International journal of pharmacy practice, vol. 22, issue 5, pp. 354-9, 2014. Abstract

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.

Sabry, N. A., S. F. Farid, and D. M. Dawoud, "Antibiotic dispensing in Egyptian community pharmacies: an observational study.", Research in social & administrative pharmacy : RSAP, vol. 10, issue 1, pp. 168-84, 2014. Abstract

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.

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. 627-32, 2012. Abstract

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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