Day 2 :
Keynote Forum
Ehab Darwish
TopLab Medical Director, Egypt
Keynote: A preliminary report of successful cleavage after Calcium Ionophore activation at ICSI in cases with previous arrest at the Pronuc lear stage
Biography:
Abstract:
- Track 1: Drug Safety
Track 2: Adverse Drug Reactions
Track 8: Pharmacokinetics & Pharmacodynamics
Track 16: Biopharmaceutics
Session Introduction
Mohamed M El-Khawanki
Najran University, KSA
Title: Title: Does Clozapine induce Myocarditis, Myocardia l oxidative stress and DNA damage in Rats?
Biography:
Mohamed M. Elkhawanky MD-PhD; Associate professor of Clinical Hematopathology in College of Medicine, Najran University, Saudi Arabia. He is a founding member of the PBL Medical Education Committee at the Najran University. Dr. Elkhawanky received his medical degree from College of Medicine, Zagazig University, Egypt in 1999. He subsequently completed a 3-years residency program at Zagazig University Hospitals. He holds MD-PhD in Clinical Hematopathology from College of Medicine, AL-Azhar University. Dr. Elkhawanky conducts several funded research projects concerning medical problems and their solutions and has published widely. He has been invited to speak at several international scientific conferences.
Abstract:
Clozapine is an atypical antipsychotic drug selectively effective in the treatment of refractory schizophrenia. However, myocarditis, as a serious cardiotoxic effect, has in several case reports been associated with clozapine therapy. An increase in the free radical production and ischemia, probably induced by clozapine-induced release of catecholamines, have been hypothesized to trigger an inflammatory response that leads to the clinically observed cardiomyopathy and sudden death even in young patients. The aim of this work is to study the role of oxidative stress in clozapine induced myocarditis and myocardial DNA damage in a rat model. Methods: Male Wistar rats, age _6 weeks, were administered 5, 10 or 25 mg/kg clozapine daily for 21 days; saline-treated rats served as the control. Heart sections were stained with hematoxylin and eosin for histopathological examination. Plasma CK-MB, LDH and TNF-α concentrations were determined. Myocardial oxidative stress (MDA and NO), antioxidant (GSH and GSH-Px) parameters, and the marker of oxidative DNA damage (8-OHdG) were determined. Results: Clozapine treatment resulted in significant dose-related increases in myocardial inflammation with increased plasma TNF-a, CK-MB and LDH levels. Myocardial MDA, NO and serum and cardiac 8-OHdG levels increased while GSH level and GSH-Px activity decreased with the highest significance seen with the largest tested dose (25 mg/kg) of clozapine. Conclusions: Clozapine, in relatively large doses induced myocarditis consistently with increased myocardial oxidative stress, DNA damage and inflammatory cytokines in a rat mode.
Marwa M Fawzi
Taibah University, KSA
Title: Medicolegal aspects concerning Tramadol abus e. The new Middle East youth Plague
Biography:
Dr Marwa M Fawzi Associate Professor & Coordinator of Forensic Medicine and Clinical Toxicology, Medical Professionalism, Medical Ethics and law courses Faculty of Medicine Taibah University ,KSA .She has received her M.D. degree in Forensic Medicine from Ain Shams University. Egypt 2006 .She had joined the academic line as a demonstrator in 1998 up to 2011 as an Assistant Professor in the department of Forensic Medicine and Clinical Toxicology ,ASU ,Egypt. She contributed in management of toxicological emergencies cases in Poison Control Center Ain Shams University Hospitals PCCASU 2000-2011. Specialized in Health Care Quality Management, patient safety MOH. She participated in WHO projects, conferences, workshops and committees. She has national and international publications in the field of medical ethics ,forensic , clinical toxicology and communications skills .She is member of national and international Forensic societies
Abstract:
An increasingly alarming phenomenon of tramadol drug abuse has been demonstrated in the Egyptian community in the last four years. Although the issue of drug abuse is not a newcomer to the Egyptian society, tramadol has been associated with a wide range of drug abuse and its illegal drug transactions had made it easily accessible and readily provided at cheap costs despite of its being a scheduled drug. The alleged usages of tramadol had also contributed greatly to its popularity and massive use especially among Egyptian youth as a remedy for premature ejaculatory function and for extended orgasm and increase sexual pleasure as promoted through many online drug stores and media.Aim of the work:To study the impact of tramadol increasing rates of drug abuse on the observed association with forms of aggression and accidents.Patients and methods:This study was carried out on the patients who presented to Poison Control Center of Ain Shams University Hospitals, Egypt in the year 2010 presented with trauma with suspected associated drug toxicity for toxicological assessment. RESULTS: Number of studied cases was 640 with the adult population showing ahigher prevalence (67.9%). The prevalence was higher in males (77.2%). Abuse form of drug intake was the highest (50.8%). The oral route of intake is the highest (96.8%). Patients abusing tramadol presented with any clinical finding denoting involvement in an act of violence or giving history of it (36.3%), forms of accidents whether road traffic accidents (18.7%), acts of violence as fights and domestic violence (33%) and accidental fall and unintentional self-induced injuries (48.3%).The most frequent forms of injuries were cerebral edema (55.9%) and the least being inter cerebral hemorrhage (5%) both diagnosed both clinically and as a CAT SCAN brain finding. Whilst as forms of injuries were lacerated wounds (38.9%), contusions (35.3%), abrasions (31.3%), cerebral concussion (22%), and bone fracture (17.8%), and polytrauma (11%).Conclusions:The significantly notable increasing violence forms are closely related to drug abuse. Tramadol’s prevalence is the mostly noted due to its wider availability and cheaper prices than other types of abused drugs.Recommendations:Drug screening for tramadol should be added to all forms of basic toxicological screening. Especially in cases of patients involved in violent crimes and road traffic accidents, also for those applying for drivers’ license fitness program
Biography:
Massoud Toussi, MD, PhD, MBA, is leader of Pacharmoepidemiology and Drug Safety Activities in IMS Health. Massoud is medical doctor with an MD degree in general medicine and a university degree in psychiatry. After working as a clinician for about three years he specialized himself in in medical informatics and pharmacoepidemiology and the analysis of healthcare data by obtaining a Master’s degree and a PhD in this domain. He also obtained an MBA from University of Paris Dauphine (France) and a Master’s degree international management from Unviersity of Quebec-Montreal (Canada). He is an active member of the International Society of pharmacoepidemiology (ISPE), European Network of centers of Pharmacoepidemiology and Pharmacovigilance (ENCePP) and European Public Health Association (EUPHA).
Abstract:
Routinely collected data include a wide variety of data sources such as electronic medical records (EMR), hospital and outpatient claims databases, pharmacy dispensing, laboratory exam, genetic data and patient reported databases as well as the data gathered through connected devices such as glucometers. Good understanding of the value and caveats of each type of data can help a better selection of data sources for research and avoiding bias. To present lessons learned and return of experience on different categories of databases and discuss on usages, data collection methods, strengths and weaknesses of each data. Generating evidence form real world data involves using a variety of data sources. Unlike the data gathered through clinical trials, the real world data sources are numerous and heterogeneous. Although there is growing interest for the use of routinely collected data in pharmacoepidemiology, the experience with some types of data such as dispensing data and prescription-diagnosis surveys is very limited in pharmacoepidemiology whereas they can provide useful insights on the appropriate use of drugs and the assessment of risk minimization measures. The methods of data collection for each type of database will be explained. Using examples from their real life practice, the speaker will discuss on the common caveats of different types of data sources and the potential biases related to their use, as well as strategies to avoid them. They will also address how to combine and link different types of data.
Hayam Ateyya
Cairo University, Egypt
Title: Amelioration of Cyclosporine induced Nephrot oxicity by Dipeptidylpeptidase inhibitior Vildagliptin
Biography:
Hayam Ateyya has completed her MB.Bch degree in medicine& surgery at the age of 25 years from Cairo University, Faculty of Medicine and M.D Degree in Pharmacology from Cairo University, faculty of Medicine. She is working now as assistant professor at Taibah university in KSA.
Abstract:
Cyclosporine A (CsA) is an immunosuppressive drug used in organ transplantation and autoimmune diseases but its clinical uses may be limited due to its dose-related nephrotoxicity. This study was carried out to evaluate the possible protective effects of vildagliptin (VLD) against CsA-induced nephrotoxicity in rats. Animals were divided into four groups treated as follows: control group (CsA & VLD vehicle); VLD group (10 mg/kg/day, orally); CsA group (20 mg/kg in sunflower oil, S.C.); and CsA-VLD group (CsA &VLD). Induced nephrotoxicity was evidenced by a significant elevation of serum creatinine, blood urea nitrogen (BUN), lactate dehydrogenase (LDH) and urinary micro total proteins (MTP), while serum albumin and urinary creatinine clearance were significantly decreased compared to control group. Moreover, renal dysfunction was further confirmed by a significant increase in renal lipid peroxide that was measured as renal malondialdehyde (MDA). Renal reduced glutathione (GSH) and superoxide dismutase (SOD) were significantly decreased. Nephrotoxicity was further confirmed by renal tissues histopathology. Also, a high protein expression of Bax with decreased Bcl-2 was revealed in renal tissue of CsA treated group. Administration of VLD significantly ameliorated the nephrotoxic effects of CsA suggesting antioxidant, anti-inflammatory and anti-apoptotic benefits of VLD in CsA-induced nephrotoxicity
Nermine El Maraghy
Suez Canal University, Egypt
Title: Pattern of Hospital-acquired Pneumonia in in tensive care unit of Suez Canal University Hospital
Biography:
Dr/ Nermine El-Maraghy is associate professor of medical microbiology & immunology . I had master and Ph.D in medical microbiology & immunology from facuulty of Medicine suez Canal University ; Ismailia, Egypt. I am member of tumor oncology unit, clinical epidemiology units at faculty of medicine suez canal University. I had great experience in the era of clinical immunology, allergy skin prick test, immunotherapy, diagnostic microbiology and infection control. I have several international publications (13) on pubmed , google scholar a. I am reviewer of the Infectious & Non-Infectious Diseases(online), Suez Canal University Medical Journal and Eastern Mediterranean Health Journal( online) .As well as professional diplome of infection control from AUC , Egypt ..
Abstract:
Hospital acquired pneumonia occurs more than 48 h after hospital admission and was not present at the time of admission, while ventilator associated pneumonia occurs after 48–72 h of endotracheal intubation or within 48 h of extubation. HAP is the second most common nosocomial infection and accounts for approximately 25% of all infections in the Intensive Care Unit worldwide. Purposes To identify the etiology, initial evaluation, prevention, and treatment of adult patients with ICU HAP, and VAP in Suez Canal University hospital and their management strategies. Methods This study was conducted in the department of ICU, Suez Canal University Hospital; Ismailia, Egypt in the period from May to August 2013. All the patients were subjected to clinical and radiological assessment, Endotracheal aspirate samples for culture, and sensitivity to determine the causative organisms, Clinical Pulmonary Infection Score was done in order to determine the severity of HAP. Results 89% of patients were suffering from VAP, while 11% were suffering from HAP, with mean age of 63.8 ± 10.47 years. Methicillin-resistant Staphylococcus aureus, and Klebsiella pneumoniae represented the most common isolated organisms that accounted about 65% of the studied population. The isolated microorganisms were resistant to Amoxicillin, MRSA showed highest sensitivity (44.4%) to Vancomycin and (27.8%) to Imipenem. K. pneumoniae were sensitive mainly to Imipenem (75.9%) and to Levofloxacin (44.8%). Conclusion Gram-negative organisms were isolated in 46% of cases, gram-positive organisms in 41% and the isolated organisms showed high resistance to most of the tested antibiotics
Biography:
Samira Saleh, PhD Cairo University and postdoctoral studies Strathclyde University, UK, is currently Head of the Department of Pharmacology, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University. She is a Board member of The Egyptian Society of Pharmacology and Experimental Therapeutics and the Editor-in-Chief of the Egyptian Journal of Basic and Clinical Pharmacology. She makes Evaluation of Science and Technology Development Fund (STDF) projects. She has published around 85 papers, supervised more than 50 thesis and made presentations at more than 60 conference. She won Prizes from the supreme council of universities for publishing papers in International journals.
Abstract:
In the 1960’s, the thalidomide disaster led to limb deformities in the newborns of those mothers who took the drug while pregnant. This implies that premarketing evaluation of drug safety, in animal experiments and in phase 1-3 clinical trials, provides insufficient evidence of safety. Accordingly, it is vital to monitor safety of all medicines throughout their marketed life because adverse drug reaction-related cost to the country may exceed the cost of the medications themselves. The study of ADRs is the concern of the field of pharmacovigilance which is gaining importance as the number of stories of drug recalls increases. The WHO international drug monitoring program started in 1968; it is located in Uppsala Sweden. In Egypt, the Egyptian PV Centre was established in 2009 and is linked to the global PV system. The program is based on voluntary ADR reporting and monitoring and is vital for maintaining drug safety. Voluntary reporting by physicians and other health providers and consumers may alert the authorities and pharmaceutical companies to possible adverse effects of drugs. It aims at reducing the risks associated with drug prescribing and administration and improving patient care, safety and treatment outcome. The Yellow Card Scheme was founded in 1964 after the thalidomide disaster. It receives more than 20,000 reports of possible side effects each year. To conclude, pharmacovigilance is a dynamic clinical and scientific discipline. It provides reliable, balanced information for the effective assessment of the risk/benefit profile of medicines. Under-reporting remains the corner stone that hinders pharmacovigilance activities.
- Track 10: Pre-Clinical and Clinical Trials
Track 12: Clinical Trials on Various Disorders
Track 14: Clinical Research and Statistics
Track 15: Case Report in Clinical Trials
Track 17: PV Data Base Management
Session Introduction
Tomaz Crochemore
Israelita Albert Einstein Hospital, Brazil
Title: Thromboelastometry-guided Hemostatic therapy : An efficacious approach to manage bleeding risk in acute fatty liver of Pregna ncy: A case report
Biography:
Dr. Tomaz Crochemore is physician, a specialist in intensive care medicine, whose area of expertise is in Hemostasis and Thrombosis, with extensive experience in the study of rotational thromboelastometry. Doctor responsible for the Support Group in coagulation and hemostasis of the intensive care unit of the Hospital Israelita Albert Einstein, São Paulo - Brazil
Abstract:
INTRODUCTION: Acute fatty liver of pregnancy (AFLP) is a rare but life-threatening disease. AFLP is characterized by liver failure with different degrees of coagulopathy. Outcome and survival can be dramatically improved with prompt recognition and treatment. Thromboelastometry has been considered a point of care for the management of bleeding patients. It could, therefore, be an alternative tool to treat the complex cases of AFLP involving liver failure and coagulopathy. Through this study, we present our successful experience of an AFLP case that was submitted to an emergency cesarean section in which blood transfusion was guided by thromboelastometry