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1. The effects of the CYP3A5*3 variant on tacrolimus pharmacokinetics and outcomes in Tunisian kidney transplant recipients.

Author

Charfi R, Bacha MM, Ben Fadhal M, Ferchichi K, El Jebari H, Gaies E, Klouz A, Abderrahim E, Ben Hamida F, Ben Abdallah T, Trabelsi S, Gorgi Y, and Sfar I

Subjects
Humans, Immunosuppressive Agents therapeutic use, Cytochrome P-450 CYP3A genetics, Polymorphism, Single Nucleotide, Genotype, Tacrolimus therapeutic use, Kidney Transplantation
Abstract

Introduction: Tacrolimus, exhibits interindividual pharmacokinetic variability and a narrow therapeutic index. The influence of the CYP3A5 6986A>G single nucleotide polymorphism (SNP) on this variability remains a topic of debate., Aim: To assess the impact of the aforementioned SNP on tacrolimus area under curve (AUC0-12h), adverse drug reactions (ADRs), and kidney graft outcomes., Methods: Blood samples were collected from Tunisian kidney transplants over a five-year period during either the early (<3 months) or late (>3 months) post-transplant phases. Through blood concentration (C0) and AUC0-12h of tacrolimus were measured. Patients were prospectively followed to assess graft outcomes. Polymerase chain reaction of restriction fragment length polymorphism was used for CYP3A5 6986A>G genotyping., Results: Fifty Tunisian kidney recipients receiving tacrolimus were enrolled in the study. Acute and chronic graft rejections were observed in eight and three patients, respectively. Twenty-one patients (42%) reported ADRs. C0 and AUC0-12h, showed a significant difference between CYP3A5*1 carriers (mean C0=4 ng.mL-1 and AUC0-12h=94.37 ng.h.mL-1) and CYP3A5*3/3 or poor metabolizers carriers (mean C0=7.45 ng.mL-1; AUC0-12h=151.27 ng.h.mL-1) (p=0.0001; p=0.003, respectively). Supratherapeutic tacrolimus levels were significantly more common in poor metabolizers (p=0.046; Odds-ratio =1.3; confidence interval 95% [1.12-1.66]). The impact of SNP was significant on C0, AUC0-12h, C0/Dose and AUC0-12h/Dose, only in the late phase (p=0.01, 0.002, 0.012, 0.003 respectively)., Conclusion: CYP3A5*3 variant was significantly associated with tacrolimus pharmacokinetics but had no impact on graft outcomes.

Published
2023

2. 2022 TUNISIAN NATIONAL CONGRESS OF MEDICINE ABSTRACTS.

Author

Yacoub A, Ayadi A, Ayed W, Ayari S, Chebbi S, Magroun I, Ben Afia L, Mersni M, Mechergui N, Brahim D, Ben Said H, Bahri G, Youssef I, Ladhari N, Mziou N, Grassa A, M'rad M, Khessairi N, Krir A, Chihaoui M, Mahjoub S, Bahlous A, Jridi M, Cherif Y, Derbal S, Chebbi D, Hentati O, Ben Dahmen F, Abdallah M, Hamdi I, Sahli F, Ouerdani Y, Mnekbi Y, Abaza H, Ajmi M, Guedria A, Randaline A, Ben Abid H, Gaddour N, Maatouk A, Zemni I, Gara A, Kacem M, Maatouk I, Ben Fredj M, Abroug H, Ben Nasrallah C, Dhouib W, Bouanene I, Sriha A, Mahmoudi M, Gharbi G, Khsiba A, Azouz M, Ben Mohamed A, Yakoubi M, Medhioub M, Hamzaoui L, Azouz M, Ben Attig Y, Hamdi S, Essid R, Ben Jemia E, Rezgui B, Boudaya MS, Hassine H, Dabbabi H, Fradi Y, Cherif D, Lassoued I, Yacoub H, Kchir H, Maamouri N, Khairi W, Ben Ammar H, Abaza H, Chelbi E, Merhaben S, Neffati W, Ajmi M, Tarchalla S, Boughzala S, Gazzeh M, Gara S, Labidi A, Touati H, Nefzi AM, Ben Mustpha N, Fekih M, Serghini M, Boubaker J, Zouiten L, Driss A, Meddeb N, Driss I, Walha S, Ben Said H, Bel Hadj Mabrouk E, Zaimi Y, Mensi A, Trad N, Ayadi S, Said Y, Mouelhi L, Dabbèche R, Belfkih H, Bani M, Moussa A, Souissi S, Trabelsi Werchfeni B, Chelly S, Ezzi O, Ammar A, Besbes M, Njah M, Mahjoub M, Ghali H, Neffati A, Bhiri S, Bannour R, Ayadi S, Khouya FE, Kamel A, Hariz E, Aidani S, Kefacha S, Ben Cheikh A, Said H, Dogui S, Atig A, Gara A, Ezzar S, Ben Fradj M, Bouanène I, M'kadmi H, Farhati M, Dakhli N, Nalouti K, Chanoufi MB, Abouda SH, Louati C, Zaaimi Y, Dabbeche R, Hermi A, Saadi A, Mokaddem S, Boussaffa H, Bellali M, Zaghbib S, Ayed H, Bouzouita A, Derouiche A, Allouche M, Chakroun M, Ben Slama R, Gannoun N, Kacem I, Tlili G, Kahloul M, Belhadj Chabbah N, Douma F, Bouhoula M, Chouchene A, Aloui A, Maoua M, Brahem A, Kalboussi H, El Maalel O, Chatti S, Jaidane M, Naija W, Mrizek N, Sellami I, Feki A, Hrairi A, Kotti N, Baklouti S, Jmal Hammami K, Masmoudi ML, Hajjaji M, Naaroura A, Ben Amar J, Ouertani H, Ben Moussa O, Zaibi H, Aouina H, Ben Jemaa S, Gassara Z, Ezzeddine M, Kallel MH, Fourati H, Akrout R, Kallel H, Ayari M, Chehaider A, Souli F, Abdelaali I, Ziedi H, Boughzala C, Haouari W, Chelli M, Soltani M, Trabelsi H, Sahli H, Hamdaoui R, Masmoudi Y, Halouani A, Triki A, Ben Amor A, Makni C, Eloillaf M, Riahi S, Tlili R, Jmal L, Belhaj Ammar L, Nsibi S, Jmal A, Boukhzar R, Somai M, Daoud F, Rachdi I, Ben Dhaou B, Aydi Z, Boussema F, Frikha H, Hammami R, Ben Cheikh S, Chourabi S, Bokri E, Elloumi D, Hasni N, Hamza S, Berriche O, Dalhoum M, Jamoussi H, Kallel L, Mtira A, Sghaier Z, Ghezal MA, Fitouri S, Rhimi S, Omri N, Rouiss S, Soua A, Ben Slimene D, Mjendel I, Ferchichi I, Zmerli R, Belhadj Mabrouk E, Debbeche R, Makhloufi M, Chouchane A, Sridi C, Chelly F, Gaddour A, Kacem I, Chatti S, Mrizak N, Elloumi H, Debbabi H, Ben Azouz S, Marouani R, Cheikh I, Ben Said M, Kallel M, Amdouni A, Rejaibi N, Aouadi L, Zaouche K, Khouya FE, Aidani S, Khefacha S, Jelleli N, Sakly A, Zakhama W, Binous MY, Ben Said H, Bouallegue E, Jemmali S, Abcha S, Wahab H, Hmida A, Mabrouk I, Mabrouk M, Elleuch M, Mrad M, Ben Safta N, Medhioub A, Ghanem M, Boughoula K, Ben Slimane B, Ben Abdallah H, Bouali R, Bizid S, Abdelli MN, Ben Nejma Y, Bellakhal S, Antit S, Bourguiba R, Zakhama L, Douggui MH, Bahloul E, Dhouib F, Turki H, Sabbah M, Baghdadi S, Trad D, Bellil N, Bibani N, Elloumi H, Gargouri D, Ben Said M, Hamdaoui R, Chokri R, Kacem M, Ben Rejeb M, Miladi A, Kooli J, Touati S, Trabelsi S, Klila M, Rejeb H, Kammoun H, Akrout I, Greb D, Ben Abdelghaffar H, Hassene H, Fekih L, Smadhi H, Megdiche MA, Ksouri J, Kasdalli H, Hayder A, Gattoussi M, Chérif L, Ben Saida F, Gueldich M, Ben Jemaa H, Dammak A, Frikha I, Saidani A, Ben Amar J, Aissi W, Chatti AB, Naceur I, Ben Achour T, Said F, Khanfir M, Lamloum M, Ben Ghorbel I, Houman M, Cherif T, Ben Mansour A, Daghfous H, Slim A, Ben Saad S, Tritar F, Naffeti W, Abdellatif J, Ben Fredj M, Selmi M, Kbir GH, Maatouk M, Jedidi L, Taamallah F, Ben Moussa M, Halouani L, Rejeb S, Khalffalah N, Ben Ammar J, Hedhli S, Azouz MM, Chatti S, Athimni Z, Bouhoula M, Elmaalel O, Mrizak N, Maalej M, Kammoun R, Gargouri F, Sallemi S, Haddar A, Masmoudi K, Oussaifi A, Sahli A, Bhouri M, Hmaissi R, Friha M, Cherif H, Baya C, Triki M, Yangui F, Charfi MR, Ben Hamida HY, Karoui S, Aouini F, Hajlaoui A, Jlassi H, Sabbah M, Fendri MN, Kammoun N, Fehri S, Nouagui H, Harzalli A, Snène H, Belakhal S, Ben Hassine L, Labbene I, Jouini M, Kalboussi S, Ayedi Y, Harizi C, Skhiri A, Fakhfakh R, Jelleli B, Belkahla A, Fejjeri M, Zeddini M, Mahjoub S, Nouira M, Frih N, Debiche S, Blibech H, Belhaj S, Mehiri N, Ben Salah N, Louzir B, Kooli J, Bahri R, Chaka A, Abdenneji S, Majdoub Fehri S, Hammadi J, Dorgham D, Hriz N, Kwas H, Issaoui N, Jaafoura S, Bellali H, Shimi M, Belhaj Mabrouk E, Sellami R, Ketata I, Medi W, Mahjoub M, Ben Yacoub S, Ben Chaabene A, Touil E, Ben Ayed H, Ben Miled S, El Zine E, Khouni H, Ben Kadhi S, Maatoug J, Boulma R, Rezgui R, Boudokhane M, Jomni T, Chamekh S, Aissa S, Touhiri E, Jlaiel N, Oueslati B, Maaroufi N, Aouadi S, Belkhir S, Daghfous H, Merhaben S, Dhaouadi N, Ounaes Y, Chaker K, Yaich S, Marrak M, Bibi M, Mrad Dali K, Sellami A, Nouira Y, Sellami S, Anane I, Trabelsi H, Ennaifer R, Benzarti Z, Bouchabou B, Hemdani N, Nakhli A, Cherif Y, Abdelkef M, Derbel K, Barkous B, Yahiaoui A, Sayhi A, Guezguez F, Rouatbi S, Racil H, Ksouri C, Znegui T, Maazaoui S, Touil A, Habibech S, Chaouech N, Ben Hmid O, Ismail S, Chouaieb H, Chatti M, Guediri N, Belhadj Mohamed M, Bennasrallah C, Bouzid Y, Zaouali F, Toumia M, El Khemiri N, El Khemiri A, Sfar H, Farhati S, Ben Chehida F, Yamoun R, Braham N, Hamdi Y, Ben Mansour A, Mtir M, Ayari M, Toumia M, Rouis S, Sakly H, Nakhli R, Ben Garouia H, Chebil D, Hannachi H, Merzougui L, Samet S, Hrairi A, Mnif I, Hentati O, Bouzgarrou L, Souissi D, Boujdaria R, Kadoussi R, Rejeb H, Ben Limem I, Ben Salah I, Greb D, Ben Abdelghaffar H, Smadhi H, Laatiri H, Manoubi SA, Gharbaoui M, Hmandi O, Zhioua M, Taboubi F, Hamza Y, Hannach W, Jaziri H, Gharbi R, Hammami A, Dahmani W, Ben Ameur W, Ksiaa M, Ben Slama A, Brahem A, Elleuch N, Jmaa A, Kort I, Jlass S, Benabderrahim S, Turki E, Belhaj A, Kebsi D, Ben Khelil M, Rmadi N, Gamaoun H, Alaya Youzbechi F, Brahim T, Boujnah S, Abid N, Gader N, Kalboussi S, Ben Sassi S, Loukil M, Ghrairi H, Ben Said N, Mrad O, Ferjaoui M, Hedhli L, Ben Kaab B, Berriche A, Charfi R, Mourali O, Smichi I, Bel Haj Kacem L, Ksentini M, Aloui R, Ferchichi L, Nasraoui H, Maoua M, Chérif F, Belil Y, Ayed MA, Alloulou Y, Belhadj S, Daghfous J, Mehiri N, Louzir B, Abbes A, Ghrab A, Chermiti A, Akacha A, Mejri O, Debbiche A, Yahiaoui C, Binous M, Tissaoui A, Mekni K, El Fekih C, Said MA, Chtioui S, Mestiri S, Smaoui H, Ben Hamida S, Haddar A, Mrizek N, Gares N, Zaibi A, Bouazizi N, Gallas S, Lachhab A, Belhadj M, Hadj Salem N, Garrouch A, Mezgar Z, Khrouf M, Abbassi H, Souissi D, Hamra I, Ben Mustapha N, Abessi I, Boubaker F, Bouchareb S, ElOmma Mrabet H, Touil I, Boussoffara L, Knani J, Boudawara N, Alaya W, Sfar MH, Fekih S, Snène H, Boudawara N, Gargouri I, Benzarti W, Knaz A, Abdelghani A, Aissa S, Hayouni A, Mejri I, Kacem M, Mhamdi S, Daboussi S, Aichaouia C, Moatemri Z, Chaachou A, Fsili R, Ben Ghezala H, Ben Jazia A, and Brahmi N

Published
2023

3. Drug interaction between carbamazepine and other antiepileptic drugs in Tunisian epileptic patients.

Author

Gaies E, Zgolli F, Charfi R, Ben Sassi M, El Jebari H, Salouage I, Daghfous R, and Trabelsi S

Subjects
Adult, Carbamazepine therapeutic use, Drug Interactions, Humans, Retrospective Studies, Anticonvulsants adverse effects, Epilepsy drug therapy, Epilepsy epidemiology
Abstract

Introduction: Carbamazepine could be used on monotherapy or associated to other antiepileptic drugs (AED). In these cases, drug interactions should be taken into account., Aim: To assess the influence of the coadministration of CBZ with other AED on the trough plasmatic concentration (C0) of CBZ in epileptic adults., Methods: We performed a retrospective study over a period of 9 years in the Department of Clinical Pharmacology in the Tunisian National Centre "Chalbi Belkahia" of Pharmacovigilance. Our study included samples from adult patients receiving CBZ alone or associated to other AED for epilepsy. Trough plasma CBZ plasma concentrations were measured by an immunological method. Included samples were divided in four groups: i/ group 1 (G1) receiving CBZ as monotherapy, ii/ group 2 (G2) treated by CBZ with an enzyme inducer (phenobarbital or phenytoin), iii/ group 3 (G3) taking CBZ associated to an enzyme inhibitor (valproic acid (VPA)), iv/ group 4 (G4), treated by CBZ associated to enzyme inducer (phenobarbital or phenytoin) and enzyme inhibitor (valproic acid) at the same time., Results: There were no significant differences between different groups in age, weight and sex ratio. However statistical analysis showed a significant decrease in C0/D CBZ ratio between G1 and G2 and between G1 and G4 (p<0.001). However, the difference was not significant between G1 and G3 (p=1.2044)., Conclusion: It is important to check and to prevent the consequences of the interaction between CBZ and other AED in order to avoid inefficiency and toxicity.

Published
2021

4. Development and validation method for estimation paclitaxel in plasma.

Author

Gaïes E, Jebabli N, Ben Said D, Charfi R, El Jebari H, Ben Sassi M, Salouage I, Daghfous R, and Trabelsi S

Subjects
Chromatography, High Pressure Liquid, Drug Monitoring, Humans, Reproducibility of Results, Antineoplastic Agents, Paclitaxel
Abstract

Background: Paclitaxel (PTX) is an anticancer drug used in the treatment of many cancer , alone or in combination with other anti-tumors. It has a narrow therapeutic range, a large inter and intra-individual pharmacokinetic variability and haematological toxicity. The most effective pharmacokinetic parameter seems to be the time during which the plasma concentration is over 0.05 μmol/L., Aim: To develop and validate a new method for PTX quantitation in plasma using HPLC with UV/visible detection., Methods: A rapid HPLC-UV method was developed for the determination of PTX level in plasma. All solvents used were HPLC grade., Results: After liquid-liquid extraction, chromatographic separation was achieved using an RP 18 (250 mm) column. The mobile phase was composed of acetonitrile and 0.1 M potassium dihyrogenophosphate (49/51) (v/v). Clonazepam was used as internal standard. This technique was linear over the range 50 ng/mL to 1500 ng/mL (r= 0.998). The evaluation of precision showed that our method is repeatable with a within-day coefficient of variation (CV) ranging from 6.94 to 18.78 % and reproducible for three studied concentrations low, medium and high with day-to-day CV of 14.92, 10.46 and 11.8% respectively. Under these conditions, each analysis required no longer than 12.81 min., Conclusion: We have developed and validate a new assay for PTX monitoring using HPLC with UV detection which is sensible, specific, reliable and easy to carry out in clinical use for its therapeutic drug monitoring.

Published
2020

5. Progress and impact of the publications of the Faculty of Medicine of Tunis: A 55 years study.

Author

Charfi R, Mlika M, Cheikhrouhou S, El Fekih H, Sellaouti F, Zakhama L, Labbene I, and Jouini M

Subjects
Adult, Biomedical Research history, Biomedical Research organization & administration, Biomedical Research statistics & numerical data, Biomedical Research trends, Cross-Sectional Studies, Education, Medical history, Education, Medical statistics & numerical data, Education, Medical trends, Faculty, Medical history, Faculty, Medical trends, Female, History, 20th Century, History, 21st Century, Humans, Male, Middle Aged, Publications history, Publications supply & distribution, Bibliometrics history, Faculty, Medical statistics & numerical data, Publications statistics & numerical data, Publications trends, Publishing history, Publishing statistics & numerical data, Publishing supply & distribution, Publishing trends
Abstract

Background: Over the past few years, efforts have been made to ensure that the teachers of the Faculty of Medicine of Tunis (FMT) cite their affiliation to the FMT and the University of Tunis El Manar in addition to their hospital institutions and their research structure in their publications., Aims: In this study, we proposed to evaluate the FMT's membership in the publications of its teachers, to identify the different types of publications and to estimate the real number., Methods: In this bibliometric cross-sectional study, we retrieved the FMT publications indexed in medline/pubmed database (1964-June2019). We have chosen the keywords corresponding to the publications of group1 (referenced FMT) and group2 (referenced FMT or annexed hospital-university institutions). Next, we calculated the rate of group1 on group2 and sorted the different types of items in group2. Finally, We estimated, after randomization, the actual number of FMT publications for a 99% confidence interval (99% CI)., Results: For groups 1 and 2, 1477 and 5194 publications were retrieved, respectively. The FMT membership rate averaged 28% ranging from 4% (1990-2010) to 44% (2011-2019). Of the FMT publications, 30% were free of charge and 55% were original articles. After a draw for 300 group2 publications, the estimated number of total FMT publications was between 4519 and 4934 for a 99% CI., Conclusions: It is essential to mention its affiliation to «the Faculty of Medicine of Tunis» and to «the University of Tunis El Manar» in order to improve the visibility and ranking of our two academic institutions.

Published
2020

6. Digoxin therapeutic drug monitoring: age influence and adverse events.

Author

Charfi R, Ben Sassi M, Gaies E, Jebabli N, Daghfous R, and Trabelsi S

Subjects
Adolescent, Adult, Age Factors, Age of Onset, Aged, Aged, 80 and over, Atrial Fibrillation epidemiology, Child, Child, Preschool, Digoxin adverse effects, Dose-Response Relationship, Drug, Drug-Related Side Effects and Adverse Reactions epidemiology, Female, Heart Failure drug therapy, Heart Failure epidemiology, Humans, Male, Middle Aged, Retrospective Studies, Young Adult, Atrial Fibrillation drug therapy, Digoxin therapeutic use, Drug Monitoring methods, Drug Monitoring statistics & numerical data
Abstract

Introduction: Digoxin is a cardiac glycoside, used to control rapid ventricular rates in atrial fibrillation and to reduce the hospitalizations due to heart failure. Digoxin has a narrow therapeutic range. So, in the treatment of older patients (≥ 65 years), it is important to set the optimal dose of digoxin to prevent toxicity and therapeutic drug monitoring of digoxin trough plasmatic concentration (C0) may be useful., Aim: To assess measured C0, to evaluate age influence on digoxin pharmacokinetic parameters and to report adverse events in patients administered digoxin., Methods: It consisted in a retrospective study. We included all the patients addressed to the department of clinical pharmacology for digoxin C0 measurement by an automated fluorescence polarization immunoassay. Therapeutic ranges of digoxin C0 were: 1 to 2.5 ng.mL-1 in children, 0.8 to 2 ng.mL-1 in adults and 0.5 to 0.9 ng.mL-1 in older adults (≥ 65 years) in atrial fibrillation and heart failure., Results: We collected 183 samples from 132 patients. Sex ratio M/W was 0.47. Mean age was 60 years and 57% of patients were older adults. Mean dose of digoxin was 0.3 mg.day-1. In older adults, 45% were administered daily doses over 0.125 mg.day-1. Mean digoxin C0 was 1.6 ng.mL-1. There was more supra-therapeutic C0 in older adults than younger ones (p<0.0001).There was no correlation between C0 and daily dose of digoxin. Adverse events, mainly cardiac and digestive, were reported in 47 patients (36%), among this population 47% were older adults., Conclusion: TDM is useful to prevent toxicity, mainly in older adults where diagnosis may be difficult to establish.

Published
2020

7. Teaching of evidence-based medicine principles in Family medicine curriculum: a descriptive study.

Author

Mlika M, Ben Hassine L, Charfi R, Mezni F, and Jouini M

Subjects
Adult, Attitude of Health Personnel, Clinical Competence, Cross-Sectional Studies, Female, Humans, Internship and Residency methods, Male, Personal Satisfaction, Prospective Studies, Tunisia, Curriculum standards, Evidence-Based Medicine education, Family Practice education, General Practitioners education
Abstract

Background: Family medicine was considered officially and legally in early 2019 in Tunisia. In order to help general practitioners to fit with the new profile of family doctors, the faculty of medicine of Tunis launched an MBA curriculum in 2018. Teaching evidence-based-medicine (EBM) principals was planned in a one-day training and was divided into a morning lecture-based session and an afternoon work team session., Aim: To assess the acceptability of this training by the participants and to highlight the consequences of this tutoring on the research skills of the trainees., Methods: This is a cross sectional, prospective and descriptive study including the trainees registered in the MBA curriculum. A web site was created and contained a pre-test. After the work team session, the participants were asked to fulfill a post test and a feed back form., Results: 20 trainees participated to the training day. 17 participants agreed to fulfil the pre-test, the post test and the feed back form. The mean and the median scores of the pre-test were estimated respectively to 11.19 and 14/20. The mean score and the median of the post-tests scores were estimated respectively to 12.69, and 14/20. No significant statistical difference was observed between the pre and post test scores (p=0.2). The majority of the trainees were totally satisfied with the training program. 13/17 participants estimated their needs' scale in EBM practice to 4/5., Conclusion: Our results highlighted the acceptability of EBM teaching in family medicine curriculum. The absence of significant difference pre test and post test scores can be explained by the fact that all participants obtained their doctorate and were able to perform a critical appraisal of medical articles.

Published
2019

8. Comparative study of two techniques of mycophenolate mofetyl monitoring.

Author

Jebabli N, Gaïes E, Charfi R, El Jebari H, Ben Sassi M, Salouage I, Daghfous R, and Trabelsi S

Subjects
Biomarkers, Pharmacological analysis, Biomarkers, Pharmacological blood, Chromatography, High Pressure Liquid methods, Humans, Immunoassay methods, Immunosuppressive Agents therapeutic use, Kidney Transplantation, Reproducibility of Results, Blood Chemical Analysis methods, Drug Monitoring methods, Mycophenolic Acid therapeutic use
Abstract

Introduction: Mycophenolic acid (MPA) requires routine therapeutic drug monitoring., Aim: To evaluate the suitability of a MPA Immunoassay CEDIA performed on Indiko® analyzer (Thermo fisher) for monitoring of MPA by comparing values obtained by HPLC-UV method., Methods: This study was carried out on 114 blood samples collected from renal transplant, using high performance liquid chromatography combined with ultraviolet detection (HPLC-UV, reference method) and the new immunoassay on CEDIA., Results: The assay was linear for a mycophenolic acid concentration up to 10 μg/mL. When MPA concentrations in all 114 transplant recipients obtained by the HPLC-UV (x-axis) method were compared with corresponding values obtained by the CEDIA® method (y-axis), the following regression equation was obtained: CEDIA® = 1.558 HPLC + 0.49 (r = 0.86). However more significant positive bias was observed (37 %)., Conclusion: The data presented suggest that the CEDIA® MPA immunoassay, run on the Indiko® analyzer, over-estimates plasma MPA concentrations. However, CEDIA® immunoassay is less laborious and time consuming than chromatographia techniques.

Published
2019

9. Evaluation and acceptability of concept maps as a learning tool in medical studies.

Author

Mlika M, Ben Khelil M, Charfi R, Dziri C, and Mezni F

Subjects
Attitude, Education, Medical methods, Students, Medical psychology
Abstract

Background: the use of concept maps (CM) in medical studies has been largely reported in the literature. In our context, we used to promote case-based-teaching methods but students aren't used to construct CM., Aim: To evaluate the acceptability of using CM by the students and the reproducibility of 2 methods of scoring, a holistic and an analytic one, associated to a master map in order to assess them., Methods: the authors supervised a 2-session-case-based-learning performed in a department of pathology. One case dealing with a real story about a colon cancer diagnosed in the musician Debussy (http://fr.wikipedia.org/wiki/Debussy) was adapted and presented to the students. At the end of the first session, the students were encouraged to construct collectively a concept map. At the end of the second session, the students were asked to fulfill a questionnaire about their acceptability of the learning process. Besides, two raters scored all the concept maps using 2 different scoring methods associated to a master map. The reproducibility of both scoring systems was evaluated using the kappa coefficient., Results: 31 students were enrolled in this study with a mean age of 21 years. The raters evaluated 8 CM. The kappa coefficient reached a value of 1 in the holistic scoring and a value of 0.46 in the hierarchical scoring indicating respectively a very strong and a moderate agreement between evaluators. 15 students reported their satisfaction about the use of CM collectively. 10 students expressed their will to use CM individually, 17 students felt that using the CM collectively made them feel to belong to a group but without expressing their own knowledge and reflecting their progress., Conclusions: our study highlighted the acceptability of using concept maps in medical studies and the possibility of reaching valid and reproducible scoring methods especially when associating a master map.

Published
2019

10. Early interaction between tacrolimus and rifampin.

Author

Charfi R, Ben Sassi M, Gaïes E, Bacha M, Jebabli N, El Jebari H, Daghfous R, Ben Abdallah T, and Trabelsi S

Subjects
Adult, Antibiotics, Antitubercular therapeutic use, Drug Interactions, Humans, Immunosuppressive Agents therapeutic use, Male, Rifampin therapeutic use, Tacrolimus therapeutic use, Time Factors, Antibiotics, Antitubercular pharmacology, Immunosuppressive Agents pharmacology, Kidney Transplantation, Rifampin pharmacology, Tacrolimus pharmacology
Abstract

Drug interactions are unavoidable and need to be proactively identified and managed, in particular, the inductive effect of rifampin on tacrolimus whose potency and duration data are limited. We report the case of a renal transplant patient who was prescribed tacrolimus with preserved tough blood levels (C0) of 7.9 +/- 2 ng/mL. He presented ganglionic tuberculosis and started rifampin. One day later, C0 was 2.6 ng/mL with 5 mg/day. The serum creatinin was normal. Nine days later, C0 was 1.6 ng/mL with 7 mg/day. In this case-report, the tacrolimus-rifampin interaction occurred just one day after rifampin introduction necessitating early C0 monitoring.

Published
2019

11. Therapeutic durg monitoring of cyclosporin using area under the curve in nephrotic syndrome.

Author

Gaies E, Ben Sassi M, Charfi R, Salouage I, Jebabli N, ElJebari H, Klouz A, Daghfous R, and Trabelsi S

Subjects
Adolescent, Adult, Area Under Curve, Child, Child, Preschool, Dose-Response Relationship, Drug, Female, Humans, Infant, Male, Middle Aged, Retrospective Studies, Young Adult, Cyclosporine pharmacokinetics, Cyclosporine therapeutic use, Drug Monitoring methods, Nephrotic Syndrome drug therapy, Nephrotic Syndrome metabolism
Abstract

The use of cyclosporin in nephrotic syndrome can be considered in cortico-resistance or cortico-dependence. Cyclosporin is an immunosuppressant with a narrow therapeutic range and large pharmacokinetics variability justifying its therapeutic drug monitoring (TDM). The aim of this study was to evaluate the TDM of cyclosporin by the measurement of AUC0-12h in patients with nephrotic syndrome and to study the correlations between the AUC0-12h and the different blood concentrations of cyclosporin. It is a retrospective study from 2009 to 2016. TDM of cyclosporin was carrying out by ARCHITECT®. Determination of the AUC0-12h was made from three samples taken at T0, T60min and T180min obtained by a model of population pharmacokinetics of cyclosporin. A total of 20 patients were evaluated (29 abbreviated kinetics). The median AUC0-12h was 4.76 mg*h/L. Considering the target 5 mg*h/L during the first 6 months, 6 AUC0-12h were sub-therapeutic and 5 supra-therapeutic, no AUC0-12h was in the therapeutic range. Considering the 3 mg*h/L as a target during the following months, 13 AUC0-12h among 18 were supra-therapeutic. A correlation coefficient between the AUC0-12h of cyclosporin and C0 was 0.798. Correlation between AUC0-12h and C2h was 0.909. The median C2h found in our work was 878 ng / mL during the first six months versus 1039 ng / mL in the following months. Our patients are overexposed to cyclosporin and TDM of this drug by determination of AUC0-12h or by C2h would be more interesting than TDM by C0. TDM allows a better individual dose adjustment to avoid especially toxicity of cyclosporin.

Published
2019

12. Response to clopidogrel and of the cytochrome CYP2C19 gene polymorphism.

Author

Charfi R, Mzoughi K, Boughalleb M, Hosni H, Kouidhi S, Sfar I, Hammami N, Zaïri I, Limam M, Zedini C, Mrabet A, Klouz A, Gorgi Y, Kharrat M, Baccar H, and Trabelsi S

Subjects
Adult, Aged, Aged, 80 and over, Cardiovascular Diseases chemically induced, Cardiovascular Diseases epidemiology, Cardiovascular Diseases genetics, Clopidogrel pharmacokinetics, Coronary Artery Disease drug therapy, Coronary Artery Disease epidemiology, Coronary Artery Disease metabolism, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions genetics, Female, Gene Frequency, Genetic Predisposition to Disease, Genotype, Genotyping Techniques, Hemorrhage chemically induced, Hemorrhage epidemiology, Heterozygote, Humans, Longitudinal Studies, Male, Middle Aged, Pharmacogenomic Testing, Polymorphism, Genetic, Tunisia epidemiology, Clopidogrel therapeutic use, Cytochrome P-450 CYP2C19 genetics
Abstract

Introduction: Clopidogrel (clopi) is a prodrug widely prescribed in the management of coronary artery disease and requires the intervention of hepatic cytochrome P450 2C19 (CYP2C19) for its activation. However, there is interindividual variability in response to clopi despite the use of recommended doses. Thus, the studies have highlighted the effect of the CYP2C19 gene polymorphism or Cyp2C19 gene on the response to clopi and particularly Cyp2C19 * 2 which may be associated with an increased risk of major cardiovascular events or MACE., Objective: To evaluate the effect of Cyp2C19 * 2 polymorphism on MACE occurrence and hemorrhagic complications in patients treated with clopi., Methods: We carried out a descriptive longitudinal study including 71 patients placed under clopi for a minimum duration of one month. Genotyping of the Cyp2C19 allele was performed by conventional polymerase chain reaction (PCR). After a follow-up period of 495 ± 183 days, we performed a statistical analysis to evaluate the association between the Cyp2C19 * 2 polymorphism and the occurrence of MACE or hemorrhagic complications., Results: Among our patients, 51% had an angioplasty, 42% medical treatment and 7% a coronary artery bypass surgery. In our study population, 52% were heterozygous (HTZ), 28% homozygous (HMZ) healthy * 1 / * 1 and 20% HMZ had the loss of function allele * 2 / * 2. The allelic frequency of Cyp2C19 * 2 was 46%. Follow-up mean duration was of 495 ± 183 days. During this period, the prevalence of MACE was 11% and that of hemorrhagic complications was 13%. In our study, we did not observe a significant association between the occurrence of MACE or hemorrhagic complications with the genotype carrying the Cyp2C19 * 2 allele., Conclusion: Among patients treated with clopi, wearing a Cyp2C19 * 2 function loss allele didn't seem to be associated with a significantly higher risk of MACE, nor a significantly lower risk of hemorragic complications. This suggests the necessity of larger studies.

Published
2018

13. Therapeutic monitoring of antiepileptic drugs in comatose patients.

Author

Charfi R, Mizouri R, Ben Sassi M, Eljebari H, Jebabli N, Ben Salem F, Zerei S, Mrabet A, Daghfous R, Klouz A, Salouage I, Gaies E, and Trabelsi S

Subjects
Adolescent, Adult, Aged, Child, Child, Preschool, Coma complications, Coma epidemiology, Drug-Related Side Effects and Adverse Reactions epidemiology, Epilepsy complications, Epilepsy epidemiology, Female, Humans, Infant, Male, Middle Aged, Retrospective Studies, Young Adult, Anticonvulsants therapeutic use, Coma drug therapy, Drug Monitoring methods, Epilepsy drug therapy
Abstract

Objective: In this study, we aimed to analyze the trough plasmatic levels (C0) of the antiepileptic drugs (AED) administered by nasogastric tubes (NGT) in comatose patients and to draw up recommendations for therapeutic drug monitoring (TDM) and for the modalities of AED administration by NGT., Methods: We conducted a retrospective study on comatose patients addressed over six years and 10 months in Clinical Pharmacology for C0 measurement of AED administered by NGT., Results: In this study, the sex-ratio was 2.38 (44 patients). The patients' median age was 24 years. There was 14.5% of children (≤16 years). Among the 103 samples, C0 measurement concerned valproic acid in 57%, phenobarbital in 28 % and carbamazepine in 15%. Two AED or more were associated in 42% of patients. AED were associated to other drugs in 85% of cases. The AED C0 were subtherapeutic in 71% of cases. C0/Dp lower than recommanded in 65 %. In these samples, 55% presented at least one drug association with the concerned AED. In 45% of the cases, there was no drug association but a non-respect of modalities of AED administration by NGT in patients., Conclusion:   The drug monitoring is a useful tool to assess drug-drug interactions and to control modalities of AED administration in comatose patients.

Published
2018

14. Progress and assessment of a contextualized teaching session of pharmacology.

Author

Charfi R, Ben Hamida E, Klouz A, Trabelsi S, and Loueslati MH

Subjects
Anticonvulsants therapeutic use, Clinical Competence, Cross-Sectional Studies, Education, Medical standards, Feasibility Studies, Humans, Personal Satisfaction, Pharmacology organization & administration, Practice Patterns, Physicians' standards, Students, Medical, Tunisia, Work Engagement, Education, Medical methods, Education, Medical organization & administration, Educational Measurement methods, Learning, Pharmacology education, Problem-Based Learning methods, Problem-Based Learning organization & administration, Problem-Based Learning standards
Abstract

Background: Learning transfer, in medical teaching, remains an essential question and optimizing it is the main preoccupation of every trainer in medical sciences. Some learning methods showed their efficacy as the contextualized learning in the framework of a professional activity or in a situation recalling it in a realistic manner., Aim: To describe steps of planning and progress of a session of clarification, illustration, application et participation (CIAP) of pharmacology teaching students from second cycle of medical studies (DCEM) and to assess the session., Methods: We performed a descriptive transversal study in April 2017 in the Faculty of Medicine of Tunis. Our work was composed of two parts. The first part consisted in a description of the preparation and the progress of the CIAP session entitled antiepileptic drugs, which is comprised in the pharmacology teaching of the certificate of Neurology to the students of DCEM. The second part consisted in an assessment of knowledge acquisition and the progress of the session by the students., Results: We proceeded to a planning of the session which resulted in a contextualized teaching and induced an active participation and an interactivity of the students. Comparison of the results of the pretest and the posttest showed a statistically significant difference in terms of good responses. The assessment of the session progress was good., Conclusion: Our study demonstrated the feasibility of a session of contextualized teaching session or CIAP of pharmacology and its input in terms of knowledge to the students.

Published
2018

15. Pharmacokinetik population of methotrexate in tunisian population with acute lymphoblastic leukemia.

Author

Jebabli N, Gaïes E, El Jebari H, Charfi R, Lakhal M, Klouz A, Salouage I, and Trabelsi S

Abstract

Background: The use of high dose of MTX in the treatment of the leukemia is actually better controlled by renal preparation, control of plasma concentrations and administration of folinic acid. However, High dose MTX has been proven to cause substantial toxicity and have high intra-and inter-patient variability. Population pharmacokinetic analysis is a useful tool for identification of sources of pharmacokinetic variability during anticancer drug development and can aid the design of alternative dosing regimens to enhance their efficacy and safety., Aim: The aim of our study is to developed and validate a population pharmacokinetics model of our population. We hereby describe the clinical covariates (age, sex and clearance of the creatinine) that influence MTX pharmacokinetic for predicting optimal dose to reduce MTX toxicity., Method: It is a prospective study achieved between January 2005 to January 2012 in the Service of Clinical Pharmacology. Including 273 patients treated for acute lymphocytic leukaemia 2582 plasma concentration was achieved. The data have been analyzed with Nonmem© software (non linear regression to mixed effect)., Results: The age of our patients varied from 2 to 23 years with an average of 13 years. The patients received high dose MTX therapy (1 to 8 g/m2) in 24 hours infusion every 15 days. Three compartiment models describe the pharmacokinetic of MTX. The most important covariables affecting the model were clearance of the creatinine, age and weight. We obtained a good correlation between the predicted and the observed concentrations., Conclusion: The development of population pharmacokinetics model of MTX allows us to propose a therapeutic diagram adapted to every patient according to its morphological and pharmacological features while taking in consideration the therapeutic objective.

Published
2015

16. [Development and validation of a new HPLC method for determination of Lamotrigine and clinical application].

Author

Jebabli N, Gaïes E, El Jebari H, Charfi R, Lakhal M, Klouz A, Trabelsi S, and Salouage I

Subjects
Adolescent, Adult, Child, Drug Monitoring methods, Female, Humans, Lamotrigine, Limit of Detection, Male, Middle Aged, Young Adult, Anticonvulsants blood, Chromatography, Liquid methods, Triazines blood
Abstract

Background: Lamotrigine is an effective anticonvulsant drug used in the treatment of epilepsy. It has a narrow therapeutic range, a large inter and intra-individual pharmacokinetic variability and some concentration-dependent side effects., Aim: The aim of this study was to develop and validate a new method for lamotrigine quantitation in plasma using HPLC with UV/visible detection., Methods: A rapid HPLC-UV method was developed for the determination of lamotrigine in plasma. All solvents used were HPLC grade., Results: After liquid-liquid extraction, chromatographic separation was achieved using an RP 18 (250 mm) column. The mobile phase was composed of acetonitrile and 0.1 M potassium dihyrogenophosphate (25/75) (v/v). Barbital sodium was used as internal standard. This technique was linear over the 2 μg/mL to 50 μg/mL range (r= 0.99). Detection and quantification limits were 0.07 μg/mL and 0.21 μg/mL, respectively. Within-day coefficient of variation (13.37 to 16 %) and day-to-day coefficients of variation (15.68 to 16.63 %) at three different concentrations. Under these conditions, each analysis required no longer than 10 min. We finally evaluated the plasma concentrations of lamotrigine in Tunisian patients treated with this drug., Conclusion: The results found are similar to those previously described and the developed method is repeatable and reproducible. It can be used for clinical applications.

Published
2015

17. [Cardiovascular complications of sleep apnea syndromes].

Author

Zakhama L, Benyoussef S, Boussabeh E, Jaafari A, Boukhris B, Thameur M, Fajraoui N, and Charfi R

Subjects
Adult, Aged, Arrhythmias, Cardiac epidemiology, Arrhythmias, Cardiac etiology, Cardiovascular Diseases epidemiology, Coronary Disease epidemiology, Coronary Disease etiology, Female, Heart Failure epidemiology, Heart Failure etiology, Humans, Hypertension epidemiology, Hypertension etiology, Hypertrophy, Left Ventricular epidemiology, Hypertrophy, Left Ventricular etiology, Incidence, Male, Middle Aged, Obesity complications, Polysomnography, Retrospective Studies, Sleep Apnea Syndromes diagnosis, Stroke epidemiology, Stroke etiology, Tunisia epidemiology, Cardiovascular Diseases etiology, Sleep Apnea Syndromes complications
Abstract

The high incidence of association between sleep apnea syndrome and cardiac disturbance was widely descripted during the last decade and has been the target of intensive investigation. Our retrospective study included 12 patients with sleep apnea syndrome diagnosed by polysomnography. 7 patients had HTA with left ventricular hypertrophy (5 cases). The CPAP stabilise blood pressure in 6 of them, 3 patients had ventricular or atrial arrhythmia. CPAP resolved 2 of them. 3 other patients had coronaropathy. Another one presented stoke. The sleep apnea syndrome has been descripted in association with heart failure or unstable HTA.

Published
2002

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