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2.
Ann Biol Clin (Paris) ; 77(4): 453-458, 2019 08 01.
Article in French | MEDLINE | ID: mdl-31418707

ABSTRACT

Infliximab (IFX) is a chimeric monoclonal antibody which has proven its efficacy in the treatment of inflammatory diseases. However, its efficacy can be limited by the development of anti-IFX antibodies (ATI) resulting in a therapeutic failure of IFX. ATI plasmatic monitoring is then indicated to optimize IFX treatment. The aim of this study was to validate an ELISA (enzyme linked immuno sorbent assay) method of ATI plasmatic monitoring. METHODS: Assessment of performance was based on the study of correlation and concordance (Bland Altman method) of the absorbances measured by the two readers. ELISA kit validation was made by calculating the accuracy and the exactitude. RESULTS: We collected 23 samples. Their mean age was 46 years and sex ratio M/W was 0.92. In nine cases, plasmatic AIT were positive and in 14 cases, they were not detected. Correlation between the two readers showed a correlation coefficient r2 of 99.95%. Concordance limits of the confidence interval 95% were [-112.768%-41.425%] with a bias of -35.671%. Repeatability and reproductibility were checked by a positive control and coefficients of variation were respectively of 5.574% and 14.184%. Limits of detection and quantification were respectively of 0.046 and 0.086. The positive predictive value was 0.5 and the negative predictive value was 1. The sensitivity was 100% and the specificity was 83%. CONCLUSION: The assessment of the performance of the tested microplate reader and the validation of the tested ELISA kit showed good results allowing ATI routine measurement to optimize therapeutic management of patients treated by IFX.


Subject(s)
Antibodies, Monoclonal/blood , Infliximab/immunology , Reagent Kits, Diagnostic , Serologic Tests/methods , Adult , Antibodies, Monoclonal/analysis , Drug Monitoring/methods , Enzyme-Linked Immunosorbent Assay/methods , Female , Humans , Male , Middle Aged , Prospective Studies , Reagent Kits, Diagnostic/standards , Rheumatic Diseases/blood , Rheumatic Diseases/diagnosis , Rheumatic Diseases/drug therapy , Sensitivity and Specificity , Spondylitis, Ankylosing/blood , Spondylitis, Ankylosing/diagnosis , Spondylitis, Ankylosing/drug therapy
3.
Therapie ; 74(5): 527-530, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31006486

ABSTRACT

BACKGROUND: Bullous fixed drug eruption (BFDE) is a rare and particular adverse drug reaction characterized by localized or generalized blisters and erosions, which can be confused with Stevens-Johnson syndrome, toxic epidermal necrolysis, major erythema multiforme and autoimmune bullous dermatosis. OBJECTIVE: The aim of our study was to assess the epidemiological, clinical and therapeutic features and outcome of BFDE. METHODS: A retrospective and descriptive study collecting all observations of BFDE was conducted in the dermatology department of Habib Thameur Hospital in Tunisia, over an 18-year period (2000-2017). The diagnosis of BFDE was confirmed by histopathological examination and all the patients underwent pharmacovigilance investigation. RESULTS: Totally, 18 cases were enrolled in our study with BFDE. The mean age was 57.9 years with a sex ratio M/F of 1. BFDE was localized in 8 cases and generalized in 10 cases. It was the first episode of BFDE in 11 patients and a recurrence in 7 patients. Drugs involved in the genesis of BFDE in our study were mainly non-steroidal anti-inflammatory drugs in 10 patients and antibiotics in 5 cases. Drug patch tests were performed in four patients on the residual plaques of FDE (fixed drug eruption) and were positive to the suspected drug. A favorable outcome was observed in all our patients under treatment and after suspected drug withdrawal. CONCLUSION: BFDE is a rare adverse drug reaction and could be severe especially when it presents as a generalized eruption. Drugs involved are mainly non-steroidal anti-inflammatory drugs followed by antibiotics.


Subject(s)
Drug Eruptions/pathology , Skin Diseases, Vesiculobullous/pathology , Anti-Bacterial Agents/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Drug Eruptions/diagnosis , Drug Eruptions/epidemiology , Female , Humans , Male , Middle Aged , Patch Tests , Recurrence , Skin Diseases, Vesiculobullous/chemically induced , Skin Diseases, Vesiculobullous/diagnosis , Skin Diseases, Vesiculobullous/epidemiology , Stevens-Johnson Syndrome/diagnosis , Stevens-Johnson Syndrome/pathology , Tunisia/epidemiology
5.
Tunis Med ; 96(2): 129-134, 2018 Feb.
Article in English | MEDLINE | ID: mdl-30324978

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.


Subject(s)
Anticonvulsants/therapeutic use , Coma/drug therapy , Drug Monitoring/methods , Epilepsy/drug therapy , 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
6.
Parasitology ; 143(12): 1622-8, 2016 10.
Article in English | MEDLINE | ID: mdl-27417681

ABSTRACT

In this study, the prevalence of piroplasms in dogs was assessed using polymerase chain reaction (PCR) to identify Babesia and Theileria species in 200 dogs from Northern and Central Tunisia between spring and autumn 2014. The overall molecular prevalence for piroplasms was 14·5% ± 0·05 (29/200); PCR detected 2 species, namely Babesia vogeli and Theileria annulata with an overall prevalence of 12·5 ± 0·04 and 2% ± 0·02, respectively. No differences in the molecular prevalences of B. vogeli were revealed for age and sex (P > 0·05). The molecular prevalence of B. vogeli was significantly higher in central Tunisia (26·5% ± 0·01) compared with the North (9·6% ± 0·04) (P 0·05). Comparison of the partial sequences of 18S rRNA and Tams 1 genes confirmed the presence of 2 novel B. vogeli and T. annulata genotypes. This is the first molecular detection of T. annulata and genetic characterization of dogs' piroplasms in Tunisia. Further studies are needed to better assess the epidemiological feature of piroplasms infection in North Africa.


Subject(s)
Babesia/isolation & purification , Babesiosis/epidemiology , Dog Diseases/epidemiology , Theileria/isolation & purification , Animals , Babesia/classification , Babesia/genetics , Babesiosis/parasitology , Cluster Analysis , DNA, Protozoan/chemistry , DNA, Protozoan/genetics , DNA, Ribosomal/chemistry , DNA, Ribosomal/genetics , Dog Diseases/parasitology , Dogs , Molecular Epidemiology , Phylogeny , Polymerase Chain Reaction , Prevalence , Protozoan Proteins/genetics , RNA, Ribosomal, 18S/genetics , Seasons , Sequence Analysis, DNA , Theileria/classification , Theileria/genetics , Tunisia/epidemiology
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