PubMed | Medical Laboratory, CHU Dinant Godinne, Drug Stability Research Group and Scientific Support Unit
Type: Journal Article | Journal: Annales pharmaceutiques francaises | Year: 2016
Ketamine hydrochloride (Ketalar()) injection is often used as a general anesthetic agent. It is particularly suited to short-term interventions. It can also be used as an inducer of anesthesia before the administration of other anesthetic agents. The aim of this study was to evaluate the stability of ketamine hydrochloride in 3ml polypropylene syringes after storage for up to 180days at room temperature.Syringes containing ketamine hydrochloride (50mg/ml) were prepared and stored at room temperature (25C) for 180days. The concentrations were measured by validated ultra-performance liquid chromatography-diode array detection at 0, 7, 14, 28, 60, 84, 112, 140 and 180days. A degradation test was performed to evaluate the specificity of the analysis. At each time point, the pH, color and visible particles of each solution were also assessed.Degradation tests proved no interfering peaks with ketamine. All solutions were physically stable during the storage. The lower confidence limit of the concentration for these solutions remains superior to 90% of the initial concentration at this date as recommended by the Food and Drug Administration (FDA) until 180days (100%2%).Solutions of ketamine (50mg/ml) were chemically stable for 180days in polypropylene syringes with storage at room temperature and could be prepared in advance by a centralized intravenous admixture service.
PubMed | AZ Sint Trudo, AZ Sint Andries, Hopital De Jolimont, Sainte Elisabeth and 19 more.
Type: Journal Article | Journal: Urologic oncology | Year: 2016
Abiraterone acetate (AA) is licensed for treating metastatic castration-resistant prostate cancer (mCRPC). Real-world data on oncological outcome after AA are scarce. The current study assesses efficacy and safety of AA in mCRPC patients previously treated with docetaxel who started treatment during the Belgian compassionate use program (January 2011-July 2012).Records from 368 patients with mCRPC from 23 different Belgian hospitals who started AA 1000mg per day with 10mg prednisone or equivalent were retrospectively reviewed (September 2013-December 2014). Prostate-specific antigen (PSA) response (decrease50%), time to PSA progression (increase>50% over PSA nadir in case of PSA response/>25% in absence of PSA response), time to radiographic progression (on bone scans or for soft tissue lesions using Response Evaluation Criteria In Solid Tumors 1.1), overall survival and adverse event rate (Common Terminology Criteria for Adverse Events v4.03) were analyzed. Kaplan-Meier statistics were applied.Overall, 92 patients (25%) had an Eastern Cooperative Oncology Group performance status2. Median age was 73 years, median PSA was 103ng/dl. PSA response was observed in 131 patients (37.4%). Median time to PSA and radiographic progression was 4.1 months (95% CI: 3.6-4.6) and 5.8 months (5.3-6.4), respectively. Median overall survival was 15.1 months (13.6-16.6). Most common grade 3 to 4 adverse events were anemia (13.9%), hypokalemia (7.3%), fatigue (6.8%), and pain (6.3%). Median duration of AA treatment was 5.3 months (interquartile range: 2.8-10.3). The main study limitation is its retrospective design.These real-world data on post-docetaxel AA efficacy are in line with the COU-AA-301 trial. Importantly, incidence of severe anemia and hypokalemia is up to 50% higher than reported in previous studies.
PubMed | AP HP Hopital Necker, CHU Dinant Godinne, CNRS Informatics Systems Laboratory, Laboratoire Of Pathologie and 10 more.
Type: Journal Article | Journal: Clinical cancer research : an official journal of the American Association for Cancer Research | Year: 2016
Next-generation sequencing (NGS) has detailed the genomic characterization of diffuse large B-cell lymphoma (DLBCL) by identifying recurrent somatic mutations. We set out to design a clinically feasible NGS panel focusing on genes whose mutations hold potential therapeutic impact. Furthermore, for the first time, we evaluated the prognostic value of these mutations in prospective clinical trials.A Lymphopanel was designed to identify mutations in 34 genes, selected according to literature and a whole exome sequencing study of relapsed/refractory DLBCL patients. The tumor DNA of 215 patients with CD20(+)de novo DLBCL in the prospective, multicenter, and randomized LNH-03B LYSA clinical trials was sequenced to deep, uniform coverage with the Lymphopanel. Cell-of-origin molecular classification was obtained through gene expression profiling with HGU133+2.0 Affymetrix GeneChip arrays.The Lymphopanel was informative for 96% of patients. A clear depiction of DLBCL subtype molecular heterogeneity was uncovered with the Lymphopanel, confirming that activated B-cell-like (ABC), germinal center B-cell like (GCB), and primary mediastinal B-cell lymphoma (PMBL) are frequently affected by mutations in NF-B, epigenetic, and JAK-STAT pathways, respectively. Novel truncating immunity pathway, ITPKB, MFHAS1, and XPO1 mutations were identified as highly enriched in PMBL. Notably, TNFAIP3 and GNA13 mutations in ABC patients treated with R-CHOP were associated with significantly less favorable prognoses.This study demonstrates the contribution of NGS with a consensus gene panel to personalized therapy in DLBCL, highlighting the molecular heterogeneity of subtypes and identifying somatic mutations with therapeutic and prognostic impact. Clin Cancer Res; 22(12); 2919-28. 2016 AACRSee related commentary by Lim and Elenitoba-Johnson, p. 2829.
Consequences burden on endometriosis: The downside for endometriosis Pregnancy Complications [Consecintele sarcinii asupra endometriozei : Reversul medaliei pentru endometrioza si complicatiile sarcinii]
Plopa N.D.,CHU Dinant Godinne |
Lupascu I.A.,Maternitatea Cuza Voda
Obstetrica si Ginecologie | Year: 2014
The consequences of endometriosis on decidualization process as well on placenta formation are well studied and is known that patients with endometriosis have higher risk of obstetrics complications than the general population. The pregnancy may also influence the endometriosis but usually this influence is favorable with the regression of the disease. There are the rare but serious complications such as bowel perforation in deep endometriosis, the spontaneous hemoperitoneum in pregnancy (SHiP) in pelvic endometriosis or malignant transformation of ovarian endometrioma. Endometrioma growth with rupture or abcess transformation as well as bowel endometriotic lesion evolution may also be possible. All these complications may occur due to different behavior of endometriotic lesions in the context of pregnancy. Clinician awareness regardind these complications and the identification of patients at risk could decrease morbidity and maternal and fetal mortality linked to this type of complications. © 2014, Romanian Society of Obstetrics and Gynecology. All rights reserved.
PubMed | CHU Dinant Godinne and cliniques universitaires Saint Luc
Type: Journal Article | Journal: Anaesthesia, critical care & pain medicine | Year: 2016
To determine the main causes for unplanned admission of children to the paediatric intensive care unit (PICU) following anaesthesia in our centre. To compare the results with previous publications and propose a data sheet for the prospective collection of such information.Inclusion criteria were any patient under 16 years who had an unplanned post-anaesthetic admission to the PICU from 1999 to 2010 in our university hospital. Age, ASA score, type of procedure, origin and causes of the incident(s) that prompted admission and time of the admission decision were recorded.Out of a total of 44,559 paediatric interventions performed under anaesthesia during the study period, 85 were followed with an unplanned admission to the PICU: 67% of patients were younger than 5years old. Their ASA status distribution from I to IV was 13, 47, 39 and 1%, respectively. The cause of admission was anaesthetic, surgical or mixed in 50, 37 and 13% of cases, respectively. The main causes of anaesthesia-related admission were respiratory or airway management problems (44%) and cardiac catheterisation complications (29%). In 62%, the admission decision was taken in the operating room.Unplanned admission to the PICU after general anaesthesia is a rare event. In our series, most cases were less than 5years old and were associated with at least one comorbidity. The main cause of admission was respiratory distress and the main type of procedure associated with admission was cardiac catheterisation.
Andre M.P.E.,CHU Dinant Godinne
Hematology/Oncology Clinics of North America | Year: 2014
Combination chemoradiotherapy achieves excellent results for the treatment of localized Hodgkin lymphoma. However, late toxic effects occur, mostly related to the radiotherapy administered after the standard adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy. The most serious sequelae are radiation-induced secondary cancers. Reducing radiotherapy has not yet prevented late malignancies. However, when radiotherapy was omitted, tumor control was inferior, with more relapses necessitating rescue treatment including high-dose chemotherapy with stem cell support. Early fluorodeoxyglucose positron emission tomography performed after a few cycles of ABVD is evaluated in several randomized trials to identify patients who might be safely treated with chemotherapy alone. © 2014 Elsevier Inc.
Management of obscure gastrointestinal bleeding...: "Fecal occult blood in colon cancer screening: Innovations in endoscopic techniques and video capsule examination..." [Prise en charge du saignement digestif d'origine indéterminée]
Druez A.,CHU Dinant Godinne |
Ronde Th.D.,CHU Dinant Godinne
Louvain Medical | Year: 2014
Upper and lower gastrointestinal endoscopy with gastric and duodenal biopsies leads to the diagnosis of obscure gastrointestinal bleeding in the majority of cases. These examinations can be repeated if they were performed following inadequate preparation or under poor tolerance conditions. If the bleeding source can still not be identified, small-bowel video capsule endoscopy is then the investigation of choice. Small bowel explorations by entero-CT and entero-MRI allow for inflammatory lesions or small bowel tumors to be identified. Single- or double-balloon enteroscopy is primarily reserved for the treatment or confirmation of a small bowel lesion visualized by video capsule or radiological examination.
PubMed | CHU Dinant Godinne
Type: | Journal: Journal de pharmacie de Belgique | Year: 2015
Dose-banding is a concept of cytotoxic drugs standardization allowing the preparation in advance of standardized rounded doses (SRD covering the most frequently prescribed doses rounded to +/-5%. Standard doses will be prepared in advance by batch in order to increase production capacity and at the same time to regulate pharmacy workflow as well as to reduce patient waiting time.To identify anticancer drugs suitable for dose banding and to fix standardized doses.The interesting molecules are first selected in accordance with several criteria: preparations frequency, long-term physicochemical stability after reconstitution, repetition of the prescribed doses and savings opportunity. The selected molecules were: Carboplatin, Cetuximab, Cisplatin, Cyclophosphamide, Doxorubicin, 5-Fluorouracil, Gemcitabine, Oxaliplatine, Paclitaxel, Rituximab, Trastuzumab and Vinorelbine. We established an inventory of the prescriptions retrospectively for a period of six months in order to highlight the most often prescribed doses. For the analysis, we fixed bands with a standard deviation of +/- 5%, 7% and +/- 10%.Standardization of doses of chemotherapy was deemed interesting if > or =60% of the doses were standardisable with a maximum of five SRD and a minimum of one delivery per week, in order to guarantee a good turnover of the batch. A maximum of 5% standard deviation is added to those three criteria, the deviation currently accepted among our medical staff. After analyzing 3506 prescriptions, 7 molecules are eligible: Doxorubicine, 5-Fluorouracil infusion, 5-Fluorouracil pump, Gemcitabine, Paclitaxel, Rituximab, Trastuzumab and Vinorelbine, with a percentage of standardisation of 77% [SRD: 30 mg), 61% [SRD: 700 mg, 750 mg, 800 mgl, 75% (SRD: 4000 mg, 4500 mg, 5000 mg), 72% [SRD: 1600 mg, 1800 mg, 2000 mg), 61% [SRD: 140 mg, 150 mg, 160 mgl, 64% (SRD: 600 mg, 700 mg, 750 mg], 71% (SRD: 350 mg, 400 mg. 450 mgl et 62% [SRD: 40 mg, 50 mg] respectively.This preliminary study allows us to consider implementing the dose banding concept in order to optimize the chemotherapy circuit at our institution.
PubMed | CHU Dinant Godinne
Type: Journal Article | Journal: Acta chirurgica Belgica | Year: 2016
Typical presentation of subacute thyroiditis (SAT) is an anterior neck pain radiating up to the jaw and ear, often associated with asthenia and fever. Biology shows hyperthyroidism and inflammation. The thyroid uptake is low at scintigraphy. However, the clinical presentation of SAT may be misleading. We report two cases of SAT whose initial manifestation was a painful thyroid nodule suspected of malignancy. In both cases, ultrasound feature was a heterogeneous, hypoechoic, ill-defined area with a low vascularization on colour Doppler. These areas were interpreted by radiologist as nodules. Surgery was then considered. Such a presentation should be known by clinicians to prevent unnecessary surgery.
PubMed | CHU Dinant Godinne
Type: Journal Article | Journal: European journal of clinical investigation | Year: 2014
The impact of an elevation of cardiac biomarkers occurring after percutaneous coronary intervention (PCI) on long-term outcome remains controversial. Most available data are based on observational registries using multivariable analysis. In this study, a case-control approach was used to assess separately the impact of post-PCI elevation of CK-MB on the short-term in-hospital outcome and on the long-term outcome after hospital discharge.Between 1 January 1996 and 31 December 2008, a postprocedural rise of CK-MB was observed in 363 among 8346 consecutive PCI procedures (43%). The overall in-hospital mortality for patients with or without CK-MB elevation after PCI was 85% and 15%, respectively (P < 0001). For 245 hospital survivors with CK-MB elevation, we found 245 control cases matched for 9 relevant clinical parameters in our PCI database during the same period. The long-term survival of these patients was assessed by KM estimates.Despite an increased in-hospital mortality among patients with periprocedural elevation of CK-MB, the long-term outcome of patients who are discharged alive is independent of CK-MB release, curves of overall survival and of survival free of recurrence of myocardial infarction being similar up to 10 years after hospital discharge.In our population, the elevation of CK-MB after PCI identified a high-risk subgroup for in-hospital mortality but had no impact on the long-term prognosis, once the patient is discharged alive from the hospital.