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ABSTRACT: Background: Mechanically ventilated patients are prone to develop ventilator associated pneumonia due to microaspirations of subglottic secretions around the endotracheal tube cuff (usually constructed of polyvinyl material). A novel polyurethane cuff has been designed to minimize these leakages. The aim of the study was to compare the tracheal sealing capacities between the two tubes. Methods: Twenty-nine consecutive patients from whom tracheal intubation was necessary as part of their care were randomized to receive either a polyvinyl HI-LO Evac® or a polyurethane SEALGUARD Evac® endotracheal tube. Patients requiring emergency intubation, with unstable hemodynamics or history of tracheal/laryngeal disease were excluded. For the entire study, cuff pressure was set at 30 cmH2O, and ventilator parameters were adjusted for a plateau pressure ≤30 cmH2O; Patients were fasting, placed in a strict 45° position during 12 hours and sedated if needed. After injection of 74 MBq 99mTc-DTPA diluted in 5ml 0.9% NaCl just above the cuff, tracheal radioactivity was assessed sequentially (hourly from T0 to T6, then T8 and T12 hours) using a scintillation camera. Results: Sixteen polyurethane and 13 polyvinyl tubes were compared. Leakages were observed in 11/29 patients (38%) [5/16 polyurethane and 6/13 polyvinyl tubes (p=NS)]. Leakages occurred more often in female (7/8) than in male patients (4/21) [p<0.001]. Microaspirations were decreased with larger tubes (size 9 vs ≤8.5: 24% vs 75%; p=0.01), whatever the cuff membrane. Conclusions:
Minerva anestesiologica 03/2013; · 2.66 Impact Factor
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ABSTRACT: Although the reliability of cyclosporine (CyA) concentration at 2 (C2) hours postdosing has been established for kidney, liver, and heart transplant recipients, its use in lung cases remains to be validated. We investigated the relationship between CyA dual time point monitoring and long-term functional outcomes after lung transplantation.
We included data from 38 lung transplant recipients receiving CyA, azathioprins, and steroids in the study. CyA dosages were based on the trough concentrations. CyA concentrations at 0 (C0) and 2 (C2) hours postdosing were obtained at 1, 2, 3, 6, 9, 12, 15, 18, and 24 months postoperative. We retrospectively compared average CyA level (C0 and C2) during the first 3 posttransplantation months with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), forced expiratory flow 25%-75 % (FEF 25-75), creatinine, systolic blood pressure (SBP), and diastolic blood pressure (DBP) using regression analysis via generalized estimating equations (GEE).
Only improvement in FVC (P = .033) and deterioration of SBP (P < .001) were related to C0 monitoring. No correlation was observed between C0 and FEV1 (P = .13), FEF 25-75 (P = .48), creatinine (P = .07), and DBP (P = .97). Nor was any relationship observed between C2 concentrations and FEV1 (P = .64), FVC (P = .38), FEF 25-75 (P = .09), creatinine (P = .95), SBP (P = .73), or DBP (P = .51).
There was a lack of a relationship between CyA concentrations (C0 and C2) and functional outcomes among de novo lung transplantations except for a positive correlation of 0 value with long-term improved FVC and increased SBP. This study suggested that C2 determinations may not improving lung recipient management.
Transplantation Proceedings 11/2012; 44(9):2880-4. · 1.00 Impact Factor
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ABSTRACT: BACKGROUND: This retrospective study compared the fast-track colon surgery program to conventional perioperative care and assessed factors that influence postoperative length of stay. DESIGN: This retrospective study included 124 fast-track and 119 conventional care colon surgical patients. Exclusion criteria were primary rectal disease, stoma, American Society of Anesthesiologists score IV, and Association Française de Chirurgie index 3 or 4. Laparoscopy was the preferred approach. Variables influencing length of stay were analyzed by multivariate linear and logistic regression. RESULTS: Overall mortality and complication rates were not significantly different between groups (fast-track vs. controls 0 vs. 0.8 %, 30.6 vs. 38.6 % respectively). As expected, median length of stay was significantly reduced in fast-track patients (3 vs. 6 days, p < 0.001), but emergency readmission rate was higher (16.9 vs. 7.6 %, p = 0.026), although rehospitalization rates were similar (8 vs. 4.2 %, not significant). Independent risk factors of increased length of stay were identified as age >69 years (p = 0.001), laparotomy (p = 0.011), and conventional perioperative care (p < 0.001). CONCLUSIONS: The introduction of a fast-track program reduced postoperative length of stay without increasing complication rate. This study proposes a modulation of the program according to patient age and surgical approach.
Surgical Endoscopy 10/2012; · 4.01 Impact Factor
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ABSTRACT: Microwave freeze-thaw treatment (MFTT) of injectable drugs can support the development of centralized intravenous admixtures services (CIVAS). The aim of this review is to collect information about the stability of cytotoxic and hazardous drugs after this treatment.
The scientific literature about drug stability studies was reviewed. The data describe the name of the drug, the manufacturer, the final concentration, the temperature and time of freezing storage, type of microwave oven, the thawing power, the measurement, the method and the results after treatment and final long-term storage at 5±3°C.
From 1980 to 2011, nine drugs (cyclophosphamide, cytarabine, daunorubicine, doxorubicine, epirubicine, fluorouracile, ganciclovir, methotrexate sodium, mitomycine C) were studied after MFTT and the results were presented in 10 publications. The storage freezing temperature ranged from -15°C to -30°C, the time storage from 14 to 364 days, the thaw from moderate to full power. High performance liquid chromatography is mainly used to measure drug concentrations. All drugs are stable during and after the treatment. However, mitomycine needs to be stored at -30°C. The long-term stability after MFTT was evaluated only for the ganciclovir after 7 days, and for fluorouracile after 28 days. The concentration of the seven drugs was measured after one to 11 freezing-thawing cycles with a loss below 5%.
This review can help the hospital pharmacist to take in charge the productions of nine dose-banded ready-to-use injectable cytotoxic and hazardous drugs. Freezing enhances their long-term stability without altering their chemical stability. Validated microwave thawing reduces the time of defrosting of these drugs at the studied concentrations.
Annales Pharmaceutiques Françaises 07/2012; 70(4):227-35.
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ABSTRACT: Although the disclosure of the diagnosis of Alzheimer's disease (AD) is recommended by several guidelines, many clinicians do not announce the diagnosis to their patient. One of the main arguments against disclosure is the fear of a depressive reaction. Our aim was to report the experience and agreement of patients and their caregivers regarding the disclosure of the diagnosis of AD. All the patients with a diagnosis of AD attending our memory clinic were screened during 1 year. The patients and their caregivers were interviewed with a structured questionnaire. We included 108 patients (mean age = 77; Mini-Mental State Examination = 21) and matched caregivers (mean age 65). Twenty-nine percent of patients said they had suffered when the diagnosis was disclosed and 5 % wished they had not been informed. Four percent felt more sad or depressed and 14 % more anxious since the disclosure. The caregivers reported that 32 % of patients had suffered from the disclosure, but only 15 % were still suffering. In 85 % of cases, the caregivers thought that the disclosure was useful. If they could go back in time and decide whether to disclose or not the diagnosis, only 4 % of caregivers would retrospectively disagree to disclose the diagnosis to the patient. The disclosure of AD can induce anxiety and sadness. However, these negative feelings seem to persist only in a minority of patients. The vast majority of patients and caregivers agrees with the disclosure.
Acta neurologica Belgica 04/2012; 112(3):249-54. · 0.54 Impact Factor
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Critical Care 04/2012; 8:1-2. · 4.93 Impact Factor
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ABSTRACT: Videolaryngoscope techniques are more and more in use and tend to modify our approach for patients difficult to intubate. We compared two techniques, Airtraq and Glidescope with direct laryngoscopy, with special emphasis on ease of access to airway (Intubation Difficulty Score - IDS score, duration and success of intubation) and the impact on hemodynamic variables among patients with a BMI of more than 30.
Prospective study randomised with minimisation technique.
Eighty patients have been allocated by minimisation to four groups: two groups being intubated with Airtraq, each one with a different investigator, and two with Glidescope videolaryngoscope technique. Induction of anesthesia was standardly performed with total intravenous anesthesia with remifentanil, propofol in TCI mode and rocuronium in bolus. Following parameters were recorded : intubation success based on intubation time and desaturation level, its duration, its impact on hemodynamic variables, IDS score and possible dental lesions.
Intubation success was 100% for Glidescope and 80.6% for Airtraq (P=0.009). Airtraq allowed a better visualisation of the vocal cords (lower Cormack and Lehane score) than Glidescope. In contrast, alternative intubation techniques were significantly more often used in the Airtraq group. No difference could be detected between both systems on hemodynamic parameters.
In obese patients, Glidescope allows intubation relatively easily without rescue techniques.
Annales francaises d'anesthesie et de reanimation 03/2012; 31(5):421-6. · 0.77 Impact Factor
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ABSTRACT: The aim of this study was to investigate the stability of a mixture of temocillin 20mg/ml in 5% dextrose and in 0.9% sodium chloride polyolefin bags after freezing, microwave thawing and long-term storage at 5±3°C.
The stability of ten polyolefin bags containing 20mg/ml of temocillin, five bags in 5% dextrose and five bags in 0.9% sodium chloride, prepared under aseptic conditions was studied after freezing for 1 month at -20°C, thawing in a microwave oven with a validated cycle, and stored at 5±3°C. Over 30 days, temocillin concentrations were measured by high-pressure liquid chromatography. Visual inspections, microscope observation, spectrophotometric measurements and pH measurements were also performed.
No precipitation occurred in the preparations but minor colour change was observed. No microaggregate was observed with optical microscopy or revealed by a change of absorbance. Based on a shelf life of 95% residual potency, temocillin infusions were stable at least 11 days in 5% dextrose and 14 days in 0.9% sodium chloride after freezing and microwave thawing (corresponding at the period where 95% lower confidence limit of the concentration-time profile remained superior to 95% of the initial concentration). During this period, the pH values of drug solutions have been observed to decrease without affecting chromatographic parameters.
Within these limits, temocillin in 5% dextrose and in 0.9% sodium chloride infusions may be prepared and frozen in advance by a centralized intravenous admixture service then thawed before use in clinical units.
Annales Pharmaceutiques Françaises 11/2011; 69(6):296-301.
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ABSTRACT: To compare outcomes after carotid endarterectomy (CEA) with saphenous vein patch closure (SV), with cervical vein (external jugular and common facial) patch closure (CV).
A total of 322 cases of CEA was achieved consecutively by using venous patch angioplasty. Propensity scores were calculated followed by a one-to-one basis case-matching.
This resulted into 90 SV and 90 CV matched cases.
The primary endpoint was the incidence of ipsilateral stroke and transient ischaemic attack at any time during follow-up.
Ten-year freedom from stroke was 94.1% ± 3.5% for the SV group and 90.5% ± 4.2% for the CV group (log rank P = 0.230). Ten-year freedom from ipsilateral neurological events (stroke and transient ischaemic attack) was 93.5% ± 3.3% for SV group and 92.4% ± 3.0% for the CV group (log rank P = 0.403). Ten-year freedom from ≥75% stenosis/occlusion was 93.1 ± 4.8% for the SV group and 89.9 ± 6.0% for the CV group (log rank P = 0.481).
CV is a good alternative to SV patching, particularly when the SV needs to be preserved for further use or is unsuitable.
European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 09/2011; 42(6):766-74. · 2.92 Impact Factor
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ABSTRACT: In hospitals, the majority of the reconstitution of injectable drugs are carried out right before the administration to the patient by the nursing staff. The risks and errors related on their preparation and administration are numerous. The standardization, the centralization of these preparations and reconstitution by the hospital pharmacy make it possible to reduce the various risks and errors To enhance the number of drugs taken in charge, it is necessary to develop the long-term stability of ready-to-use drugs. Freezing seems an easy method but defrosting takes too much time. Some authors develop the concept of microwave treatment and apply this to different drugs. A characteristic of these studies was nevertheless the short period of study after thawing.
Long-term stability studies were started for different drugs mainly used in the hospital, and verify their stability after freezing at temperature<- 25°C, long-term storage (1 to 4 months), microwave-thawing and long-term storage at 5 ± 3°C.
Sixteen molecules were tested and preserve more than 90% of their initial concentration the day of defrosting by microwave oven like this value a certain number of days at 5 ± 3°C. All the analyses were carried out by HPLC.
The microwave freeze/thawing treatment allows the production of more important batches, makes profit of this technique in workload and material beyond a certain produced quantity. The described results encourage to check the possibilities of taking in charge other molecules regularly used in the Hospital Institutions.
Annales Pharmaceutiques Françaises 09/2011; 69(5):270-6.
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ABSTRACT: This study aimed to assess long-term function after total perineal reconstruction (TPR) with dynamic graciloplasty (DG) and systematic Malone appendicostomy (MA) adjunction after abdominoperineal excision (APR) for rectal cancer.
From 1999 to 2004, TPR using DG and MA was performed in 10 patients [seven women; median age 40 (range 28-55) years] after APR for rectal cancer (cT2 in one patient, cT3 in six patients and cT4 in three patients). We prospectively recorded early and late morbidity, mortality, oncological outcome, functional results (using the modified Working Party on Anal Sphincter Replacement 'WPASR' scoring system) and quality of life (QoL; using the European Organisation for Research and Treatment of Cancer 'EORTC' QLQ-C30 and QLQ-CR38 questionnaires).
There was no procedure-related mortality. One patient required intra-abdominal re-operation. Nine patients required local and multiple revisions [there was one coloperineal anastomosis (CPA) stenosis, five CPA mucosal prolapse, three stenosis related to graciloplasty, two MA stenosis and one MA reflux]. After a median follow up of 78 months, there was no local recurrence and six patients were alive and disease-free. Regarding the functional results, the median modified WPASR score, of 8, after a follow up of 78 months, was good. The overall QoL scores remained stable over time.
In carefully selected patients who want to avoid definitive abdominal colostomy after APR for rectal cancer, reconstruction involving MA and DG after APR for low rectal cancer is followed by good long-term function and QoL.
Colorectal Disease 04/2011; 13(4):406-13. · 2.93 Impact Factor
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ABSTRACT: Reduction of exposure to sensitising agents causing occupational asthma has been proposed as an alternative to total avoidance in order to minimise the adverse socio-economic impact of the condition. The aim of this systematic review was to compare the effects of these two management options on asthma and socio-economic outcomes. A bibliographic search was conducted to identify studies examining the outcome of workers with occupational asthma after reduction or cessation of exposure to the causal agent. The changes in asthma symptoms and nonspecific bronchial hyperresponsiveness after reduction or cessation of exposure were described in nine and five studies, respectively. The meta-analysis of pooled data showed that a reduction of exposure was associated with a lower likelihood of improvement (OR 0.16, 95% CI 0.03-0.91) and recovery (OR 0.30, 95% CI 0.11-0.84) of asthma symptoms and a higher risk of worsening of the symptoms (OR 10.23, 95% CI 2.97-35.28) and nonspecific bronchial hyperresponsiveness (OR 5.65, 95% CI 1.11-28.82), compared with complete avoidance of exposure. This systematic review indicates that reduction of exposure cannot be routinely recommended as an alternative to cessation of exposure in the management of occupational asthma. However, further investigations are required before drawing evidence-based conclusions on the cost-effectiveness of this approach.
European Respiratory Journal 03/2011; 38(4):804-11. · 5.89 Impact Factor
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ABSTRACT: To compare whole-body MRI (WB-MRI) and axial skeleton MRI (AS-MRI) in detecting and measuring bone metastases in patients with prostate cancer (PCa).
WB-MRI and AS-MRI examinations were performed in 60 patients with PCa at high risk of metastases. Two radiologists separately categorised the AS-MRI and WB-MRI as negative or positive for metastases, and measured focal metastases using the "Response evaluation criteria in solid tumours" (RECIST) criteria transposed to bone. One radiologist reviewed all examinations 2 months later. Inter- and intraobserver agreements in establishing the presence/absence of metastases were calculated. Bland-Altman plots were used to assess measurement agreement between AS-MRI and WB-MRI.
Strong to perfect inter- and intraobserver agreements were found between AS-MRI and WB-MRI in defining the presence/absence of bone metastases. There were no patients with isolated "peripheral" metastases at WB-MRI, missed at AS-MRI. There was no difference in lesion count between the two radiologists. AS-MRI and WB-MRI provided statistically equivalent RECIST values for one radiologist and slightly lower values at AS-MRI for the other.
In our series of PCa patients, AS-MRI and WB-MRI were equivalent in determining the presence/absence of bone metastases and provided similar evaluation of the metastatic burden.
European Radiology 12/2010; 20(12):2973-82. · 3.22 Impact Factor
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ABSTRACT: The profile of recurrent ischemic strokes has not been much investigated. The aim of this study was to evaluate how the therapeutic strategies recommended for secondary prevention after an ischemic stroke are implemented in the real world of clinical practice. All patients admitted for a recurrent ischemic stroke or TIA were prospectively registered. The etiology was determined according to the TOAST classification. The risk factors and cardiovascular treatment at the time of the recurrence were recorded. A total of 168 patients were evaluated. Most of the patients (61%) recurred after 1 year. The recurrent stroke was not associated with a particular etiological subtype. The most frequent risk factor was hypertension (79%), followed by hypercholesterolemia (43%), smoking (25%), and diabetes (22%). Most of the patients had more than 1 risk factor (84%). Hypertension was not satisfactorily controlled in 38% of patients, hypercholesterolemia in 42%, and diabetes in 59%. A significant minority of patients (15%) were not taking any antithrombotic agent despite a history of stroke or TIA. Only 34% of the cases with a known atrial fibrillation were on anticoagulant therapy and the International Normalized Ratio was < 2.0 in 71% of them. In conclusion, stroke prevention needs to be improved by better implementation of therapeutic strategies in clinical practice. The patients should also be better informed about target values as well as the importance of physical activity and smoking cessation.
Acta neurologica Belgica 12/2010; 110(4):299-302. · 0.54 Impact Factor
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ABSTRACT: To investigate the stability of tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose solution stored at 5+/-3 degrees C.
Solutions of 5% dextrose 100ml in polyolefin bags (n=5) containing approximately tramadol hydrochloride 100mg associated with alizapride 50mg were prepared under aseptic conditions and stored about 32 days at 5+/-3 degrees C. The tramadol hydrochloride and alizapride concentrations were measured by high-performance liquid chromatography (HPLC). Visual inspection was performed and pH was measured periodically during the storage. Stability of the solutions was defined as the common regression line 95% lower confidence limit of the concentration remaining superior to 90% of the initial concentration as recommended by the Food and Drug Administration (FDA).
No color change or precipitation in the solutions was observed. Tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose infusions was stable when stored at 5+/-3 degrees C during 32 days. Throughout this period, the lower confidence limit of the estimated regression line of concentration-time profile remained above 90% of the initial concentration. There was no significant change in pH during storage.
Under the conditions of this study, tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose infusions stored up to 32 days at 5+/-3 degrees C remain stable and may be prepared in advance by a Centralized Intravenous Additive Service (CIVAS) to improve safety and management.
Annales Pharmaceutiques Françaises 05/2010; 68(3):157-62.
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ABSTRACT: To compare post aural soft tissues tolerance of the old and new titanium RetroX (Auric GmbH, Rheine, Germany) tube, and to compare the hearing improvements between the old (DSP-pro) and the new (Concertino) hearing aid units of the RetroX.
Retrospective case review of 46 patients with high-frequency sensorineural hearing loss, fitted with DSP-pro or Concertino, and who received 51 implantations (with the old or new generation titanium tube) in a tertiary referral center at a university hospital. The RetroX consists of an electronic unit situated in the postaural sulcus connected to a titanium tube implanted under the auricle between the sulcus and the external auditory meatus. Implanting requires minor surgery (10 minutes under local anaesthesia). Three months after their implantation, patients were asked to fill out a questionnaire to evaluate acoustic feedback annoyance and to undergo 3 audiometric tests: pure-tone audiometry in silence, speech audiometry in silence, and speech audiometry in noise.
The new tube is more reliable (12 explantations from patients who received 26 older tubes compared with 1 explantation in 25 who received new tubes) even if the size must be adjusted more often (2/26 for the old model and 5/25 for the new one). Concertino allows a higher amplification before feedback appears, which improves hearing gain.
The new RetroX is better tolerated than the older one, and improves hearing ability.
B-ENT 01/2010; 6(1):1-8.
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ABSTRACT: Preparation in advance of intravenous solution could be efficient to improve quality assurance, security, time management and cost saving of drug delivery. The aim of this study was to investigate the stability of a mixture of diclofenac 75 mg/100 ml and sodium bicarbonate 42 mg/100 ml in 5% glucose polyolefin bags after freezing, long-term storage, and microwave thawing.
The stability of five polyolefin bags containing approximately 75 mg/100ml of diclofenac and 42 mg/100ml of sodium bicarbonate in 5% glucose prepared under aseptic conditions was studied after freezing for 2 months at -20 degrees C, thawing in a microwave oven with a validated cycle, and stored at 5 + or - 3 degrees C. Diclofenac concentrations were measured by high-pressure liquid chromatography using a reversed-phase column, a mobile phase consisting of 40% of acetonitrile (v/v) in KH(2)PO(4) buffer 0.02 M, pH 8.40 + or - 0.05, and UV detection at 276.0 nm. Visual inspection, microscope observation, spectrophotometric measurements and pH measurement were also performed.
No colour change or precipitation occurred in the preparations. No microaggregate was observed with optical microscopy or revealed by a change of absorbance. Based on a shelf-life of 90% residual potency, diclofenac was stable for at least 30 days after freezing and microwave thawing, period where 95% lower confidence limit of the concentration-time profile remained superior to 90% of the initial concentration. During this period, the pH values of drug solutions have not been altered.
Within these limits, diclofenac in 5% glucose infusion may be prepared and frozen in advance by a centralized intravenous admixture service, then thawed before use in clinical units.
Annales Pharmaceutiques Françaises 11/2009; 67(6):427-32.
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ABSTRACT: Calcium levofolinate infusions could be prepared in advance by a centralized intravenous additive service (CIVAS) to improve safety and time management.
To investigate the effect of freezing, microwave thawing and long-term storage at 5 +/- 3 degrees C on the stability of calcium levofolinate in 5% dextrose solution.
Solutions of 250 mL of 5% dextrose in polyolefin bags (n = 5) containing approximately 400 mg of calcium levofolinate were prepared under aseptic conditions and frozen for 95 days at -20 degrees C. The solutions were then thawed using microwaves and stored at 5 +/- 3 degrees C for 1 month. The calcium levofolinate concentrations were measured by high performance liquid chromatography (HPLC). Visual inspection was performed and pH was measured periodically during the storage at 5 +/- 3 degrees C. Stability of the solution was defined as a concentration remaining superior to 90% of the initial concentration by regression analysis as recommended by the Food and Drug Administration (FDA).
No colour change or precipitation in the solutions was observed. Calcium levofolinate infusions were stable when stored at 5 +/- 3 degrees C during 1 month after freeze-thaw treatment. Throughout this period, the lower confidence limit of the estimated regression line of concentration-time profile remained above 90% of the initial concentration. Slight change in pH values from 6.52 +/- 0.01 to 6.50 +/- 0.01 during storage time did not affect retention time on HPLC and has no clinical consequence, the solutions remaining in the acceptable range for perfusion (4 <or= pH <or= 10).
Under the conditions of this study, calcium levofolinate in 5% dextrose infusion may be prepared, frozen in advance by CIVAS, and then microwave thawed before use. Such treatment extends long-term stability and releases pharmacist's time for major activities such as checking medication order errors.
Journal of Clinical Pharmacy and Therapeutics 09/2009; 34(4):423-8. · 1.57 Impact Factor
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ABSTRACT: To investigate the stability of tramadol hydrochloride 100mg associated with droperidol 2.5mg in 100ml of 5% dextrose solution stored at 5+/-3 degrees C.
Solutions of 5% dextrose 100ml in polyolefin bags (n=5) containing approximately tramadol hydrochloride 100mg associated with droperidol 2.5mg were prepared under aseptic conditions and stored about 32 days at 5+/-3 degrees C. The tramadol hydrochloride and droperidol concentrations were measured by high performance liquid chromatography (HPLC). Visual inspection was performed and pH was measured periodically during the storage. Stability of the solutions was defined as the common regression line 95% lower confidence limit of the concentration remaining superior to 90% of the initial concentration as recommended by the Food and Drug Administration (FDA).
No colour change or precipitation in the solutions was observed. Tramadol hydrochloride 100mg associated with droperidol 2.5mg in 100 ml of 5% dextrose infusions was stable when stored at 5+/-3 degrees C during 32 days. Throughout this period, the lower confidence limit of the estimated regression line of concentration-time profile remained above 90% of the initial concentration. There was no significant change in pH during storage.
Under the conditions of this study, tramadol hydrochloride 100mg associated with droperidol 2.5mg in 100 ml of 5% dextrose infusions stored up to 32 days at 5+/-3 degrees C remain stable and may be prepared in advance by CIVAS to improve safety and management.
Annales Pharmaceutiques Françaises 08/2009; 67(4):272-7.
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ABSTRACT: Basiliximab (BAS), an interleukin-2 monoclonal antibody, has shown promising results as induction therapy in liver and kidney transplantation. We compared the efficacy and patient tolerability of BAS and antithymocyte globulin (ATG) in lung transplantation (LTx).
The study included 37 patients in two groups (ATG and BAS, respectively). The indication for LTx was emphysema in 62.6% of patients in group 1 and 57.1% of patients in group 2. Mean (SD) patient characteristics compared in the two groups included age (52.0 [9.8] vs 54 [10.6] years), height (172.0 [10.1] vs 169 [7.55] cm), and weight (73.9 [15.3] vs 64.4 [14.2] kg) (P = .049). Induction therapy after LTx in the two groups was as follows: in 16 transplantation procedures (eight single and eight bilateral) performed between April 1998 and December 2002, ATG, 3 mg/kg/d for 3 days, was administered, and in 21 transplantation procedures (15 single and 6 bilateral) performed between January 2003 and July 2005, BAS, 20 mg on days 0 and 4, was given. Dosages of cyclosporine, azathioprine, and steroids for maintenance therapy were equivalent in the two groups. We retrospectively compared patient tolerability, occurrence of acute rejection or infection (from bacteria, cytomegalovirus [CMV], or Aspergillus), and outcomes between the two groups during 2 years of follow-up.
No cytokine-mediated reaction was observed in either group; however, there was a difference in hematologic effects. On day 2, mean (SD) platelet count was significantly lower in the ATG group at 113,500 (56,400)/mm(3) vs 151,900 (57,300)/mm(3) (P = .046). Because of severe thrombocytopenia, three patients could not be given ATG on day 3. The overall incidence of aspergillosis (18.8% vs 19.0%) and CMV infection (31% vs 57%) was similar in the two groups. However, when the recipient was CMV-positive and the donor was CMV-negative, the there was a clear trend (33.3% vs 88.9%). The number of acute rejection episodes was similar (43.8% vs 52.4%). Survival increased by 20% in the BAS group (P = .03).
In LTx, safety of BAS use is as good as or better than that of ATG, with no difference in acute rejection episodes or infections, with the possible exception of increased reactivation of CMV infection. Thus, BAS could be an alternative to ATG as induction therapy in LTx; however, further studies are necessary.
Transplantation Proceedings 04/2009; 41(2):607-9. · 1.00 Impact Factor
