scholarly journals Clinical Use of Lymphocyte Subset Analysis: As a Prognostic Marker for Dogs with Pyometra

2021 ◽  
Author(s):  
Shunya Yokota ◽  
Masashi YUKI ◽  
Kohei Fujikake ◽  
Kenichi Masuda ◽  
Takashi Hirano ◽  
...  
Keyword(s):  
Adverse Events ◽  
Small Animal ◽  
Reference Interval ◽  
Lymphocyte Subset ◽  
Clinical Usefulness ◽  
Multivariable Logistic Regression Analysis ◽  
Common Disease ◽  
Subset Analysis ◽  
Group 2 ◽  
Group 1

Abstract BackgroundLymphocyte subset analysis is clinically applied in human medicine. However, lymphocyte subset analysis is rarely used in small animal practice. We hypothesized that lymphocyte subsets analysis was useful in small animal practice as a biomarker for evaluating immune competence and predicting the disease prognosis. Lymphocyte subset analysis was performed prospectively for pyometra, a common disease in dogs, to assess its clinical usefulness in small animal practice.ResultsThis study included 29 dogs diagnosed with pyometra. They were classified into group 1 and group 2 on the basis of clinical course postoperatively. Sixteen dogs were classified in group 1 with no adverse events postoperatively. Thirteen dogs experienced adverse events such as increase in C-reactive protein concentration and white blood cell count, discharge from operation site, and hypoglycemia. These dogs were classified as group 2. Nine dogs were below the reference interval for the lymphocyte subset, eight of which were in group 2. Group 2 included significantly more dogs with lymphocyte subset abnormalities (p = 0.005). In the multivariable logistic regression analysis, only the result of lymphocyte subset analysis was significantly associated with adverse events (p = 0.02, 95% confidence interval = 1.68–192). Most dogs in group 2 were successfully treated.ConclusionsThese results indicate that lymphocyte subset analysis is useful as a prognostic tool for pyometra. Further studies are necessary for evaluating the clinical usefulness of lymphocyte subset analysis in pyometra and other diseases.

Effect of bandaging on postoperative swelling after tibial plateau levelling osteotomy

2010 ◽  
Vol 23 (04) ◽  
pp. 240-244 ◽  
Author(s):  
J.K. Roush ◽  
K. L. Bilicki ◽  
G.Baker. Baker ◽  
M.D. Unis
Keyword(s):  
Tibial Plateau ◽  
Case Series ◽  
Small Animal ◽  
Significant Linear Correlation ◽  
Significant Difference ◽  
Group 2 ◽  
Prospective Case Series ◽  
Distal Aspect ◽  
Postoperative Swelling ◽  
Group 1

Summary Objective: To compare the effects of bandaging on immediate postoperative swelling using a modified Robert-Jones bandage after tibial plateau levelling osteotomy (TPLO) in dogs. Study design: Prospective case series. Methods: Dogs undergoing a TPLO were randomly placed into two groups. Group 1 received a modified Robert-Jones bandage postoperatively for a 24 hour period and Group 2 was not bandaged. Hindlimb circumference was measured at the level of the mid-patella, the distal aspect of the tibial crest, the midpoint of the tibial diaphysis and the hock. Measurements were recorded and compared in each group preoperatively and at 24 hours and 48 hours post-operatively. Interobserver variability was compared between the two observers. Results: There was no significant difference in postoperative swelling, as measured by the percentage change in circumference, between bandaged and unbandaged operated limbs after the TPLO at 24 and 48 hours at any site. Some significant differences in measurement at particular sites were observed between the two different observers, but there was a significant linear correlation at all sites between observers. The observer with the least experience consistently had slightly higher measurements at these sites. Clinical relevance: The use of a modified Robert-Jones bandage after TPLO did not prevent statistically significant postoperative swelling, and thus may not be indicated for this purpose. Postoperative bandages placed to control swelling after other small animal orthopaedic procedures should be evaluated individually for efficacy.

scholarly journals The Threshold of Admission Glycemia as a Predictor of Adverse Events in Diabetic and Non-Diabetic Patients with Acute Coronary Syndrome

2009 ◽  
Vol 3 ◽  
pp. CMC.S2289 ◽  
Author(s):  
Taysir S. Garadah ◽  
Salah Kassab ◽  
Qasim M. Al-Shboul ◽  
Abdulhai Alawadi
Keyword(s):  
Acute Coronary Syndrome ◽  
Adverse Events ◽  
Diabetic Patients ◽  
Stress Hyperglycemia ◽  
Coronary Syndrome ◽  
History Of ◽  
Group 3 ◽  
Group 2 ◽  
High Level ◽  
Group 1

Recent studies indicated a high prevalence of hyperglycemia in non-diabetic patients presenting with acute coronary syndrome (ACS). However, the threshold of admission glucose (AG) as a predictor of adverse events in ACS is unclear. Objective The aim of this study was to assess the threshold of admission glucose (AG) as a predictor of adverse events including Major Acute Cardiac Events (MACE) and mortality, during the first week of admitting patients presenting with ACS. Material and Methods The data of 551 patients with ACS were extracted and evaluated. Patients were stratified according to their blood glucose on admission into three groups: group 1: <7 mmol/L (n = 200, 36.3%) and group 2: >7 mmol/L and <15 mmol/L (n = 178, 32.3%) and group 3: ≥15 mmol/L (n = 173, 31.4%). Stress hyperglycemia was arbitrarily defined as AG levels > 7 mmol/L (group 2 and 3). Patients with ACS were sub-divided into two groups: patients with unstable angina (UA, n = 285) and those with ST segment elevation myocardial Infarction (STEMI, n = 266) and data were analyzed separately using multiple regression analysis. Results The mean age of patients was 59.7 ± 14.8 years and 63% were males. The overall mortality in the population was 8.5% (5.4% in STEMI and 3.1% in UA) patients. In STEMI patients, the odds ratio of stress hyperglycemia as predictor of mortality in group 3 compared with group 1 was 3.3 (CI 0.99-10.98, P < 0.05), while in group 2 compared with group 1 was 2.4 (CI: 0.75-8.07, P = 0.065) after adjustment for age and sex. Similarly, in UA patients, the odds ratio of stress hyperglycemia in group 3 compared with group 1 was 2.7 (CI 0.37-18.98, P < 0.05), while in group 2 compared with group 1 was 2.4 (CI: 0.4-15.2, P = 0.344) after adjustment for age and sex. The incidence of more than 2 MACE in both STEMI and UA patients was higher in group 3 compared with the other two groups. Regression analysis showed that history of DM, high level of LDL cholesterol, high level of HbA1c, and anterior infarction were significant predictors of adverse events while other risk factors such as BMI, history of hypertension and smoking were of no significance. Conclusion This study indicates that the stress hyperglycemia on admission is a powerful predictor of increased major adverse events and hospital mortality in patients with acute coronary syndrome.

scholarly journals Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study

2021 ◽  
Author(s):  
Benjamin Gaborit ◽  
Eric Dailly ◽  
Bernard Vanhove ◽  
Régis Josien ◽  
Karine Lacombe ◽  
...  
Keyword(s):  
Adverse Events ◽  
High Serum ◽  
Serum Concentrations ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Good Tolerability ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. To evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia. Methods : In this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5mg/kg at day 1 and day 5 (group 1), 2mg/kg at day 1 and day 5 (group 2), 2mg/kg at day 1 (group 3) or placebo. Results : Eighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (μg/mL, median, range) at C max and at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/mL (tow fold the in vitro 100% inhibitory concentration [IC 100 ]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug. Conclusions : Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384

scholarly journals Does Teleradiology Improve Inter-hospital Management of Head-Injury?

1997 ◽  
Vol 24 (3) ◽  
pp. 235-239 ◽  
Keyword(s):  
Head Injury ◽  
Adverse Events ◽  
Hospital Management ◽  
District General Hospital ◽  
Therapeutic Interventions ◽  
Head Injured ◽  
Hospital Transfer ◽  
Group 2 ◽  
Injured Patients ◽  
Group 1

ABSTRACT:Objective:In many countries, neurosurgical care is concentrated in regional centres, which often necessitates the inter-hospital transfer of patients with head injury for optimal treatment. The aim of this study was to evaluate the role of teleradiology in the management of head-injured patients when referred from a district general hospital to a tertiary neurosurgical centre.Methods:Prospective data were collected over a fifteen month period from March '95 to May '96. Head-injured patients referred without the facility of teleradiology (Group 1), were compared to similar patients referred with teleradiologie images (Group 2), with particular regard to therapeutic intervention before transfer and adverse events during transfer.Results:There were 28 patients in Group 1 and 35 in Group 2, of which 31 were transferred. Both groups were comparable with respect to age, admission Glasgow Coma Scale score, and intracranial pathology. For patients transferred with teleradiology consultation (Group 2), therapeutic interventions were more (32.1% vs. 10.7%, p = 0.06), adverse events during transfer were significantly lower (6.4% vs. 32.1%, p = 0.01), and transfer time was reduced (72 vs. 80 minutes, p = 0.38). Four patients in Group 2 were treated by a mobile neurosurgical team at the referring hospital because of rapid clinical deterioration.Conclusion:Our findings indicate that teleradiology has an important role in improving inter-hospital management of head-injured patients.

Abstract 16929: Are Patients Implanted with a Ventricular Assist Device as Destination Therapy Created Equal? Analysis of Outcomes by Implant Indications

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Simon Maltais ◽  
Mary E Davis ◽  
Nicholas A Haglund ◽  
John A Schirger ◽  
Keith Aaronson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Ventricular Assist Device ◽  
Left Ventricular ◽  
Advanced Age ◽  
Destination Therapy ◽  
Gi Bleeding ◽  
Assist Device ◽  
Ventricular Assist ◽  
Group 2 ◽  
Group 1

Introduction: A growing number of patients are implanted with a continuous-flow left ventricular assist device (CF-LVAD) for destination therapy (DT). Hypothesis: We sought to determine if indication for DT was associated with adverse events and survival. Methods: Between May 2004 and May 2014, 211 patients (age 66 (19-82), 89% male) underwent implantation of a HeartMate II CF-LVAD. The cohort was stratified according to primary listed indication for DT at time of implant: Group 1=advanced age (n=124, 59%); Group 2=high BMI (n=33, 16%), and Group 3=end-organ comorbidities (n=54, 25%). DT patients who later became BTT were eliminated for homogeneity. Results: Follow-up was available in all patients for a total of 376 patient-years of support (median 1.4 years). Preoperative characteristics (creatinine 1.5, INTERMACS 3, IABP 49%) were comparable between groups (all p>0.05). Overall 1, 3 and 5-year survival was 81%, 58%, and 41%, respectively. Kaplan-Meier analysis revealed comparable survival between groups stratified by DT indications (Figure, p=0.07). While gastrointestinal (GI) bleeding was more frequent in patients implanted for advanced age DT indications (p=0.01, group 1 vs group 2 and 3), the incidence of adverse events (pump thrombus/exchange, stroke) was comparable between groups. After adjusting for covariates (creatinine, hemoglobin, prior sternotomy and diabetes), Cox regression analysis demonstrated only preoperative renal dysfunction (HR 1.86 CI 1.28, 2.69; p=0.001) and lower Hemoglobin (HR 0.82 CI 0.71, 0.95; p=0.008) were associated with late mortality after implantation. Conclusions: Advanced age remains the most frequent contemporary indication for DT in patients undergoing CF-LVAD implantation. Indication for DT implantation does not influence long-term survival. Elderly patients may be at greater risk of GI bleeding events. These results continue to favor a uniform selection process across the spectrum of DT indications.

scholarly journals Treatment of Optic Canal Decompression Combined with Umbilical Cord Mesenchymal Stem (Stromal) Cells for Indirect Traumatic Optic Neuropathy: A Phase 1 Clinical Trial

2020 ◽  
Vol 64 (3) ◽  
pp. 398-404
Author(s):  
Jia Li ◽  
Xu Bai ◽  
Xiaoyue Guan ◽  
Hongfeng Yuan ◽  
Xiang Xu
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Phase 1 ◽  
Optic Canal ◽  
Traumatic Optic Neuropathy ◽  
Corrected Visual Acuity ◽  
Group 2 ◽  
Best Corrected Visual Acuity ◽  
Group 1

<b><i>Purpose:</i></b> This study was aimed to investigate the safety and feasibility of umbilical cord-derived mesenchymal stem cell (MSC) transplantation in patients with traumatic optic neuropathy (TON). <b><i>Methods:</i></b> This is a single-center, prospective, open-labeled phase 1 study that enrolled 20 patients with TON. Patients consecutively underwent either optic canal decompression combined with MSC local implantation treatment (group 1) or only optic canal decompression (group 2). Patients were evaluated on the first day, seventh day, first month, third month, and sixth month postoperatively. Adverse events, such as fever, urticarial lesions, nasal infection, and death, were recorded at each visit. The primary outcome was changes in best-corrected visual acuity. The secondary outcomes were changes in color vision, relative afferent pupillary defect, and flash visual evoked potential. <b><i>Results:</i></b> All 20 patients completed the 6-month follow-up. None of them had any systemic or ocular complications. The change in best-corrected visual acuity at follow-up was not significantly different between group 1 and group 2 (<i>p</i> &#x3e; 0.05); however, group 1 showed better visual outcome than group 2. Both groups showed significant improvements in vision compared with the baseline (<i>p</i> &#x3c; 0.05); however, there were no statistically significant differences between the groups (<i>p</i> &#x3e; 0.05). In addition, no adverse events related to local transplantation were observed in the patients. <b><i>Conclusions:</i></b> A single, local MSC transplantation in the optic nerve is safe for patients with TON.

scholarly journals DOES AGE INFLUENCE IN ENDOSCOPIC THERAPEUTIC SUCCESS ON THE BILIARY TRACT?

2021 ◽  
Vol 34 (3) ◽  
Author(s):  
Luciano HYBNER ◽  
Fernando Issamu TABUSHI ◽  
Luis Martins COLLAÇO ◽  
Érika Gomes DA ROSA ◽  
Bruno de Faria Melquíades DA ROCHA ◽  
...  
Keyword(s):  
Adverse Events ◽  
Biliary Tract ◽  
Acute Cholangitis ◽  
Young Patients ◽  
Therapeutic Success ◽  
Adequate Treatment ◽  
Number Of Patients ◽  
Endoscopic Cholangiopancreatography ◽  
Group 2 ◽  
Group 1

ABSTRACT Background: Retrograde endoscopic cholangiopancreatography (ERCP) effectively treats biliary and pancreatic disorders. Its indications are limited and precise, since its misuse delays adequate treatment, increases costs and to patient´s adverse events. Aim: To compare clinical, radiological and exploratory characteristics in relation to therapeutic success in patients undergoing ERCP in relation to age. Method: 421 patients who underwent the method were retrospectively studied; those who were not able to access the duodenal papilla were excluded. The patients were divided into two age groups: <60 years (group 1) and >60 years (group 2), and the variables of gender, examination indications, radiological findings, therapeutic success, diagnosis and the occurrence of immediate adverse events were analyzed. Results: 177 patients were allocated to group 1 and 235 to group 2. The main indication found in both groups was choledocholithiasis. In group 2, the number of cases of acute cholangitis (p=0.001), biliary stenosis (p=0.002) and papilla cancer (p=0.046) was higher. In this group, urgent indication for ERCP was higher (p=0.042), as well as the diagnosis of biliary tract dilatation (p<0.001). The placement of prostheses was the most common procedure performed in both groups, but the greatest number of patients in absolute quantity occurred in group 2. In group 1, the success in catheterization and the chance of achieving clearing of the biliary tract was significantly higher in compared to group 2 (p=0.016, OR=2.1). Conclusion: The success of catheterization and complete clearance of the bile duct was significantly higher in the group of young patients.

scholarly journals Experience on the use of photodynamic therapy in vulvovaginal lichen plane

2020 ◽  
Vol 23 (6) ◽  
pp. 408-413
Author(s):  
Sergey I. Surkichin ◽  
Luidmila S. Holupova
Keyword(s):  
Photodynamic Therapy ◽  
Adverse Events ◽  
Oral Cavity ◽  
Rating Scale ◽  
Secondary Infection ◽  
Treatment Method ◽  
Anogenital Region ◽  
Group 2 ◽  
Corticosteroid Drugs ◽  
Group 1

BACKGROUND: Lichen plane (LP) occurs in 0.5%1% of the population. The exact epidemiology of genital LP is unknown. According to various data, LP occurs in 49% of all cases of vulvar lesions. The LP of the oral cavity and the vulva occurs in 1957% of cases. The clinical forms of LP that occur in the anogenital region in women include the erosive, papulosquamous, and less often hypertrophic forms. No distinct guidelines are available for the treatment of vulvar LP. Except for the use of photodynamic therapy (PDT), no randomized controlled trials have been conducted for the treatment of erosive vulvar LP. The research results have shown that PDT can be effective in lichen plane of the oral cavity. AIM: To evaluate the effectiveness of PDT in women with genital LP compared to topical glucocorticosteroids. MATERIALS AND METODS: The study group included 15 patients with a diagnosis of vulvar LP. The patients were divided into two groups depending on the treatment method. Group 1 patients were treated with PDT. Group 2 patients with topical 0.05% betamethasone cream once daily for 1.5 months. RESULTS: Six months after the last procedure, the regression on the genital LP rating scale was 32% in group 1 patients and 25% in group 2 patients. The severity of pain, according to the visual analog scale, was 29% in group 1 and 22% in group 2. As for adverse events, in group 1, four patients experienced a burning sensation and dryness for 23 days after the procedure, and one patient, after two procedures, had blood discharge, which ceased after 1 day. In group 2, five patients complained of burning and dryness during treatment, two patients had acute candidiasis during treatment, and one patient had bacterial vaginosis. CONCLUSION: The use of PDT can reduce the frequency of use of corticosteroid drugs in the genital area and accordingly reduce the frequency of steroid adverse events, such as atrophy and secondary infection.

scholarly journals AML-CM Score Predicts Prognosis in Hemato-Geriatric Patients with New-Onset Acute Myeloid Leukemia (AML) Who Receive Hypomethylating Agents (HMA)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2617-2617
Author(s):  
Giovanni Marconi ◽  
Roberta di Nicola ◽  
Chiara Sartor ◽  
Mariachiara Abbenante ◽  
Jacopo Nanni ◽  
...  
Keyword(s):  
Adverse Events ◽  
Board Of Directors ◽  
Advisory Committees ◽  
Group 4 ◽  
Group A ◽  
Group 3 ◽  
Group 2 ◽  
Group B ◽  
Idh2 Mutation ◽  
Group 1

Background Although much efforts have been made to precisely define fitness of AML patients, in patients who are not candidate to chemotherapy, there is no prognostic model and the respective weight of AML biology and patient fitness are not well established. Here we test AML-CM score (Sorror, JAMA 2018), that is validated in fit population, in a set of old AML patients who received HMAs. Methods We retrospectively collected data of consecutive patients who received HMAs in our institution from 1st Jan 2008 with an age > 65 years at AML diagnosis. AML-CM score was applied to all the patients. Patients were divided in 4 groups (score 1-4: group 1, score 5-6: group 2; score 7-9: group 3, score > 9: group 4) and in 2 macro-groups (score 1-6: group A and score > 6 group B) for the analyses. Descriptive data are presented as median with interquartile ranges (IQR). Adverse events are graded according to CTCAE v4.03. Survival analysis was conducted with Kaplan-Meyer and are presented as 95% confidence intervals (C.I.) and differences in overall survival (OS) were tested with 2-side log rank test. Fisher exact test and Person's chi squared test were used whenever appropriate. Results At data cut-off, 1st Jan 2019, 60 consecutive patients received decitabine or azacytidine as 1st line therapy for AML. Median age of the population was 75.94 years (IQR 72.53-80.38). Most of the patients (37/62, 59.7%) had de novo AML, 19/62 (30.6%) had AML secondary to previous myeloid disorders and 6/62 (9.7%) had AML secondary to chemotherapy or radiotherapy. Most of the patients were smokers (19/33, 57.57%, 29 no data), and few were usual drinkers (4/16, 25.00%, 46 no data). In our set, out of 62 patients, 2 patients (3.2%) had inv(3), 1 (1.6%) a translocation involving 11q23, 1 (1.6%) del(5q), 4 (6.4%) mon(7) or del (7q), 1 (1.6%) del(17p), 15 (24.2%) complex karyotype, 27 (43.5%) normal karyotype, 4 (6.5%) other alterations and 5 were not evaluable; 3/17 (17.65%, 45 no data) harbored IDH2 mutation, 1/16 (6.25%) IDH2 mutation, 2/33 FLT3 mutation (6.06%, 29 no data), 1/24 (4.17%, 38 no data), 2/15 (13.33%, 47 no data) TP53 mutation. According to ELN 2017, 3/62 patients (4.83%) had low risk, 34/62 (54.84%) intermediate risk and 23/62 (37.10%) high risk AML. According to AML-CM score, 13/62 patients (20.97%) were in group A, 20/62 (32.36%) in group B, 21/62 (33.87%) in group C, 6/62 (9.68%) in group D, 2/62 (3.23%) were not allocated for incomplete AML-CM score. There was no difference in term of age, ELN risk, secondary AML prevalence, HMA administered, or response to HMA according to ELN criteria between group 1, 2, 3, 4 or between macro-group A and B. Cardiovascular comorbidity, diabetes mellitus, obesity, previous tumor, hypoalbuminemia, elevated LDH were prevalent in higher risk AML-CM groups (3-4) and in macro-group B. Median OS was 658 days (95% C.I. 316-1000) in group 1, 556 days (95% C.I. 463-649 in group 2, 243 days (95% C.I. 153-353) in group 3, 107 days (95% C.I. 47-167) in group 4 (p=.021, figure 1A). Furthermore, we observed a median OS of 589 days (95% C.I. 328-850) in macro-group A and 219 days (95% C.I. 96-342) in macro-group B (p=.003, figure 1B). Reduced survival was correlated with a non-statistical trend toward augmented incidence of infections and adverse events in higher risk AML-CM groups (3-4). Conclusions AML-CM is a useful indicator of prognosis in old patients that receive HMAs. Prognosis in our set is influenced by comorbidity (measured with AML-CM, a quantitative score) more than by disease biology. We identified a group of patients (macro-group A) that has median OS after HMAs outlying OS reported in literature. This brilliant result can be due to lower comorbidity. AML-CM could help in defining candidate patients for therapy intensification and care utilization or for team comorbidity management. GM and RDN equally contributed Figure 1 Disclosures Martinelli: Roche: Consultancy; Novartis: Consultancy; ARIAD: Consultancy; BMS: Consultancy; Pfizer: Consultancy. Baccarani:Novartis: Consultancy, Speakers Bureau; Incyte: Consultancy, Speakers Bureau; Takeda: Consultancy. Papayannidis:Pfizer: Honoraria; Teva: Honoraria; Shire: Honoraria; Novartis: Honoraria; Amgen: Honoraria; Incyte: Honoraria. Cavo:janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau; bms: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; novartis: Honoraria; takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Comparison of the Toxicity of Amphotericin B in 5% Dextrose with That of Amphotericin B in Fat Emulsion in a Randomized Trial with Cancer Patients

1999 ◽  
Vol 43 (6) ◽  
pp. 1445-1448 ◽  
Author(s):  
Marcio Nucci ◽  
Monique Loureiro ◽  
Fernanda Silveira ◽  
Anna Raquel Casali ◽  
Luis Fernando Bouzas ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Trial ◽  
Cancer Patients ◽  
Amphotericin B ◽  
Fungal Infections ◽  
Serum Levels ◽  
Success Rates ◽  
Fat Emulsion ◽  
Group 2 ◽  
Group 1

ABSTRACT A multicentric randomized trial was undertaken to compare the toxicity of amphotericin B in 5% dextrose with that of amphotericin B in a fat emulsion (Intralipid) in cancer patients. Group 1 (n = 33) received amphotericin B diluted in 5% dextrose with premedication consisting of promethazine plus an antipyretic. Group 2 (n = 28) received amphotericin B diluted in 20% Intralipid without premedication. Amphotericin B was infused daily at a dose of 1 mg/kg of body weight over a 1-h period to members of both groups for empirical antifungal therapy (in neutropenic patients) or for the treatment of documented fungal infections. The majority of patients (80%) received empirical amphotericin B treatment. The two groups were comparable with regard to age, gender, underlying disease, and the following baseline characteristics: use of other nephrotoxic drugs and serum levels of potassium and creatinine. The median cumulative doses of amphotericin B were 240 mg in group 1 and 245 mg in group 2 (P = 0.73). Acute adverse events occurred in 88% of patients in group 1 and in 71% of those in group 2 (P = 0.11). Forty percent of the infusions in group 1 were associated with fever, compared to 23% in group 2 (P < 0.0001). In addition, patients in group 2 required less meperidine for the control of acute adverse events (P = 0.008), and fewer members of this group presented with hypokalemia (P = 0.004) or rigors (P < 0.0001). There was no difference in the proportions of patients with nephrotoxicity (P = 0.44). The success rates of empirical antifungal treatment were similar in the two groups (P = 0.9). Amphotericin B diluted in a lipid emulsion seems to be associated with a smaller number of acute adverse events and fewer cases of hypokalemia than amphotericin B diluted in 5% dextrose.

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