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.

Administration of Lipid-Emulsion Versus Conventional Amphotericin B in Patients with Neutropenia

1995 ◽  
Vol 29 (12) ◽  
pp. 1197-1201 ◽  
Author(s):  
Begoña Pascual ◽  
Ana Ayestaran ◽  
José B Montoro ◽  
Juan Oliveras ◽  
Antero Estibalez ◽  
...  
Keyword(s):  
Amphotericin B ◽  
Lipid Emulsion ◽  
Fungal Infections ◽  
Hematologic Malignancies ◽  
Fat Emulsion ◽  
Sodium Potassium ◽  
Significant Difference ◽  
Emulsion Group ◽  
Group 2 ◽  
Group 1

Objective: To evaluate the usefulness of a 20% lipid emulsion as a delivery system for amphotericin B (1 mg/mL) administered over 1 hour to patients with neutropenia with hematologic malignancies compared with amphotericin B (0.1 mg/mL) administered in dextrose 5% solution over the same time. Design: A prospective, comparative, randomized, labeled study. Setting: Hematology unit, pharmacy service, university general hospital. Participants: Twenty patients with neutropenia with hematologic malignancies and proven or suspected fungal infections, 10 in the fat emulsion group (group 1) and 10 in the dextrose 5% group (group 2). Main Outcome Measures: Clinical tolerance (i.e., fever, shaking chills, nausea, blood pressure, pulse rate) and biologic tolerance (i.e., urea, creatinine, sodium, potassium). Results: Clinical tolerance was comparable in both groups although amphotericin B in fat emulsion was better tolerated. Medication for symptoms related to the administration of amphotericin B was given in 6 cases in group 1 and in 8 cases in group 2. There was a statistically significant difference in the urea concentrations between the 2 groups (p = 0.023); there was an observed increase between the initial and the final serum urea (56.8 mg/d in group 1, 79.8 mg/dL in group 2). Statistically significant differences in creatinine serum concentrations (84.9 μmol/L in group 1, 123.8 μmol/L in group 2) (p = 0.047) were found. No differences were found in the antifungal efficacy of the treatment. However, as amphotericin B was started in the majority of cases (75%) as empiric treatment for fever unresponsive to antibiotic therapy, it is difficult to compare the efficacy of both preparations. Conclusions: The clinical tolerance of lipid-emulsion infusions is similar to that of conventionally administered amphotericin B therapy. Renal toxicity appears to be decreased when the drug is administered in a fat emulsion. This type of preparation permits the reduction of the volume and the time of administration for amphotericin B therapy.

scholarly journals Complex biliary stones management: cholangioscopy versus papillary large balloon dilation – a randomized controlled trial

2018 ◽  
Vol 06 (02) ◽  
pp. E131-E138 ◽  
Author(s):  
Tomazo Franzini ◽  
Renata Moura ◽  
Priscilla Bonifácio ◽  
Gustavo Luz ◽  
Thiago de Souza ◽  
...  
Keyword(s):  
Adverse Events ◽  
Success Rate ◽  
Balloon Dilation ◽  
Success Rates ◽  
Biliary Stones ◽  
Stone Removal ◽  
Large Balloon ◽  
Group 2 ◽  
Large Balloon Dilation ◽  
Group 1

Abstract Background and study aims Endoscopic removal of biliary stones has high success rates, ranging between 85 % to 95 %. Nevertheless, some stones may be challenging and different endoscopic methods have evolved. Papillary large balloon dilation after sphincterotomy is a widely used technique with success rates ranging from 68 to 90 % for stones larger than 15 mm. Cholangioscopy allows performing lithotripsy under direct biliary visualization, either by laser or electrohydraulic waves, which have similar success rate (80 % – 90 %). However, there is no study comparing these 2 techniques. Patients and methods From April 2014 to June 2016, 100 patients were enrolled and randomized in 2 groups, using a non-inferiority hypothesis: cholangioscopy + electrohydraulic lithotripsy (group 1) and endoscopic papillary large balloon dilation (group 2). The main outcome was complete stone removal. Adverse events were documented. Mechanical lithotripsy was not performed. Failure cases had a second session with crossover of the methods. Results The mean age was 56 years. 74 (75.5 %) patients were female. The initial overall complete stone removal rate was 74.5 % (77.1 % in group 1 and 72 % in group 2, P > 0.05). After second session the overall success rate achieved 90.1 %. Procedure time was significantly lower in group 2, – 25.2 min (CI95 % – 12.48 to – 37.91). There were no significant differences regarding technical success rate, radiologic exposure and adverse events. Conclusion Single-operator cholangioscopy-guided lithotripsy and papillary large balloon dilation are effective and safe approaches for removing complex biliary stones.

scholarly journals Serum Neopterin Levels and the Clinical Presentation of COVID-19

Pteridines ◽  
2020 ◽  
Vol 31 (1) ◽  
pp. 185-192
Author(s):  
Deniz Öğütmen Koç ◽  
Hande Sipahi ◽  
Cemile Dilşah Sürmeli ◽  
Mustafa Çalık ◽  
Nilgün Bireroğlu ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Presentation ◽  
Serum Levels ◽  
Neutrophil Lymphocyte Ratio ◽  
Serum Neopterin ◽  
Protein Levels ◽  
Reactive Protein ◽  
Group 2 ◽  
Immune Activation Marker ◽  
Group 1

AbstractIn Coronavirus disease 2019 (COVID-19), it is important to evaluate disease activity and investigate possible biomarkers. Therefore, in this study, we investigated the relationship between disease activity and serum levels of possible immune activation marker neopterin in patients with COVID-19. The study enrolled 45 patients (23 females, 51.1%) treated for COVID-19. The patients were divided into two groups according to their clinical presentation: those who recovered quickly (Group 1) and those who worsened progressively (Group 2). The neopterin and C-reactive protein levels were high in all patients on admission. In Group 1, neopterin concentrations and serum neopterin/creatinine ratios were significantly higher on admission compared to Day 14 of the disease, whereas in Group 2, levels were significantly higher at Day 14 of the disease than on admission. Neopterin levels at admission were significantly higher in Group 1. The serum neopterin concentrations at admission were markedly higher in patients with a derived neutrophil–lymphocyte ratio (dNLR) > 2.8 compared to those with a dNLR ≤ 2.8 (p < 0.05). Serum neopterin levels can be used as a prognostic biomarker in predicting disease activity in COVID-19.

scholarly journals AB0051 SERUM AMYLOID A AND PENTRAXIN 3: INNATE IMMUNE RESPONSE AND DISEASE ACTIVITY IN SYSTEMIC LUPUS ERYTHEMATOSUS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1328.1-1328
Author(s):  
R. Assandri ◽  
G. Martellosio ◽  
A. Montanelli
Keyword(s):  
Disease Activity ◽  
Lupus Erythematosus ◽  
Serum Amyloid A ◽  
Serum Levels ◽  
Innate Immune ◽  
Pentraxin 3 ◽  
Systemic Lupus ◽  
Amyloid A ◽  
Group 2 ◽  
Group 1

Background:Systemic Lupus Erythematosus (SLE) is an autoimmune disease that involves several molecular patterns with a wide spectrum of clinical manifestations and symptoms. Inflammation and related pathway play a role in SLE pathogenesis. The pentraxin superfamily including long and short pentraxin, C Reactive Protein CRP, Serum amyloid A (SAA), Pentraxin 3 (PTX3) are key components of innate immune system and induce a variety of inflammation associated pathway. However Literature provides several evidences that CRP serum levels not correlated with clinical and immunological manifestations. This situation affected clinical practice and the patient follow up. PTX3 have been identified as a component of inflammatory status in several autoimmune conditions. SAA is an acute phase protein secreted in large quantity during inflammation.Objectives:We want to evaluated SAA, PTX3 and CRP concentrations, their correlation between SLE Disease Activity Index (SLEDAI), that including complement fractions C3, C4.Methods:We enrolled fifty patients that fulfilled the SLE American College of Rheumatology criteria and fifty healthy subjects. The SLE disease activity was classified with the SLEDAI (0 to 12). Patients were divided into two groups according to SLEDAI score: inactive group (Group 1, 25 patients, 50%: SLEDAI < 4) and active group (Group 2, 25 patients, 50%: SLEDAI 5 to 12). PTX3 concentration was measured by a sandwich ELISA kit (Hycult) with 2.8 ng/mL cut-off point. SAA concentration was detected by nephelometry performed on a BN ProSpec System (Siemens, Germany), with assay kit based on polyclonal antibodies (Siemens Healthcare Diagnostics Products, Germany, 6.5 mg/L cut-off point). High sensitive CRP concentrations were determined using the ci8200 platform (Abbott Laboratories Chicago, Illinois).Results:Plasma PTX3 and serum SAA levels was significantly higher in SLE patients than in the healthy subjects (PTX311.5 ± 7.3 ng/mL vs 2.3 ± 1.1; p < 0.001; SAA: 87 ±77 mg/L vs 2.6±2.5; p < 0.001). These differences were not evident in CRP levels (8.5 ± 7.8 mg/L vs 6.2± 2.5). Considering two groups, there were statistical differences in PTX3 level (Group 2: 14.9 ± 12 ng/mL vs Group 1: 2.16 ±0.5 ng/mL, p<0,05) and SAA concentration (Group 2: 114 ± 89 ng/mL vs Group 1: 3.6 ±1.7 ng/mL, p<0,05) but not in CRP concentration (Group 2: 11.5 ± 8.4 mg/L vs Group 1: 9.5 ±3.5). There was a significantly negative correlation between C3, C4 fractions, PTX3 and SSA levels (respectively r = −0.74, p=<0.05, and r = −0.79, p<0.05). No statistical correlation were appeared between C3, C4 fractions and CRP serum levels (r= −0,12., p= 0.82, and r= −0.18, p= 0,21). We noted a positive significant correlation between SLEDAI, PTX3 and SAA concentration (r = 0.79, p < 0.05, 0.83, p < 0.05, respectively) an increase in PTX3 and SAA levels followed the lupus flare and symptoms. No significant correlation appeared between SLEDAI and CRP (r= 0.15, p=0.89)Conclusion:PTX3 and SAA concentration was significantly higher in SLE patients than the healthy control subjects and their levels reflected disease activity. We showed a direct correlation between PTX3 and SAA. In SLE patients PTX3 and SAA concentrations were correlated with SLEDAI. We suggest an integrate viewpoint in witch SAA and PTX3 may play a role as a biomarker of disease activity, with synergic work during SLE events. Evidences suggested that PTX3 and SAA could trigger the same molecular pathway, by TLR4, via NF-kB.References:[1]Assandri R, Monari M Montanelli A. Pentraxin 3 in Systemic Lupus Erithematosus: Questions to be Resolved, Translational Biomedicine (2015)Disclosure of Interests:None declared

Decreased Cysteine and Glutathione Levels: Possible Determinants of Liver Toxicity Risk in Ghanaian Subjects

1994 ◽  
Vol 22 (3) ◽  
pp. 171-176 ◽  
Author(s):  
N-A Ankrah ◽  
T Rikimaru ◽  
F A Ekuban ◽  
M M Addae
Keyword(s):  
Vitamin A ◽  
Liver Toxicity ◽  
Malonic Dialdehyde ◽  
Serum Levels ◽  
Blood Levels ◽  
Liver Inflammation ◽  
Body Tissues ◽  
Group 2 ◽  
Β Carotene ◽  
Group 1

Cysteine, methionine, vitamin A, β-carotene and glutathione (GSH) are known to protect body tissues against oxidative damage and inflammation but their value as protection against liver inflammation in tropical areas has received little attention. Blood levels of these nutrients were measured in Ghanaian volunteers with (Group 2) or without (Group 1) increased lipid peroxidation and signs of liver inflammation, as indicated by blood malonic dialdehyde, serum α1-antitrypsin and triglyceride levels, and the α1-acid glycoprotein: pre-albumin ratio. Serum levels of cysteine and blood glutathione were significantly lower ( P < 0.02) in group 2 than in group 1 volunteers. In contrast, serum levels of methionine, vitamin A and β-carotene were similar in both groups. Deficits in cysteine and glutathione may increase the risk of liver toxicity from oxidants in Ghanaians.

scholarly journals Relationship between two year PSA nadir and biochemical recurrence in prostate cancer patients treated with iodine-125 brachytherapy

2014 ◽  
Vol 47 (2) ◽  
pp. 89-93 ◽  
Author(s):  
Carlos Antônio da Silva Franca ◽  
Sérgio Lannes Vieira ◽  
Antonio Carlos Pires Carvalho ◽  
Antonio Jose Serrano Bernabe ◽  
Antonio Belmiro Rodrigues Campbell Penna
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Biochemical Recurrence ◽  
Disease Free Survival ◽  
Disease Recurrence ◽  
Recurrence Rates ◽  
Psa Nadir ◽  
Group 2 ◽  
Iodine 125 ◽  
Group 1

Objective To evaluate the relationship between two year PSA nadir (PSAn) after brachytherapy and biochemical recurrence rates in prostate cancer patients. Materials and Methods In the period from January 1998 to August 2007, 120 patients were treated with iodine-125 brachytherapy alone. The results analysis was based on the definition of biochemical recurrence according to the Phoenix Consensus. Results Biochemical control was observed in 86 patients (71.7%), and biochemical recurrence, in 34 (28.3%). Mean PSAn was 0.53 ng/ml. The mean follow-up was 98 months. The patients were divided into two groups: group 1, with two year PSAn < 0.5 ng/ml after brachytherapy (74 patients; 61.7%), and group 2, with two year PSAn ≥ 0.5 ng/ml after brachytherapy (46 patients; 38.3%). Group 1 presented biochemical recurrence in 15 patients (20.3%), and group 2, in 19 patients (43.2%) (p < 0.02). The analysis of biochemical disease-free survival at seven years, stratified by the two groups, showed values of 80% and 64% (p < 0.02), respectively. Conclusion Levels of two year PSAn ≥ 0.5 ng/ml after brachytherapy are strongly correlated with a poor prognosis. This fact may help to identify patients at risk for disease recurrence.

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 Can pharmacokinetic dosing decrease nephrotoxicity associated with aminoglycoside therapy.

1993 ◽  
Vol 4 (1) ◽  
pp. 81-90
Author(s):  
D J Leehey ◽  
B I Braun ◽  
D A Tholl ◽  
L S Chung ◽  
C A Gross ◽  
...  
Keyword(s):  
Peak Level ◽  
Serum Levels ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Aminoglycoside Therapy ◽  
Concentration Peak ◽  
Trough Serum ◽  
Individualized Dosing ◽  
Group 2 ◽  
Group 1

A randomized, controlled clinical trial was performed to determine whether individualized dosing by use of Bayesian pharmacokinetic modeling could decrease nephrotoxicity accosted with aminoglycoside therapy. Two hundred forty-three patients receiving aminoglycosides for suspected or proven infection were randomly assigned to one of three groups: usual physician-directed dosing (Group 1), pharmacist-assisted dosing (Group 2), or pharmacist-directed dosing (Group 3). Dosing in Groups 2 and 3 was based on a Bayesian pharmacokinetic dosing program, whereas Group 1 served as the control group. Individualized dosing resulted in higher mean postinfusion (peak) serum aminoglycoside levels, higher ratios of mean peak level to minimum inhibitory concentration (peak/MIC ratios), and a trend toward lower trough serum levels. Milligrams per dose were higher and number of doses per day was lower in the pharmacist-dosed groups. However, the incidence of nephrotoxicity (> or = 100% increase in serum creatinine) was not different among the three groups (16, 27, and 16% in Groups 1, 2, and 3, respectively). Similarly, severity of toxicity was not affected by the dosing intervention. Risk factors for toxicity included duration of therapy, shock, treatment with furosemide, older age, and liver disease. After controlling for these factors, the dosing intervention still had no effect on nephrotoxicity. It was concluded that Bayesian pharmacokinetic dosing did not decrease the risk of nephrotoxicity associated with aminoglycoside therapy.

scholarly journals Relationship between NT-proBNP and Cardio-Renal Dysfunction in Patients with Advanced Liver Cirrhosis

2014 ◽  
Vol 23 (1) ◽  
pp. 51-56 ◽  
Author(s):  
Adriana Cavasi ◽  
Eduard Cavasi ◽  
Mircea Grigorescu ◽  
Adela Sitar-Taut
Keyword(s):  
Liver Cirrhosis ◽  
Liver Disease ◽  
Renal Dysfunction ◽  
Cardiac Dysfunction ◽  
Serum Levels ◽  
Qtc Interval ◽  
Advanced Liver Cirrhosis ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background & Aims: ProBNP is a sensitive marker of cardiac dysfunction. We assessed the concentration of circulating NT-proBNP in patients with liver cirrhosis in various stages of the disease and its correlation with markers of cardiac and renal dysfunction and with markers of liver disease severity.Patients and methods: A number of 88 patients with liver cirrhosis were included in the study, divided into 3 groups: group 1 - 18 control patients without ascites; group 2 - 35 non-azotemic patients with ascites; group 3 - 35 patients with hepatorenal syndrome. The cardiac dysfunction was assessed by measuring the NT-proBNP serum levels and the QTc interval. The markers of renal dysfunction were the estimated glomerular filtration rates - formulas involving creatinine and serum cystatin C. The Child-Pugh score was used to assess the liver disease severity.Results: The median NT-proBNP serum levels significantly increased in patients with advanced liver cirrhosis (group 3: 960 fmol/ml and group 2:  660 fmol/ml) as compared to group 1 (435 fmol/ml) (p<0.05). A significant direct correlation was found between the NT-proBNP concentration and the QTc interval (r=0.540, p<0.001). The NT-proBNP levels also correlated with the Child-Pugh score (r=0.501, p<0.01), proving the link between the cardiac dysfunction and the liver disease severity. The cardio-renal interrelation is supported by the relationship between the NT-proBNP concentration and the estimated clearances.Conclusion: The high NT-proBNP levels in patients with advanced cirrhosis indicate the presence of cardiac dysfunction, which has a role in the pathogenesis of the hepatorenal syndrome.Abbreviations: DP: diastolic pressure; GFR: glomerular filtration rate; HRS: hepatorenal syndrome; MAP:mean arterial pressure; NT-proBNP: N-terminal fragment of the prohormone B-type natriuretic peptide; proBNP: prohormone brain natriuretic peptide; SBP: spontaneous bacterial peritonitis; SP: systolic pressure; TIPS: tranjugular intrahepatic portosystemic shunt.

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