Plasma Beta-Thromboglobulin, Fibrinopeptide A and Bβ15–42 Antigen in Relation to Postoperative DVT, Malignancy and Stanozolol Treatment

1985 ◽  
Vol 53 (02) ◽  
pp. 235-238 ◽  
Author(s):  
Jessie T Douglas ◽  
S L Blamey ◽  
G D O Lowe ◽  
D C Carter ◽  
C D Forbes
Keyword(s):  
Thrombin Generation ◽  
Double Blind Study ◽  
Fibrinopeptide A ◽  
Intestinal Surgery ◽  
Plasmin Activity ◽  
Double Blind ◽  
Treatment Groups ◽  
Risk Patients ◽  
Platelet Release

SummaryPlasma levels of betathromboglobulin (BTG), fibrinopeptide A (FPA) and Bβ15–42 fragment, indices of platelet release, thrombin generation and plasmin activity respectively, were measured in 32 high risk patients during a double blind study of a single dose of the anabolic steroid stanozolol (50 mg IM) in the prevention of DVT after major gastro-intestinal surgery. The prevalence of malignancy and the incidence of DVT (125I fibrinogen scan) were similar in the two treatment groups. On the first postoperative day, BTG, FPA and Bβ15–42 levels were increased in most patients. Plasma BTG levels were significantly increased on the first post-operative day in patients who developed a DVT (n = 14) compared to those patients who did not (n = 18). A significant increase in FPA levels was found in the DVT group, 7 days after surgery. On the morning before surgery, plasma Bβ15–42 levels were significantly increased in patients who developed a DVT. In patients undergoing surgery for early malignancy (n = 17), we observed a pre-operative increase in FPA levels when compared to patients without malignancy. At post-operative day 7, Bβ15–42 levels were significantly increased in patients who received stanozolol (n = 15), when compared to the placebo group, suggesting that intramuscular stanozolol increases fibrinolysis in vivo.

Enhanced thrombin and plasmin activity with exercise in man

1980 ◽  
Vol 48 (5) ◽  
pp. 821-825 ◽  
Author(s):  
T. M. Hyers ◽  
B. J. Martin ◽  
D. S. Pratt ◽  
R. B. Dreisin ◽  
J. J. Franks
Keyword(s):  
Physical Training ◽  
Fibrinopeptide A ◽  
O2 Uptake ◽  
Plasmin Activity ◽  
Cycle Exercise ◽  
Fibrin Plate ◽  
Platelet Release ◽  
D Antigen

We measured products of thrombin and plasmin action and of the platelet release reaction during exercise to determine if the well-known effect of exercise on in vitro coagulation and fibrinolytic tests reflects activity of these systems in vivo. Plasma fibrinopeptide A, produced by thrombin-mediated proteolysis of fibrinogen, increased with graded treadmill and cycle exercise to postexercise levels of 20--30 times resting values. Fibrin/fibrinogen-related D antigen increased in a similar fashion with peak levels at maximal O2 uptake. Plasma-activated partial thromboplastin times fell as fibrinopeptide A levels increased. Unheated fibrin plate lysis areas increased as D antigen concentrations rose, indicating increased release of plasminogen activator. In contrast to activation of the soluble coagulation and fibrinolytic systems, platelet counts and plasma levels of beta-thromboglobulin, a platelet release protein, did not change significantly with exercise. The effect of exercise on thrombin and plasmin was not influenced by prior physical training, but appeared to be less with cycle exercise than with treadmill exercis.

Plasma Fibrinopeptide A and Beta-Thromboglobulin in Patients with Chest Pain

1983 ◽  
Vol 50 (02) ◽  
pp. 541-542 ◽  
Author(s):  
J T Douglas ◽  
G D O Lowe ◽  
C D Forbes ◽  
C R M Prentice
Keyword(s):  
Myocardial Infarction ◽  
Chest Pain ◽  
Unstable Angina ◽  
Plasma Levels ◽  
Thrombin Generation ◽  
Acute Chest Pain ◽  
Fibrinopeptide A ◽  
Control Hospital ◽  
Hospital Patients ◽  
Platelet Release

SummaryPlasma levels of β-thromboglobulin (BTG) and fibrinopeptide A (FPA), markers of platelet release and thrombin generation respectively, were measured in 48 patients within 3 days of admission to hospital for acute chest pain. Twenty-one patients had a confirmed myocardial infarction (MI); 15 had unstable angina without infarction; and 12 had chest pain due to noncardiac causes. FPA and BTG were also measured in 23 control hospital patients of similar age. Mean plasma BTG levels were not significantly different in the 4 groups. Mean plasma FPA levels were significantly higher in all 3 groups with acute chest pain when compared to the control subjects (p < 0.01), but there were no significant differences between the 3 groups. Increased FPA levels in patients with acute chest pain are not specific for myocardial infarction, nor for ischaemic chest pain.

scholarly journals Effect of Clarithromycin on Inflammatory Markers in Patients with Atherosclerosis

2003 ◽  
Vol 10 (4) ◽  
pp. 525-528 ◽  
Author(s):  
Hans F. Berg ◽  
Boulos Maraha ◽  
Gert-Jan Scheffer ◽  
Marcel F. Peeters ◽  
Jan A. J. W. Kluytmans
Keyword(s):  
Inflammatory Markers ◽  
Interleukin 2 ◽  
Patient Characteristics ◽  
Double Blind Study ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Treatment Groups ◽  
Reactive Protein ◽  
Factor Alpha ◽  
Artery Disease

ABSTRACT Atherosclerosis can to a certain extent be regarded as an inflammatory disease. Also, inflammatory markers may provide information about cardiovascular risk. Whether macrolide antibiotics, especially clarithromycin, have an anti-inflammatory effect in patients with atherosclerosis is not exactly known. To study this phenomenon, a placebo-controlled, randomized, double-blind study was performed. A total of 231 patients with documented coronary artery disease received a daily dose of either 500 mg of slow-release clarithromycin or placebo until the day of surgery. Levels of inflammatory markers (C-reactive protein, interleukin-2 receptor [IL-2R], IL-6, IL-8, and tumor necrosis factor alpha) were assessed during the preoperative outpatient visit, on the day of surgery, and 8 weeks after surgery. Also, changes in the levels of inflammatory markers between visits were determined by delta calculations. Baseline patient characteristics were balanced between the two treatment groups: the average age was 66 years (standard deviation [SD] = 9.0), 79% of the patients were male, and the average number of tablets used was 16 (SD = 9.3). The inflammatory markers of the groups as well as the delta calculations were not significantly changed. Treatment with clarithromycin did not influence the inflammatory markers in patients with atherosclerosis.

A Double-Blind Study Comparing the Effectiveness of Cromolyn Sodium and Sustained-Release Theophylline in Childhood Asthma

PEDIATRICS ◽  
1984 ◽  
Vol 74 (4) ◽  
pp. 453-459
Author(s):  
Clifton T. Furukawa ◽  
Gail G. Shapiro ◽  
C. Warren Bierman ◽  
Michael J. Kraemer ◽  
Daniel J. Ward ◽  
...  
Keyword(s):  
Side Effects ◽  
Challenge Test ◽  
Serum Levels ◽  
Cromolyn Sodium ◽  
Base Line ◽  
Double Blind Study ◽  
Office Visits ◽  
Double Blind ◽  
Treatment Groups ◽  
Asthma In Children

The effectiveness of cromolyn sodium and theophylline on asthma in children was compared during a 3-month trial. Forty-six children (aged 5 to 15 years) with asthma were assigned at random to cromolyn or theophylline (Theo-Dur) treatment groups. Each subject received theophylline placebo or cromolyn placebo in addition to the active drugs. A methacholine challenge test was done at the start of the study to document asthma and was repeated during the third month. The theophylline dosage was regulated to obtain serum levels of 10 to 15 µg/mL by a physician not involved directly with patient care. Forty patients completed the study. Both theophylline and cromolyn treatment groups showed improvement from base-line status in terms of symptom scores, pulmonary function, and decreased use of inhaled albuterol. Patients treated with theophylline had more side effects and required more frequent office visits than those treated with cromolyn. Both groups had decreased sensitivity to methacholine, and for one statistical test patients treated with cromolyn improved significantly. These results indicate that cromolyn is as effective as theophylline in treating mild to moderate asthma in children; additional benefits were fewer side effects and a possible decrease in bronchial hyperactivity.

scholarly journals Role of plasma lipoproteins in the transport of the soyabean isoflavones daidzein and daidzein-7-O-β-d-glucoside

2009 ◽  
Vol 102 (6) ◽  
pp. 793-796 ◽  
Author(s):  
Corinna E. Rüfer ◽  
Sabine E. Kulling ◽  
Jutta Möseneder ◽  
Peter Winterhalter ◽  
Achim Bub
Keyword(s):  
Lipoprotein Fraction ◽  
Plasma Lipoproteins ◽  
Ldl Oxidation ◽  
Double Blind Study ◽  
Post Dose ◽  
Double Blind ◽  
Time Profiles ◽  
Lipoprotein Distribution

Isoflavone intake is associated with various properties beneficial to human health which are related to their antioxidant activity, for example, to their ability to increase LDL oxidation resistance. However, the distribution of isoflavones among plasma lipoproteins has not yet been elucidated in vivo. Therefore, the objective of the present study was to investigate the association between daidzein (DAI) and lipoproteins in human plasma upon administration of the aglycone and glucoside form. Five men aged 22–30 years participated in a randomised, double-blind study in cross-over design. After ingestion of DAI and daidzein-7-O-β-d-glucoside (DG) (1 mg DAI aglycone equivalents/kg body weight) blood samples were drawn before isoflavone administration as well as 1, 2, 3, 4·5, 6, 8, 10, 12, 24 and 48 h post-dose. Concentrations of DAI in the different lipoprotein fractions (chylomicrons, VLDL, LDL, HDL) and in the non-lipoprotein fraction were analysed using isotope dilution capillary GC/MS. The lipoprotein fraction profiles were similar for all subjects and resembled those obtained for plasma in our previously published study. The lipoprotein distribution based on the area under the concentration–time profiles from 0 h to infinity in the different fractions were irrespective of the administered form: non-lipoprotein fraction (53 %) > LDL (20 %) > HDL (14 %) > VLDL (9·5 %) > chylomicrons (2·5 %). Of DAI present in plasma, 47 % was associated to lipoproteins. Concentrations in the different lipoprotein fractions as well as in the non-lipoprotein fraction were always higher after the ingestion of DG than of DAI. Taken together, these results demonstrate an association between isoflavones and plasma lipoproteins in vivo.

A Comparative Clinical Trial of Diflunisal and Ibuprofen in the Control of Pain in Osteoarthritis

1979 ◽  
Vol 7 (4) ◽  
pp. 272-276 ◽  
Author(s):  
J G M Keet
Keyword(s):  
Clinical Trial ◽  
Blind Study ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Comparative Clinical Trial ◽  
Treatment Groups ◽  
Ambulatory Patients ◽  
Efficacy Parameters ◽  
Osteoarthritis Of Hip

A randomized double-blind study in ambulatory patients with osteoarthritis of hip and/or knee was conducted, comparing the efficacy and safety of diflunisal 500 mg daily with ibuprofen 1200 mg daily, over a period of 8 weeks. Thirty-five patients participated in the study. The results revealed no significant differences between the treatment groups with regard to the efficacy parameters.

scholarly journals 110. A Phase 3, Multicenter, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Ceftolozane/Tazobactam Plus Metronidazole Versus Meropenem in Chinese Participants With Complicated Intra-abdominal Infections

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S67-S68
Author(s):  
Yihong Sun ◽  
Jia Fan ◽  
Gang Chen ◽  
Xiaofei Chen ◽  
Xiaoling Du ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Additional Treatment ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
Study Drug Administration ◽  
Treatment Groups ◽  
Secondary Endpoints ◽  
Abdominal Infections

Abstract Background In China, the prevalence of infections due to multidrug-resistant gram-negative bacteria is high and additional treatment options for complicated intra-abdominal infections (cIAI) are needed. This study compared the efficacy and safety of ceftolozane/tazobactam (C/T) + metronidazole (MTZ) versus meropenem (MEM) + placebo (pbo) for the treatment of cIAI in adult Chinese participants. Methods This was a phase 3, double-blind study conducted at 21 centers in China (NCT03830333). Participants aged 18-75 years with cIAI requiring surgical intervention within 24 hours of study drug administration were stratified by site of infection and randomized 1:1 to receive 1.5 g C/T (1 g ceftolozane and 0.5 g tazobactam) + 0.5 g MTZ administered intravenously (IV) every 8 hours (q8h) or 1 g MEM + pbo administered IV q8h for 4-14 days. The primary endpoint was clinical cure at test of cure (TOC) in the clinically evaluable (CE) population. Secondary endpoints included rates of clinical cure, per-participant microbiologic response, per-pathogen microbiologic response, and adverse events (AE). Non-inferiority for clinical cure at TOC in the CE population was confirmed if the lower bound of the 2-sided 95% CI for the between-treatment difference in the clinical cure rate was larger than −12.5%. Results A total of 134 participants were randomized to each treatment group. Demographics and baseline characteristics were generally well balanced between treatment groups (Table 1). The median (range) age in the ITT population was 50 (18-75) years and 61% were men. The most frequent sites of infection were the appendix (C/T + MTZ, 50.0%; MEM + pbo, 49.3%) and gallbladder (C/T + MTZ, 27.6%; MEM + pbo, 29.1%). Overall, the most frequently isolated pathogens were Escherichia coli (61.4%) and Klebsiella pneumoniae (17.3%); few anaerobes were isolated (Table 1). C/T + MTZ was non-inferior to MEM + pbo for clinical cure in the CE population (C/T + MTZ, 95.2%; MEM + pbo, 93.1%; difference, 2.1% [95% CI, −4.7% to 8.8%]). Results for key secondary endpoints were comparable between treatment groups (Table 2). Rates of AEs were generally similar between treatment groups (Table 3). Conclusion C/T + MTZ was non-inferior to MEM + pbo in the treatment of adult Chinese participants with cIAI and demonstrated a favorable safety profile. Disclosures Xiaofei Chen, n/a, MSD, China (Employee) Xiaoling Du, n/a, MSD, China (Employee) Ye Wang, n/a, MSD, China (Employee) Hui Wang, n/a, MSD, China (Employee) Fang Sun, n/a, MSD, China (Employee) Matthew G. Johnson, MD, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (Employee) Mekki Bensaci, PhD, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (Employee) Jennifer A. Huntington, PharmD, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (Employee) Christopher Bruno, MD, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (Employee)

The HET-CAM Test: A Study of the Irritation Potential of Chemicals and Formulations

1992 ◽  
Vol 20 (3) ◽  
pp. 432-437 ◽  
Author(s):  
Odile de Silva ◽  
André Rougier ◽  
Koovi G. Dossou
Keyword(s):  
Evaluation Studies ◽  
Chorioallantoic Membrane ◽  
Rank Correlation ◽  
In Vitro Tests ◽  
Double Blind Study ◽  
Double Blind ◽  
Spearman's Rho ◽  
Spearman’S Rho

The HET-CAM (hen's egg test-chorio-allantoic membrane), described by Luepke in 1985, permits the study of immediate effects following the administration of test substances to the chorioallantoic membrane of 10-day-incubated White Leghorn chicken eggs. The results of a study of 60 chemicals and 41 cosmetic formulations are presented here. Intralaboratory reproducibility was established with a double-blind study of 20 surfactants at two concentrations. The results show a high rank correlation between the scores given by both experimenters: the Spearman's rho is greater than 0.9 (p < 10-8). The 60 chemicals were studied at a concentration equivalent to 10% of the concentration tested in vivo. They were classified according to the three EEC categories of ocular irritancy, and when a correlation between the HET-CAM scores and historical Draize in vivo data was determined, the corresponding Spearman's rho value was 0.72 (p < 10-4). The 41 formulations (make-up removers, shower gels, shampoos, creams and body milks) were tested by two protocols: rinsed and non-rinsed. The correlation between the HET-CAM scores and the historical Draize in vivo maximum average scores was studied, and the rhos obtained were 0.77 and 0.76 (p < 10 -8), respectively. The advantages of the HET-CAM method lie in its sensitivity, rapidity and moderate cost. Both chemicals and cosmetics formulations can be tested, and specific families can be assessed using modified and more-appropriate protocols. However, to ensure that a good reproducibility and sensitivity is provided, the use of reference materials is strongly recommended. The satisfactory performances of the HET-CAM test in many previous evaluation studies (e.g. those of the BGA, CTFA, EEC and OPAL) show that it can be a useful assay as part of a battery of in vitro tests for the screening of new ingredients and formulations.

scholarly journals Arnica/Hydroxyethyl Salicylate Combination Spray for Ankle Distortion: A Four-Arm Randomised Double-Blind Study

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Miroslav Kučera ◽  
Pavel Kolar ◽  
Milos Barna ◽  
Alexander Kučera ◽  
Marie Hladiková
Keyword(s):  
Analogue Scale ◽  
Cumulative Effect ◽  
Double Blind Study ◽  
Additive Effects ◽  
Double Blind ◽  
Active Constituents ◽  
Treatment Groups ◽  
Group A ◽  
Baseline Values ◽  
Pain Improvement

570 patients with acute ankle joint distortion were randomized to four treatment groups: a combination spray of arnica tincture and hydroxyethyl salicylate (HES; group A, ), arnica (B, ), HES (C, ), and placebo (D, ). The medication was applied 4-5 times daily for 10 days. Efficacy was assessed on day 3-4 by evaluating pain on motion on a visual analogue scale (VAS). Pain improvement in group A was significantly superior over groups B–D (-test with unadjusted baseline values, and ANCOVA after adjustment, ) and approximately corresponded to the cumulative effect of the single constituents (12.1, 7.5, and 18.7 mm VAS for A versus B, A versus C, and A versus D; 95% CI 8.0–16.2, 4.7–10.4, and 14.8–22.5 mm). The combination is justified by the additive effects of the single active constituents.

scholarly journals The Antinociceptive Effect of Epidural Lignocaine and Fentanyl during Lithotripsy

1997 ◽  
Vol 25 (1) ◽  
pp. 11-14 ◽  
Author(s):  
B. Fredman ◽  
D. Olsfanger ◽  
H. Blubstein ◽  
R. Jedeikin
Keyword(s):  
Postoperative Pain ◽  
Antinociceptive Effect ◽  
Painful Stimulus ◽  
Epidural Fentanyl ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Arterial Blood ◽  
Blood Pressures ◽  
Intraoperative Pain

To determine the antinociceptive effect of combining epidural fentanyl with lignocaine during non-immersion lithotripsy, 56 healthy patients were enrolled into a prospective, randomized, double-blind study. Epidural anaesthesia was induced with either lignocaine 300 mg alone, or lignocaine 300 mg, or 200 mg in combination with fentanyl 100 μg. Throughout the procedure analgesia was assessed by comparing the incidence of (a) spontaneous complaints of pain, (b) patients’ attempts to withdraw from the painful stimulus, (c) supplemental epidural lignocaine requirements, (d) the haemodynamic response to lithotripsy and (e) the time to first postoperative pain. The patients who received the fentanyl-lignocaine 300 mg combination required no supplemental lignocaine, experienced marginally less intraoperative pain and recorded lower mean arterial blood pressures when compared with lignocaine 300 mg alone. However, when the combination of lignocaine 200 mg and fentanyl 100 μg was administered, patients experienced significantly more pain, withdrew from the painful stimulus more often and received more supplemental lignocaine when compared with the other two treatment groups. No difference was found in the time to the first complaint of postoperative pain. Similarly, discharge times were unaffected by treatment modality. We conclude that despite the addition of fentanyl, adequate analgesia during lithotripsy is dependent upon the dose of local anaesthetic administered.

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