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Biomedical subjects

D Massey

Publications and source records attributed to D Massey.

16 recordsLinked to original sources
PubMed1998

Clinical trials of antibacterial agents: a practical guide to design and analysis. Statisticians in the Pharmaceutical Industry Working Party.

Guidelines on the conduct of clinical trials of antibacterial agents produced by the US Food and Drug Administration, the British Society for Antimicrobial Chemotherapy, the Infectious Diseases Society of America and a European Working Party have been reviewed. Although very informative, these guidelines provide limited practical guidance on the design and statistical aspects of phase III studies of antimicrobial agents. This paper describes the differences between antibacterial trials and clinical studies in other therapeutic areas with regard to subjective endpoints, dual clinical and bacteriological endpoints, frequent protocol violations and difficulty of using placebo controls. The importance of a detailed protocol and planned analysis strategy is emphasized. The choice of comparator agents, practical issues with the blinding of trial materials and the documentation of patients excluded from study entry are discussed. The use of different patient groups and different endpoints in analyses are described. The principles of equivalence and their application to trials of antibacterial agents are discussed, together with an approach to calculating sample size. A variety of statistical analyses of results are compared for different situations indicating some of the problems that can arise. Different methods of presentation of study data are included with emphasis on regulatory submissions rather than scientific publications. Some graphical presentations are recommended and issues regarding data across different studies are discussed.

Anti-Infective Agents↗
PubMed1997

Lansoprazole and amoxycillin: observations on the treatment of Helicobacter pylori infection.

Symptomatic patients (n = 101) with Helicobacter pylori infection were enrolled into a double-blind, double-dummy study to assess the efficacy of lansoprazole plus amoxycillin in the treatment of H. pylori infection. Patients were randomized to either lansoprazole 30 mg once daily (days 0-28) together with placebo (matched to amoxycillin) three times a day (days 0-14) followed by either placebo or amoxycillin 500 mg three times daily (days 15-28). Biopsy specimens for culture and histology were collected on days 0 and 56 or upon symptomatic relapse. Blood for serology was collected at days 0, 56 and 168. A [14C]-urea breath test was performed on day 168. Eighty-one (80.2%) patients completed the 56 day assessment. Of patients treated with lansoprazole plus amoxycillin, 35.1% (13/37) were cured of infection as assessed at day 56 (26.5% on an intention-to-treat basis), compared with 4.8% (2/42) of the placebo group (4% on an intention-to-treat basis). Recrudescence/re-infection occurred in one patient upon re-evaluation at day 168. Analysis of prognostic factors indicated that smoking and alcohol intake had little impact on the treatment outcome. Inflammation (both acute and chronic) improved in patients treated with lansoprazole plus amoxycillin. The relatively low efficacy of the treatment may relate to a single daily dose of lansoprazole (30 mg) being prescribed, treatment with amoxycillin being commenced 2 weeks after the initiation of lansoprazole or accurate assessment of treatment efficacy (both antral and body biopsy specimens taken).

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1994

Recovery units: the future of postoperative cardiac care.

In the current climate of scarce financial resources health care managers have had to question the financial viability of a 36-hour stay in an ICU for patients undergoing cardiac surgery. The management of this group of patients has had to be reexamined. The solution to this problem appears to lie in the utilisation of a designated recovery area for the management of this group of patients. This paper is an audit of the first 100 cardiac patients who recovered in such a designated recovery unit. The audit examines types of operations performed, average length of time patients required artificial ventilation, blood loss in the first 4h, average length of stay in hospital, and postoperative complications. Possible methods of improving the utilisation of a recovery area in the management of postoperative cardiac patients are discussed. The conclusion is that utilisation of a designated recovery area for the immediate postoperative management of cardiac surgical patients is a financially viable alternative to an intensive care environment. More importantly, high quality service and care is maintained without increasing the utilisation of resources.

Cardiac Surgical Procedures↗
PubMed1991

Lipocortin IV is a basolateral cytoskeleton constituent of rabbit enterocytes.

A monoclonal antibody, BL7B1, which specifically recognized rabbit lipocortin IV, was produced. The BL7B1 epitope is localized between the methionine residues that occupy positions 148 and 259 in human lipocortin IV. Immunofluorescence and subcellular fractionation studies showed that in the rabbit enterocytes, lipocortin IV is specifically associated with the basolateral membranes. When these membranes are solubilized by Triton X-100 in the presence of 1 mM of Ca2+ the lipocortin IV, like the cytoskeleton, remained insoluble suggesting that it might be associated with this structure in vivo. No lipocortin IV was detected in the brush border using immunofluorescence techniques and less than 10% of the amount present in the purified basolateral membranes was detected in the brush border membrane fraction.

Amino Acid Sequence↗
PubMed1991

Cellular and subcellular localization of annexin IV in rabbit intestinal epithelium, pancreas and liver.

The results of immunoblot analysis performed with a specific monoclonal antibody showed that the intestinal mucosa, pancreas and liver are privileged tissues for the expression of annexin IV. Immunofluorescence labelling of thin frozen sections of these tissues showed a strong concentration of annexin IV along the basolateral domain of the plasma membrane of intestinal absorbing cells, hepatocytes and pancreatic acinar cells, whereas in intestinal mucous secreting cells and centro acinar pancreatic cells, annexin IV was found to be present throughout the cytoplasm.

Animals↗
PubMed1987

Evidence for the transit of aminopeptidase N through the basolateral membrane before it reaches the brush border of enterocytes.

In vivo pulse-chase labeling of rabbit jejunum loops was used in conjunction with subcellular fractionation and quantitative immunoprecipitation to determine whether or not the newly synthesized aminopeptidase N transits through the basolateral membrane before it reaches the apical brush border, its final localization. The kinetics of the arrival of the newly synthesized enzyme in the Golgi complex, basolateral and brush border membrane fractions strongly suggest that on leaving the Golgi aminopeptidase N is transiently integrated into the basolateral domain before reaching the brush border.

Aminopeptidases↗
PubMed1986

Evidence for selective transport of two brush-border glycoproteins from endoplasmic reticulum to Golgi complex in rabbit enterocytes.

In vivo pulse-chase labeling of rabbit jejunum loops was used in conjunction with subcellular fractionation and quantitative immunoprecipitation to compare the intracellular transport kinetics of aminopeptidase with that of a 140 kDa brush-border antigen not belonging to the hydrolase class. As judged by the maturation kinetics of Asn-linked glycans, these glycoproteins were found to be transported from the endoplasmic reticulum into the Golgi apparatus at different rates (t1/2 = 25-50 min). The transport from the Golgi complex to the brush-border was rapid and seemed to occur at the same rate for both glycoproteins. In keeping with these kinetic data, the steady-state levels of aminopeptidase and the 140 kDa antigen in the Golgi complex were low, although that of aminopeptidase was significantly higher.

Aminopeptidases↗
PubMed1985

The carbohydrate moiety of aminopeptidase N of rabbit intestinal brush-border membrane.

Endoglycosidase F was used to eliminate the N-linked complex glycans from intestinal aminopeptidase N. The glycans which were probably O-linked remaining after the endoglycosidase F treatment exhibited the human blood group A and H determinants expressed in enzymes from A+ or A- rabbits, respectively. The molecular mass estimation of the two types of glycans by SDS-polyacrylamide gel electrophoresis and the sugar composition of aminopeptidase from A+ and A- rabbits strongly suggested the presence of eight N-linked complex glycans and two O-linked oligosaccharides bearing the human group antigenicity.

ABO Blood-Group System↗
PubMed1983

Recognition of sodium- and potassium-dependent adenosine triphosphatase in organs of the mouse by means of a monoclonal antibody.

The antigen detected by the rat anti-mouse monoclonal antibody (m Ab), anti-BSP-3, has been initially described as a brain cell-surface protein. Evidence is presented that this m Ab recognizes mouse (Na+ + K+)-ATPase (ATP phosphohydrolase, E.C.3.6.1.3). The antigen, purified from mouse brain by means of affinity chromatography, migrated in SDS-polyacrylamide gels in the form of two polypeptide chains of 100 000 and 48 000 molecular weight, which could be shown to react with subunit-specific polyclonal antisera against ATPase in immunoblotting experiments. Purified BSP-3 antigen was bound to the specific (Na+ + K+)-ATPase inhibitor ouabain. Finally, the anti-BSP-3 m Ab was capable of immunoprecipitating the ATPase activity of a microsomal fraction from mouse kidney. The m Ab was used to study the localization of (Na+ + K+)-ATPase in different organs of the mouse. It stained the basolateral plasma membranes of polarized cells in immunofluorescence experiments, while the entire cell surface of unpolarized cells was labeled. Interestingly, several cell types did not react with the m Ab, indicating a possible heterogeneity of ATPases. Such a m Ab could prove to be a useful tool for studying localization, structure and function of (Na+ + K+)-ATPase.

Animals↗