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1.
Diabetes Obes Metab ; 12(10): 916-22, 2010 Oct.
Article in English | MEDLINE | ID: mdl-20920045

ABSTRACT

AIMS: The addition of basal insulin to existing oral therapy can help patients with type 2 diabetes (T2D) achieve glycaemic targets. This study compares the efficacy and safety of insulin lispro protamine suspension (ILPS) and insulin glargine in insulin-naive patients with T2D and inadequate control on oral antihyperglycaemic medication (OAM). MATERIALS AND METHODS: An open-label, randomized, multicentre, multinational 24-week study of 471 patients receiving ≥2 OAMs for ≥3 months with a body mass index between 25 and 45 kg/m(2) and HbA1c 7.5-10.0% was conducted. ILPS was injected once or twice daily vs. glargine injected once daily plus prestudy OAMs. Primary objective compared the HbA1c change from baseline. RESULTS: HbA1c change from baseline to endpoint was similar in both groups [-1.46% (ILPS) and -1.41% (glargine)]. Least-squares mean difference (95% CI) for HbA1c (-0.05 [-0.21, 0.11]%), glycaemic variability (0.06 [-0.06, 0.19] mmol/l) and weight change (-0.01 [-0.61, 0.59] kg) showed non-inferiority (margins of 0.4%, 0.8 mmol/l and 1.5 kg, respectively). Percentages of patients achieving HbA1c <7.0% were 43.8% ILPS and 41.2% glargine. Mean daily insulin dose was 0.39 vs. 0.35 U/kg (p = 0.02) and weight gain was 1.04 vs. 1.07 kg for ILPS vs. glargine (p = 0.98). Overall hypoglycaemia (episodes/patient/year) was similar for ILPS and glargine (24.2 ± 28.8 vs. 23.0 ± 30.9); nocturnal (6.1 ± 10.6 vs. 4.1 ± 9.4, p < 0.001) rates were higher for ILPS. Severe hypoglycaemia was higher for ILPS vs. glargine (n = 9 vs. n = 2; p = 0.04). CONCLUSIONS: At endpoint, ILPS was non-inferior to glargine in HbA1c change from baseline, but associated with increased risk of hypoglycaemia.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin/analogs & derivatives , Body Mass Index , Drug Administration Schedule , Drug Therapy, Combination , Female , Humans , Hypoglycemic Agents/pharmacology , Insulin/administration & dosage , Insulin/pharmacology , Insulin Glargine , Insulin Lispro , Insulin, Long-Acting , Male , Middle Aged , Treatment Outcome
2.
Scanning ; 32(3): 150-4, 2010.
Article in English | MEDLINE | ID: mdl-20593427

ABSTRACT

A new cryo-scanning transmission electron microscopy (cryo-STEM) technique for imaging casein micelles in a field emission scanning electron microscope is presented. Thin films of micellar casein suspensions on lacey carbon grids were prepared using a modified sample holder developed by Gatan UK. Bright and dark field images were obtained at -135°C showing casein micelles in their frozen hydrated state and in the size range 30-500 nm. Results were compared favorably with published images of casein micelles obtained with conventional cryo-transmission electron microscopy, suggesting that cryo-STEM is a useful alternative technique for visualizing food colloids close to their native state.


Subject(s)
Colloids , Cryoelectron Microscopy/methods , Food , Microscopy, Electron, Scanning/methods , Caseins/ultrastructure , Macromolecular Substances/ultrastructure
3.
Diabet Med ; 27(5): 589-92, 2010 May.
Article in English | MEDLINE | ID: mdl-20536957

ABSTRACT

AIMS: Self-monitoring of blood glucose (SMBG) is an important self-management tool for insulin-treated patients with Type 2 diabetes mellitus (T2DM). Its value in estimating glycaemic control in insulin-treated T2DM patients remains unclear. The relationship between glycated haemoglobin (HbA(1c)) and SMBG measures in T2DM patients treated with premixed insulin lispro mixtures or basal insulin glargine was examined. METHODS: HbA(1c) and plasma equivalent glucose (PGe) data derived from SMBG profiles were pooled from five randomized clinical trials of patients with T2DM on one or more oral glucose-lowering medication +/- 0-2 insulin injections per day switching to insulin lispro mixtures (N = 317) or glargine (N = 306). Patients generated seven-point SMBG profiles three times in a 2-week period prior to each HbA(1c) measurement. Pearson's correlation coefficients (r) were calculated for PGe values and HbA(1c). Receiver-operating characteristic (ROC) curves determined the ability of sets of PGe to estimate HbA(1c) (< or > 7.0%). RESULTS: Mean +/- standard deviation age was 57.5 +/- 9.5 years, body mass index 31.3 +/- 5.6 kg/m(2), 52.5% were male and HbA(1c) overall was 7.4 +/- 1.0% at end-point. Among individual SMBG measures, r for HbA(1c) ranged from 0.34 to 0.49. For means of two or more PGe measures, r for HbA(1c) ranged from 0.51 to 0.59. Correlations were similar for either regimen. ROC curves were consistent with the correlation data. CONCLUSIONS: These data provide patients and clinicians information on the relationship between HbA(1c) and SMBG measurements in patients with T2DM, and support the value of frequent blood glucose measurements for assessing overall glycaemic control.


Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/metabolism , Glycated Hemoglobin/metabolism , Insulin/analogs & derivatives , Aged , Diabetes Mellitus, Type 2/drug therapy , Female , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Insulin Glargine , Insulin Lispro , Insulin, Long-Acting , Male , Middle Aged
5.
J Gen Intern Med ; 13(5): 311-6, 1998 May.
Article in English | MEDLINE | ID: mdl-9613886

ABSTRACT

OBJECTIVE: To determine the incidence of major hemorrhage among outpatients started on warfarin therapy after the recommendation in 1986 for reduced-intensity anticoagulation therapy was made, and to identify baseline patient characteristics that predict those patients who will have a major hemorrhage. DESIGN: Retrospective cohort study. SETTING: A university-affiliated Veterans Affairs Medical Center. PATIENTS: Five hundred seventy-nine patients who were discharged from the hospital after being started on warfarin therapy. MEASUREMENTS AND MAIN RESULTS: The primary outcome variable was major hemorrhage. In our cohort of 579 patients, there were 40 first-time major hemorrhages with only one fatal bleed. The cumulative incidence was 7% at 1 year. The average monthly incidence of major hemorrhage was 0.82% during the first 3 months of treatment and decreased to 0.36% thereafter. Three independent predictors of major hemorrhage were identified: a history of alcohol abuse, chronic renal insufficiency, and a previous gastrointestinal bleed. Age, comorbidities, medications known to influence prothrombin levels, and baseline laboratory values were not associated with major hemorrhage. CONCLUSIONS: The incidence of major hemorrhage in this population of outpatients treated with warfarin was lower than previous estimates of major hemorrhage measured before the recommendation for reduced-intensity anticoagulation therapy was made, but still higher than estimates reported from clinical trials. Alcohol abuse, chronic renal insufficiency, and a previous gastrointestinal bleed were associated with increased risk of major hemorrhage.


Subject(s)
Ambulatory Care , Anticoagulants/adverse effects , Hemorrhage/chemically induced , Warfarin/adverse effects , Aged , Alcoholism/epidemiology , Anticoagulants/therapeutic use , Cohort Studies , Female , Gastrointestinal Hemorrhage/epidemiology , Hemorrhage/epidemiology , Humans , Incidence , Kidney Failure, Chronic/epidemiology , Male , Retrospective Studies , Risk Factors , Warfarin/therapeutic use
6.
Am J Clin Oncol ; 21(3): 294-7, 1998 Jun.
Article in English | MEDLINE | ID: mdl-9626802

ABSTRACT

This phase II trial investigated the activity and toxicity of CODE (cisplatin, vincristine, doxorubicin, etoposide) chemotherapy with the addition of granulocyte colony-stimulating factor (G-CSF) in patients who had chemotherapy-naive, advanced, or metastatic non-small-cell lung cancer. Treatment consisted of cisplatin, 25 mg/m2, administered weeks 1 through 9; vincristine, 1 mg/m2, weeks 1, 2, 4, 6, and 8; doxorubicin, 40 mg/m2, weeks 1, 3, 5, 7, and 9; and etoposide, 80 mg/m2 intravenously day 1 and 160 mg/m2 orally, days 2 and 3 on weeks 1, 3, 5, 7, and 9. Granulocyte colony-stimulating factor, 5 microg/kg, was administered subcutaneously on all days that patients were not receiving chemotherapy. From April 1992 through April 1993, 42 patients were entered on study. The principal toxicities were hematologic. Grade 3-4 anemia was seen in 21 patients. Grade 3-4 thrombocytopenia was seen in 9 patients. Grade 3-4 neutropenia occurred in 29 patients. Eight patients experienced a neutropenic febrile episode requiring antibiotics. Nonhematologic toxicities included weight loss and fatigue. Responses were seen in 10 of 42 patients, for an overall response rate of 24% (95% confidence interval, 12%-39%) and a median survival of 7.1 months. The CODE chemotherapy regimen has activity similar to other previously described cisplatin-based regimens, with a significant amount of both hematologic and nonhematologic toxicity. Its continued use in patients who have previously untreated non-small-cell lung cancer cannot be recommended, based on the results of this study.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/secondary , Granulocyte Colony-Stimulating Factor/administration & dosage , Lung Neoplasms/drug therapy , Lung Neoplasms/secondary , Adult , Aged , Anemia/chemically induced , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carcinoma, Non-Small-Cell Lung/mortality , Cisplatin/administration & dosage , Cisplatin/adverse effects , Disease-Free Survival , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Etoposide/administration & dosage , Etoposide/adverse effects , Female , Humans , Leukopenia/chemically induced , Lung Neoplasms/mortality , Male , Middle Aged , Survival Rate , Vincristine/administration & dosage , Vincristine/adverse effects
7.
Radiology ; 199(3): 658-64, 1996 Jun.
Article in English | MEDLINE | ID: mdl-8637983

ABSTRACT

PURPOSE: To compare results of transjugular intrahepatic portosystemic shunt (TIPS) placement with 10- and 12-mm Wallstents. MATERIALS AND METHODS: Forty-six TIPS procedures in 47 patients were retrospectively reviewed. Wallstents that were 10 mm in diameter were used in 23 patients, and those that were 12 mm in diameter were used in 23 patients. Immediate results were compared, which included initial portosystemic gradient and Doppler measurements of blood flow velocity through the shunt at 1 day. Long-term patency and velocities were also assessed. RESULTS: TIPS were successfully created in 46 of 47 patients (98%). In one patient in the 10-mm group, the portal vein could not be accessed. When compared with TIPS in the 10-mm group, TIPS placed in the 12-mm group required dilation to larger diameters (mean, 11.1 vs 9.2 mm; P < .0001) to achieve an identical target gradient of 10 mm Hg and exhibited lower 1-day velocities (mean, 1.3 m/sec vs 1.7 m/sec; P < .03). The 1-day occlusion rate was 17% (four of 23 patients) in the 12-mm group versus 0% in the 10-mm group (P < .02). Patient survival was statistically significantly less in the 12-mm group (P < .03). CONCLUSION: Twelve-millimeter Wallstents yield statistically significantly poorer short- and long-term results in TIPS procedures. This is most likely due to the decreased radial strength of the larger stent, which is 50% less than that of the 10-mm stent.


Subject(s)
Portasystemic Shunt, Surgical/instrumentation , Stents , Adolescent , Adult , Aged , Child , Evaluation Studies as Topic , Female , Follow-Up Studies , Humans , Jugular Veins , Life Tables , Male , Middle Aged , Portal System/diagnostic imaging , Portasystemic Shunt, Surgical/methods , Portasystemic Shunt, Surgical/mortality , Portasystemic Shunt, Surgical/statistics & numerical data , Portography , Radiography, Interventional/instrumentation , Radiography, Interventional/methods , Radiography, Interventional/statistics & numerical data , Retrospective Studies , Stents/statistics & numerical data , Ultrasonography
8.
J Bone Miner Res ; 10(11): 1816-22, 1995 Nov.
Article in English | MEDLINE | ID: mdl-8592960

ABSTRACT

The identification of those at highest risk of osteoporotic fractures is a clinical goal that requires appropriate statistical comparisons of potential predictors of fractures. This article provides a formal approach of comparing individual predictors (e.g., bone mass at one site vs bone mass at another), or sets of predictors (e.g., bone mass vs other risk factors), and contrasts newer methods, such as bootstrapping, to receiver-operating-characteristics (ROC) curves, which have been previously used. The advantages of the bootstrapping approach are illustrated using time-to-fracture data from a published study demonstrating the use of baseline bone mass measurements in the prediction of fractures in 521 subjects with variable lengths of follow-up, extending to 12.5 years. Bone mineral density (BMD) was shown to be significantly better than bone mineral content (BMD) in predicting fractures in free-living subjects, but not in retirement-community subjects. Bone mineral apparent density (BMAD) was also compared with BMC and BMD and shown not to improve fracture prediction in these subjects.


Subject(s)
Bone Density/physiology , Fractures, Bone/epidemiology , Osteoporosis, Postmenopausal/physiopathology , Osteoporosis/physiopathology , Cohort Studies , Female , Follow-Up Studies , Fractures, Bone/physiopathology , Homes for the Aged , Humans , Models, Statistical , Proportional Hazards Models , ROC Curve , Risk Assessment , Risk Factors
9.
Transfusion ; 32(4): 312-7, 1992 May.
Article in English | MEDLINE | ID: mdl-1585434

ABSTRACT

The role of the immune system in microbial translocation must be clarified. In these studies, the effect of blood transfusion-related immunosuppression on translocation was investigated in a burn animal model previously known to increase the gut's permeability to 14C-radiolabeled Escherichia coli. In a first experiment, Balb/c mice underwent transfusion (T) with 0.2 mL per mouse of allogeneic C3H/HeJ mouse blood 5 days prior to undergoing 30-percent burn injury (B) and simultaneous gavage (G) with 10(9) E. coli bacteria labeled with 14C. An additional six groups of Balb/c mice underwent different combinations of T, B, and G procedures (TG, BG, TB, T, B, G). Survival rate was recorded for all groups on Day 10. This experiment suggested that B and T, to a lesser extent, were the factors affecting survival, although the combination of T, B, and G clearly showed a synergistic effect on mortality. In a second experiment, 18 Balb/c mice belonging to TBG, BG, TG, and G groups were sacrificed 1, 4, and 24 hours after burn or gavage. The residual radioactivity and the percentage of viable bacteria were computed for mesenteric lymph nodes, spleen, liver, lungs, blood, and peritoneal fluid. Statistical analysis of the radionuclide counts recognized B as the only variable able to enhance the magnitude of 14C E. coli translocation. The percentage of viable bacteria showed that T and, more moderately, B were the factors leading to the failure of bacterial clearance in the tissues.


Subject(s)
Blood Transfusion , Burns/microbiology , Escherichia coli/physiology , Intestines/microbiology , Animals , Burns/mortality , Female , Immune Tolerance/physiology , Liver/microbiology , Lung/microbiology , Lymph Nodes/microbiology , Mice , Mice, Inbred BALB C , Mice, Inbred C3H , Spleen/microbiology , Survival Rate
10.
Eval Health Prof ; 15(1): 107-14, 1992 Mar.
Article in English | MEDLINE | ID: mdl-10117741

ABSTRACT

Validity of research in a medical environment is enhanced through incorporating the patient's perspective by using qualitative approaches. Our efforts to improve the validity of measures led us to examine the research process more broadly through mechanisms of patient participation: a protocol adviser, a participant advisory panel, and focus groups. In our research program of biopsychosocial HIV studies in the military population, feedback from patient participants provided the research staff with information important for refining standard measures, improving the research process, and interpreting the quantitative data analyses.


Subject(s)
HIV Infections/psychology , Patient Participation , Program Evaluation/methods , Research Design/standards , Clinical Protocols , Humans , Military Personnel/psychology , Patient Participation/psychology , United States
11.
Ann Surg ; 213(6): 558-66; discussion 566-7, 1991 Jun.
Article in English | MEDLINE | ID: mdl-2039286

ABSTRACT

The present investigation was performed to study the kinetics of tissue distribution and deposition of Escherichia coli and endotoxin translocating from the intestine after thermal injury. Escherichia coli was grown in the presence of 14C glucose and both labeled bacteria and endotoxin prepared from the labeled bacteria were used as translocation probes. Escherichia coli (10(8) to 10(10) bacteria) and E. coli endotoxin (100 micrograms per animal) were gavaged into the stomach immediately before a 30% burn injury was inflicted in mice. Animals were killed 1, 4 and 24 hours after burn injury. Translocation occurred extensively within 1 hour after burn injury. Expressed as amount of radioactivity per gram of tissue, translocation was greatest in the mesenteric lymph node (MLN) followed by spleen, lung, and liver. Translocation of endotoxin was similar to translocation of intact bacteria, with the exception that less radioactivity could be found in the peritoneal cavity and more in the liver. Both intact E. coli and endotoxin translocated directly through the intact bowel wall. Killing of bacteria was greatest in the MLN and spleen, approximating 95% to more than 99% of translocating bacteria. Killing efficiency was lowest in the lungs. It is concluded that estimation of translocation by viable bacterial counts in tissues grossly underestimates the extent of translocation of bacteria and ignores the extent of translocation of endotoxin. Translocation of endotoxin may have biologic significance that is independent of and in addition to translocation of intact bacteria.


Subject(s)
Burns/microbiology , Escherichia coli/physiology , Intestines/microbiology , Animals , Colon/metabolism , Endotoxins/pharmacokinetics , Female , Intestines/physiology , Mice , Mice, Inbred BALB C , Movement , Stomach/microbiology , Tissue Distribution
14.
Agents Actions ; 27(3-4): 313-5, 1989 Jun.
Article in English | MEDLINE | ID: mdl-2552763

ABSTRACT

Ro 23-6457, (all-E)-3,7-dimethyl-9-[2-(trifluoromethyl)-6-(nonyloxy)phenyl]-2, 4,6,8- nonatetraenoic acid, and Ro 23-2895, (all-E)-9-[2-(nonyloxy)phenyl]-3,7-dimethyl-2,4,6,8-nonatetraen oic acid, are two novel retinoid analogs which exhibit antiinflammatory activity in both the developing and the established rat adjuvant arthritis models [8]. Here we investigated the effect of these two compounds on the production of arachidonic acid (AA) metabolites in two in vitro test systems [i.e., Ca2+ ionophore A23187 (I)-stimulated resident rat peritoneal macrophages (MO) and cytokine-stimulated human dermal fibroblasts (HDF)]. Both compounds, Ro 23-6457 and Ro 23-2895, significantly inhibited the release of 14C-AA metabolites and the production of LTB4, PGE2, and 6-keto-PGF1 alpha in I-stimulated MO, at concentrations of 1-33 microM. Both compounds also inhibited the production of PGE2 in HDF stimulated by either rhuIL-1 alpha or huTNF alpha at concentrations of 1 x 10(-5) to 1 x 10(-7) M. Ro 23-2895 was also a potent inhibitor of IL-1-induced collagenase production in rheumatoid synovial cells (IC50 approximately 1 to 2.5 x 10(-8) M). The inhibitory profile of these novel compounds in these cell systems is therefore similar to that of other known antiinflammatory retinoids (e.g., all-trans- and 13-cis-retinoic acid). Inhibitory effects such as those described here might in part contribute to the antiinflammatory activity of these compounds in vivo.


Subject(s)
Arachidonic Acids/metabolism , Retinoids/pharmacology , Animals , Arachidonic Acid , Arachidonic Acids/antagonists & inhibitors , Dinoprostone/metabolism , Fibroblasts/metabolism , In Vitro Techniques , Macrophages/metabolism , Male , Microbial Collagenase/antagonists & inhibitors , Peritoneal Cavity/cytology , Rats , Rats, Inbred Strains
15.
Am Rev Respir Dis ; 124(4): 376-81, 1981 Oct.
Article in English | MEDLINE | ID: mdl-6794394

ABSTRACT

The nutritional status of 38 patients with chronic obstructive pulmonary disease (COPD) was assessed by dietary intake, anthropometric measurements biochemical analysis, and immunologic testing. The mean intakes for 9 nutrients were significantly greater than the 1974 Recommended Dietary Allowances of the National Academy of Sciences. Results of the anthropometric measurements for usual weight for height, fat stores, and muscle mass were significantly less than standard. Of the 32 subjects evaluated for immunocompetence, 9 were anergic (induration, 0) on all 3 skin tests. The results of this study indicated that the marasmic type of protein calorie malnutrition is a common finding among patients with COPD, and that patients with COPD who are immunoincompetent may be more susceptible to mixed protein calorie malnutrition of the kwashiorkor-marasmus type.


Subject(s)
Lung Diseases, Obstructive/diagnosis , Nutritional Physiological Phenomena , Adult , Aged , Blood Proteins/analysis , Body Height , Body Weight , Diet , Female , Humans , Immunocompetence , Iron/blood , Leukocyte Count , Lung Diseases, Obstructive/complications , Lung Diseases, Obstructive/immunology , Lymphocytes , Male , Middle Aged , Protein-Energy Malnutrition/diagnosis , Skin Tests , Skinfold Thickness
17.
Talanta ; 13(8): 1081-7, 1966 Aug.
Article in English | MEDLINE | ID: mdl-18959977

ABSTRACT

The conditions for the spectrophotofluorometric determination of terbium and europium, in solutions of potassium carbonate, have been established. The apparent excitation and fluorescence wavelengths used, respectively, are 245 mmu and 550 mmu for terbium and 400 mmu and 620 mmu for europium. The fluorescence varies linearly with the concentration of terbium and europium in the range 0.3-70 mug, of terbium/ml and 4-800 mug of europium/ml. Large amounts of gadolinium, lutetium and yttrium do not interfere. Cerium(IV) interferes seriously.

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