A phase I/II evaluation of oral L-2-oxothiazolidine-4-carboxylic acid in asymptomatic patients infected with human immunodeficiency virus.

A randomized double-blind, placebo-controlled study was conducted in 37 asymptomatic HIV-infected individuals (mean CD4 count 707 cells/mm3) to characterize the safety, pharmacokinetics, and effect on blood thiols of three dosage levels of a cysteine prodrug, L-2-oxothiazolidine-4-carboxylic acid (OTC; Procysteine; Clintec Technologies, Deerfield, IL). Single-dose administration of OTC resulted in measurable plasma levels at all dosages, with a mean peak plasma concentration of 734 +/- 234 nmol/mL at the highest dosage studied. After 4 weeks of administration three times daily, a statistically significant increase was seen in whole blood glutathione in the 1,500 mg and 3,000 mg dose groups compared with the placebo group. A significant increase in whole blood cysteine and peripheral blood mononuclear cell (PBMC) glutathione was not seen during the study period.

The influence of signal variation, bias, noise and effect size on statistical significance in treatment studies of the common cold.

Many groups are working on new and improved methods of common cold treatment that include antivirals, synthetic viral receptor, compounds which block symptom pathways, and combinations of these approaches. Because the common cold syndrome is in large part subjective, symptom measurement remains an important parameter in evaluating the effectiveness of cold treatments. This review examines the features of the experimental and natural cold testing methods that effect recognition of illness signal and influence its variance and strength. Also, the importance of changes in signal variance and in the magnitude of therapeutic effect size as they relate to statistical probability were compared using a symptom data set from young adults with experimental rhinovirus colds.

Efficacy of a mixture of medium-chain triglyceride (75%) and long-chain triglyceride (25%) fat emulsions in the nutritional management of multiple-trauma patients.

Ten severely injured patients who were admitted to the intensive care unit and who needed total parenteral nutrition (TPN) were randomly enrolled in a prospective double-blind study comparing two 20%-fat intravenous emulsions: one (MCT-LCT) containing a physical mixture of 75% medium-chain triglyceride (MCT) and 25% long-chain triglyceride (LCT) and another containing 100% LCT. TPN (30 kcal.kg-1.day-1) was given continuously as amino acids (20% of energy) and glucose (50% of energy) over 7 days with the respective lipid emulsion (30% of energy) provided from 0800 to 1600 each day. Plasma substrate concentrations, nitrogen balance, resting energy expenditure, substrate net oxidation rates, whole-body lipolysis rates, and fatty acid reesterification rates were measured or calculated. Plasma concentrations of lipid metabolites (glycerol, triglycerides, and fatty acids) indicated rapid hydrolysis and efficient use of the MCT-LCT emulsion. Whole-body lipolysis rate decreased by 53% in the MCT-LCT group and by 34% in the LCT group. Net fat oxidation was greater and FFA reesterification less with MCT-LCT than with LCT, indicating more efficient and rapid fuel utilization in the post-traumatic period with the MCT-LCT emulsion. In critically ill patients dependent on intravenous nutrition, an MCT-LCT mixture may be useful as an obligate fuel and to limit net hepatic lipogenesis.