A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia

STUDY OBJECTIVES: Evaluate the efficacy of eszopiclone in primary insomnia. DESIGN/SETTING: Randomized, double-blind, placebo-controlled multicenter in outpatient setting with weekly visits. PARTICIPANTS: Two-hundred thirty one men and women aged 65 to 85 years (mean age 72.3 years) with primary insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition. INTERVENTIONS: Eszopiclone 1 mg (n = 72), eszopiclone 2 mg (n = 79), or placebo (n = 80) nightly for 2 weeks. MEASUREMENTS/RESULTS: Efficacy was assessed using an interactive voice response system. Following the predefined hierarchical testing strategy, the eszopiclone 2-mg group had a significantly shorter sleep latency compared with placebo over the double-blind period (P = .0034). The eszopiclone 2-mg group had significantly longer total sleep time (P = .0003) and eszopiclone 1-mg group had significantly shorter sleep latency (P < or = .012) compared with placebo. The eszopiclone 1-mg group was not significantly different from placebo on total sleep time or any other secondary efficacy endpoint. Secondary analyses indicated that the eszopiclone 2-mg group had significantly less wake after sleep onset; significantly fewer and shorter in duration daytime naps; and significantly higher ratings of sleep quality and depth, daytime alertness, and sense of physical well-being compared with placebo (P < .05). Eszopiclone was well tolerated. The most frequent treatment-related adverse event was unpleasant taste. CONCLUSION: Nightly treatment with eszopiclone 1 mg effectively induced sleep, while the 2-mg dose was effective in inducing and maintaining sleep. Eszopiclone was well tolerated in elderly patients with primary insomnia, and the sleep efficacy was accompanied by significantly less napping and significantly higher ratings of daytime alertness, sense of physical well-being, and several quality-of-life parameters at the higher dose.     

Comparison of an Adherence Domain and a Structural Region of Streptococcus mutans Antigen I/II in Protective Immunity against Dental Caries in Rats after Intranasal Immunization

Previous studies have identified an N-terminal saliva-binding region (SBR) on Streptococcus mutans surface antigen I/II (AgI/II) and suggested its importance in the initial adherence of S. mutans to saliva-coated tooth surfaces and subsequent development of dental caries. In this study, we compared the SBR with a C-terminal structural region of AgI/II (AgII) in their abilities to induce protective immunity against caries in rats. When SBR, AgII, or the whole AgI/II molecule was administered intranasally as a conjugate with the B subunit of cholera toxin (CT), in the presence of CT adjuvant, substantial levels of salivary immunoglobulin A anti-AgI/II antibodies were induced. Evaluation of caries activity showed that the SBR, though not as protective as the parent molecule, was superior to AgII and thus can be further considered as a component in a multivalent caries vaccine.     

Detection of clonal immunoglobulin gene rearrangements in the peripheral blood progenitor cells of patients with multiple myeloma: the potential role of purging with CD34 positive selection

Aims—To determine the extent of clonal cell contamination of peripheral blood progenitor cell (PBPC) collections in patients with multiple myeloma (MM) and to assess the purging efficacy of CD34 positive selection.     

Technical note: preventive maintenance quality assurance

Performance improvements in healthcare and, specifically, in clinical engineering are required by the Joint Commission on the Accreditation of Healthcare Organizations' Plant Technology and Safety Management (PTSM) documents. The goals of healthcare service quality assurance are to establish performance requirements and improve patient outcomes. It is important that these goals be kept in the forefront of the design of clinical engineering quality assurance planning. Indicator/threshold pairs must be carefully chosen on the basis of some logical relation to the desired goals of the overall program.     

Memory for actions in children with autism: self versus other

In order to ask whether autism is associated with difficulty in self-monitoring we gave a group of children and adolescents with autism a task in which they themselves had to remember whether they or another person had performed certain actions. In our first experiment, three groups of participants had to recall whether placements of picture cards had been made by themselves or by the experimenter. The participants with autism performed at a much lower level than the two comparison groups and, unlike the comparison groups, were not better at recalling their own placements. A second experiment tested the prediction arising from the monitoring-deficit account that the children with autism would be unimpaired when the placement of the items did not alternate between self and other. This prediction was confirmed moderately well. Additionally, in contrast to that of the comparison groups, the performance of the participants with autism was unaffected by whether self or other displaced the items. This is consistent with the existence of a monitoring deficit.     

Incorporation of simian virus 5 fusion protein into murine leukemia virus particles and its effect on the co-incorporation of retroviral envelope glycoproteins

We describe the generation of murine leukemia virus (MLV) virus particles carrying the paramyxovirus fusion protein F from simian virus 5 (SV5-F). This glycoprotein was expressed in cells providing Moloney MLV (MoMLV) Gag and Pol proteins and a lacZ retroviral vector. SV5-F was correctly expressed, processed, and efficiently incorporated into retroviral particles. SV5-F-bearing retroviruses were not infectious although a weak binding to primate and rodent cells could be detected and SV5-F could mediate cell to cell fusion. We then co-expressed the SV5-F glycoprotein in retroviral particles with chimeric and wild-type MoMLV envelope glycoproteins. Our results show that F strongly inhibited infection via the retroviral envelopes although the mechanism of inhibition was different depending on the retroviral envelope used.     

The MD-MPH program at the University of North Carolina at Chapel Hill.

In 1997, the Schools of Medicine and Public Health at the University of North Carolina at Chapel Hill (UNC) developed a formal MD-MPH program, called the Health Care and Prevention (HC&P) Program, located in the Public Health Leadership Program in the UNC School of Public Health. Since then, and especially since 2003, the number of UNC medical students taking a year out of their medical studies to pursue an MPH has increased dramatically. At present, more than 20% of UNC medical students enter an MPH program at some point between entering medical school and leaving for residency.The HC&P Program is designed to introduce clinicians to the population sciences and to create physicians who can think in both individual and population terms. The curriculum is a rigorous, 12-month program that includes a practicum experience and a master's paper. Several of the traditional MPH introductory courses have been redesigned to be more relevant to physicians. The program allows a maximum number of electives and places a value on flexibility so that students, together with faculty, can design the educational experience that best meets their needs. Many members of the faculty of the program themselves have both MD and MPH degrees, and some have dual appointments in the schools of medicine and public health.The authors have begun a longitudinal cohort study of program graduates and other medical graduates to understand the effect of the program on students' perceptions of their competency and their ability to exert leadership in various areas of population health.     

The role of the carbohydrate chains in complement (C3) fixation by solid-phase-bound human IgA.

In contrast to antigen-antibody complexes containing native human IgA, solid-phase-deposited IgA activates the alternative complement pathway and binds C3b. To investigate the role of carbohydrate chains in this, various human IgA preparations were treated with neuraminidase alone or together with N-glycanase or O-glycanase, or with mixed glycosidases from the oral bacterium, Streptococcus mitis. Depletion of oligosaccharides was determined by carbohydrate analysis. Removal of sialic acid and N-linked glycan chains greatly increased the C3b-fixing properties of normal serum IgA1 and IgA2. Myeloma IgA1 and IgA2 proteins and secretory IgA had higher C3b-binding activity than normal serum IgA, and this was further increased by removal of sialic acid and N-linked glycans. Fc alpha and Fc alpha-SC fragments of myeloma and secretory IgA1, respectively, but not Fab alpha fragments, obtained by cleavage with bacterial IgA1 proteases and also free secretory component, fixed C3b by the alternative pathway.     

Calibration of Mg2SiO4(Tb) thermoluminescent dosimeters for use in determining diagnostic x-ray doses to adult health study participants

Characteristics of Mg2SiO4(Tb) thermoluminescent dosimeters (TLD) were ascertained preparatory to measuring doses from diagnostic x-ray examinations received by Adult Health Study participants. These detectors are small, relatively sensitive to low-dose x-rays, and are appropriate for precise dosimetry. Extensive calibration is necessary for precisely determining doses according to their thermoluminescent intensities. Their sensitivities were investigated by dose, according to x-ray tube voltage, and by exposure direction, to obtain directional dependence. Dosimeter sensitivity lessened due to the fading effect and diminution of the planchet. However, these adverse effects can be avoided by storing the dosimeters at least 1.5 h and by using fresh silver-plated planchets. Thus the TLDs, for which sensitivities were determined in this study, will be useful in subsequent diagnostic x-ray dosimetry.