On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events

Therapy by human immunoglobulin G (IgG) concentrates is a success story ongoing for decades with an ever increasing demand for this plasma product. The success of IgG concentrates on a clinical level is documented by the slowly increasing number of registered indication and the more rapid increase of the off-label uses, a topic dealt with in another contribution to this special issue of Frontiers in Immunology. A part of the success is the adverse event (AE) profile of IgG concentrates which is, even at life-long need for therapy, excellent. Transmission of pathogens in the last decade could be entirely controlled through the antecedent introduction by authorities of a regulatory network and installing quality standards by the plasma fractionation industry. The cornerstone of the regulatory network is current good manufacturing practice. Non-infectious AEs occur rarely and mainly are mild to moderate. However, in recent times, the increase in frequency of hemolytic and thrombotic AEs raised worrying questions on the possible background for these AEs. Below, we review elements of non-infectious AEs, and particularly focus on hemolysis and thrombosis. We discuss how the introduction of plasma fractionation by ion-exchange chromatography and polishing by immunoaffinity chromatographic steps might alter repertoire of specificities and influence AE profiles and efficacy of IgG concentrates.

An evaluation of the impact of Inner City Development's Cooperative Home School: An educational alternative program to increase the quality and level of education in San Antonio's West Side community

The research study was intended to evaluate the effectiveness of Inner City Development's (I.C.D.) Cooperative Home School, an educational alternative program to the Title I public schools of San Antonio's West Side community. The study investigated students', parents' and tutors' perception of parental involvement and educational resources. The study also investigated each student's academic achievement. ^ The study found that students progressed toward expected math proficiency at a faster rate than they did in reading proficiency. However, because the target population size was small and a comparison group was not used, the results of this study are only suggestive. This research also indicated that study subjects believed students' quality and level of education increased substantially since program exposure. Study subjects mainly attributed the students' strides in academic performance to the increased amount of individualized attention students received in the small twelve-student class size. Study subjects were more satisfied with the home school's educational resources than those of the Title I public schools. Study subjects also perceived that parental involvement both at home and at school increased since enrollment in the home school program because: (1) there were more opportunities for involvement in the home school; and (2) parents felt closer to the tutors than the teachers in public school. ^ This evaluation also suggested improvements to program operations. With the help of additional volunteers, I.C.D. program operators could improve collection and organization of academic records. Furthermore, as suggested by program participants, science could be added to the curriculum. Lastly, a formal tutor orientation could be implemented to familiarize and train tutors on classroom management procedures. ^

A comparison of worker risk of injury while working on fully automated side loaders and other residential collection trucks at a large solid waste collection company

The study aim was to determine whether using automated side loader (ASL) trucks in higher proportions compared to other types of trucks for residential waste collection results in lower injury rates (from all causes). The primary hypothesis was that the risk of injury to workers was lower for those who work with ASL trucks than for workers who work with other types of trucks used in residential waste collection. To test this hypothesis, data were collected from one of the nation’s largest companies in the solid waste management industry. Different local operating units (i.e. facilities) in the company used different types of trucks to varying degrees, which created a special opportunity to examine refuse collection injuries and illnesses and the risk reduction potential of ASL trucks.^ The study design was ecological and analyzed end-of-year data provided by the company for calendar year 2007. During 2007, there were a total of 345 facilities which provided residential services. Each facility represented one observation.^ The dependent variable – injury and illness rate, was defined as a facility’s total case incidence rate (TCIR) recorded in accordance with federal OSHA requirements for the year 2007. The TCIR is the rate of total recordable injury and illness cases per 100 full-time workers. The independent variable, percent of ASL trucks, was calculated by dividing the number of ASL trucks by the total number of residential trucks at each facility.^ Multiple linear regression models were estimated for the impact of the percent of ASL trucks on TCIR per facility. Adjusted analyses included three covariates: median number of hours worked per week for residential workers; median number of months of work experience for residential workers; and median age of residential workers. All analyses were performed with the statistical software, Stata IC (version 11.0).^ The analyses included three approaches to classifying exposure, percent of ASL trucks. The first approach included two levels of exposure: (1) 0% and (2) >0 - <100%. The second approach included three levels of exposure: (1) 0%, (2) ≥ 1 - < 100%, and (3) 100%. The third approach included six levels of exposure to improve detection of a dose-response relationship: (1) 0%, (2) 1 to <25%, (3) 25 to <50%, (4) 50 to <75%, (5) 75 to <100%, and (6) 100%. None of the relationships between injury and illness rate and percent ASL trucks exposure levels was statistically significant (i.e., p<0.05), even after adjustment for all three covariates.^ In summary, the present study shows that there is some risk reduction impact of ASL trucks but not statistically significant. The covariates demonstrated a varied yet more modest impact on the injury and illness rate but again, none of the relationships between injury and illness rate and the covariates were statistically significant (i.e., p<0.05). However, as an ecological study, the present study also has the limitations inherent in such designs and warrants replication in an individual level cohort design. Any stronger conclusions are not suggested.^

(Table 2) Taxonomic composition of diatoms in dredged samples from the island-side slope of the Kuril-Kamchatka Trench

Studies of diatoms from dredge samples collected on the island slope of the Kuril-Kamchatka Trench have allowed to recognize well-preserved marine diatom assemblages corresponding to assemblages of the followed Oligocene zones: Rhizosolenia oligocaenica (subzone ''a'', 33.6-31 Ma), Cavitatus rectus (29.6-28.2 Ma), and Rocella gelida (28.2-24.0 Ma) as identified in the North Pacific zonal scale. Description of these assemblages and their complete taxonomic composition are presented. Diversity of species together with abundance and degree of preservation of diatoms and accompanying siliceous microorganisms suggests their autochtonous origin and favorable conditions of their development. Assemblages of the Early Oligocene zones Rhizosolenia oligocaenica and Cavitatus rectus recognized in sediments of the outer zone of the Lesser Kuril Ridge (submarine slope of the Shikotan Island) and on the Vityaz' submarine ridge were most probably formed under conditions of a vast shelf, while assemblage of the Late Oligocene zone Rocella gelida encountered only in the region of the Lesser Kuril Ridge formed under more deep-water conditions, presumably, over an island slope. Deepening of the basin in the region of the outer zone of the Lesser Kuril Ridge in Late Oligocene probably reflects one of stages of evolution of the Kuril-Kamchatka Trench.

Predicting bed form roughness: the influence of lee side angle

Flow transverse bedforms (ripples and dunes) are ubiquitous in rivers and coastal seas. Local hydrodynamics and transport conditions depend on the size and geometry of these bedforms, as they constitute roughness elements at the bed. Bedform influence on flow energy must be considered for the understanding of flow dynamics, and in the development and application of numerical models. Common estimations or predictors of form roughness (friction factors) are based mostly on data of steep bedforms (with angle-of-repose lee slopes), and described by highly simplified bedform dimensions (heights and lengths). However, natural bedforms often are not steep, and differ in form and hydraulic effect relative to idealised bedforms. Based on systematic numerical model experiments, this study shows how the hydraulic effect of bedforms depends on the flow structure behind bedforms, which is determined by the bedform lee side angle, aspect ratio and relative height. Simulations reveal that flow separation behind bedform crests and, thus, a hydraulic effect is induced at lee side angles steeper than 11 to 18° depending on relative height, and that a fully developed flow separation zone exists only over bedforms with a lee side angle steeper than 24°. Furthermore, the hydraulic effect of bedforms with varying lee side angle is evaluated and a reduction function to common friction factors is proposed. A function is also developed for the Nikuradse roughness (k s), and a new equation is proposed which directly relates k s to bedform relative height, aspect ratio and lee side angle.