Safety Information From Spontaneous and Literature Adverse Reaction Reports: A Comparison.

Marketing authorization holders should report adverse drug reactions (ADRs) derived from spontaneous case reports and literature for their medicinal products to competent authorities. Yet the difference in quality of data from both sources has never been analyzed. To this end, YES Pharmaceutical Development Services in cooperation with the German Medicines Manufacturers Association has conducted an analysis examining more than 25,100 spontaneous and literature cases that occurred between 2007 and 2008.

Reciprocal alterations of Th1/Th2 function in gammadelta T-cell subsets of human immunodeficiency virus-1-infected patients.

While T cells that express Vgamma9 as a variable T-cell receptor chain dominate among peripheral blood gammadelta T cells in healthy adults, Vdelta1 cells are the major subpopulation of gammadelta T cells in human immunodeficiency virus (HIV)-infected patients. We used intracellular cytokine staining and flow cytometry to analyse whether an imbalance of T helper 1 (Th1)/T helper 2 (Th2) cytokine patterns, as observed in alphabeta T cells, also occurs in gammadelta T cells. When compared with healthy HIV-negative subjects, HIV+ patients had a decreased number of interferon-gamma (IFN-gamma)+gammadelta T cells, which showed a linear relation to the CD4+ cell count but not to the plasma viral load.

Quantification of human interleukin 18 mRNA expression by competitive reverse transcriptase polymerase chain reaction.

Interleukin 18 (IL-18) is a recently identified cytokine, originally called interferon gamma inducing factor, due to its capacity to induce interferon gamma production in Th1 type cells. IL-18 is expressed by a wide variety of cell types including mononuclear phagocytes, osteoblasts, keratinocytes and adrenal cortex cells. To quantify human IL-18 mRNA expression in small-scale cell samples the authors developed a competitive reverse transcriptase polymerase chain reaction using a competitive template as an internal standard.

Quantitation of apolipoprotein epsilon gene expression by competitive polymerase chain reaction in a patient with familial apolipoprotein E deficiency.

A simple method of obtaining semiquantitative and reliable data on apolipoprotein (apo) sigma gene expression is described. We detected apo sigma specific sequences by reverse transcription (rT)-PCR. For quantitative measurement, an apo sigma DNA standard was produced allowing the development of a competitive PCR-method.

Differential expression of bcl-2 and susceptibility to programmed cell death in lymphocytes of HIV-1-infected individuals.

The bcl-2 protooncogene encodes an inner mitochondrial membrane protein that blocks programmed cell death. There is now increasing evidence that regulation of bcl-2 expression is a determinant of life or death in normal lymphocytes. In this study, we examined bcl-2 expression in lymphocytes from human immunodeficiency virus type 1 (HIV-1)-infected and healthy subjects by flow cytometry.