In this report, the process of designating a GLP facility by the Korean Ministry of Environment (MOE) is described in detail using the case of the Center of Occupational Toxicology (COT). The COT, which had been prepared as a GLP facility, filed an application to the National Institute of Environmental Research (NIER) of the MOE. The GLP system of the COT was evaluated by a harmonized evaluation team that consisted of several authorities including the NIER, the National Institute of Agricultural Science and Technology (NIAST), and the National Institute of Toxicological Research (NITR). The evaluation was arranged for mutual acceptance of data among GLP authorities. The designation process, additional documents necessary for applying GLP facility, the process of test facility evaluation including reviewing the application and site inspection, and inspection results and submission of correction plans are explained by using the instance of the inspection process of the COT. COT was evaluated as a suitable GLP facility for acute oral and inhalation toxicity tests and the Ames test.

Documentation↗

PubMedDate not supplied

Clinical implications of antineutrophil cytoplasmic antibody test in lupus nephritis.

To elucidate the prevalence and clinical implications of antineutrophil cytoplasmic antibody (ANCA) in lupus nephritis (LN), we examined ANCA by indirect immunofluorescence and by ELISA against antilactoferrin (anti-LF) and antimyeloperoxidase (anti-MPO) antibody. To discriminate perinuclear ANCA (pANCA) with antinuclear antibody (ANA), all the ANCA-positive sera were tested again after incubating patients' sera with single-stranded (SS) and double-stranded (ds) DNA. These results were compared with clinicopathologic manifestations and clinical courses of LN. ANCA was positive in 19 (37.3%) of 51 LN patients. Among these LN patients, 3 had cytoplasmic ANCA (cANCA) and 16 had pANCA. ANCA was not found in 8 SLE patients without nephritis and 30 normal controls. The presence of ANCA, particularly pANCA, was associated with the presence of nephritis (18/51 cases vs. 0/8 cases, p < 0.05), especially with diffuse proliferative lupus nephritis, WHO class IV (17/18 cases vs. 21/31 cases, p < 0.05) as well as the presence of anti-dsDNA antibody (17/19 cases vs. 18/30 cases, p < 0.05). Patients with ANCA frequently had deterioration of renal function (3/16 vs. 0/26 cases). Anti-LF antibody was positive in 13 patients. Among those, 12 patients had nephritis. Five patients with anti-LF antibody did not have ANCA, but 7 had pANCA, and 1 had cANCA. Patients with anti-LF antibody had lower initial creatinine levels than those without it [serum creatinine (mg/dl): 0.78 (0.6-1.0) vs. 1.43 (0.5-5.0), p < 0.05]. Anti-MPO antibody was positive in only 1 patient, suggesting that MPO is a rare antigen for ANCA in LN.

Adult↗

PubMedDate not supplied

Endothelium-dependent dilation of the coronary arteries in syndrome X: effects of the cold pressor test.

The coronary flow reserve is abnormal in syndrome X, but the response to the cold pressor test, which in normals produces flow-mediated endothelium-dependent epicardial coronary dilation, has not been studied. In this study, in 12 patients with typical syndrome X and angiographically normal coronary arteries, the response to the cold pressor test was abnormal with a mean fall in diameter (10 +/- 8%) in 6 patients, no change in 1, and a minimal increase (4 +/- 2%) in 5 patients (normal increase 12 +/- 1%). The coronary blood flow fell slightly during the cold pressor test, and the coronary vascular resistance increased significantly (from 2.4 +/- 1.1 to 3.2 +/- 1.7 mm Hg/cm.s-1.mm2; p = 0.05), both abnormal responses. This study confirms that in syndrome X patients there is coronary endothelial dysfunction which is apparent in response to physiological stimuli induced by the cold pressor test.

Adult↗