Inventory of microbial species with a rationale: a comparison of the IDF/EFFCA inventory of microbial food cultures with the EFSA Biohazard Panel qualified presumption of safety.

In order to provide a harmonised preassessment to support risk assessment performed by the European Food Safety Authority (EFSA), the Biohazard Panel in 2007 published guidelines for evaluation of the safety of a strain included in the food chain, the Qualified Presumption of Safety (QPS). Since 2008, the Biohazard Panel has published on a regular basis an update of the microbial strains submitted for approval and extends the list of species which have been granted QPS status. The International Dairy Federation (IDF) and the European Food and Feed Cultures Association (EFFCA) have, since 2002, been conducting a project on the safety demonstration of microbial food cultures (MFCs). Following the publication of IDF Bulletin 377-2002, an inventory of MFCs was published in IDF Bulletin 455-2012 and updated most recently in IDF Bulletin 495-2018. These two lists developed by EFSA (QPS) and IDF/EFFCA both propose as an outcome an inventory of microbial species that are safe for human consumption. To avoid confusion when these two inventories are compared, this review attempts to explain the rationale that was used to develop them and explain how the two lists should be understood.

[Adrenal cortex function in patients with AIDS and healthy HIV-positive persons]. / Binyrebarkfunktionen hos AIDS-patienter og raske HIV1-positive personer.

Adrenal function was estimated by synthetic ACTH test in 18 men with AIDS (or AIDS-related complex) and compared with that of 10 HIV positive but otherwise healthy men. According to this test none fulfilled the criteria for adrenal insufficiency defined as plasma cortisol concentration less than 500 nmol/l 30 minutes after ACTH stimulation. Seven of eighteen AIDS patients had baseline cortisol concentrations above 0.5 mumol/l compared to none in the HIV-positive group. Three of eighteen AIDS patients had a limited response to synthetic ACTH injection compared to none in the HIV-positive group. Two of these three AIDS patients had lowered serum Na+ concentration; they survived for two and three weeks, respectively. Otherwise the basal cortisol level and response to synthetic ACTH was uncorrelated with survival time, other signs of adrenal insufficiency, treatment with ketokonazole, CMV-infection, T-helper cell count or Th/Ts-ratio. The pituitary-adrenal axis was estimated by measuring the diurnal rhythm of serum ACTH and cortisol in eight patients and was found intact and normal in all of them. Thus, absolute adrenal insufficiency is uncommon in AIDS-patients. Relative adrenal insufficiency may occur in severely ill preterminal patients as a result of primary target organ failure, but the pituitary-adrenal axis generally appears to be undisturbed.

Patho-anatomical studies in patients dying of AIDS.

The incidence of AIDS in Denmark is the highest reported among the countries of Western Europe. This preliminary account is a report of the autopsy findings in 10 patients, 9 homosexual men and 1 woman. Our aim is to provide a detailed description of the patho-anatomical findings, as well as to compare these with corresponding results reported from the United States, with a view to establishing possible geographical differences in the disease picture. The results of the patho-anatomical studies correspond in all essentials to those from the United States. However, it must be stated that no malignant lymphomas were demonstrated in our patients, although the disease can give rise to very pronounced, possibly transitory, lesions in the lymphatic tissue, easily misinterpreted as malignant. Further features that should be emphasized are the often widespread mycobacterial infection found in the intestinal wall in protracted cases, the occurrence of CMV vasculitis, particularly in the adrenal cortex and medulla, and thromboembolic lesions, often demonstrated in a variety of tissues. The studies made so far emphasize the importance of autopsy in AIDS deaths, as it has extended our detailed knowledge of the patho-anatomical lesions associated with certain opportunistic infections. Further, the autopsy findings have been demonstrably significant either for confirming or for rejecting the clinical diagnosis. On the basis of an analysis of the cellular immunological profile in AIDS, parallels can be drawn to the conditions in certain lymphoproliferative diseases. In autopsied AIDS cases, we recommend a standard scheme covering the tissue specimens to be obtained for histological examination. Strict safety precautions should be observed against infection during autopsy.

Intravenous digital subtraction angiography with iohexol (Omnipaque) and sodium meglumin diatrizoate (Urografin).

A randomized, double-blind crossover trial in intravenous digital subtraction angiography (DSA) (aorto-femoral or aorto-cervical) was performed in 38 patients with Omnipaque, 350 mg I/ml versus Urografin, 370 mg I/ml. The aim of the study was to compare subjective reactions, ECG, heart rate, blood pressure, image quality and disturbing artefacts. The median volume of contrast media given per patient was 165 ml, ranging from 85 to 250 ml. No serious complications occurred. Fewer and significantly (p less than 0.05) less intense reactions as sensations of heat and taste were experienced after Omnipaque. Significantly more patients preferred Omnipaque. The heart rate changed significantly more after Urografin than after Omnipaque. Urografin also caused a significantly greater but transient decrease in systolic and diastolic blood pressure. There was a tendency to better overall quality and less artefacts when using Omnipaque, but the difference between the two media was not statistically significant.

Iohexol and ioxithalamate for intravenous urography. A comparative parallel study.

Omnipaque (iohexol) 350 mg I/ml has been compared with Telebrix (ioxithalamate) 380 mg I/ml in 48 patients undergoing intravenous urography. The contrast medium dose corresponded to 400 mg I/kg body weight. No cardiovascular reactions (BP and pulse rate) were observed. Subjective reactions occurred somewhat more frequently after Telebrix than after Omnipaque. Sensation of warmth was significantly less with Omnipaque (p less than or equal to 0.05). The overall radiological quality was equally good for the two contrast media.

Omnipaque and Urografin in left ventriculography and coronary arteriography. A randomised, double blind study.

In order to compare tolerability and radiographic properties of Omnipaque (iohexol) 350 mg I/ml and Urografin (sodium meglumine diatrizoate) 76% (370 mg I/ml) in left ventriculography and coronary arteriography, a randomised, double-blind parallel study was conducted. ECG, heart rate, blood pressure, cardiac output, oxygen saturation, CK-MB, adverse reactions and opacification were recorded. Twenty-five patients received Omnipaque and 24 Urografin and all patients were included in the final material. Omnipaque was found to have less influence on haemodynamics than Urografin. Few adverse reactions were encountered in the entire study, but fewer after injections of Omnipaque than after Urografin. Equally good opacification was demonstrated for both media. Omnipaque was found well suited for cardioangiography and superior to standard ionic media.

Intravascular studies with iohexol (Omnipaque). Results from the first 49 clinical trials.

In order to assess the vascular clinical trial program of iohexol (Omnipaque) in Europe, the results from the first 49 vascular trials are collectively reported. The included iohexol material comprises 1742 patients. In 40 comparative trials, other contrast media like metrizamide (Amipaque), ioxaglate (Hexabrix) and various monomeric ionic media were administered in 1292 patients included in this analysis. No severe or unexpected adverse reactions related to iohexol were encountered. No clinically significant differences in radiographic image quality between the media were documented. The overall tolerability of iohexol was superior to that of monomeric ionic media and seemed to be as good as that of metrizamide.

Non-tropical sprue. Malignant diseases and mortality rate.

The complications of non-tropical sprue were registered in 100 patients seen during an 18-year period. The patients had a significantly higher mortality than the age- and sex-matched general population. They had an increased incidence of malignancies, predominantly malignant lymphomas and carcinomas of the gastrointestinal tract. The disease must be considered a premalignant condition.

Clinical testing of omnipaque and amipaque in external carotid and vertebral angiography: randomized double-blind crossover study.

Omnipaque, 300 mg l/ml, was compared with Amipaque, 300 mg l/ml, for cerebral angiography. Twelve patients were included in a randomized, double-blind, crossover study. Twenty comparisons were made in the external carotid and 21 in the vertebral artery, Both contrast media caused no or minor changes in blood pressure and heart rate. Good to excellent radiographic visualization of the cerebral arteries was obtained with both agents. The frequency of subjective reactions was almost equal, but the intensity of the reactions was less with Amipaque. No severe reactions were observed. Omnipaque is a more practical nonionic contrast medium than Amipaque because it is delivered in ready-to-use solutions.

A case of malignant lymphoma and myasthenia gravis.

A 25-year-old man with myasthenia gravis and a non-Hodgkin lymphoma stage III B involving the thymus, is reported. The association myasthenia gravis and non-Hodgkin lymphoma has not been described previously. Treatment with chlormetin, vincristine, procarbazine, prednisone (MOPP) resulted in complete remission of both the myasthenic symptoms and the malignant lymphoma.

A Danish adult case of EBV-positive Burkitt's lymphoma.

A 50-year-old Danish male presenting with swelling in fossa supraclavicularis and slight swelling of axillary and inguinal lymphnodes was diagnosed histologically as having malignant, non-Hodgkin, blast lymphoma. The EBV association was established by demonstration of EBV-DNA-positive tumor cells and the presence of high titers of antibodies of the IgG class to VCA, EA (D) and EBNA. The unique finding in this case was the high titers of IgA antibodies to VCA and to EA (D). This latter serological picture is characteristic of nasopharyngeal carcinoma (NPC) but has not previously been observed in Burkitt's lymphoma.