Frozen-section examination in the management of paediatric testicular lesions.

PURPOSE: Paediatric testicular and para-testicular lesions have traditionally been managed according to adult protocols. Testis-sparing surgery (TSS) has gained popularity as it has become apparent benign lesions predominate in childhood. Frozen-section examination (FSE) for intra-operative diagnosis has been extensively utilised in adults, though its use in paediatric practice remains limited. We reviewed our experience of FSE in paediatric patients with an aim to identify the utility and efficacy of this tool in the management of testicular and para-testicular pathology. METHODS: A retrospective, single-centre review of paediatric patients who underwent intra-operative FSE for a range of testicular and para-testicular lesions was performed. FSE results were compared to final pathology. TSS was performed if appropriate, and was utilised in adolescent patients, and in lesions with a diameter greater than 20 mm. RESULTS: Nine males underwent FSE from 2013 to 2020. Median age at surgery was 9 years (range 1-15). Eight (89%) patients had benign pathology. FSE result correlated with the final pathological examination in 100% of cases. FSE facilitated TSS in 7/9 cases. CONCLUSION: FSE has 100% diagnostic accuracy for paediatric testicular and para-testicular pathology. We would recommend all lesions be evaluated by FSE to guide intra-operative decision making and facilitate TSS in appropriate cases.

Analytical, biopharmaceutical and regulatory evaluation of topical testosterone preparations.

Testosterone-containing pharmaceutical products for topical use were obtained from the pharmacist or through the internet. The legal status of the different products obtained is discussed: some products through the internet were clearly a medicinal product according to the current definitions, while they are not registered as such. Assay and impurity profiles of each of the marketed samples were obtained using HPLC-UV and ESI-iontrap MS. The analytical results were evaluated relative to the reporting, identification and qualification thresholds as defined by the the International Conference on Harmonisation (ICH) and the European Pharmacopoeia (Ph. Eur.). Preparations with impurities above the qualification threshold were observed. Moreover, in vitro release profiles over an artificial membrane were obtained using a standardised cell in a paddle dissolution bath as well as in a static Franz diffusion cell, using phosphate buffered saline (PBS; pH 7.0) containing 5% bovine serum albumin (BSA) as dissolution or receptor fluid. This biopharmaceutical quality attribute differs significantly between the preparations tested. In conclusion, the equivalency of topical testosterone preparations is not assured, nor on their legal status, nor on their impurity profiling nor on their biopharmaceutical behaviour. This calls for an urgent trans-national product-class harmonisation approach.

Comparison of two sites in Mobile Bay using in vivo biomarkers in largemouth bass, sediment bioassays, and sediment contaminant analysis.

This research addresses whether chemical contaminants are having a biologically measurable effect on largemouth bass (Micropterus salmoides), an important fish species in the Mobile Bay National Estuary. Bass and sediment samples were collected in September 2001 from Big Bateau and D'Olive Bays; the latter has been suggested to be an environmentally impacted site. There was a significant difference in the age distribution of bass collected from the two sites. However, none of the animals showed any evidence of reproductive activity or had mature gametes. The age and gonadosomatic index were greater in animals collected from the Bateau site. Fish liver microsome ethoxyresorufin-O-deethylase (EROD) activities (elevated in the presence of CYP1A-inducing contaminants) were not significantly different between sites but were significantly higher in older bass. Plasma steroid concentrations in younger animals (less than 1 year old) tended to be higher and more variable than the concentrations found in older animals. Once the significant effects of age on plasma steroid concentrations were removed, an analysis of the residual change in steroids revealed no differences in testosterone or estradiol between animals collected at the two sites. Sediments were collected for chemical extraction and analysis in two bioassays: the H4IIE rat hepatoma EROD assay and the yeast estrogen screen (YES assay). The H4IIE bioassay indicated the presence of sediment BaP induction equivalents between 72 and 320 ng/g, whereas the YES assay indicated that potent estrogenic substances were not present in the sediment samples. The H4IIE bioassay results were higher for D'Olive samples, which was consistent with higher PAH concentrations in those sediments. Taken together the biomarkers and chemical analysis suggested generally low organic contamination at these two sites.