PubMed · 9289628
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B Bornkessel. 1997. [Randomized controlled trials].. https://pubmed.ncbi.nlm.nih.gov/9289628/
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The main goal of the present study was to investigate the response of the human skin equivalent Apligraf in vitro to the application of irritant substances and its predictivity as a screening tool for cumulative skin irritant potential in humans. Vaseline, calcipotriol, trans-retinoic acid, and sodium lauryl sulfate were applied to Apligraf in vitro for 24 h. Cell viability (lactate dehydrogenase leakage), release and mRNA expression of the proinflammatory cytokines IL-1alpha and IL-8, and morphological changes were assessed. The same products were applied to 30 healthy volunteers in a double-blind, randomized, vehicle-controlled within-subject study. The skin reactions after repeated 24-h applications over 3 weeks under Finn chamber patches were monitored by visual scoring and biophysical methods (trans-epidermal water loss, chromametry, and blood flow). Sodium lauryl sulfate was cytotoxic to Apligraf, and increased the release and expression of cytokines at low (0.2%, 0. 4%), but not at high (0.8%, 1%) concentrations. It induced severe irritancy in vivo. Trans-retinoic acid increased the expression and release of cytokines with no detectable cytotoxicity and showed moderate irritancy in humans. Although calcipotriol did neither affect cell viability nor the production of cytokines, it induced morphological signs of irritation and was mildly irritant for healthy volunteers. Vaseline was innocuous in vivo and induced no changes in Apligraf. In conclusion, the cumulative skin irritation potential of the tested products could be predicted with Apligraf in a sensitive and specific manner, by monitoring cytotoxicity, proinflammatory cytokines, and morphological changes.
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OBJECTIVE: The efficiency of venous thromboembolism prophylaxis with low molecular weight heparins (LMWH) has not been established in non surgical patients, so their official preventive use has been limited in France since 1995 to surgery. However, a survey conducted in 5 university hospitals in non surgical patients showed that 21-29% of patients still received a LMWH prescription. It seemed necessary to define the medical conditions for which the practical use of these heparins would be justified. We contacted external experts to obtain a consensus by using the Delphi method. METHODS: The Delphi method, created by the "Rand Corporation" in the USA and used in medicine since the nineteen seventies, is based on a light logistic, with questionnaires been sent by mail with a feed-back report A total of 48 experts were chosen by local staff teams in the 5 hospitals. For the 3 rounds, from March to October 1998, questions were devised by a multicentred staff team. RESULTS: Among the 48 experts contacted, 32 completed the 3 questionnaires, 7 of them did for 2, and 43 did for at least one questionnaire. The experts first defined a list of 12 risk or high risk situations and 11 aggravating factors. For any high risk situation, prescription is justified. For other cases, 2 risk situations are required, or one risk situation with at least 2 aggravating factors, to justify a prescription. If no risk situation is present, prescription is, according to experts, usually not justified. CONCLUSION: The maximal agreement defines the situations in which one use of low molecular weight heparins is proposed to prevent deep venous thrombosis in non surgical inpatients, in most current hospital situations and for more than 24 hours of hospitalization. Clinical trials are needed, to validate their effectiveness and define the optimal dose in these indications. To date, epidemiological studies should be conducted to evaluate the experts proposals by estimating risk factors for deep venous thrombosis.