Background: Over the last two decades, there have been a number of studies in Europe on contact sensitivity in patients with chronic leg ulcerations with a frequency of positive patch test results ranging from 40 to 82.5%. The prevalence of sensitization has not been studied in North America. Furthermore, many of the newer dressings and wound care products in the market have not been studied for contact sensitivity in patients with chronic wounds.
Objectives: 1) To determine the prevalence of allergen sensitivity in patients with history of leg ulcers in two North American study centers, 2) to compare our results to the European studies and to the North American Contact Dermatitis Group (NACDG) database and 3) to help delineate a standard battery of allergens for patch testing in North American leg ulcer patients
Methods: 54 patients with an active or past leg ulcer were prospectively entered in the study. The patients were patch tested to both the NACDG Standard series, as well as, a comprehensive supplemental series of 48 allergens including wound care medicaments and dressings.
Results: 63% of patients were sensitized to at last one allergen. The most common allergens were Balsam of Peru (29.6%), bacitracin (24.1%), fragrance mix (20.4%), wood tar mix (20.4%), propylene glycol (13.5%), neomycin sulfate (13%), benzalkonium chloride (13%), carba mix (11.1%), nickel sulfate (11.1%) and Duoderm CGF (11.1%). Duoderm CGF was the most allergenic dressing in our study group.
Conclusion: There is a high incidence of positive patch tests in patients with past or current leg ulcerations. Using a modified leg ulcer series along with the standard NACDG series is very important in evaluating patients with leg ulcers.
Anabolic steroids have been used to treat lower extremity ulcerations, including venous and cryofibrinogenemic ulcers and lipodermatosclerosis (LDS). Yet there have been no studies to determine the severity and reversibility of side effects of anabolic steroids on liver enzymes and lipid profiles in elderly patients. We therefore evaluated, in a prospective, randomized, double-blinded, placebo-controlled trial, the extent and reversibility of abnormal liver enzymes and lipid profiles in patients with LDS and venous leg ulcers treated with stanozolol at 2 mg twice daily for up to 6 months. Follow-up laboratory testing was done for 2 months after cessation of treatment. A total of 44 patients with LDS and venous ulcers were enrolled and treated with either leg compression alone (placebo) or leg compression plus oral stanozolol 2 mg twice daily (active). Baseline and follow-up laboratory testing of liver enzymes and lipid profiles were obtained. A total of 21 active and 23 placebo patients were treated and evaluated. We measured liver enzymes (aspartate aminotransferase [AST/SGOT], alanine aminotransferase [ALT/SGPT], γ-glutamyl transferase [GGT]) and lipid profile components (high-density lipoprotein [HDL], low-density lipoprotein [LDL], total cholesterol) before, during, and after the treatment period. We found that AST/SGOT and ALT/SGPT became significantly elevated in 29% (P = .0415 at 2 months) and 33% (P = .0182 at 1 month) of patients treated with stanozolol or placebo, respectively, with return to baseline in the posttreatment period. Unexpectedly, 91% of patients on stanozolol developed a significant (P < .0001) decrease in HDL levels, by as much as 37 U/L. All patients remained asymptomatic and levels returned to baseline after discontinuation of the drug. We conclude that low-dose stanozolol, 2 mg twice daily, produces asymptomatic and temporary elevation of liver transaminases and depression of the HDL level in a significant proportion of patients.
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