| Autor: |
Tatti, S., Stockfleth, E., Beutner, K. R., Tawfik, H., Elsasser, U., Weyrauch, P., Mescheder, A. |
| Předmět: |
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| Zdroj: |
British Journal of Dermatology; Jan2010, Vol. 162 Issue 1, p176-184, 9p, 4 Charts, 2 Graphs |
| Abstrakt: |
Background External genital warts (EGWs, condylomata acuminata) are a common, highly contagious disease caused by human papillomavirus (HPV), predominantly HPV 6 and HPV 11. Green tea catechins have been identified for their immunostimulatory, antiproliferative and antitumour properties. Two phase III trials evaluated treatment of EGWs with ointment containing a mixture of green tea catechins (Polyphenon E®, U.S. adopted name: sinecatechins). Objectives To obtain additional data on the efficacy and safety of Polyphenon E® ointment in the treatment of EGWs from two randomized, double-blind, vehicle-controlled trials. Methods Men and women aged ≥ 18 years ( n = 1005), with two to 30 EGWs (12–600 mm2 total area) applied vehicle (GVeh; n = 207), Polyphenon E® ointment 10% (G10%; n = 401) or Polyphenon E® ointment 15% (G15%; n = 397) three times daily until complete clearance of all EGWs (baseline + new EGWs) or for a maximum of 16 weeks. Results A total of 1004 patients were evaluable for safety and 986 for efficacy; 838 completed treatment after 16 weeks. Complete clearance of all EGWs was obtained in 53·6% (G10%) and 54·9% (G15%) of patients with Polyphenon E® vs. vehicle (35·4%) ( P < 0·001). Statistically significant differences in clearance rates appeared after 6 weeks of active treatment. Odds ratios vs. GVeh for G10% [2·10; 95% confidence interval (CI) 1·49–2·98] and G15% (2·22; 95% CI 1·57–3·14) indicated about a twofold higher chance of complete clearance under active treatment. Time to complete clearance was shorter with active treatment (hazard ratios 1·57 and 1·87, respectively, for G10% and G15% vs. GVeh groups; P < 0·001). Recurrence rates during follow-up were low and similar across groups: 5·8%, 6·8% and 6·5% (GVeh, G10% and G15% groups, respectively). Adverse events were evenly distributed across groups (∼ 30% of patients). Severe local signs were more frequent but moderate in the active treatment groups (1·5%, 9·2% and 13·5% for GVeh, G10% and G15% groups, respectively). Conclusions Polyphenon E® ointment is effective and well tolerated in the treatment of EGWs. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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