| Single-blind, multicenter, placebo controlled, parallel study to assess the safety and efficacy of intralesional interferon alpha-2B for minimally invasive treatment for Peyronie's disease. | |
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MedLine Citation:
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PMID: 16753449 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: We investigated the efficacy and safety of intralesional interferon alpha-2b for the treatment of Peyronie's disease. MATERIALS AND METHODS: A total of 117 consecutive patients with a mean age of 55.1 years who had Peyronie's disease were enrolled in a single-blind, multicenter, placebo controlled, parallel study to determine the efficacy and safety of intralesional interferon alpha-2b therapy (Schering, Kenilworth, New Jersey), including 62 who received placebo and 55 who received interferon alpha-2b. Saline (10 ml) in controls and interferon alpha-2b (5 x 10(6) U) were administered biweekly for 12 weeks. Each patient was evaluated for penile curvature, plaque size and density, penile pain, erectile function and penile hemodynamics before and after study completion. Improvement in these parameters was statistically compared between the groups. RESULTS: A total of 53 patients in the control arm and 50 in the interferon alpha-2b arm completed the study. Improvement in penile curvature, plaque size and density, and pain resolution was significantly greater in patients treated with interferon alpha-2b vs placebo. The increase in mean International Index of Erectile Function scores was not significantly different between the groups. Penile blood flow improvement was observed in interferon alpha-2b treated patients but not in those who received placebo. The decrease in the number of penile vascular pathologies was significantly higher in interferon alpha-2b cases. Side effects, mostly flu-like symptoms, which were frequently noted in patients on interferon alpha-2b, were mild to moderate in degree and of short duration. CONCLUSIONS: This single-blind, multicenter, placebo controlled, parallel study demonstrates that intralesional interferon alpha-2b at a dose of 5 x 10(6) units biweekly for 12 weeks is effective and safe as minimally invasive therapy for Peyronie's disease. |
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Authors:
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Wayne J G Hellstrom; Muammer Kendirci; Richard Matern; Yolanda Cockerham; Leann Myers; Suresh C Sikka; Dennis Venable; Stanton Honig; Andrew McCullough; Lawrence S Hakim; Ajay Nehra; Lance E Templeton; Jon L Pryor |
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Publication Detail:
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Type: Controlled Clinical Trial; Journal Article; Multicenter Study |
Journal Detail:
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Title: The Journal of urology Volume: 176 ISSN: 0022-5347 ISO Abbreviation: J. Urol. Publication Date: 2006 Jul |
Date Detail:
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Created Date: 2006-06-06 Completed Date: 2006-07-27 Revised Date: 2007-03-19 |
Medline Journal Info:
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Nlm Unique ID: 0376374 Medline TA: J Urol Country: United States |
Other Details:
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Languages: eng Pagination: 394-8 Citation Subset: AIM; IM |
Affiliation:
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Department of Urology, Tulane University School of Medicine, 1430 Tulane Avenue, New Orleans, LA 70112, USA. whellst@tulane.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Humans Injections, Intralesional Interferon Alfa-2b / administration & dosage*, adverse effects Male Middle Aged Pain Penile Erection Penile Induration / drug therapy*, pathology, physiopathology Penis / blood supply, pathology Single-Blind Method Sodium Chloride / administration & dosage |
| Chemical | |
Reg. No./Substance:
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7647-14-5/Sodium Chloride; 99210-65-8/Interferon Alfa-2b |
| Comments/Corrections | |
Comment In:
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J Urol. 2006 Jul;176(1):12-3
[PMID:
16753356
]
Nat Clin Pract Urol. 2007 Jan;4(1):22-3 [PMID: 17211421 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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