Development of intralesional therapy with fluorouracil/adrenaline injectable gel for management of condylomata acuminata: two phase II clinical studies
| Autor: | B H Miller, A Korey, J M McCarty, R B Skinner, E K Orenberg, S K Tyring, J M Swinehart |
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| Rok vydání: | 1997 |
| Předmět: |
Adult
Male Sexually transmitted disease Antimetabolites Antineoplastic medicine.medical_specialty Randomization Adolescent Epinephrine medicine.medical_treatment Dermatology Injections Intralesional Placebo law.invention Double-Blind Method Randomized controlled trial Recurrence law medicine Humans Adverse effect Aged Aged 80 and over Chemotherapy business.industry Middle Aged Surgery Drug Combinations Treatment Outcome Infectious Diseases Condylomata Acuminata Fluorouracil Delayed-Action Preparations Anesthesia Female business Gels Research Article medicine.drug |
| Zdroj: | Sexually Transmitted Infections. 73:481-487 |
| ISSN: | 1368-4973 |
| DOI: | 10.1136/sti.73.6.481 |
| Popis: | OBJECTIVES: To evaluate a sustained release chemotherapy for treating condylomata acuminata with an injectable gel containing fluorouracil and adrenaline (5-FU/adrenaline gel). Study 1-- To assess contributions of the components of 5-FU/adrenaline gel to efficacy. Study 2--To assess therapeutic contribution of adrenaline and safety and efficacy of the formulations. DESIGN: Randomised, double blind, placebo controlled studies. SETTING: Private practices and university clinics in the United States. PATIENTS: Men and women with new, recurrent, or refractory external condylomata acuminata. INTERVENTION: Six injections over 8 weeks; follow up visits at weeks 1, 4, 8, and 12. MAIN OUTCOME MEASURES: Efficacy: patient/wart response, times to complete response, recurrence rates. Safety: injection reactions, tissue conditions, other adverse events, laboratory studies. RESULTS: Study 1: 132 evaluable patients. Complete response (CR) rate was highest for the 5-FU/adrenaline gel group, followed by the 5-FU/adrenaline solution group, then the 5-FU gel group. 5-FU, adrenaline, and the collagen gel vehicle (in the presence of 5-FU) significantly affected CR and strongly influenced time to CR. The effects of 5-FU and adrenaline were statistically significant. Cutaneous reactions were mild to moderate. Study 2: 187 evaluable patients. Patients treated with 5-FU/adrenaline gel had a significantly higher CR rate and lower cumulative 90 day recurrence rate than those treated with 5-FU gel without adrenaline. Treatments were generally well tolerated, with only three treatment related, serious adverse events. CONCLUSION: 5-FU/adrenaline gel is safe and efficacious for treatment of condylomata acuminata, and when compared with individual or various combinations of components, this formulation provided the greatest therapeutic advantage. |
| Databáze: | OpenAIRE |
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