Volume 14, Issue 43 (Jun 2004)
J Mazandaran Univ Med Sci 2004, 14(43): 25-34 |
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Shokohi T, Ëmami M, Soojodian Z. Clinical efficacy of 1% terbinafine cream (Lamizil)® in comparison to 2% miconazole cream in patients with pityriasis versicolor . J Mazandaran Univ Med Sci 2004; 14 (43) :25-34
URL: http://jmums.mazums.ac.ir/article-1-377-en.html
URL: http://jmums.mazums.ac.ir/article-1-377-en.html
Abstract: (131786 Views)
Background and purpose: Terbinafine, a drug of allylamines group, is a new class of antimycotic agents that blocks sterol biosynthesis in the fungi through inhibition of sequalene epoxidase and consequent sequalene accumulation, a primarily fungicidal process. Terbinafine is very effective on various fungi as an oral and topical antifungal agent.
Ïn present study, the antifungal efficacy of 1% terbinafine cream vs. 2% miconazole was assessed in a double blind randomized trial in patients with pityriasis versicolor.
Materials and methods : Forty patients (24 male, 16 female), mean age 25.1 (range: 13-63) were enrolled on the basis of random sample table, and the treatment with terbinafine or miconazole were applied twice daily for 4 weeks. To evaluate the efficacy and cure rate of the drug, mycological examination was performed before starting the study and at the end of each week of treatment. Â patient was considered mycologically cured when direct microscopy was negative, and clinically cured when all clinical parameter considered were negative.
Results : Negativizations of all clinical parameters were observed within 2 weeks in 70% of terbinafine and 35% miconazole patients. Ât the end of the treatment, 85% of terbinafine and 80% of miconazole patients were clinically cured (χ2 and exact fisher test were not shown any difference). Negativizations pattern of hyperchromia and desquamation in two treatment groups were not significantly different. The percentage of Negativization of direct microscopy was 1.4 fold in 1% terbinafine vs. 2% miconazole after 2 weeks of treatment (These differences were not statistically significant). Drug eruption and intolerance in two groups were not significantly different. Çlinical relapse after 2 weeks were obsened in 7.1% terbinafine patients and 42.8% miconazole patients. Çlinical relapse after 16 weeks was 18.2% in terbinafine patients and 64.3% miconazole patients (Significantly different).
Çonclusion : The results of the present trial indicate that fungicidal activity of 1% terbinafine and 2% miconazole was similar and both were not 100% effective. Terbinafine was rapid in action. Âlthough terbinafine is slightly more effective than miconazole, it is available only on prescription at much greater cost. The relapse rate of %1 terbinafine was less than %2 miconazole. Thus based on the most cost effective strategy, we recommend initial treatment with miconazole and the use of terbinafine only if that fails.
Materials and methods : Forty patients (24 male, 16 female), mean age 25.1 (range: 13-63) were enrolled on the basis of random sample table, and the treatment with terbinafine or miconazole were applied twice daily for 4 weeks. To evaluate the efficacy and cure rate of the drug, mycological examination was performed before starting the study and at the end of each week of treatment. Â patient was considered mycologically cured when direct microscopy was negative, and clinically cured when all clinical parameter considered were negative.
Results : Negativizations of all clinical parameters were observed within 2 weeks in 70% of terbinafine and 35% miconazole patients. Ât the end of the treatment, 85% of terbinafine and 80% of miconazole patients were clinically cured (χ2 and exact fisher test were not shown any difference). Negativizations pattern of hyperchromia and desquamation in two treatment groups were not significantly different. The percentage of Negativization of direct microscopy was 1.4 fold in 1% terbinafine vs. 2% miconazole after 2 weeks of treatment (These differences were not statistically significant). Drug eruption and intolerance in two groups were not significantly different. Çlinical relapse after 2 weeks were obsened in 7.1% terbinafine patients and 42.8% miconazole patients. Çlinical relapse after 16 weeks was 18.2% in terbinafine patients and 64.3% miconazole patients (Significantly different).
Çonclusion : The results of the present trial indicate that fungicidal activity of 1% terbinafine and 2% miconazole was similar and both were not 100% effective. Terbinafine was rapid in action. Âlthough terbinafine is slightly more effective than miconazole, it is available only on prescription at much greater cost. The relapse rate of %1 terbinafine was less than %2 miconazole. Thus based on the most cost effective strategy, we recommend initial treatment with miconazole and the use of terbinafine only if that fails.
Type of Study: Research(Original) |
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