Onikomikozda sistemik flukonazol ve terbinafin tedavilerinin karşılaştırılması
An open, randomized, comparative study of oral fluconazole, itraconazole and terbinafine therapy in onychomycosis
- Tez No: 49453
- Danışmanlar: PROF.DR. NÜZHET ARAZ
- Tez Türü: Tıpta Uzmanlık
- Konular: Dermatoloji, Dermatology
- Anahtar Kelimeler: Belirtilmemiş.
- Yıl: 1996
- Dil: Türkçe
- Üniversite: GATA
- Enstitü: Tıp Fakültesi
- Ana Bilim Dalı: Deri ve Zührevi Hast. Ana Bilim Dalı
- Bilim Dalı: Belirtilmemiş.
- Sayfa Sayısı: 72
Özet
VI. ÖZET Onikomikoz popülasyonun %2-5'ini etkileyen kronik, inatçı bir mantar enfeksiyonudur. Tedavisi zordur ve daha önce kullanılan tedavi metodlan ile iyi yanıtlar alınamamıştır. Bu açık, rastgele ve karşılaştırmalı çalışmada klinik ve mikolojik olarak ayak onikomikozu tanısı konan 50 olguda sistemik flukonazol, itrakonazol ve terbinafin tedavilerinin 3 aylık sürede etkinlikleri ve daha sonraki 6 aylık takip sonundaki durumları araştırıldı. Rastgele seçilen 16 olguya oral flukonazol (haftada bir 150 mg kapsül, 3 ay boyunca), 18 olguya oral itrakonazol (her ayın ilk haftasında 400 mg/gün kapsül 3 ay boyunca) ve geri kalan 16 olguya da terbinafin (250 mg/gün tablet, 3 ay boyunca) tok karma uygulandı. Olguların %68'inde (34/50) Trichophyton rubrum, %10'unda (5/50) Trichophyton mentagraphytes etken olarak saptanırken, %22'sinde (1 1/50) KOH ile hifalar görülmüş ancak kültürde bir fungal ajan izole edilemedi. İlaç gruplarının kendi içlerinde ayn ayrı onikoliz, subungual hiperkeratoz, tutulum yüzde puanı ve toplam skor açısından, tedavi öncesinin skorları, tedavi bitimi ve takip dönemi skorları arasındaki farklar istatistiksel olarak anlamlı bulundu (PO.001). Klinik, mikolojik ve genel değerlendirmede takip dönemi sonunda ilaçlar arasındaki farklar istatistiksel olarak anlamlı bulundu (P
Özet (Çeviri)
VII. SUMMARY AN OPEN, RANDOMIZED, COMPARATIVE STUDY OF ORAL FLUCONAZOLE, ITRACONAZOLE AND TERBINAFINE THERAPY IN ONYCHOMYCOSIS Onychomycosis is a chronic, recalcitrant fungal infectious disease that affects 2-5% of the population. The treatment of toe-nail fungal infection is difficult. The traditional therapies are not satisfactory. In this open, randomized and comparative study, the safety and efficacy of systemic fluconazole, itraconazole and terbinafine in 50 patients with toe-nail onychomycosis that diagnosed by clinically and mycological. The treatment duration was 3 months and the follow- up period was 6 months. Randomly assigned 16 patients received 150 mg fluconazole once-weekly for 3 months, 18 patients received 200 mg itraconazole twice daily with meal during the first week of each month for 3 months and the remainder 16 patients received 250 mg/day terbinafine for three months. Trichopyton rubrum was cultured from the toe-nails of 68% (34/50) of the patients and Trichophyton mentagraphytes from the toe-nails of 10% (5/50) of the patients. In 22% (1 1/50) of the patients, no fungal agent was cultured although they had positive microscopy. Statistically significant intragroup reductions from baseline symptom severity values were seen at endpoint of treatment and at endpoint of follow-up period for all three treatment groups for all parameters: onycholysis, subungual hyperkeratosis, affected-area percentage score and total score (PO.Q01). At the endpoint of follow-up period, statistically significant differences between the treatment groups were seen in clinical, mycological and overall assessment (PO.05). However, while no statistically significant difference between terbinafine and itraconazole group was seen, there was a clinically and statistically difference between the other groups and fluconazole group. In clinical evaluation, at the endpoint of follow-up period, the clinical cure rates were 81.3% (13/16) for terbinafine group, 77.8% (14/18) for itraconazole and 37.5% (6/16) for fluconazole group. The mycological cure rates were 75% (12/16), 61.1% (11/18) and 31.2% (5/16) respectively. The overall assessment rates were 62.6% (10/16), 61.1% (11/18) and 31.2% (5/16) respectively. Side effects that were all mild gastrointestinal and central nervous system symptoms and were not need to stop the treatment, were noted in 4 patients in fluconazole group (25%), in 5 patients in the itraconazole group (27.8%) and in 3 patients in the terbinafine group (18.75%). The clinical laboratory data on all three drug groups did not show any statistically or clinically significant intragroup changes from baseline values at endpoint (P>0.05). In conclusion, in this first comparative study of systemic fluconazole, itraconazole and terbinafine, it was concluded that all three drugs were effective and safe in the treatment of onychomycosis, but fluconazole was less effective than the others and with the regard of cost- effectiveness, side effects and the cure rates, terbinafine could be the firs-choice of drug in short-term treatment of toe-nail onychomycosis. 64
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