Efficacy and safety of terbinafine in the treatment of dermatophytosis at Nghean provincipal leprosy, dermatology centre (2015-2016)

Objective: To evaluate the efficacy and safety of the drug in the treatment of tinea. Subjects and methods: 29 patients with mild, moderate lesions of ringworm take topical terbinafine 1% for 2 - 4 weeks (group 1); 27 patients with extensive tinea or respond poorly to topical treatment take a combination of topical and oral terbinafine for 1 - 14 days (group 2).
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Efficacy and safety of terbinafine in the treatment of dermatophytosis at Nghean provincipal leprosy, dermatology centre (2015-2016)JOURNAL OF MILITARY PHARMACO-MEDICINE N07-2016EFFICACY AND SAFETY OF TERBINAFINE IN THE TREATMENTOF DERMATOPHYTOSIS AT NGHEAN PROVINCIPAL LEPROSY,DERMATOLOGY CENTRE (2015 - 2016)Nguyen Thai Dung*; Le Tran Anh**; Nguyen Khac Luc**SUMMARYTerbinafine - an allylamine drug has been shown to be fungicidal against dermatophytes andhas been approved by Vietnam’s Ministry of Health for treating dermatophytosis, but no studyon evaluating its effect and safety has been done in Vietnam. Objective: To evaluate the efficacyand safety of the drug in the treatment of tinea. Subjects and methods: 29 patients with mild,moderate lesions of ringworm take topical terbinafine 1% for 2 - 4 weeks (group 1); 27 patientswith extensive tinea or respond poorly to topical treatment take a combination of topical and oralterbinafine for 1 - 14 days (group 2). Clinical and mycological assessments were made at 2 and4 weeks after starting treatment. Results: The clinical cure after 2 weeks was 73.21% andmycological cure was 85.71%; complete cure was 68.76%. The rate of complete cure in group 1(82.76%) was higher than group 2 (50%; p < 0.05). 4 weeks after treatment, all patients werecured completely. Patients taking only topical medication did not have undesirable effects.Some patients in group 2 experienced side effects such as nausea (25.93%); flatulence (3.70%)and dizziness (40.74%). Conclusion: Terbinafine is effective and safe in the treatment of ringworm.* Key words: Ringworm; Terbinafine; Efficacy; Safety.INTRODUCTIONTinea is common disease in thecommunity and can be treated by topicalor systemic antifungal agents. There aremany drugs to treat the disease withdifferent advantages and disadvantages.Terbinafine is an allylamine antifungalwith good profile of efficacy and safety.Around the world, there have been manystudies assessing the effects of the drugin the treatment of different types of tinea.In Vietnam, the drug is also included inthe list of medications to treat ringwormbut no study has yet been done toevaluate its effect and safety. This studyhas been conducted to evaluate the efficacyand safety of this drug in patients withdermatophytosis at the Nghean ProvincialLeprosy, Dermatology Centre.SUBJECTS AND METHOD1. Patients.Patients with ringworm and agree tobe involved in the study.2. Materials.Drugs: Terbinafine (brand name TERBISIL)250 mg (SANTA FARMA ILAC SANAYIIA.S Turkey). TRIGENOL cream 1%; (NEWGENE PHARM Inc., Korea).KOH solution 10 - 20%; Sabouraudmedium.* Nghean Provincial Leprosy - Dermatology Centre** Military Medical UniversityCorresponding author: Le Tran Anh (anh_lt@vmmu.edu.vn)53JOURNAL OF MILITARY PHARMACO-MEDICINE N07-20163. Study design.Uncontrolled clinical trial.Patients with ringworm (have lesionsand positive mycology test by directexamination or culture) were graded asmild, moderate and severe according tocriteria by Vietnam Dermatology Association(mild: 1 lesion and lesion area < 1 hand;moderate: 2 - 5 lesions and/or area oflesion from 2 - 5 hands; severe: morethan 5 lesions and/or lesions covering anarea of more than 5 hands). 29 patientswith mild or moderate lesions of ringwormtake topical terbinafine 1% daily for 2 - 4weeks (group 1); 27 patients with extensivetinea or responding poorly to topicaltreatment take a combination of topicaland oral terbinafine (250 mg twice a dayfor 1 - 14 days (group 2). Mycological andclinical assessments were made after2 and 4 weeks of treatment. Clinicalresponse was qualified as following:clinical cure: clearing of 70 - 100% oflesions; decrease: clearing 50 - 69% oflesions; not curing: clearing < 50% oflesions. Complete cure was defined asmycological cure (negative microscopy)and clinical cure.* Site and time:Nghean Provincial Leprosy, DermatologyCentre and fungal laboratory, Departmentof Parasitology, Vietnam Military MedicalUniversity.Time: October 2015 to August 2016.* Statistical analysis: by SPSS 11.5software.* Ethnic: this study was approved bythe ethics committee of Vietnam NationalInstitute of Malariology Parasitology andEntomology. All patients were well-informedand voluntarily provided information. Theinformation is kept confidentially and usedfor research only.RESULTS AND DISCUSSIONTable 1: Demographic characteristics of patients (n = 56).CriteriaAgeNumberPercentage (%)2-923.5710 - 191425.0020 - 291933.9330 - 391119.6440 - 4911.7950 - 59610.7160 - 6935.36Group30.02 ± 15.067Mean ( X ±SD)GenderMale3460.71Female2239.29The average age of patients was 30.02 years old; mostly men (60.71%).The patients involved in the study were characterized by ringworm, a disease mostlyaffects male and young people [1, 3].54 ...