| Background:Sporotrichosis is the most common subcutaneous and deep mycosis caused by dimorphic fungus Sporothrix schenckii. This disease is world-wide distributed and is prevalent in Northeast China, with the incidence elevated in recent years. Potassium iodide (KI) is the first choice for treating sporotrichosis in China. However, some disadvantages of this agent limited its clinical application; the first line of treatment in Europe and America is itraconazole (ITC), but there is still no prospective random controlled trial to compare the effect of KI and ITC in treating sporotrichosis, also there is no well designed clinical trial to evaluate the effect of KI.Objective:To compare the clinical therapeutic effects and safety of ITC and 10% KI solution in treatment of cutaneous sporotrichosis, and to evaluate the clinical value of these two agents.Method:Prospective randomized controlled study. From January 2010 to July 2010, eighty one patients who were diagnosed as sporotrichosis by fungal culture and who matched the inclusion criteria were included in this study. They were divided randomly into ITC group and KI group with the ratio of 1:1 by a random number table. Patients in ITC group were given oral itraconazole 100mg twice daily, KI group were given 10% potassium iodide solution of 10ml three times a day orally. The information of each patient is recorded on a unified table. We compared the efficacy, safety and the onset of effect.with the therapy between these two groups. T test was used for the measurement data, count data using Fisher exact test. Results:There were eighty one patients in all. ITC group included forty one patients and thirty six of them finished the treatment, one patient failed to respond, four patients were lost to follow up; KI group included forty patients and thirty nine finished the treatment, one patient was lost to follow up. The total number of patients treated was seventy six, and five patients were lost to follow up, expulsion rate was 6%.(1) General information:28 cases were male (36.8%),48 cases were female (63.2%). The patients were between 16 and 65 years, and the average age was 45.5 years (M). Courses of the disease before presentation ranged from 20 days to5 years, (mean 7.5 months),34 cases had cutaneous-fixed forms (44.7%) and 42 cases had cutaneous-lymphatic forms (55.3%). Various aspects of the two groups of cases in general had no significant differences (p>0.05).(2) Onset of effect:6 cases(16.2%) in ITC group can be seen the reaction within 7 days,11 cases (29.7%) within 8 to 15 days,5 cases (13.5%) within 16 to30 days,1 case(2.7%) within 31to 60 days; 16 cases(41.0%) in KI group can be seen the reaction within 7 days,2cases(5.1%) in the 8-15 days, 1case (2.6%)within 16 to 30 days. The reaction of ITC group showed slower than KI group.(3) Effect:36 cases were cured in ITC group, the average course of treatment was 2.36±0.91 months, cure rate at 3 months was 86.5% and cure rate at 6 months was 97.3%; 39 cases were cured in KI group, the average course of treatment was 1.97±0.79 months, cure rate at 3 months was 94.9% and cure rate at 6 months was 100%. These parameters of two groups showed no significant differences (p> 0.05).(4) Adverse effects:Major adverse effects in ITC group were headache and stomach discomfort, which could be seen in 16.2% of the patients; the major adverse effects in KI group were facial adema and flu-like symptoms, which could be seen in 30.8% of patiets. The incidences of adverse effects in both groups had no significant difference.Conclusion:(1) BothITC and KI are safe and effective treatments of cutaneous sporotrichosis.(2) There is no significant difference in efficacy and adverse effects between ITC and KI for treatment of Sporotrichosis.(3) The time of onset of effect of ITC is shorter than that of KI.
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