伊曲康唑间歇冲击治疗趾甲真菌病疗效和血清及甲中药物水平临床研究

Clinical study of efficacy and levels of itraconazole in serum and nail samples of toenail onychomycosis treatment with itraconazole intermittent pulse therapy

目的:研究伊曲康唑间歇冲击疗法治疗趾甲真菌病(甲母质未受累)的疗效和在血清及甲中药物水平的变化。方法:41例趾甲真菌病患者应用伊曲康唑连续3个冲击治疗,第52周进行最终疗效评价;采用高压液相色谱仪(HPLC)法对其中15例趾甲真菌病患者进行了血清及甲中药物测定。结果:每次冲击后4周,血清中均未测得伊曲康唑;甲组织中伊曲康唑水平较高,在8或12周时达到高峰,停药后,伊曲康唑仍能以较高的水平在甲中储留36周;同一时间点,指甲和趾甲中的药物水平相似(P>0.05)。在第52周时,趾甲真菌病的临床治愈率为66.7％,临床有效率为79.5％,真菌学清除率为64.1％。结论:伊曲康唑口服吸收后从血液迅速向甲组织分布,停药后仍以较高水平储留在甲组织中并持续存在36周以上。

Objective: To study the efficacy and levels of itraconazole in serum and nail samples of toenail onychomycosis without matrix area involvement in patients who were treated with itraconazole intermittent pulse therapy. Methods: Forty-one cases of toenail onychomycosis were treated for three pulses of 1-week itraconazole therapy. The global efficacy was evaluated 52 weeks after the treatment. The levels of itraconazole in nail and serum samples were measured by high performance liquid chromatography(HPLC) for 15 cases. Results: Itraconazole could not be detected in serum samples at the fourth week after each pulse therapy. The levels of itraconazole in nails could get to peak value in 8-12 weeks. Itraconazole could persist in nails for more than 36 weeks after cessation of treatment. The levels of itraconazole in fingernail had no differences statistically compared with that in toenail. At the fifty-second week, the clinical cure rate was 66.7%, the clinical efficacy rate 79.5% and the mycology clearance rate 64.1% for toenail onychomycosis. Conclusions: Itraconazole could be rapidly distributed to nail tissue from blood cycle and persist there more than 36 weeks after the discontinuation of treatment.