Haneke E, Tajerbashi M, De Doncker P, Heremans A
Department of Dermatology, Wuppertal Hospitals, University of Witten/Herdecke, Beerse, Belgium.
Dermatology. 1998;196(3):323-9. doi: 10.1159/000017905.
In recent years, itraconazole pulse therapy for onychomycosis has been developed [three 1-week pulses with itraconazole 400 (2 x 200) mg daily every month]. This has proved an effective and safe regimen which requires only 50% of the medication used for continuous dosing schedules. Parallel to the development of the new dosage schedule, additional studies were conducted to further document the safety and efficacy of itraconazole 200 mg once daily for 3 months to treat onychomycosis.
To compare the safety of itraconazole 200 mg once daily for 3 months, with or without itraconazole 200 mg once weekly for a further 3 months, with that of miconazole cream twice daily for 6 months, in the treatment of onychomycosis. Treatment efficacy was compared as a secondary objective.
In this multicenter, double-blind study, patients were randomized to receive itraconazole 200 mg once daily for 3 months followed by either itraconazole 200 mg once weekly for 3 months (ITR-ITR group, n = 599) or oral placebo once weekly for 3 months (ITR-PLAC group, n = 613), or to receive miconazole cream twice daily for 6 months (MIC-MIC group, n = 396). The primary variable was elevation of alanine amino-transferase (ALT) concentration above 50 U/I.
Overall incidence of elevation of ALT concentration above 50 U/I, adverse events and rate of withdrawal because of adverse events were low and similar in the three treatment groups. Efficacy was significantly greater in the ITR groups than the MIC-MIC group.
Itraconazole and miconazole were well tolerated and had no significant effect on liver function, but itraconazole was significantly more effective.
近年来，已开发出伊曲康唑脉冲疗法治疗甲癣[每月进行三个为期1周的脉冲治疗，每日服用伊曲康唑400（2×200）mg]。这已被证明是一种有效且安全的治疗方案，所需药物仅为连续给药方案的50%。在新给药方案研发的同时，还进行了其他研究，以进一步证明每日一次服用200mg伊曲康唑，持续3个月治疗甲癣的安全性和有效性。
比较每日一次服用200mg伊曲康唑持续3个月、之后再连续3个月每周一次服用200mg伊曲康唑，与每日两次使用咪康唑乳膏持续6个月治疗甲癣的安全性。将治疗效果作为次要目的进行比较。
在这项多中心、双盲研究中，患者被随机分组，分别接受每日一次服用200mg伊曲康唑，持续3个月，随后3个月每周一次服用200mg伊曲康唑（ITR-ITR组，n = 599），或3个月每周一次服用口服安慰剂（ITR-PLAC组，n = 613），或每日两次使用咪康唑乳膏，持续6个月（MIC-MIC组，n = 396）。主要变量为丙氨酸氨基转移酶（ALT）浓度升高至50 U/I以上。
三个治疗组中，ALT浓度升高至50 U/I以上的总体发生率、不良事件以及因不良事件导致的停药率均较低且相似。ITR组的疗效显著优于MIC-MIC组。
伊曲康唑和咪康唑耐受性良好，对肝功能无显著影响，但伊曲康唑的疗效显著更佳。
