Therapeutic Options for the Treatment of Tinea Capitis Caused by Trichophyton Species: Griseofulvin Versus the New Oral Antifungal Agents, Terbinafine, Itraconazole, and Fluconazole
Therapeutic Options for the Treatment of Tinea Capitis Caused by Trichophyton Species: Griseofulvin Versus the New Oral Antifungal Agents, Terbinafine, Itraconazole, and Fluconazole
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毛癣菌引起的头癣的治疗选择：灰黄霉素与新型口服抗真菌药物特比萘芬、伊曲康唑和氟康唑
DOI：
10.1046/j.1525-1470.2001.01978.x
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发表时间：
2001
影响因子：
1.5
通讯作者：
R. Summerbell
中科院分区：
文献类型：
--
作者：
Aditya K. Gupta;P. Adam;N. Dlova;C. Lynde;S. Hofstader;N. Morar;J. Aboobaker;R. Summerbell
头皮炎是一种相对常见的儿童真菌感染。灰黄霉素一直是管理的支柱。然而，更新的口服抗真菌药物正在更频繁地使用。在加拿大和南非的研究中心进行了一项多中心、前瞻性、随机、单盲、非行业申办的研究，以确定灰黄霉素、特比萘芬、伊曲康唑和氟康唑治疗毛癣菌属引起的头皮炎的相对疗效和安全性。治疗头癣的方案为灰黄霉素微粒20 mg/kg/天× 6周，特比萘芬[> 40 kg，1片250 mg片剂; 20-40 kg，125 mg（250 mg片剂的一半）; <20 kg，62.5 mg（250 mg片剂的四分之一）] × 2-3周，伊曲康唑5 mg/kg/天× 2- 3周，氟康唑6 mg/kg/天× 2-3周。 要求患者在研究开始后第4、8和12周返回。灰黄霉素给药6周，在第12周进行最终评价。特比萘芬、伊曲康唑和氟康唑给药2周，患者在治疗开始后4周进行评估。此时，如果有临床指征，则给予额外一周的治疗。将200例患者随机分配至4个治疗组（每组50例）。在第12周的最终评估中，可评估的患者数量为灰黄霉素，46例;特比萘芬，48例;伊曲康唑，46例;氟康唑，46例。停止治疗或失访的患者为灰黄霉素，1/3;伊曲康唑，0/4;特比萘芬，0/4;氟康唑，0/4。致病菌为断端毛癣菌和毛癣菌。violaceum物种。如果患者在第12周时真菌学治愈且临床治愈或仅有少量残留症状，则认为患者得到了有效治疗。有效治疗记录如下，意向治疗：灰黄霉素（46/50，92.0%）、特比萘芬（47/50，94.0%）、伊曲康唑（43/50，86.0%）和氟康唑（42/50，84.0%）（p=0.33）。仅灰黄霉素组报告了不良反应（6例患者发生胃肠道反应）。仅灰黄霉素组发生因不良反应而停止治疗（1例患者发生恶心）。对于治疗由毛癣菌属引起的头皮炎，在本研究中，给予灰黄霉素6周的疗效与给予特比萘芬、伊曲康唑和氟康唑2-3周的疗效相似。每种药物都有良好的不良反应。
Tinea capitis is a relatively common fungal infection of childhood. Griseofulvin has been the mainstay of management. However, newer oral antifungal agents are being used more frequently. A multicenter, prospective, randomized, single‐blinded, non‐industry‐sponsored study was conducted in centers in Canada and South Africa to determine the relative efficacy and safety of griseofulvin, terbinafine, itraconazole, and fluconazole in the treatment of tinea capitis caused by Trichophyton species. The regimens for treating tinea capitis were griseofulvin microsize 20 mg/kg/day × 6 weeks, terbinafine [> 40 kg, one 250 mg tablet; 20–40 kg, 125 mg (half of a 250 mg tablet); < 20 kg, 62.5 mg (one‐quarter of a 250 mg tablet)] × 2–3 weeks, itraconazole 5 mg/kg/day × 2–3 weeks, and fluconazole 6 mg/kg/day × 2–3 weeks. Patients were asked to return at weeks 4, 8, and 12 from the start of the study. Griseofulvin was administered for 6 weeks and the final evaluation was at week 12. Terbinafine, itraconazole, and fluconazole were administered for 2 weeks and the patient evaluated 4 weeks from the start of therapy. At this time, if clinically indicated, one extra week of therapy was given. There were 200 patients randomized to four treatment groups (50 in each group). At the final evaluation at week 12, the number of evaluable patients were griseofulvin, 46; terbinafine, 48; itraconazole, 46; and fluconazole, 46. Patients who discontinued therapy or were lost to follow‐up were griseofulvin, 1/3; itraconazole, 0/4; terbinafine, 0/4; and fluconazole, 0/4. The causative organisms were Trichophyton tonsurans and T. violaceum species. Patients were regarded as effectively treated at week 12 if there was mycologic cure and either clinical cure or only a few residual symptoms. Effective treatment was recorded in, intention to treat, griseofulvin (46 of 50, 92.0%), terbinafine (47 of 50, 94.0%), itraconazole (43 of 50, 86.0%), and fluconazole (42 of 50, 84.0%) (p=0.33). Adverse effects were reported only in the griseofulvin group (gastrointestinal effects in six patients). Discontinuation from therapy due to adverse effects occurred only in the griseofulvin group (nausea in one patient). For the treatment of tinea capitis caused by the Trichophyton species, in this study, griseofulvin given for 6 weeks is similar in efficacy to terbinafine, itraconazole, and fluconazole given for 2–3 weeks. Each of the agents has a favorable adverse‐effects profile.