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特比萘芬与灰黄霉素治疗趾甲甲真菌病的双盲、平行组比较

Double-blind, parallel-group comparison of terbinafine and griseofulvin in the treatment of toenail onychomycosis.

作者信息

Faergemann J, Anderson C, Hersle K, Hradil E, Nordin P, Kaaman T, Molin L, Pettersson A

机构信息

Department of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden.

出版信息

J Am Acad Dermatol. 1995 May;32(5 Pt 1):750-3. doi: 10.1016/0190-9622(95)91454-4.

DOI:10.1016/0190-9622(95)91454-4
PMID:7722020
Abstract

BACKGROUND

Griseofulvin has been used in the treatment of toenail onychomycosis with limited success. Evidence suggests that terbinafine may be more effective.

OBJECTIVE

In a double-blind, parallel-group study we compared 250 mg/day terbinafine for 16 weeks with 500 mg/day griseofulvin for 52 weeks (or for shorter periods in cured patients) in patients with toenail onychomycosis.

METHODS

Eighty-nine patients with culture-proved tinea unguium were included, and 43 in the terbinafine group and 41 in the griseofulvin group were assessable for efficacy. Patients who had not improved after 16 weeks were entered into an open study and were given 250 mg/day terbinafine for 16 weeks with the study code still blinded and were then followed up for 20 weeks.

RESULTS

Terbinafine was significantly more effective than griseofulvin, with 42% being completely cured and 84% mycologically cured compared with only 2% with total cure and 45% with mycologic cure in the griseofulvin-treated group. The number of side effects was significantly lower in the terbinafine group (11%) compared with the griseofulvin group (29%).

CONCLUSION

Terbinafine is significantly more effective than griseofulvin in the treatment of toenail onychomycosis.

摘要

背景

灰黄霉素用于治疗趾甲甲癣,疗效有限。有证据表明特比萘芬可能更有效。

目的

在一项双盲平行组研究中,我们将250毫克/天的特比萘芬治疗16周与500毫克/天的灰黄霉素治疗52周(或治愈患者缩短疗程)用于趾甲甲癣患者进行了比较。

方法

纳入89例经培养证实的甲癣患者,特比萘芬组43例、灰黄霉素组41例可进行疗效评估。16周后未改善的患者进入开放研究,给予250毫克/天的特比萘芬治疗16周,研究编码仍保持盲态,然后随访20周。

结果

特比萘芬比灰黄霉素显著更有效,特比萘芬组42%完全治愈,84%真菌学治愈,而灰黄霉素治疗组分别仅为2%完全治愈和45%真菌学治愈。特比萘芬组的副作用发生率(11%)显著低于灰黄霉素组(29%)。

结论

在治疗趾甲甲癣方面,特比萘芬比灰黄霉素显著更有效。

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