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联合治疗应留作甲真菌病的二线治疗:甲真菌病临床试验的系统评价

Combination Therapy Should Be Reserved as Second-Line Treatment of Onychomycosis: A Systematic Review of Onychomycosis Clinical Trials.

作者信息

Falotico Julianne M, Lapides Rebecca, Lipner Shari R

机构信息

Renaissance School of Medicine at Stony Brook University, Stony Brook, NY 11794, USA.

Robert Larner, M.D. College of Medicine at the University of Vermont, Burlington, VT 05405, USA.

出版信息

J Fungi (Basel). 2022 Mar 9;8(3):279. doi: 10.3390/jof8030279.

DOI:10.3390/jof8030279
PMID:35330281
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8949799/
Abstract

Onychomycosis is the most common nail disease encountered in clinical practice. Its importance extends well beyond aesthetics, often causing pain, difficulty with ambulation and performing daily activities, and impairing quality of life. Many patients fail to achieve cure with antifungal monotherapy and recurrences are common. Combination therapy has therefore gained considerable interest, given the potential for drug synergy and prevention of antifungal resistance, but it has not been well studied. A systematic review of onychomycosis medication only, as well as medication and procedural (laser, debridement, photodynamic therapy), clinical or randomized controlled trials evaluating combination vs. monotherapies was performed. After exclusions, 30 studies were included in the final analysis. There were conflicting results for medication-only trials, with some showing significant benefit of combination therapy over monotherapy, however, trials were not robustly designed and lacked sufficient follow-up. Procedural studies also lacked long-term follow-up, and failed to demonstrate efficacy in some severe onychomycosis cases. Considering the high cure rates demonstrated in pivotal antifungal monotherapy trials, and conflicting results, costs, and safety concerns associated with combination therapy, we recommend that combination therapy be reserved as second-line treatment options in patients with poor prognostic factors or for those who failed monotherapy for onychomycosis.

摘要

甲癣是临床实践中最常见的指甲疾病。其影响远不止美观问题,常导致疼痛、行走困难及日常生活不便,还会损害生活质量。许多患者采用抗真菌单一疗法无法治愈,复发很常见。鉴于联合疗法具有药物协同作用及预防抗真菌耐药性的潜力,因此备受关注,但尚未得到充分研究。我们对仅涉及甲癣药物治疗,以及药物与手术治疗(激光、清创、光动力疗法)的临床或随机对照试验进行了系统评价,比较联合疗法与单一疗法。排除相关研究后,最终纳入分析的有30项研究。仅药物治疗的试验结果相互矛盾,一些研究表明联合疗法比单一疗法有显著益处,但这些试验设计不够严谨,且缺乏足够的随访。手术治疗研究也缺乏长期随访,在一些严重甲癣病例中未能证明其疗效。鉴于关键的抗真菌单一疗法试验显示出高治愈率,以及联合疗法存在相互矛盾的结果、成本和安全问题,我们建议将联合疗法作为预后因素较差或单一疗法治疗甲癣失败患者的二线治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ee0/8949799/3e9d1424c1c8/jof-08-00279-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ee0/8949799/3e9d1424c1c8/jof-08-00279-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ee0/8949799/3e9d1424c1c8/jof-08-00279-g001.jpg

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