Chang Chia-Hsuin, Young-Xu Yinong, Kurth Tobias, Orav John E, Chan Arnold K
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Am J Med. 2007 Sep;120(9):791-8. doi: 10.1016/j.amjmed.2007.03.021.
We estimated the absolute risks of treatment termination and incidence of adverse liver outcomes among all commonly used oral antifungal treatments for superficial dermatophytosis and onychomycosis.
MEDLINE, EMBASE, and Cochrane Library were searched to identify randomized and nonrandomized controlled trials, case series, and cohort studies published before December 31, 2005. Two reviewers independently applied selection criteria, performed quality assessment, and extracted data. Treatment arms with the same regimen in terms of drug, type (continuous or intermittent), and dosage were combined to estimate the risk of an outcome of interest.
We identified 122 studies with approximately 20,000 enrolled patients for planned comparison. The pooled risks (95% confidence intervals) of treatment discontinuation resulting from adverse reactions for continuous therapy were 3.44% (95% confidence interval [CI], 2.28%-4.61%) for terbinafine 250 mg/day; 1.96% (95% CI, 0.35%-3.57%) for itraconazole 100 mg/day; 4.21% (95% CI, 2.33%-6.09%) for itraconazole 200 mg/day; and 1.51% (95% CI, 0%-4.01%) for fluconazole 50 mg/day. For intermittent therapy, the pooled risks were as follows: pulse terbinafine: 2.09% (95% CI, 0%-4.42%); pulse itraconazole: 2.58% (95% CI, 1.15%-4.01%); intermittent fluconazole 150 mg/week: 1.98% (95% CI, 0.05%-3.92%); and intermittent fluconazole 300 to 450 mg/week: 5.76% (95% CI, 2.42%-9.10%). The risk of liver injury requiring termination of treatment ranged from 0.11% (continuous itraconazole 100 mg/day) to 1.22% (continuous fluconazole 50 mg/day). The risk of having asymptomatic elevation of serum transaminase but not requiring treatment discontinuation was less than 2.0% for all treatment regimens evaluated.
Oral antifungal therapy against superficial dermatophytosis and onychomycosis, including intermittent and continuous terbinafine, itraconazole, and fluconazole, was associated with a low incidence of adverse events in an immunocompetent population.
我们评估了所有常用的口服抗真菌药物治疗浅表皮肤癣菌病和甲癣时治疗终止的绝对风险以及不良肝脏结局的发生率。
检索MEDLINE、EMBASE和Cochrane图书馆，以识别2005年12月31日前发表的随机和非随机对照试验、病例系列和队列研究。两名审阅者独立应用选择标准、进行质量评估并提取数据。将在药物、类型（连续或间歇）和剂量方面具有相同方案的治疗组合并，以估计感兴趣结局的风险。
我们确定了122项研究，纳入约20000名患者进行计划比较。连续治疗因不良反应导致治疗中断的合并风险（95%置信区间）为：特比萘芬250mg/天，3.44%（95%置信区间[CI]，2.28%-4.61%）；伊曲康唑100mg/天，1.96%（95%CI，0.35%-3.57%）；伊曲康唑200mg/天，4.21%（95%CI，2.33%-6.09%）；氟康唑50mg/天，1.51%（95%CI，0%-4.01%）。对于间歇治疗，合并风险如下：脉冲式特比萘芬：2.09%（95%CI，0%-4.42%）；脉冲式伊曲康唑：2.58%（95%CI，1.15%-4.01%）；氟康唑150mg/周间歇给药：1.98%（95%CI，0.05%-3.92%）；氟康唑300至450mg/周间歇给药：5.76%（95%CI，2.42%-9.10%）。因肝损伤需要终止治疗的风险范围为0.11%（连续伊曲康唑100mg/天）至1.22%（连续氟康唑50mg/天）。对于所有评估的治疗方案，血清转氨酶无症状升高但无需中断治疗的风险低于2.0%。
在免疫功能正常人群中，口服抗真菌药物治疗浅表皮肤癣菌病和甲癣，包括间歇和连续使用的特比萘芬、伊曲康唑和氟康唑，不良事件发生率较低。
