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股癣和体癣的外用抗真菌治疗。

Topical antifungal treatments for tinea cruris and tinea corporis.

作者信息

El-Gohary Magdy, van Zuuren Esther J, Fedorowicz Zbys, Burgess Hana, Doney Liz, Stuart Beth, Moore Michael, Little Paul

机构信息

Primary Care and Population Sciences, Faculty of Medicine, Aldermoor Health Centre, University of Southampton, Aldermoor Close, Southampton, UK, SO16 5ST.

出版信息

Cochrane Database Syst Rev. 2014 Aug 4;2014(8):CD009992. doi: 10.1002/14651858.CD009992.pub2.

Abstract

BACKGROUND

Tinea infections are fungal infections of the skin caused by dermatophytes. It is estimated that 10% to 20% of the world population is affected by fungal skin infections. Sites of infection vary according to geographical location, the organism involved, and environmental and cultural differences. Both tinea corporis, also referred to as 'ringworm' and tinea cruris or 'jock itch' are conditions frequently seen by primary care doctors and dermatologists. The diagnosis can be made on clinical appearance and can be confirmed by microscopy or culture. A wide range of topical antifungal drugs are used to treat these superficial dermatomycoses, but it is unclear which are the most effective.

OBJECTIVES

To assess the effects of topical antifungal treatments in tinea cruris and tinea corporis.

SEARCH METHODS

We searched the following databases up to 13th August 2013: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2013, Issue 7), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We also searched five trials registers, and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials. We handsearched the journal Mycoses from 1957 to 1990.

SELECTION CRITERIA

Randomised controlled trials in people with proven dermatophyte infection of the body (tinea corporis) or groin (tinea cruris).

DATA COLLECTION AND ANALYSIS

Two review authors independently carried out study selection, data extraction, assessment of risk of bias, and analyses.

MAIN RESULTS

Of the 364 records identified, 129 studies with 18,086 participants met the inclusion criteria. Half of the studies were judged at high risk of bias with the remainder judged at unclear risk. A wide range of different comparisons were evaluated across the 129 studies, 92 in total, with azoles accounting for the majority of the interventions. Treatment duration varied from one week to two months, but in most studies this was two to four weeks. The length of follow-up varied from one week to six months. Sixty-three studies contained no usable or retrievable data mainly due to the lack of separate data for different tinea infections. Mycological and clinical cure were assessed in the majority of studies, along with adverse effects. Less than half of the studies assessed disease relapse, and hardly any of them assessed duration until clinical cure, or participant-judged cure. The quality of the body of evidence was rated as low to very low for the different outcomes.Data for several outcomes for two individual treatments were pooled. Across five studies, significantly higher clinical cure rates were seen in participants treated with terbinafine compared to placebo (risk ratio (RR) 4.51, 95% confidence interval (CI) 3.10 to 6.56, number needed to treat (NNT) 3, 95% CI 2 to 4). The quality of evidence for this outcome was rated as low. Data for mycological cure for terbinafine could not be pooled due to substantial heterogeneity.Mycological cure rates favoured naftifine 1% compared to placebo across three studies (RR 2.38, 95% CI 1.80 to 3.14, NNT 3, 95% CI 2 to 4) with the quality of evidence rated as low. In one study, naftifine 1% was more effective than placebo in achieving clinical cure (RR 2.42, 95% CI 1.41 to 4.16, NNT 3, 95% CI 2 to 5) with the quality of evidence rated as low.Across two studies, mycological cure rates favoured clotrimazole 1% compared to placebo (RR 2.87, 95% CI 2.28 to 3.62, NNT 2, 95% CI 2 to 3).Data for several outcomes were pooled for three comparisons between different classes of treatment. There was no difference in mycological cure between azoles and benzylamines (RR 1.01, 95% CI 0.94 to 1.07). The quality of the evidence was rated as low for this comparison. Substantial heterogeneity precluded the pooling of data for mycological and clinical cure when comparing azoles and allylamines. Azoles were slightly less effective in achieving clinical cure compared to azole and steroid combination creams immediately at the end of treatment (RR 0.67, 95% CI 0.53 to 0.84, NNT 6, 95% CI 5 to 13), but there was no difference in mycological cure rate (RR 0.99, 95% CI 0.93 to 1.05). The quality of evidence for these two outcomes was rated as low for mycological cure and very low for clinical cure.All of the treatments that were examined appeared to be effective, but most comparisons were evaluated in single studies. There was no evidence for a difference in cure rates between tinea cruris and tinea corporis. Adverse effects were minimal - mainly irritation and burning; results were generally imprecise between active interventions and placebo, and between different classes of treatment.

AUTHORS' CONCLUSIONS: The pooled data suggest that the individual treatments terbinafine and naftifine are effective. Adverse effects were generally mild and reported infrequently. A substantial number of the studies were more than 20 years old and of unclear or high risk of bias; there is however, some evidence that other topical antifungal treatments also provide similar clinical and mycological cure rates, particularly azoles although most were evaluated in single studies.There is insufficient evidence to determine if Whitfield's ointment, a widely used agent is effective.Although combinations of topical steroids and antifungals are not currently recommended in any clinical guidelines, relevant studies included in this review reported higher clinical cure rates with similar mycological cure rates at the end of treatment, but the quality of evidence for these outcomes was rated very low due to imprecision, indirectness and risk of bias. There was insufficient evidence to confidently assess relapse rates in the individual or combination treatments.Although there was little difference between different classes of treatment in achieving cure, some interventions may be more appealing as they require fewer applications and a shorter duration of treatment. Further, high quality, adequately powered trials focusing on patient-centred outcomes, such as patient satisfaction with treatment should be considered.

摘要

背景

癣感染是由皮肤癣菌引起的皮肤真菌感染。据估计,全球10%至20%的人口受到皮肤真菌感染的影响。感染部位因地理位置、相关病原体以及环境和文化差异而有所不同。体癣(也称为“癣”)和股癣(或“股癣”)都是基层医疗医生和皮肤科医生经常遇到的病症。可根据临床表现做出诊断,并可通过显微镜检查或培养加以证实。广泛使用多种外用抗真菌药物来治疗这些浅表皮肤真菌病,但尚不清楚哪种药物最为有效。

目的

评估外用抗真菌治疗对股癣和体癣的疗效。

检索方法

截至2013年8月13日,我们检索了以下数据库:Cochrane皮肤小组专业注册库、Cochrane图书馆中的CENTRAL(2013年第7期)、MEDLINE(从1946年起)、EMBASE(从1974年起)以及LILACS(从1982年起)。我们还检索了五个试验注册库,并检查了纳入和排除研究的参考文献列表,以进一步查找相关随机对照试验的参考文献。我们手工检索了1957年至1990年的《真菌病》杂志。

入选标准

针对已证实患有体部皮肤癣菌感染(体癣)或腹股沟皮肤癣菌感染(股癣)的人群进行的随机对照试验。

数据收集与分析

两位综述作者独立进行研究选择、数据提取、偏倚风险评估和分析。

主要结果

在识别出的364条记录中,129项研究(涉及18,086名参与者)符合纳入标准。一半的研究被判定存在高偏倚风险,其余研究的偏倚风险判定为不清楚。在这129项研究中,共评估了92种不同的比较,其中大部分干预措施为唑类药物。治疗持续时间从一周到两个月不等,但在大多数研究中为两到四周。随访时间从一周到六个月不等。63项研究没有可用或可检索的数据,主要原因是缺乏针对不同癣感染的单独数据。大多数研究评估了真菌学和临床治愈情况以及不良反应。不到一半的研究评估了疾病复发情况,几乎没有研究评估直至临床治愈的持续时间或参与者判定的治愈情况。对于不同结局,证据质量被评为低至极低。汇总了两种个别治疗的几个结局的数据。在五项研究中,与安慰剂相比,接受特比萘芬治疗的参与者临床治愈率显著更高(风险比(RR)4.51,95%置信区间(CI)3.10至6.56,需治疗人数(NNT)3,95%CI 2至4)。该结局的证据质量被评为低。由于存在实质性异质性,无法汇总特比萘芬真菌学治愈的数据。在三项研究中,与安慰剂相比,1%萘替芬的真菌学治愈率更高(RR 2.38,95%CI 1.80至3.14,NNT 3,95%CI 2至4),证据质量被评为低。在一项研究中,1%萘替芬在实现临床治愈方面比安慰剂更有效(RR 2.42,95%CI 1.41至4.16,NNT 3,95%CI 2至5),证据质量被评为低。在两项研究中,与安慰剂相比,1%克霉唑的真菌学治愈率更高(RR 2.87,95%CI 2.28至3.62,NNT 2,95%CI 2至3)。汇总了不同类别治疗之间三项比较的几个结局的数据。唑类药物和苄胺类药物在真菌学治愈方面没有差异(RR 1.01,95%CI 0.94至1.07)。该比较的证据质量被评为低。在比较唑类药物和烯丙胺类药物时,由于存在实质性异质性,无法汇总真菌学和临床治愈的数据。与唑类和类固醇联合乳膏相比,唑类药物在治疗结束时立即实现临床治愈的效果略差(RR 0.67,95%CI 0.53至0.84,NNT 6,95%CI 5至13),但在真菌学治愈率方面没有差异(RR 0.99,95%CI 0.93至1.05)。这两个结局的真菌学治愈证据质量被评为低,临床治愈证据质量被评为极低。所有接受检查的治疗似乎都有效,但大多数比较仅在单项研究中进行评估。没有证据表明股癣和体癣的治愈率存在差异。不良反应极少——主要是刺激和烧灼感;活性干预措施与安慰剂之间以及不同类别治疗之间的结果通常不精确。

作者结论

汇总数据表明,特比萘芬和萘替芬这两种个别治疗方法是有效的。不良反应通常较轻,且报告频率较低。大量研究已有20多年历史,偏倚风险不明确或较高;然而,有一些证据表明其他外用抗真菌治疗也能提供类似的临床和真菌学治愈率,特别是唑类药物,尽管大多数仅在单项研究中进行了评估。没有足够的证据来确定广泛使用的药物惠菲尔德软膏是否有效。虽然目前任何临床指南都不推荐外用类固醇和抗真菌药物的联合使用,但本综述纳入的相关研究报告称,在治疗结束时,联合使用的临床治愈率更高,真菌学治愈率相似,但由于不精确、间接性和偏倚风险,这些结局的证据质量被评为极低。没有足够的证据来可靠地评估个别治疗或联合治疗中的复发率。虽然不同类别治疗在实现治愈方面差异不大,但一些干预措施可能更具吸引力,因为它们所需的用药次数更少,治疗持续时间更短。此外,应考虑开展以患者为中心的高质量、有足够效力的试验,例如患者对治疗的满意度。

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