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米诺环素治疗寻常痤疮:疗效与安全性。

Minocycline for acne vulgaris: efficacy and safety.

作者信息

Garner Sarah E, Eady Anne, Bennett Cathy, Newton John Norman, Thomas Karen, Popescu Catalin Mihai

机构信息

Research and Development, National Institute for Health and Clinical Excellence (NICE), London, UK.

出版信息

Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD002086. doi: 10.1002/14651858.CD002086.pub2.

Abstract

BACKGROUND

Minocycline is an oral antibiotic used for acne vulgaris. Its use has lessened due to safety concerns (including potentially irreversible pigmentation), a relatively high cost, and no evidence of any greater benefit than other acne treatments. A modified-release version of minocycline is being promoted as having fewer side-effects.

OBJECTIVES

To assess new evidence on the effects of minocycline for acne vulgaris.

SEARCH METHODS

Searches were updated in the following databases to November 2011: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We also searched trials registers and checked reference lists for further references to relevant randomised controlled trials (RCTs).The Cochrane Skin Group's Trials Search Co-ordinator undertook searches exploring minocycline's adverse effects in EMBASE and MEDLINE in February 2012.

SELECTION CRITERIA

We selected randomised controlled trials (RCTs) comparing minocycline, at any dose, to an active or a placebo control, in participants with inflammatory acne vulgaris. For adverse effects, we selected additional studies that reported the number of adverse effects and the number of participants treated.

DATA COLLECTION AND ANALYSIS

Outcome measures used in the trials included lesion counts, acne grades/severity scores, doctors' and participants' global assessments, adverse effects, and dropout rates. Two authors independently assessed the quality of each study. Effect sizes were calculated, and meta-analyses were undertaken where possible.Sixteen studies met the inclusion criteria for the review of adverse effects.

MAIN RESULTS

We included 12 new RCTs for this update, giving a total of 39 RCTs (6013 participants). These additional 12 RCTs have not changed the original conclusions about the clinical efficacy of minocycline.The identified RCTs were generally small and poor quality. Meta-analysis was rarely possible because of the lack of data and different outcome measures and trial durations. Although minocycline was shown to be an effective treatment for moderate to moderately-severe acne vulgaris, there was no evidence that it is better than any of the other commonly-used acne treatments. One company-sponsored RCT found minocycline to be less effective than combination treatment with topical erythromycin and zinc. No trials have been conducted using minocycline in those participants whose acne is resistant to other therapies. Also, there is no evidence to guide what dose should be used.The adverse effects studies must be interpreted with caution. The evidence suggests that minocycline is associated with more severe adverse effects than doxycycline. Minocycline, but not other tetracyclines, is associated with lupus erythematosus, but the risk is small: 8.8 cases per 100,000 person-years. The risk of autoimmune reactions increases with duration of use. The evidence does not support the conclusion that the more expensive extended-release preparation is safer than standard minocycline preparations.

AUTHORS' CONCLUSIONS: Minocycline is an effective treatment for moderate to moderately-severe inflammatory acne vulgaris, but there is still no evidence that it is superior to other commonly-used therapies. This review found no reliable evidence to justify the reinstatement of its first-line use, even though the price-differential is less than it was 10 years ago. Concerns remain about its safety compared to other tetracyclines.

摘要

背景

米诺环素是一种用于治疗寻常痤疮的口服抗生素。由于安全问题(包括潜在的不可逆色素沉着)、成本相对较高,且没有证据表明其比其他痤疮治疗方法有更大益处,其使用量已有所减少。一种缓释型米诺环素正在被推广,称其副作用较少。

目的

评估米诺环素治疗寻常痤疮效果的新证据。

检索方法

检索以下数据库至2011年11月:Cochrane皮肤组专业注册库、Cochrane图书馆中的CENTRAL、MEDLINE(从1946年起)、EMBASE(从1974年起)和LILACS(从1982年起)。我们还检索了试验注册库,并检查参考文献列表以获取更多相关随机对照试验(RCT)的参考文献。Cochrane皮肤组试验检索协调员于2012年2月在EMBASE和MEDLINE中检索了有关米诺环素不良反应的研究。

选择标准

我们选择了比较任何剂量米诺环素与活性对照或安慰剂对照,针对炎性寻常痤疮患者的随机对照试验(RCT)。对于不良反应,我们选择了报告不良反应数量和接受治疗参与者数量的其他研究。

数据收集与分析

试验中使用的结局指标包括皮损计数、痤疮分级/严重程度评分、医生和参与者的整体评估、不良反应和脱落率。两位作者独立评估每项研究的质量。计算效应量,并在可能的情况下进行荟萃分析。16项研究符合不良反应综述的纳入标准。

主要结果

本次更新纳入了12项新的RCT,使RCT总数达到39项(6013名参与者)。这12项新增的RCT并未改变关于米诺环素临床疗效的原有结论。所纳入的RCT通常规模较小且质量较差。由于缺乏数据、结局指标不同以及试验持续时间不同,很少能够进行荟萃分析。虽然米诺环素被证明是治疗中度至中度重度寻常痤疮的有效方法,但没有证据表明它比任何其他常用的痤疮治疗方法更好。一项由公司赞助的RCT发现米诺环素比外用红霉素和锌联合治疗效果差。尚未对痤疮对其他疗法耐药的参与者使用米诺环素进行试验。此外,没有证据指导应使用何种剂量。对不良反应研究的解读必须谨慎。证据表明,米诺环素比多西环素的不良反应更严重。米诺环素(而非其他四环素类药物)与红斑狼疮有关,但风险较小:每10万人年8.8例。自身免疫反应的风险随使用时间增加。没有证据支持更昂贵的缓释制剂比标准米诺环素制剂更安全这一结论。

作者结论

米诺环素是治疗中度至中度重度炎性寻常痤疮的有效方法,但仍没有证据表明它优于其他常用疗法。本综述未发现可靠证据支持恢复其一线用药地位,尽管价格差异比10年前小。与其他四环素类药物相比,其安全性仍令人担忧。

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