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米卡芬净治疗侵袭性念珠菌感染的疗效和安全性:一项随机对照试验的荟萃分析。

Efficacy and safety of micafungin for invasive candida infections: a meta-analysis of randomized controlled trials.

机构信息

Department of Clinical Pharmacology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.

出版信息

Chin Med J (Engl). 2012 Jan;125(2):345-51.

PMID:22340571
Abstract

BACKGROUND

Invasive fungal infections such as candidiasis and mold infections cause significant morbidity and mortality in seriously ill patients. Micafungin is an echinocandin antifungal agent with potent activity against most species of Candida and Aspergillus. We did this meta-analysis to clarify whether micafungin offers superior efficacy and safety compared with other antifungal agent for treating infections associated with invasive candidiasis.

METHODS

We did a meta-analysis of randomized controlled trials to examine whether micafungin has superior efficacy and safety compared with other antifungal agents recommended by the treatment guidelines for fungal infection. Seven trials involving 2913 patients were included in this analysis. Odds ratios (OR) and 95% confidence intervals (CI) were calculated.

RESULTS

Micafungin was associated with significantly better treatment success compared with the comparator antifungal agents (modified intention to treat, 2851 patients; random-effects model, OR 1.20, 95%CI 1.00 - 1.45, P = 0.0487). In addition, micafungin was more effective than the comparators for antifungal prophylaxis of neutropenic patients undergoing hematopoietic stem cell transplantation (OR 1.47, 95%CI 1.08 - 2.00, P = 0.01). Although there was no significant difference between the compared regimens in terms of the incidence of adverse drug effects (OR 0.94, 95%CI 0.77 - 1.11), fewer patients treated with micafungin withdrew from the studies because of adverse events (OR 0.64, 95%CI 0.44 - 0.94).

CONCLUSIONS

Micafungin has a good safety and tolerability profile, with an efficacy at least comparable to the other antifungal agents. Micafungin offers advantages over other agents for antifungal prophylaxis. Micafungin offers an appropriate alternative for antifungal prophylaxis rather than the treatment of invasive candida infections.

摘要

背景

侵袭性真菌感染,如念珠菌病和霉菌感染,会导致重病患者出现严重的发病率和死亡率。米卡芬净是一种棘白菌素类抗真菌药物,对大多数念珠菌属和曲霉菌属具有强大的活性。我们进行了这项荟萃分析,以明确米卡芬净在治疗侵袭性念珠菌感染相关感染方面是否比其他抗真菌药物更有效和更安全。

方法

我们对随机对照试验进行了荟萃分析,以检查米卡芬净与真菌感染治疗指南推荐的其他抗真菌药物相比是否具有更好的疗效和安全性。这项分析共纳入了 7 项涉及 2913 名患者的试验。计算了比值比(OR)和 95%置信区间(CI)。

结果

与对照抗真菌药物相比,米卡芬净治疗成功率显著更高(意向治疗人群,2851 名患者;随机效应模型,OR 1.20,95%CI 1.00-1.45,P=0.0487)。此外,米卡芬净在预防接受造血干细胞移植的中性粒细胞减少症患者发生真菌感染方面比对照药物更有效(OR 1.47,95%CI 1.08-2.00,P=0.01)。虽然比较方案在药物不良反应发生率方面没有显著差异(OR 0.94,95%CI 0.77-1.11),但接受米卡芬净治疗的患者因不良反应而退出研究的比例较低(OR 0.64,95%CI 0.44-0.94)。

结论

米卡芬净具有良好的安全性和耐受性,其疗效至少与其他抗真菌药物相当。米卡芬净在预防真菌感染方面优于其他药物。米卡芬净是预防侵袭性念珠菌感染的一种合适替代药物,而非治疗药物。

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