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达托霉素与其他抗生素治疗皮肤和软组织感染的安全性及有效性:一项随机对照试验的荟萃分析

The safety and efficacy of daptomycin versus other antibiotics for skin and soft-tissue infections: a meta-analysis of randomised controlled trials.

作者信息

Wang Shou Zhen, Hu Jun Tao, Zhang Chi, Zhou Wei, Chen Xian Feng, Jiang Liang Yan, Tang Zhan Hong

机构信息

Surgical Intensive Care Unit, First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.

出版信息

BMJ Open. 2014 Jun 24;4(6):e004744. doi: 10.1136/bmjopen-2013-004744.

Abstract

OBJECTIVE

Daptomycin, a cyclic lipopeptide that exhibits rapid, concentration-dependent bactericidal activity in vitro against a broad spectrum of Gram-positive pathogens, has now, since 2003, been approved in more than 70 countries and regions to treat skin and soft-tissue infections (SSTIs). The purpose of this meta-analysis was to compare the safety and efficacy of daptomycin with other antibiotics, especially with vancomycin which has long been considered the standard therapy for complicated SSTIs.

DESIGN

Meta-analysis of randomised controlled trials (RCTs).

DATA SOURCES

We thoroughly searched PubMed, EMBASE, Cochrane Central to identify relevant RCTs. Six RCTs with a total of 1710 patients were included in this meta-analysis.

RESULTS

The results demonstrated that the efficacy of daptomycin was at par with or maybe better than other first-line antibiotics for treating SSTIs as shown by the OR for clinical success (OR=1.05, 95% CI 0.84 to 1.31, p=0.65, I(2)=0%); daptomycin versus vancomycin subgroup (OR=1.19, 95% CI 0.77 to 1.83, p=0.43, I(2)=0%); overall microbiological success (OR=1.05, 95% CI 0.61 to 1.79, p=0.86, I(2)=42%); microbiological success of daptomycin versus comparators for Staphylococcus aureus (SA, OR=1.05, 95% CI 0.61 to 2.60, p=0.53, I(2)=47%), for methicillin-resistant S. aureus (OR=0.90, 95% CI 0.77 to 1.06, p=0.20, I(2)=56%). However, daptomycin tended to have a similar treatment-related adverse events (AEs) incidence in comparison with other antibiotics (OR=1.06, 95% CI 0.71 to 1.59, p=0.76, I(2)=41%). The trend showed that daptomycin might cause less discontinuation due to AEs and death compared with other first-line antibiotics (OR=0.71, 95% CI 0.46 to 1.10, p=0.12, I(2)=11%). Significantly more patients in the daptomyicn group had creatine phosphokinase elevation than those in the control group; however, it could be reversed when the therapy ended (OR=1.95, 95% CI 1.04 to 3.65, p=0.04, I(2)=0).

CONCLUSIONS

This meta-analysis demonstrated that the safety and efficacy of daptomycin was not inferior to that of other first-line drugs, and daptomycin tended to exhibit superior efficacy when compared with vancomycin or with comparators for SA infections; nevertheless, more high-quality RCTs are needed to draw a more credible conclusion.

摘要

目的

达托霉素是一种环脂肽,在体外对多种革兰氏阳性病原体具有快速、浓度依赖性杀菌活性。自2003年以来,它已在70多个国家和地区获批用于治疗皮肤和软组织感染(SSTIs)。本荟萃分析的目的是比较达托霉素与其他抗生素的安全性和疗效,尤其是与长期以来被视为复杂性SSTIs标准治疗药物的万古霉素进行比较。

设计

随机对照试验(RCTs)的荟萃分析。

数据来源

我们全面检索了PubMed、EMBASE、Cochrane Central以识别相关的RCTs。本荟萃分析纳入了6项RCTs,共1710例患者。

结果

结果表明,达托霉素治疗SSTIs的疗效与其他一线抗生素相当或可能更好,临床成功的比值比(OR = 1.05,95%可信区间0.84至1.31,p = 0.65,I² = 0%);达托霉素与万古霉素亚组(OR = 1.19,95%可信区间0.77至1.83,p = 0.43,I² = 0%);总体微生物学成功(OR = 1.05,95%可信区间0.61至1.79,p = 0.86,I² = 42%);达托霉素与金黄色葡萄球菌(SA)比较的微生物学成功(OR = 1.05,95%可信区间0.61至2.60,p = 0.53,I² = 47%),耐甲氧西林金黄色葡萄球菌(OR = 0.90,95%可信区间0.77至1.06,p = 0.20,I² = 56%)。然而,与其他抗生素相比,达托霉素的治疗相关不良事件(AEs)发生率趋于相似(OR = 1.06,95%可信区间0.71至1.59,p = 0.76,I² = 41%)。趋势表明与其他一线抗生素相比,达托霉素可能因AEs和死亡导致的停药较少(OR = 0.71,95%可信区间0.46至1.10,p = 0.12,I² = 11%)。达托霉素组肌酸磷酸激酶升高的患者明显多于对照组;然而,治疗结束时可恢复(OR = 1.95,95%可信区间)。

结论

本荟萃分析表明,达托霉素的安全性和疗效不低于其他一线药物,与万古霉素或SA感染的对照药物相比,达托霉素的疗效趋于更好;然而,需要更多高质量的RCTs来得出更可靠的结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e6a/4078778/af9b0012ebc6/bmjopen2013004744f01.jpg

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