目的:在本研究中,我们旨在比较omadacycline(OMC)治疗成人患者并发皮肤和软组织感染(cSTTI)的临床疗效和安全性.
方法:在PubMed,Embase,科克伦,WebofScience,和临床试验,到2022年7月。主要结果是临床疗效和微生物反应,次要结局是安全性.
结果:纳入了由1,757名患者组成的四个随机对照试验,利奈唑胺(LZD)作为比较药物。为了临床疗效,OMC在改良意向治疗(MITT)中不劣于LZD(OR:1.24,95%Cl:[0.93,1.66],P=0.15)和临床可评估(CE)人群(OR:1.92,95%Cl:[0.94,3.92],P=0.07)。对于微生物反应,OMC在微生物学评估(ME)中的数值高于LZD(OR:1.74,95%Cl:[0.81,3.74],P=0.16)和微生物MITT(micro-MITT)种群(OR:1.27,95%Cl:[0.92,1.76],P=0.14)。在单一微生物或多微生物混合感染种群的亚群中没有发现显着差异。OMC和LZD的死亡率和不良事件发生率相似。
结论:OMC在临床疗效和微生物学反应方面与LZD一样好,在治疗cSSTI方面也有类似的安全问题。OMC可能是治疗成年患者cSTTI的有希望的选择。
OBJECTIVE: In the present study, we aimed to compare the clinical efficacy and safety of omadacycline (OMC) with its comparators for the treatment of complicated skin and soft tissue infections (cSSTIs) in adult patients.
METHODS: Randomized controlled trials (RCTs) evaluating OMC for cSSTIs were searched in databases of PubMed, Embase, Cochrane, Web of Science, and Clinical Trial, up to July 2022. The primary outcomes were clinical efficacy and microbiological response, with secondary outcome was safety.
RESULTS: Four RCTs consisting of 1,757 patients were included, with linezolid (LZD) as a comparator drug. For clinical efficacy, OMC was not inferior to LZD in the modified intent-to-treat (MITT) (OR: 1.24, 95% Cl: [0.93, 1.66], P = 0.15) and clinically evaluable (CE) populations (OR: 1.92, 95% Cl: [0.94, 3.92], P = 0.07). For microbiological response, OMC was numerically higher than LZD in the microbiologically evaluable (ME) (OR: 1.74, 95% Cl: [0.81, 3.74], P = 0.16) and microbiological MITT (micro-MITT) populations (OR: 1.27, 95% Cl: [0.92, 1.76], P = 0.14). No significant difference was found in subpopulations of monomicrobial or polymicrobial mixed infection populations. The mortality and adverse event rates were similar between OMC and LZD.
CONCLUSIONS: OMC was as good as LZD in terms of clinical efficacy and microbiological response, and has similar safety issues in treating cSSTIs. OMC might be a promising option for treating cSSTIs in adult patients.