PDF(Pubmed)
Abstract：
Despite evidence suggesting the benefit of prophylactic regional antibiotic delivery (RAD) to sternal edges during cardiac surgery, it is seldom performed in clinical practice. The value of topical vancomycin and gentamicin for sternal wound infections (SWI) prophylaxis was further questioned by recent studies including randomized controlled trials (RCTs). The aim of this systematic review and meta-analysis was to comprehensively assess the safety and effectiveness of RAD to reduce the risk of SWI.We screened multiple databases for RCTs assessing the effectiveness of RAD (vancomycin, gentamicin) in SWI prophylaxis. Random effects meta-analysis was performed. The primary endpoint was any SWI; other wound complications were also analysed. Odds Ratios served as the primary statistical analyses. Trial sequential analysis (TSA) was performed.Thirteen RCTs (N = 7,719 patients) were included. The odds of any SWI were significantly reduced by over 50% with any RAD: OR (95%CIs): 0.49 (0.35-0.68); p < 0.001 and consistently reduced in vancomycin (0.34 [0.18-0.64]; p < 0.001) and gentamicin (0.58 [0.39-0.86]; p = 0.007) groups (psubgroup = 0.15). Similarly, RAD reduced the odds of SWI in diabetic and non-diabetic patients (0.46 [0.32-0.65]; p < 0.001 and 0.60 [0.44-0.83]; p = 0.002 respectively). Cumulative Z-curve passed the TSA-adjusted boundary for SWIs suggesting adequate power has been met and no further trials are needed. RAD significantly reduced deep (0.60 [0.43-0.83]; p = 0.003) and superficial SWIs (0.54 [0.32-0.91]; p = 0.02). No differences were seen in mediastinitis and mortality, however, limited number of studies assessed these endpoints. There was no evidence of systemic toxicity, sternal dehiscence and resistant strains emergence. Both vancomycin and gentamicin reduced the odds of cultures outside their respective serum concentrations\' activity: vancomycin against gram-negative strains: 0.20 (0.01-4.18) and gentamicin against gram-positive strains: 0.42 (0.28-0.62); P < 0.001. Regional antibiotic delivery is safe and effectively reduces the risk of SWI in cardiac surgery patients.
摘要：
尽管有证据表明在心脏手术期间预防性局部抗生素递送（RAD）到胸骨边缘的益处，在临床实践中很少进行。包括随机对照试验（RCT）在内的最新研究进一步质疑了局部万古霉素和庆大霉素预防胸骨伤口感染（SWI）的价值。本系统评价和荟萃分析的目的是全面评估RAD的安全性和有效性，以降低SWI的风险。我们筛选了多个评估RAD有效性的随机对照试验数据库(万古霉素，庆大霉素）在SWI预防中。进行随机效应荟萃分析。主要终点是任何SWI；还分析了其他伤口并发症。赔率比作为主要的统计分析。进行试验序贯分析(TSA)。包括13个RCT（N=7,719例患者）。使用任何RAD：OR（95CIs）：0.49（0.35-0.68）；p<0.001，并且在万古霉素（0.34[0.18-0.64]；p<0.001）和庆大霉素（0.58[0.39-0.86]；p=0.007）组（psubgroup=0.15）中，任何SWI的几率均显着降低超过50％。同样，RAD降低了SWI在糖尿病和非糖尿病患者中的几率(分别为0.46[0.32-0.65];p<0.001和0.60[0.44-0.83];p=0.002)。累积Z曲线通过了SWIs的TSA调整边界，表明已经达到了足够的功率，不需要进一步的试验。RAD显著降低深度(0.60[0.43-0.83];p=0.003)和浅层SWI(0.54[0.32-0.91];p=0.02)。纵隔炎和死亡率没有差异，然而,评估这些终点的研究数量有限。没有全身毒性的证据,胸骨开裂和抗性菌株出现。万古霉素和庆大霉素均降低了培养物超出其各自血清浓度的几率：万古霉素对革兰氏阴性菌株：0.20（0.01-4.18），庆大霉素对革兰氏阳性菌株：0.42（0.28-0.62）；P<0.001。区域性抗生素给药是安全的，有效地降低了心脏手术患者的SWI风险。
