McDonald M, Grabsch E, Marshall C, Forbes A
Infectious Diseases Service, The Geelong Hospital, Victoria, Australia.
Aust N Z J Surg. 1998 Jun;68(6):388-96. doi: 10.1111/j.1445-2197.1998.tb04785.x.
Single-dose antimicrobial prophylaxis for major surgery is a widely accepted principle; recommendations have been based on laboratory studies and numerous clinical trials published in the last 25 years. In practice, single-dose prophylaxis has not been universally accepted and multiple-dose regimens are still used in some centres. Moreover, the principle has recently been challenged by the results of an Australian study of vascular surgery. The aim of this current systematic review is to determine the overall efficacy of single versus multiple-dose antimicrobial prophylaxis for major surgery and across surgical disciplines.
Relevant studies were identified in the medical literature using the MEDLINE database and other search strategies. Trials included in the review were prospective and randomized, had the same antimicrobial in each treatment arm and were published in English. Rates of postoperative surgical site infections (SSI) were extracted, 2 x 2 tables prepared and odds ratios (OR) [with 95% confidence intervals (95% CI)] calculated. Data were then combined using fixed and random effects models to provide an overall figure. In this context, a high value for the combined OR, with 95% CI > 1.0, indicates superiority of multiple-dose regimens and a low OR, with 95% CI < 1.0, suggests the opposite. A combined OR close to 1.0, with narrow 95% CI straddling 1.0, indicates no clear advantage of one regimen over another. Further subgroup analyses were also performed.
Combined OR by both fixed (1.06, 95% CI, 0.89-1.25) and random effects (1.04, 95% CI, 0.86-1.25) models indicated no clear advantage of either single or multiple-dose regimens in preventing SSI. Likewise, subgroup analysis showed no statistically significant differences associated with type of antimicrobial used (beta-lactam vs other), blinded wound assessment, length of the multiple-dose arm (> 24 h vs 24 h or less) or type of surgery (obstetric and gynaecological vs other).
Continued use of single-dose antimicrobial prophylaxis for major surgery is recommended. Further studies are required, especially in previously neglected surgical disciplines.
大手术单剂量抗菌药物预防是一项广泛接受的原则；相关建议基于过去25年发表的实验室研究和大量临床试验。在实际应用中，单剂量预防尚未被普遍接受，一些中心仍在使用多剂量方案。此外，该原则最近受到澳大利亚一项血管外科研究结果的挑战。本系统评价的目的是确定大手术及不同外科领域中单剂量与多剂量抗菌药物预防的总体疗效。
使用MEDLINE数据库和其他检索策略在医学文献中识别相关研究。纳入评价的试验为前瞻性随机试验，各治疗组使用相同的抗菌药物，且以英文发表。提取术后手术部位感染（SSI）发生率，编制2×2表格并计算比值比（OR）[及95%置信区间（95%CI）]。然后使用固定效应模型和随机效应模型合并数据以得出总体数据。在此背景下，合并OR值高且95%CI>1.0表明多剂量方案更具优势，OR值低且95%CI<1.0则相反。合并OR值接近1.0且95%CI狭窄并跨越1.0表明一种方案相对于另一种方案无明显优势。还进行了进一步的亚组分析。
固定效应模型（1.06，95%CI，0.89 - 1.25）和随机效应模型（1.04，95%CI，0.86 - 1.25）得出的合并OR值均表明，单剂量或多剂量方案在预防SSI方面均无明显优势。同样，亚组分析显示，所用抗菌药物类型（β-内酰胺类与其他）、盲法伤口评估、多剂量组时长（>24小时与24小时或更短）或手术类型（妇产科手术与其他手术）之间无统计学显著差异。
建议继续对大手术采用单剂量抗菌药物预防。需要进一步开展研究，尤其是在以往被忽视的外科领域。
