Chan Samuel, Ng Samantha, Chan Hooi P, Pascoe Elaine M, Playford Elliott Geoffrey, Wong Germaine, Chapman Jeremy R, Lim Wai H, Francis Ross S, Isbel Nicole M, Campbell Scott B, Hawley Carmel M, Johnson David W
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.
General Practice Queensland, Brisbane, Australia.
Cochrane Database Syst Rev. 2020 Aug 4;8(8):CD013209. doi: 10.1002/14651858.CD013209.pub2.
Solid organ transplant recipients are at high risk for infections due to the complexity of surgical procedures combined with the impact of immunosuppression. No consensus exists on the role of antibiotics for surgical site infections in solid organ transplant recipients.
To assess the benefits and harms of prophylactic antimicrobial agents for preventing surgical site infections in solid organ transplant recipients.
The Cochrane Kidney and Transplant Register of Studies was searched up to 21 April 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.
All randomised controlled trials (RCTs) and quasi-RCTs in any language assessing prophylactic antibiotics in preventing surgical site infections in solid organ transplant recipients at any time point after transplantation.
Two authors independently determined study eligibility, assessed quality, and extracted data. Primary outcomes were surgical site infections and antimicrobial resistance. Other outcomes included urinary tract infections, pneumonias and septicaemia, death (any cause), graft loss, graft rejection, graft function, adverse reactions to antimicrobial agents, and outcomes identified by the Standardised Outcomes of Nephrology Group (SONG), specifically graft health, cardiovascular disease, cancer and life participation. Summary effect estimates were obtained using a random-effects model and results were expressed as risk ratios (RR) and 95% confidence intervals (CI). The quality of the evidence was assessed using the risk of bias and the GRADE approach.
We identified eight eligible studies (718 randomised participants). Overall, five studies (248 randomised participants) compared antibiotics versus no antibiotics, and three studies (470 randomised participants) compared extended duration versus short duration antibiotics. Risk of bias was assessed as high for performance bias (eight studies), detection bias (eight studies) and attrition bias (two studies). It is uncertain whether antibiotics reduce the incidence of surgical site infections as the certainty of the evidence has been assessed as very low (RR 0.42, 95% CI 0.21 to 0.85; 5 studies, 226 participants; I = 25%). The certainty of the evidence was very low for all other reported outcomes (death, graft loss, and other infections). It is uncertain whether extended duration antibiotics reduces the incidence of surgical site infections in either solid organ transplant recipients (RR 1.19, 95% CI 0.58 to 2.48; 2 studies, 302 participants; I = 0%) or kidney-only transplant recipients (RR 0.50, 95% CI 0.05 to 5.48; 1 study, 205 participants) as the certainty of the evidence has been assessed as very low. The certainty of the evidence was very low for all other reported outcomes (death, graft loss, and other infections). None of the eight included studies evaluated antimicrobial agent adverse reactions, graft health, cardiovascular disease, cancer, life participation, biochemical and haematological parameters, intervention cost, hospitalisation length, or overall hospitalisation costs.
AUTHORS' CONCLUSIONS: Due to methodological limitations, risk of bias and significant heterogeneity, the current evidence for the use of prophylactic perioperative antibiotics in transplantation is of very low quality. Further high quality, adequately powered RCTs would help better inform clinical practice.
由于手术操作的复杂性以及免疫抑制的影响,实体器官移植受者面临着较高的感染风险。对于实体器官移植受者手术部位感染时抗生素的作用,目前尚无共识。
评估预防性抗菌药物在预防实体器官移植受者手术部位感染方面的利弊。
通过与信息专家联系,使用与本综述相关的检索词,检索截至2020年4月21日的Cochrane肾脏与移植研究注册库。注册库中的研究通过检索CENTRAL、MEDLINE、EMBASE、会议论文集、国际临床试验注册平台(ICTRP)检索入口和ClinicalTrials.gov来识别。
所有评估预防性抗生素在实体器官移植受者移植后任何时间点预防手术部位感染的随机对照试验(RCT)和半随机对照试验,不限语言。
两位作者独立确定研究的合格性、评估质量并提取数据。主要结局为手术部位感染和抗菌药物耐药性。其他结局包括尿路感染、肺炎和败血症、死亡(任何原因)、移植物丢失、移植物排斥、移植物功能、对抗菌药物的不良反应以及肾脏病学组标准化结局(SONG)确定的结局,具体为移植物健康、心血管疾病、癌症和生活参与度。使用随机效应模型获得汇总效应估计值,结果以风险比(RR)和95%置信区间(CI)表示。使用偏倚风险和GRADE方法评估证据质量。
我们确定了8项合格研究(718名随机参与者)。总体而言,5项研究(248名随机参与者)比较了抗生素与不使用抗生素,3项研究(470名随机参与者)比较了延长疗程与短疗程抗生素。对于实施偏倚(8项研究)、检测偏倚(8项研究)和失访偏倚(2项研究),偏倚风险被评估为高。由于证据的确定性被评估为非常低(RR 0.42,95%CI 0.21至0.85;5项研究,226名参与者;I² = 25%),因此不确定抗生素是否能降低手术部位感染的发生率。对于所有其他报告的结局(死亡、移植物丢失和其他感染),证据的确定性也非常低。不确定延长疗程的抗生素是否能降低实体器官移植受者(RR 1.19,95%CI 0.58至2.48;2项研究,302名参与者;I² = 0%)或仅肾脏移植受者(RR 0.50,95%CI 0.05至5.48;1项研究,205名参与者)手术部位感染的发生率,因为证据的确定性被评估为非常低。对于所有其他报告的结局(死亡、移植物丢失和其他感染),证据的确定性也非常低。8项纳入研究均未评估抗菌药物不良反应、移植物健康、心血管疾病、癌症、生活参与度、生化和血液学参数、干预成本、住院时间或总体住院费用。
由于方法学局限性、偏倚风险和显著的异质性,目前关于围手术期预防性使用抗生素在移植中的证据质量非常低。进一步开展高质量、有足够样本量的随机对照试验将有助于为临床实践提供更好的信息。