Almeida Ricardo A M B, Hasimoto Claudia N, Kim Anna, Hasimoto Erica N, El Dib Regina
Department of Tropical Diseases and Imaging Diagnosis, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Montenegro, s/n, Distrito de Rubiao Jr, Botucatu, Sao Paulo, Brazil, 18618-970.
Cochrane Database Syst Rev. 2015 Dec 5;2015(12):CD010164. doi: 10.1002/14651858.CD010164.pub2.
Surgical site infection is more frequent in liver transplantation than in other types of solid organ transplantation with different antibiotics. Studies have shown that the rate of surgical site infection varies from 8.8% to 37.5% after liver transplantation. Therefore, antimicrobial prophylaxis is likely an essential tool for reducing these infections. However, the literature lacks evidence indicating the best prophylactic antibiotic regimen that can be used for liver transplantation.
To assess the benefits and harms of antibiotic prophylactic regimens for surgical site infection in people undergoing liver transplantation.
We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded and Latin American Caribbean Health Sciences Literature (LILACS). The most recent search was performed on 11 September 2015.
All eligible randomised clinical trials comparing any antibiotic regimen versus placebo, versus no intervention or versus another antibiotic regimen for surgical site infection in liver transplant recipients, regardless of age, sex and reason for transplantation. Quasi-randomised studies and other observational studies were considered for data on harm if retrieved with search results for randomised clinical trials.
Two review authors selected relevant trials, assessed risk of bias of studies and extracted data.
The electronic search identified 786 publications after removal of duplicates. From this search, only one seemingly randomised clinical trial, published in abstract form, fulfilled the inclusion criteria of this review. This trial was conducted at Shiraz Transplant Centre, Shiraz, Iran, where investigators randomly assigned a total of 180 consecutive liver transplant recipients. We judged the overall risk of bias of the trial published in abstract form as high. Researchers reported no numerical data but mentioned that 163 participants met the inclusion criteria after randomisation, and hence were included in the analyses. Most probably, the 17 excluded participants were high-risk liver transplant recipients. Trial authors concluded that they could find no differences between the two antibiotic regimens - ceftriaxone plus metronidazole versus ampicillin-sulbactam plus ceftizoxime - when given to liver transplant recipients. Review authors could not reconfirm the analyses because, as it has been mentioned, trial authors provided no trial data for analyses.
AUTHORS' CONCLUSIONS: Benefits and harms of antibiotic prophylactic regimens for surgical site infection in liver transplantation remain unclear. Additional well-conducted randomised clinical trials adhering to SPIRIT (Spirit Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) guidelines are needed to determine the exact role of antibiotic prophylactic regimens in patients undergoing liver transplantation.
与使用不同抗生素的其他实体器官移植相比，肝移植手术部位感染更为常见。研究表明，肝移植后手术部位感染率在8.8%至37.5%之间。因此，抗菌预防可能是减少这些感染的重要手段。然而，文献中缺乏证据表明可用于肝移植的最佳预防性抗生素方案。
评估抗生素预防方案对肝移植受者手术部位感染的利弊。
我们检索了Cochrane肝胆组对照试验注册库、Cochrane对照试验中央注册库（CENTRAL）、MEDLINE、EMBASE、科学引文索引扩展版和拉丁美洲加勒比健康科学文献数据库（LILACS）。最近一次检索于2015年9月11日进行。
所有符合条件的随机临床试验，比较任何抗生素方案与安慰剂、与无干预或与另一种抗生素方案用于肝移植受者手术部位感染的情况，无论年龄、性别和移植原因如何。如果在随机临床试验的检索结果中检索到准随机研究和其他观察性研究，则考虑其危害数据。
两名综述作者选择相关试验，评估研究的偏倚风险并提取数据。
去除重复项后，电子检索共识别出786篇出版物。在此次检索中，只有一项以摘要形式发表的看似随机的临床试验符合本综述的纳入标准。该试验在伊朗设拉子的设拉子移植中心进行，研究人员将总共180名连续的肝移植受者随机分组。我们将以摘要形式发表的试验的总体偏倚风险判定为高。研究人员未报告数值数据，但提到163名参与者在随机分组后符合纳入标准，因此被纳入分析。很可能，17名被排除的参与者是高风险肝移植受者。试验作者得出结论，他们发现给予肝移植受者头孢曲松加甲硝唑与氨苄西林-舒巴坦加头孢唑肟这两种抗生素方案之间没有差异。综述作者无法再次确认分析结果，因为如前所述，试验作者未提供用于分析的试验数据。
肝移植手术部位感染的抗生素预防方案的利弊仍不明确。需要更多遵循SPIRIT（干预试验的标准协议项目：建议）和CONSORT（报告试验的统一标准）指南进行的高质量随机临床试验，以确定抗生素预防方案在肝移植患者中的确切作用。
