中国手术部位感染预防指南
中华胃肠外科杂志, 2019,22(4) : 301-314. DOI: 10.3760/cma.j.issn.1671-0274.2019.04.001

手术部位感染（surgical site infection, SSI）是指发生在手术切口、深部器官和腔隙的感染，是中低收入国家最多见、最高发的卫生保健相关感染（health care-associated infection，HAI），总体发生率达11.8%（1.2%~23.6%）；而在高收入国家，SSI发生率在1.2%~5.2%之间[1,2]。虽然SSI的发生率在高收入国家明显降低，但依然是第二常见的HAI。

术前、术中和术后一系列措施均可降低SSI风险。现有影响力较大的SSI预防指南均来自欧美发达国家的研究机构，如1999年美国疾病控制预防中心（Center for Disease Control and Prevention，CDC）发布SSI预防指南[3]，其在2017年进行了更新[4]。2008年，英国国家卫生与临床优化研究所（National Institute for Health and Clinical Excellence，NICE）发布了SSI预防与治疗的指南[5]。2014年，美国医疗保健流行病学学会（Society for Healthcare Epidemiology of America，SHEA）更新了2008年其发布的指南[6]。2016年，世界卫生组织（World Health Organization，WHO）发布了预防SSI的全球指南[7]。我国卫生健康委员会也在2010年发布了《外科手术部位感染预防与控制技术指南（试行）》[8]。虽然目前SSI预防指南或规范众多，但是不同指南预防SSI的措施尚未达成共识。为此，中华医学会外科学分会外科感染与重症医学学组、中国医师协会外科医师分会肠瘘外科医师专业委员会组织国内部分专家，经过反复多次讨论和修改，结合中国临床实践，制定了《中国手术部位感染预防指南》，探索适合我国国情的SSI防控策略，供同道参考。

一、循证医学证据质量等级

在总结国内外研究进展及专家经验的基础上，按照循证医学的原则进行深入的论证，最终形成本指南，旨在为SSI的预防提供参考。指南主要依据循证医学证据质量等级和GRADE系统的推荐强度等级，见表1。

点击查看表格
表1

循证医学证据质量等级和推荐强度[9]

表1

循证医学证据质量等级和推荐强度[9]

质量等级和推荐强度 说明
质量等级  
  高 对真实效应值接近效应估计值很有信心
  中 对效应估计值有中等程度的信心：真实值有可能接近估计值，但仍存在二者大不相同的可能性
  低 对效应估计值的确信程度有限：真实值可能与估计值大不相同
  极低 对效应估计值几乎没有信心：真实值很可能与估计值大不相同
推荐强度  
  强烈推荐 支持或反对某项干预措施的强烈推荐，且利大于弊
  条件推荐 支持或反对某项干预措施的条件推荐，利弊不确定
二、SSI的预防措施
（一）术前预防措施

1.营养支持：推荐意见1：建议接受大手术的低体质量患者口服或鼻饲富含多种营养素配方的营养液以预防SSI（条件推荐，极低质量证据）。

证据小结：营养不良可影响免疫状态，增加患者对感染的易感性。早期营养支持可改善营养不良或严重创伤的手术患者的预后，减少感染性并发症的发生。关于营养支持的系统评价共纳入10项研究[含8项随机对照临床试验（randomized controlled trial，RCT）[10,11,12,13,14,15,16,17]和2项观察性研究（observational study，OBS）[18,19]]，研究对比了多种营养素配方的营养液（精氨酸、谷氨酰胺、鱼油、核苷酸等）与标准营养液对SSI的影响，多种配方的营养液较标准营养液显著降低SSI发生风险（RCT：OR=0.53，95%CI：0.30~0.91；OBS：OR=0.07，95%CI：0.01~0.53），证据质量为极低。而单一营养素配方的营养液（精氨酸、甘氨酸或支链氨基酸）和标准配方营养液相比，对SSI发生率无影响（RCT：OR=0.61，95%CI：0.13~2.79[17,20,21,22,23]；OBS：OR=0.29，95%CI：0.06~1.39[24]），证据质量为低。因此，术前给予患者富含多种营养素配方的营养液可降低SSI发生的风险。

2.免疫抑制剂：推荐意见2：建议不以预防SSI为目的在术前停用免疫抑制剂（条件推荐，极低质量证据）。

证据小结：免疫抑制剂通常用于预防移植器官的排斥反应或治疗炎性疾病，可能会导致愈合延迟和感染的风险增加。而停药则可能导致疾病复发，抗药抗体生成，从而减弱药物的疗效。综合8项临床研究的系统评价表明，与围手术期继续服用氨甲喋呤相比，围手术期停用氨甲喋呤可能会对患者造成伤害且不影响SSI的发生（RCT：OR=7.75，95%CI：1.66~36.24[25,26]；OBS：OR=0.37，95%CI：0.07~1.89[27,28,29,30,31,32]），证据质量为极低。另外的研究显示，围手术期停用肿瘤坏死因子（TNF）抑制剂可能有助于降低SSI发生率（OR=0.59，95%CI：0.37~0.95）[27,31]。但基于目前较少证据支持停用TNF抑制剂以及停用氨甲喋呤可能导致的潜在伤害，指南编审专家组不建议以预防SSI为目标而在术前停用免疫抑制剂。

3.术前沐浴：推荐意见3：在手术日前一晚（或更早时候），患者应该使用抗菌/非抗菌肥皂或其他抗菌剂进行淋浴或全身沐浴（条件推荐，中等质量证据）。

证据小结：患者术前沐浴或淋浴为临床规范。涵盖17 087例外科患者的9项研究比较了术前沐浴使用抗菌肥皂和普通肥皂降低SSI的疗效，与普通肥皂相比，使用抗菌肥皂不能显著降低SSI的发生率（OR=0.92，95%CI：0.80~1.04）[33,34,35,36,37,38,39,40,41]。因此，患者术前沐浴时，无论使用抗菌皂还是非抗菌皂在降低SSI的疗效上无显著差异。

4.机械性肠道准备与口服抗生素：推荐意见4：建议术前口服抗生素联合机械性肠道准备以降低接受择期结直肠手术的成年患者发生SSI的风险（条件推荐，中等质量证据）。

推荐意见5：不推荐对择期结直肠手术的成年患者只实施机械性肠道准备（不联合口服抗生素）以降低SSI（强烈推荐，中等质量证据）。

证据小结：机械性肠道准备指通过口服导泻药进行的全肠道清洁。由于可去除粪便负荷、减少细菌数量，理论上可减少术后感染性并发症的发生。肠道准备联合口服抗生素可进一步减轻肠道内的细菌负荷。综合11项RCT的荟萃分析显示，与仅行机械性肠道准备相比，术前肠道准备联合口服抗生素可显著降低接受择期结直肠手术的成年患者的SSI风险（OR=0.56，95%CI：0.37~0.83），但是两者在吻合口漏发生率上无差异[42,43,44,45,46,47,48,49,50,51,52]。但是，术前仅行机械性肠道准备，与未行肠道准备相比，不会显著降低的SSI发生率（OR=1.31，95%CI：0.99~1.72），该证据质量为中等[53,54,55,56,57,58,59,60,61,62,63,64,65]。但同时须指出，该干预方式只适用于术前；且联合使用口服抗生素和机械性肠道准备不能取代手术前的预防性抗生素。

5.去除毛发：推荐意见6：不推荐对准备接受手术的患者去除毛发；如果确有必要，只能使用剪刀去除毛发。无论是在手术前或在手术室中，任何情况下均强烈反对使用剃刀去除毛发（强烈推荐，中等质量证据）。

证据小结：去除毛发虽然有利于暴露手术切口和做标记，但是去除的方法不当可增加皮肤的创伤，增加SSI发生的风险。15项研究比较了采用剃毛、剪毛、脱毛膏等不同方式去除毛发与不去除毛发对SSI发生率的影响[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80]，发现去除毛发与不去除毛发相比降低SSI的疗效差异无统计学意义（OR=1.78，95%CI：0.96~3.29；OR=1.00；95%CI：0.06~6.34；OR=1.02，95%CI：0.42~2.49），证据质量为低或极低。不同毛发去除方式的比较则显示，剪刀较剃刀可显著降低SSI发生率（OR=0.51，95%CI：0.29~0.91），证据质量为低[70,71,74]。脱毛膏与剃刀相比，降低SSI的疗效差异无统计学意义（OR=2.78，95%CI：0.86~9.03），证据质量为极低[66,67,68,78,80]。若将剪刀去除毛发与不去除毛发合并，荟萃分析显示，其SSI发生率显著低于剃毛（OR=0.51，95%CI：0.34~0.78），证据质量为中等[68,72,73,75,76,77,79]。去除毛发的时机方面，手术前去除毛发不会较手术当天去除毛发显著降低SSI发生率（OR=1.22，95%CI：0.44~3.42）。

6.外科手术预防性抗生素的最佳时机：推荐意见7：推荐必要时在手术切皮前预防性应用抗生素（强烈推荐，低质量证据）。

推荐意见8：推荐切皮前120 min内给予预防性抗生素，但同时需考虑抗生素半衰期（强烈推荐，中等质量证据）。

证据小结：预防性抗生素的应用需要选择合适的时机以保证术中抗感染药物在手术部位维持在有效的血药浓度。关于预防性抗生素给药时机的研究只有观察性研究，缺乏RCT研究[81,82,83,84,85,86,87,88,89,90,91,92,93]。低等级的证据表明，切皮后应用预防性抗生素较切皮前应用SSI发生率显著升高（OR=1.89，95%CI：1.05~3.40）[81,82,85,89]。中等质量证据显示，切皮前120 min之前给予预防性抗生素较120 min之内给药SSI发生率显著升高（OR=5.26，95%CI：3.29~8.39）[81,83,89,90,91,92]。切皮前60 min内给药较60~120 min内给药对SSI发生率的降低没有影响，此证据为低质量；同样，切皮前30 min内给药较30~60 min内给药亦对SSI发生率的降低无影响。

7.外科手消毒：推荐意见9：推荐戴无菌手套之前用抗菌肥皂和流动水刷手，或使用含酒精的速干消毒剂进行外科手消毒（强烈推荐，中等质量证据）。

证据小结：比较擦手、刷手对SSI影响的循证医学证据有限，对仅有的研究做荟萃分析显示，使用含酒精的速干消毒剂消毒与抗菌肥皂或普通肥皂结合流动水刷手在降低SSI发生率方面差异无统计学意义。2009年WHO推出的《手卫生指南》明确了外科手消毒的方法[94]，遵从该版指南的消毒方法可有效降低SSI发生率。

（二）术中和术后预防措施

1.维持体温：推荐意见10：建议维持围手术期正常体温（条件推荐，中等质量证据）。

证据小结：术中和术后的低体温是由麻醉引起的体温调节受损和手术室的低温暴露共同导致的。非预期的低体温与心血管并发症增加、凝血功能受损、伤口愈合减缓、免疫功能下降有关，增加了SSI感染的风险。2项RCT比较了术前和术中是否使用保温设备对降低SSI发生率的影响，荟萃分析显示，在手术时对患者采用保温措施可显著降低SSI的发生率（OR=0.33，95%CI：0.17~0.62），证据质量为中等[95,96]。但是基于目前的研究，无法对目标体温的具体数值、维持体温的方式和持续时间等形成推荐意见。

2.围手术期血糖控制：推荐意见11：无论是否患有糖尿病，都应控制患者围手术期血糖，血糖控制的目标可设定为6.1~8.3 mmol/L，特殊人群的控制目标应综合判定（条件推荐，低质量证据）。

证据小结：由于手术的应激，患者在术中和术后均会出现血糖的升高，而高血糖可增加糖尿病和非糖尿病患者发生SSI的风险。系统评价提示，围手术期严控血糖较常规调控血糖可显著降低SSI的发生率（OR=0.43，95%CI：0.29~0.64），而且严控血糖降低SSI发生风险的效果在糖尿病和非糖尿病患者中均有体现[97,98,99,100,101,102,103,104,105,106,107,108,109,110,111]。血糖调控的时机方面，只在术中调控血糖（OR=0.88，95%CI：0.45~1.74）降低SSI的效果弱于术后调控或术中联合术后调控（OR=0.47，95%CI：0.25~0.55，P=0.049）[97,98,99,100,101,102,103,104,105,106,107,108,109,110,111]。入选的各项研究调控血糖的目标不尽相同，有以6.1 mmol/L为目标，也有以6.1~8.3 mmol/L为目标。虽然不同的调控目标之间差异无统计学意义（P=0.328），但是指南编审专家组考虑到较低的血糖控制目标相比较高的目标导致低血糖的可能性更大，为尽可能避免严苛降糖引起的低血糖，建议将血糖调控的目标设定为6.1~8.3 mmol/L。特殊人群血糖调控的目标还需结合患者实际情况有所调整。

3.液体治疗：推荐意见12：建议采用目标导向性液体治疗以降低SSI风险（条件推荐，低质量证据）。

证据小结：液体治疗是围手术期重要的治疗手段，也是争论最多的问题之一。限制性液体治疗、目标导向性液体治疗先后被提出并发展，本指南比较了上述液体治疗策略对SSI的影响。低质量的证据表明，与标准液体治疗相比，术中目标导向性液体治疗能够显著降低SSI的发生率（OR=0.56，95%CI：0.35~0.88）[112,113,114,115,116,117,118,119,120,121,122,123,124,125]；同样，术后目标导向性液体治疗也可降低SSI的发生率（OR=0.24，95%CI：0.11~0.52）[126,127]。限制性液体治疗与标准液体治疗相比，对SSI的发生率无影响（OR=0.73，95%CI：0.41~1.28）[128,129,130,131,132]。

基于目前的循证医学证据，指南编审专家组认为术中和术后行目标导向性液体治疗可降低SSI发生率，但是需注意入选的研究设定液体治疗的目标（心脏指数、收缩压、平均动脉压等）各不相同，并且对正常容量的定义也不相同，加之可靠的容量评估手段亦缺乏，未来还需进一步开展研究，指导围手术期液体管理。

4.手术铺巾和手术衣、贴膜：推荐意见13：无菌的一次性无纺布或可重复利用的手术铺巾和手术衣均可用于预防SSI（条件推荐，中到极低质量证据）。

推荐意见14：不论贴膜是否抗菌，不一定必须使用塑料贴膜预防SSI（条件推荐，低到极低质量证据）。

证据小结：现有指南并未提及一次性或反复使用的铺巾和手术衣降低SSI的效果，而对塑料贴膜降低SSI的作用多以否定为主。本指南的系统评价共纳入11项研究。其中5项研究分析了使用无菌的一次性无纺布和可重复利用的铺巾与手术衣对SSI的影响，发现两者预防SSI的效果差异无统计学意义（RCT：OR=0.85，95%CI：0.66~1.09；OBS：OR=1.56，95%CI：0.89~2.72）[133,134,135,136,137]。4项研究比较了切口贴膜对SSI发生率的影响，证据表明，与未使用切口贴膜相比，使用含碘的切口贴膜不会降低SSI发生率（RCT：OR=2.62，95%CI：0.68~10.04；OBS：OR=0.49，95%CI：0.16~1.49）；而使用不含碘的切口贴膜也有相似的结果[138,139,140,141]。因此，基于现有的循证证据，专家建议，不应以预防SSI为目的使用抗菌或非抗菌切口贴膜。

5.切口保护套：推荐意见15：腹部清洁-污染切口、污染切口和污秽或感染切口可考虑使用切口保护套（条件推荐，极低质量证据）。

证据小结：切口保护套是一种应用型手术辅巾材料，可有效绝缘切口与周围组织，防止血液、体液、冲洗液渗透，从而减少手术切口污染机会，并能减少手术对切口组织过分牵拉及破坏，从而降低切口感染风险。从11项研究（10项RCT，1项非随机前瞻性对照研究）得到的证据表明，与传统的手术铺单保护切口相比，无论是单环还是双环的切口保护套，均可显著降低SSI的发生率（OR=0.42，95%CI：0.28~0.62），证据质量为极低。但Meta回归比较单环切口保护套与双环切口保护套降低SSI发生率的差异无统计学意义（P=0.107）[142,143,144,145,146,147,148,149,150,151,152]。对不同级别切口行亚组分析显示，切口保护套在降低清洁-污染切口（P=0.244）、污染切口（P=0.305）、污秽或感染切口（P=0.675）的SSI发生率方面差异无统计学意义。考虑到证据质量为极低以及切口保护套本身的费用，指南编审专家组建议只在腹部清洁-污染切口、污染切口和污秽或感染切口中使用。

6.切口冲洗：推荐意见16：可考虑在关闭切口前使用聚维酮碘溶液冲洗切口，特别是清洁切口和清洁-污染切口。不应以预防SSI为目的，在关闭切口前使用抗生素溶液冲洗切口（条件推荐，低质量证据）。

证据小结：由于循证医学证据有限，本推荐意见只涉及切口冲洗，不包括腹腔灌洗和纵隔灌洗。使用聚维酮碘溶液冲洗切口有利于降低SSI（OR=0.31，95%CI：0.13~0.73，P=0.007）[153,154,155,156]。此外，综合5项RCT的荟萃分析表明，使用抗生素溶液冲洗切口和不冲洗或与生理盐水冲洗对比，SSI的发生率差异无统计学意义（OR=1.16，95%CI：0.64~2.12，P=0.63），证据质量为极低[157,158,159,160,161]。

7.预防性伤口负压治疗：推荐意见17：对高风险的一期缝合切口，建议预防性使用伤口负压治疗（条件推荐，低质量证据）。

证据小结：来自19篇文献的20项研究（包括5篇文献中的6项RCT[162,163,164,165,166]，14项OBS[167,168,169,170,171,172,173,174,175,176,177,178,179,180]）分析了负压伤口疗法降低SSI发生率的效果，其结果显示，与传统的敷料相比，预防性伤口负压治疗可降低一期缝合切口发生SSI的风险（RCT：OR=0.56，95%CI：0.32~0.96；OBS：OR=0.30，95%CI：0.22~0.42）。针对不同术式的亚组分析显示，腹部手术和心脏手术使用该预防措施可显著降低SSI的发生率。在不同级别切口间的亚组分析显示，预防性伤口负压治疗能明显降低清洁-污染切口（OBS：OR=0.29，95%CI：0.17~0.50）、清洁切口（OBS：OR=0.27，95%CI：0.17~0.42）的SSI发生率。

8.抗菌涂层缝线：推荐意见18：建议在各类手术中使用抗菌涂层缝线以预防SSI（条件推荐，中等质量证据）。

证据小结：具有抗菌性能的缝线可减少缝线材料上细菌的定植。为比较抗菌涂层缝线能否更有效减少SSI的发生率，一共18项临床研究（13项RCT[181,182,183,184,185,186,187,188,189,190,191,192,193]，5项OBS[194,195,196,197,198]）被纳入进行系统综述，纳入研究的抗菌涂层缝线均为含三氯生抗菌剂的缝线。荟萃分析结果显示，与不含三氯生抗菌剂的普通缝线相比，抗菌涂层缝线能够显著降低SSI的发生率（RCT：OR=0.72，95%CI：0.59~0.88；OBS：OR=0.58，95%CI：0.40~0.83），证据质量为中等。对于具体的缝线类型，抗菌Vicryl Plus缝线较普通Vicryl缝线能显著降低SSI的发生率（RCT：OR=0.62，95%CI：0.44~0.88；OBS：OR=0.58，95%CI：0.37~0.92）。Meta回归分析显示，抗菌涂层缝线降低SSI的疗效与手术方式、切口类型、缝线编织方式等均无关[181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198]。基于目前的循证证据，指南编审专家组建议在任何术式中均可使用抗菌涂层缝线以降低SSI发生率。

9.引流放置时的预防性抗生素与引流移除的时机：推荐意见19：不建议因存在切口引流而延长围手术期预防性抗生素的使用（条件推荐，低质量证据）。

推荐意见20：建议根据临床实际情况拔除切口引流。尚无证据支持拔除切口引流的最佳时机（条件推荐，极低质量证据）。

证据小结：通过对7项RCT的荟萃分析表明，与仅在切皮前单剂量预防性抗生素相比，因为存在切口引流而延长预防性抗生素不能降低SSI的发生率（OR=0.79，95%CI：0.53~1.20），证据质量为低[199,200,201,202,203,204,205]。考虑到无证据支持存在引流管时延长用药可预防SSI以及抗生素应用可能导致的不良后果，指南编审专家组一致不建议以预防SSI为目的延长预防性抗生素。

另由11项RCT提供的证据表明，早期拔除切口引流（术后12 h、24 h、48 h）与术后3~5 d拔除引流对SSI的影响差异无统计学意义（OR=0.86，95%CI：0.49~1.50），证据质量为极低[206,207,208,209,210,211,212,213,214,215,216]。基于目前的循证证据质量，专家组认为，应根据临床实际情况，拔除切口引流。

10.切口敷料：推荐意见21：不建议以预防SSI为目的在一期缝合的切口上应用特殊敷料（条件推荐，低质量证据）。

证据小结：近年来，亲水胶体、纤维胶体、凝胶、聚氨酯矩阵敷料和蒸汽渗透膜敷料等多种特殊敷料相继问世。为比较特殊敷料与普通敷料降低SSI发生率的效果，综合10项RCT进行系统评价的结果显示，相比普通敷料，特殊敷料并不能显著降低SSI发生率（OR=0.80，95%CI：0.52~1.23）[217,218,219,220,221,222,223,224,225,226]。因此，指南编审专家组不建议以预防SSI为目的使用特殊敷料。

11.延长预防性抗生素使用时间：推荐意见22：不推荐以预防SSI为目的延长术后预防性抗生素的使用时间（强烈推荐，中等质量证据）。

证据小结：常规使用预防性抗生素的效果众所周知，但关于术后抗生素的持续时间仍然存在相当多的争议。大多数指南推荐，预防性抗生素最长可延长至术后24 h，但有越来越多的证据表明术前单剂量给药（含手术时间长导致术中增加给药）的效果不劣于术后继续给药。为避免延长用药可能带来的抗生素耐药，指南编审专家组认为，在手术结束后，不应以预防SSI为目的继续给药。

结语　SSI是一类顽固但可预防的HAI，制定全面的SSI的预防措施尚需更多高质量的循证医学证据。本共识基于现有的医学研究结果并结合中国临床实践，经过专家反复多次讨论而最终形成，但仍存在一定的局限性。比如由于循证医学证据有限，术前皮肤消毒、围手术期氧合等预防措施尚未形成推荐意见，这些未解决的问题仍需要在未来进行更多研究。需注意的是，临床医生在应用推荐意见时应结合所在医院的条件，根据患者的具体情况而定，以提高患者的安全。

编审专家组名单

组长：任建安[东部战区总医院（原南京军区南京总医院）]

成员（按姓名汉语拼音首字母排序）：安友仲（北京大学人民医院）、陈超武（湖南省人民医院）、迟强（哈尔滨医科大学附属第二医院）、杜斌（中国医学科学院北京协和医院）、范朝刚[东部战区总医院（原南京军区南京总医院）]、顾国胜[东部战区总医院（原南京军区南京总医院）]、管向东（中山大学附属第一医院）、韩刚（吉林大学第二医院）、黄志勇（华中科技大学同济医学院附属同济医院）、李国逊（天津市人民医院）、李洪涛（解放军联勤保障部队第九四〇医院）、李世宽（青岛大学附属医院）、李玉民（兰州大学第二医院）、梁斌（北京大学人民医院）、刘洪俊（山东省立医院）、刘玉琪（福建医科大学附属第二医院）、刘正才（空军军医大学第一附属医院）、马涛（天津医科大学总医院）、仇毓东（南京大学医学院附属鼓楼医院）、任建安[东部战区总医院（原南京军区南京总医院）]、孙宝友（山东省立医院）、唐云（解放军总医院海南医院）、王革非[东部战区总医院（原南京军区南京总医院）]、王建忠（赣南医学院第一附属医院）、王培戈（青岛大学附属医院）、王铮（西安交通大学第一附属医院）、王志明（中南大学湘雅医院）、武华（山西医科大学第一医院）、伍晓汀（四川大学华西医院）、吴秀文[东部战区总医院（原南京军区南京总医院）]、许戈良（安徽省立医院）、颜荣林（海军军医大学附属长征医院）、杨士民（天津市南开医院）、杨振华（湖北宜昌市中心人民医院）、于文胜（山东潍坊市人民医院）、张平（吉林大学白求恩第一医院）、张匀（浙江大学医学院附属第二医院）、赵海鹰（中国医科大学附属第四医院）、赵允召[东部战区总医院（原南京军区南京总医院）]

执笔：吴秀文[东部战区总医院（原南京军区南京总医院）]

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