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头孢菌素联合吗啉硝唑预防肠外瘘手术部位感染的临床价值

郑涛, 王革非, 顾国胜, 任华建, 洪之武, 王之伟, 任建安

郑涛, 王革非, 顾国胜, 等. 头孢菌素联合吗啉硝唑预防肠外瘘手术部位感染的临床价值[J]. 中华消化外科杂志, 2021, 20(11): 1206-1211. DOI: 10.3760/cma.j.cn115610-20211012-00501
引用本文: 郑涛, 王革非, 顾国胜, 等. 头孢菌素联合吗啉硝唑预防肠外瘘手术部位感染的临床价值[J]. 中华消化外科杂志, 2021, 20(11): 1206-1211. DOI: 10.3760/cma.j.cn115610-20211012-00501
Zheng Tao, Wang Gefei, Gu Guosheng, et al. Clinical value of cephalosporin combined with morinidazole in the prevention of surgical site infection for gastrointestinal fistula[J]. Chinese Journal of Digestive Surgery, 2021, 20(11): 1206-1211. DOI: 10.3760/cma.j.cn115610-20211012-00501
Citation: Zheng Tao, Wang Gefei, Gu Guosheng, et al. Clinical value of cephalosporin combined with morinidazole in the prevention of surgical site infection for gastrointestinal fistula[J]. Chinese Journal of Digestive Surgery, 2021, 20(11): 1206-1211. DOI: 10.3760/cma.j.cn115610-20211012-00501

头孢菌素联合吗啉硝唑预防肠外瘘手术部位感染的临床价值

基金项目: 

江苏省医学杰出人才基金 JCRCB20160006

详细信息
    通讯作者:

    任建安,Email:jiananr@nju.edu.cn

Clinical value of cephalosporin combined with morinidazole in the prevention of surgical site infection for gastrointestinal fistula

Funds: 

Medical Talent Foundation of Jiangsu Province JCRCB20160006

More Information
  • 摘要:
    目的 

    探讨头孢菌素联合吗啉硝唑预防肠外瘘病人手术部位感染(SSI)的临床价值。

    方法 

    采用回顾性队列研究方法。收集2017年1―12月中国人民解放军东部战区总医院收治的107例行择期消化道重建手术肠外瘘病人的临床病理资料;男76例,女31例;中位年龄为46岁,年龄范围为18~79岁。107例病人中,43例病人给予头孢菌素预防SSI,设为头孢菌素单药组;64例病人给予头孢菌素联合吗啉硝唑预防SSI,设为联合用药组。观察指标:(1)SSI发生情况。(2)分层分析。(3)SSI致病菌培养结果。(4)药物不良反应发生情况。(5)随访情况。采用门诊和电话方式进行随访,了解病人其他并发症发生情况。正态分布的计量资料以x±s表示,组间比较采用独立样本t检验;偏态分布的计量资料以M(范围)表示,组间比较采用Mann‑Whitney U检验。计数资料以绝对数或百分比表示,组间比较采用χ²检验或Fisher确切概率法。

    结果 

    (1)SSI发生情况:107例病人中,29例发生SSI,其中浅层切口感染15例、深层切口感染7例、器官和(或)腔隙感染7例。头孢菌素单药组病人发生总体SSI、浅层切口感染、深层切口感染、器官和(或)腔隙感染的例数分别为18、7、5、6例,联合用药组上述指标分别为11、8、2、1例,两组病人总体SSI比较,差异有统计学意义(χ²=7.925,P<0.05)。两组病人器官和(或)腔隙感染比较,差异有统计学意义(P<0.05)。两组病人浅层切口感染比较,差异无统计学意义(χ²=0.305,P>0.05)。两组病人深层切口感染比较,差异无统计学意义(P>0.05)。(2)分层分析:43例头孢菌素单药组病人中,Ⅱ类切口10例、Ⅲ类切口33例;64例联合用药组病人中,上述指标分别为11、53例。在Ⅱ类切口中,头孢菌素单药组病人发生SSI 1例,联合用药组2例,两组比较,差异无统计学意义(P>0.05)。在Ⅲ类切口中,头孢菌素单药组病人发生SSI 17例,联合用药组9例,两组比较,差异有统计学意(χ²=11.499,P<0.05)。(3)SSI致病菌培养结果:29例发生SSI病人中,细菌培养阳性21例,其中单一细菌感染12例,多种细菌混合感染9例,共培养出33株细菌。(4)药物不良反应发生情况:107例病人均未见药物相关不良反应发生。(5)随访情况:107例病人均获得随访,随访时间为术后30 d。所有病人未见其他并发症。

    结论 

    头孢菌素联合吗啉硝唑可用于预防肠外瘘病人SSI。

    Abstract:
    Objective 

    To investigate the clinical value of cephalosporin combined with morinidazole in the prevention of surgical site infection (SSI) for gastrointestinal fistula.

    Methods 

    The retrospective cohort study was conducted. The clinicopathological data of 107 patients with gastrointestinal fistula who undergoing selective digestive tract reconstruction surgery in General Hospital of Eastern Theater Command from January to December 2017 were collected. There were 76 males and 31 females, aged from 18 to 79 years, with a median age of 46 years. Of 107 patients, 43 cases receiving cephalosporin for prevention of SSI were allocated into cephalosporin monotherapy group, 64 cases receiving cephalosporin combined with morinidazole were allocated into combination therapy group, respectively. Observation indicators: (1) incidence of SSI; (2) stratification; (3) pathogen culture results of SSI; (4) adverse drug reaction; (5) follow-up. Follow-up using outpatient examination and telephone interview was performed to detect other complications of patients. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was analyzed using the independent sample t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was analyzed using the Mann-Whitney U test. Count data were described as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test or Fisher exact probability.

    Results 

    (1) Incidence of SSI: 29 of 107 patients had postoperative SSI, including 15 cases with superficial SSI, 7 cases with deep SSI, and 7 cases with organ/space SSI. There were 18 cases of cephalosporin monotherapy group with SSI, including 7 cases with superficial SSI, 5 cases with deep SSI, and 6 cases with organ/space SSI. The above indicators were 11, 8, 2, 1 of combination therapy group, respectively. There was a significant difference in the overall SSI between the two groups (χ2=7.925, P<0.05). There was also a significant difference in the organ/space SSI between the two groups (P<0.05). There was no significant difference in the superficial SSI between the two groups (χ2=0.305, P>0.05). There was no significant difference in the deep SSI between the two groups (P>0.05). (2) Stratification: there were 10 cases and 33 cases with type Ⅱ incision and type Ⅲ incision in the 43 cases of cephalosporin monotherapy therapy group, respectively. The above indicators were 11 and 53 in the combination group, respectively. For the type Ⅱ incision, 1 patient of cephalosporin monotherapy group had SSI, and 2 cases of combination therapy group had SSI, showing no significant difference between the two groups (P>0.05). For the type Ⅲ incision, 17 patient of cephalosporin monotherapy group had SSI, and 9 cases of combina-tion therapy group had SSI, showing a significant difference between the two groups (χ2=11.499, P<0.05). (3) Pathogen culture results of SSI: of 29 patients with SSI, 21 were positive for bacterial culture, including 12 cases with single bacterial infection, 9 cases with mixed infection of multi-bacteria. A total of 33 strains were cultured. (4) Adverse drug reaction: there was no adverse drug reaction in the 107 patients. (5) Follow-up: 107 patients were followed up for 30 days after surgery. No complication occurred in the 107 patients.

    Conclusion 

    Cephalosporin combined with morini-dazole can be used to prevent the SSI for patients with gastrointestinal fistula.

  • 手术部位感染(surgical site infection,SSI)是指没有植入物的病人术后30 d内或有植入物病人术后1年内发生与手术相关感染,包括浅层切口感染、深层切口感染及器官和(或)腔隙感染[1]。已有的研究结果显示:SSI是常见的院内感染类型之一,是延长病人住院时间,导致病人死亡的重要原因[23]。肠外瘘是指肠瘘穿透腹壁与外界相通,同时伴有胃肠内容物溢出,通常需要手术治疗[45]。肠外瘘病人SSI发生率高达30%,高于常规胃肠道手术[6]。这可能与肠外瘘手术区域污染较重,病人合并不同程度的营养不良等因素有关[79]

    预防性应用抗菌药物是降低SSI发生率的有效措施[1016]。已有的研究结果显示:头孢菌素联合甲硝唑可降低SSI发生风险[1718]。本研究回顾性分析2017年1—12月中国人民解放军东部战区总医院收治的107例行择期消化道重建手术肠外瘘病人的临床病理资料,探讨头孢菌素联合吗啉硝唑预防肠外瘘病人SSI的临床价值。

    采用回顾性队列研究方法。收集107例行择期消化道重建手术肠外瘘病人临床病理资料;男76例,女31例;中位年龄为46岁,年龄范围为18~79岁。107例病人中,43例病人给予头孢菌素预防SSI,设为头孢菌素单药组;64例病人给予头孢菌素联合吗啉硝唑预防SSI,设为联合用药组。两组病人性别、年龄、BMI、外瘘口数目、美国麻醉医师协会(ASA)分级、术前血液检验指标(Hb、TBil、血清Alb、空腹血糖、C反应蛋白)、手术部位、切口分类、手术时间、术中出血量、使用头孢菌素类型一般资料比较,差异均无统计学意义(P>0.05),具有可比性。见表1。本研究通过中国人民解放军东部战区总医院医学伦理委员会审核,批号为2018NZKY⁃023‑02。病人及家属均签署知情同意书。

    表  1  头孢菌素单药组和联合用药组肠外瘘病人一般资料比较
    Table  1.  Comparison of general data of the patients with gastrointestinal fistula between cephalosporin monotherapy group and combination therapy group
    组别例数性别(例)年龄(x±s,岁)体质量指数(x±s,kg/m2外瘘口数目(例)美国麻醉医师协会分级(例)
    单发多发<3级≥3级
    头孢菌素单药组43321143±1419.8±3.5349385
    联合用药组64442048±1619.9±2.75014559
    统计值χ2=0.402t=1.842t=0.061χ2=0.014χ2=0.408
    P>0.05>0.05>0.05>0.05>0.05
    注:头孢菌素单药组给予头孢菌素单药预防手术部位感染;联合用药组给予头孢菌素联合吗啉硝唑预防手术部位感染
    下载: 导出CSV 
    | 显示表格

    纳入标准:(1)病人年龄≥18岁且<80岁。(2)经临床和影像学检查确诊为肠外瘘。(3)择期成功施行消化道重建手术。(4)采用头孢菌素单药或头孢菌素联合吗啉硝唑预防SSI。

    排除标准:(1)同时存在其他部位感染。(2)术前1周内静脉使用抗菌药物治疗。(3)术前3个月内使用糖皮质激素或其他免疫抑制剂治疗。(4)存在严重心、肝、肾功能不全和血液系统疾病。(5)术中有人工植入物。(6)术后再次出现肠瘘。(7)术后出现腹腔大出血。(8)使用其他抗菌药物预防SSI。

    参照《抗菌药物临床应用指导原则(2015年版)》预防性应用抗菌药物[19]。头孢菌素单药组在手术开始前1 h静脉滴注头孢菌素,手术时间>3 h,术中追加头孢菌素1次,术后继续使用48 h。头孢菌素用法用量参照药品说明书。联合用药组在手术开始前1 h静脉滴注头孢菌素+吗啉硝唑氯化钠注射液,头孢菌素用法用量参照药品说明书,吗啉硝唑剂量为0.5 g/次,每12 h给药1次,术后继续联合用药48 h。病人术后至拆线前,隔天进行切口换药。若出现发热、切口疼痛不适及敷料有浸湿情况则及时进行切口换药。术后出现SSI或其他感染则继续进行抗菌治疗。

    观察指标:(1)SSI发生情况,包括SSI总体发生例数、浅层切口感染情况、深部切口感染情况、器官和(或)腔隙感染情况。(2)分层分析:切口分类情况、Ⅱ类切口SSI发生情况、Ⅲ类切口SSI发生情况。(3)SSI致病菌培养结果:细菌培养阳性情况、单一细菌感染情况、多种细菌混合感染情况。(4)药物不良反应发生情况。(5)随访情况:获得随访的病人例数、随访时间及其他并发症生存情况。

    评价标准:(1)切口类别包括Ⅱ类切口(清洁‑污染手术)为手术部位存在大量人体寄殖细菌,手术时可能污染手术部位导致感染。Ⅲ类切口(污染手术)为已造成手术部位严重污染的手术切口。(2)SSI评价标准:SSI分为浅层切口感染、深部切口感染、器官和(或)腔隙感染3类[1]。(3)安全性评价:参照文献[20]判断不良事件与研究药物之间的关系。

    采用门诊和电话方式进行随访,了解病人其他并发症发生情况。随访至术后30 d。

    应用SPSS19.0统计软件进行分析。正态分布的计量资料以x±s表示,组间比较采用独立样本t检验;偏态分布的计量资料以M(范围)表示,组间比较采用Mann‑Whitney U检验。计数资料以绝对数或百分比表示,组间比较采用χ²检验或Fisher确切概率法。P<0.05为差异有统计学意义。

    107例病人中,29例发生SSI,其中浅层切口感染15例、深层切口感染7例、器官和(或)腔隙感染7例。头孢菌素单药组病人发生总体SSI、浅层切口感染、深层切口感染、器官和(或)腔隙感染的例数分别为18、7、5、6例,联合用药组上述指标分别为11、8、2、1例,两组病人总体SSI比较,差异有统计学意义(χ²=7.925,P<0.05)。两组病人器官和(或)腔隙感染比较,差异有统计学意义(P<0.05)。两组病人浅层切口感染比较,差异无统计学意义(χ²=0.305,P>0.05)。两组病人深层切口感染比较,差异无统计学意义(P>0.05)。

    43例头孢菌素单药组病人中,Ⅱ类切口10例、Ⅲ类切口33例;64例联合用药组病人中上述指标分别为11、53例。在Ⅱ类切口中,头孢菌素单药组病人发生SSI 1例,联合用药组2例,两组比较,差异无统计学意义(P>0.05)。在Ⅲ类切口中,头孢菌素单药组病人发生SSI 17例,联合用药组9例,两组比较,差异有统计学意义(χ²=11.499,P<0.05)。

    29例发生SSI病人中,细菌培养阳性21例,其中单一细菌感染12例,多种细菌混合感染9例,共培养33株细菌。33株细菌中,大肠埃希菌13株,肺炎克雷伯菌4株,粪肠球菌4株,铜绿假单胞菌、摩氏摩根菌、嗜水气单胞菌、奇异变形杆菌、屎肠球菌均为2株,脆弱拟杆菌、阴沟肠杆菌均为1株。

    107例病人均未见药物相关不良反应发生。

    107例病人均获得随访,随访时间为术后30 d。所有病人未见其他并发症。

    胃肠外科SSI发生率为9.4%~23.2%,而污秽‑感染手术切口SSI发生率可高达17.8%~39.8%[21]。SSI是影响手术病人预后,增加病人病死率,延长住院时间的重要因素,40%~60%的SSI可预防[22]。多部预防手术部位感染的指南均推荐使用抗菌药物预防SSI[1,2324]

    日本1项有关SSI的细菌学调查结果显示:厌氧菌在SSI感染的检出率逐年升高[25]。美国1项研究结果显示:SSI分离出的细菌中约60%为厌氧杆菌[26]。硝基咪唑类药物(甲硝唑和奥硝唑)是治疗厌氧菌感染的主要药物。已有的研究结果显示:在结直肠手术中,使用头孢唑啉联合甲硝唑的SSI发生率为7.2%,显著低于单用头孢西丁的13.9%和单用头孢替坦的14.2%[27]。美国相关机构发布的《外科预防性抗菌药物使用临床实践指南》中推荐在非复杂性阑尾炎阑尾切除术、梗阻性小肠手术、结直肠手术中使用头孢菌素联合甲硝唑预防SSI[23]。我国《抗菌药物临床应用指导原则(2015年版)》针对普通外科手术中的肝胆系统及胰腺手术、结肠、直肠、阑尾手术推荐使用头孢菌素单药或联合甲硝唑预防SSI。然而甲硝唑的不良反应较多,且耐药菌已经出现,使其广泛使用受到限制[28]

    吗啉硝唑是一种新型的第3代硝基咪唑类药物,其剂型、药代动力学参数、给药途径等与奥硝唑类似[29]。已有的研究结果显示:吗啉硝唑联合阑尾切除术治疗化脓性或坏疽性阑尾炎疗效与奥硝唑相当[30]。本研究结果显示:与头孢菌素单药比较,头孢菌素联合吗啉硝唑可显著降低肠外瘘病人SSI发生率,并且其在预防器官和(或)腔隙感染方面疗效显著。本研究对不同切口类别进行分层分析,结果显示:与头孢菌素单药比较,在污染手术中,头孢菌素联合吗啉硝唑可显著降低肠外瘘病人SSI发生率。这表明切口污染程度是决定围手术期是否预防性使用抗菌药物的重要依据[31]

    本研究结果还显示:肠外瘘病人SSI最常见的病原菌为大肠埃希菌,其次为肺炎克雷伯菌和粪肠球菌。这与非胃肠道手术病人SSI致病菌为金黄色葡萄球菌不同[3235]。安全性方面,两组病人均未见与药物相关的不良反应,这说明药物的安全性较好。

    综上,头孢菌素联合吗啉硝唑可用于预防肠外瘘病人SSI。本研究结论有待大样本、前瞻性研究进一步验证。

    所有作者均声明不存在利益冲突
    郑涛, 王革非, 顾国胜, 等. 头孢菌素联合吗啉硝唑预防肠外瘘手术部位感染的临床价值[J]. 中华消化外科杂志, 2021, 20(11): 1206-1211. DOI: 10.3760/cma.j.cn115610-20211012-00501.

    http://journal.yiigle.com/LinkIn.do?linkin_type=cma&DOI=10.3760/cma.j.cn115610-20211012-00501

  • 表  1   头孢菌素单药组和联合用药组肠外瘘病人一般资料比较

    Table  1   Comparison of general data of the patients with gastrointestinal fistula between cephalosporin monotherapy group and combination therapy group

    组别例数性别(例)年龄(x±s,岁)体质量指数(x±s,kg/m2外瘘口数目(例)美国麻醉医师协会分级(例)
    单发多发<3级≥3级
    头孢菌素单药组43321143±1419.8±3.5349385
    联合用药组64442048±1619.9±2.75014559
    统计值χ2=0.402t=1.842t=0.061χ2=0.014χ2=0.408
    P>0.05>0.05>0.05>0.05>0.05
    注:头孢菌素单药组给予头孢菌素单药预防手术部位感染;联合用药组给予头孢菌素联合吗啉硝唑预防手术部位感染
    下载: 导出CSV
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  • 收稿日期:  2021-10-11
  • 网络出版日期:  2024-07-18
  • 刊出日期:  2021-11-19

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