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[病历讨论] 预防性抗生素在选择性腹腔镜胆囊切除术中的作用:系统评价和荟萃分析

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概要
背景/宗旨
预防性抗生素在低风险患者腹腔镜胆囊切除术中的作用尚不清楚。本研究旨在验证以前关于低风险患者选择性腹腔镜胆囊切除术中抗生素预防有效性的荟萃分析的结论。

方法
对电子数据库和人工搜索进行了全面的文献检索。随机对照试验(RCTs),前瞻性研究和回顾性研究比较了低风险选择性腹腔镜胆囊切除术中抗生素预防与安慰剂或无抗生素的比较。

结果
该研究包括28项随机对照试验,3项前瞻性研究和3项回顾性研究。在随机对照试验中,预防性抗生素不能预防深部手术部位感染(SSI)(RR 1.10,95%置信区间[CI] [0.45-2.69],p = 0.84)但SSI降低(RR 0.70,95%CI [0.53-0.94] ],p = 0.02)和表面SSI(RR 0.58,95%CI [0.42-0.82],p = 0.01)。前瞻性研究显示,预防性抗生素并未降低表面SSI(RR 0.35,95%CI [0.01-8.40],p = 0.52),但SSI降低(RR 0.12,95%CI [0.04-0.35],p = 0.0001)。在回顾性研究中,抗生素预防并未降低SSI(RR 1.59,95%CI [0.30-8.32],p = 0.58)。汇总数据(12121例患者)包括随机对照试验和前瞻性和回顾性研究表明,预防性抗生素在预防深度SSI方面无效(RR 1.01 95%CI [0.46-2.21],p = 0.98),但有效降低SSI(RR 0.67, 95%CI [0.51-0.88],p = 0.003)和表面SSI(RR 0.61,95%CI [0.45-0.83],p = 0.002)。

结论
预防性抗生素的使用对于降低SSI和表面SSI的发生率是有效的,但对于预防接受选择性腹腔镜胆囊切除术的低风险患者的深度SSI无效。

关键词:腹腔镜胆囊切除术,抗生素预防,Meta分析

介绍
腹腔镜胆囊切除术是治疗开放性胆囊切除术中无并发症的胆囊结石和其他良性胆囊疾病的金标准方法。微创腹腔镜胆囊切除术的发展减少了手术部位感染(SSI),住院时间,医疗费用和术后疼痛

虽然在选择性手术前使用预防性抗生素被认为是预防术后感染并发症的最佳方法,但最近在苏格兰大学间指南网络和美国的SSI指南中不建议对低风险组进行选择性腹腔镜胆囊切除术的抗生素预防。卫生系统药剂师协会.1,2然而,接受腹腔镜胆囊切除术的低风险患者仍在几个临床中心接受预防性抗生素治疗。

最近的荟萃分析3,4,5,6,7,8,9,10,11,12,13研究了预防性抗生素在选择性腹腔镜胆囊切除术之前预防SSI的效果,其样本量相对较小,统计功效较低。此外,关于选择性腹腔镜胆囊切除术的抗生素预防效果仍然存在争议。因此,作者进行了一项最新的荟萃分析,以评估预防性抗生素在低风险选择性腹腔镜胆囊切除术中的价值,通过随机对照试验(RCT)降低SSI,浅表SSI和深SSI的发生率。关于这一主题的前瞻性和回顾性研究。本研究旨在验证先前荟萃分析的结论.3,4,5,6,7,8,9,10,11,12,13

材料和方法
该系统评价和荟萃分析的研究方案遵循系统评价和Meta分析的首选报告项目(PRISMA)指南.14

搜索和其他资源
MEDLINE,Embase,Cochrane对照试验中心注册,PubMed和KMbase使用医学主题标题术语和以下关键词组合进行检索:“腹腔镜”,“胆囊切除术”,“抗生素”,“预防性”和“荟萃分析”。 “表1显示了本次审查中电子数据库的搜索策略。此外,使用原始文章的参考列表以及系统评价和荟萃分析进行人工搜索。文献检索仅限于1995年至2018年间发表的文章,不受语言限制。

表格1
搜索策略
t1.jpg
纳入和排除标准
纳入标准是(i)研究设计:RCTs和前瞻性和回顾性研究评估抗生素预防用于安慰剂或未治疗对照组的选择性腹腔镜胆囊切除术的有效性; (ii)人群:接受选择性腹腔镜手术的低风险患者; (iii)所有在手术前和/或术后天内接受抗生素治疗的患者; (iv)所有具有以下结果参数中的至少一个的研究:SSI,浅表SSI和深SSI。

排除标准是(i)不是全文原始文章的研究和(ii)比较不含安慰剂或未治疗组的不同抗生素预防组的干预措施。

SSI包括浅表和深层,并根据指南的定义收集数据.15,16根据糖尿病,肥胖,开放转换,急诊手术,术前内镜或经皮胆道介入,急性胆囊炎确定SSI的高危因素,术中胆囊破裂,阻塞性黄疸,免疫抑制,假体装置插入和30天内绞痛发作的准则.1,2

数据收集和分析
该系统评价和荟萃分析是根据Cochrane干预系统评价手册的建议进行的

研究选择
两位评价员(Kim和Yu)独立搜索可用文章,包括符合条件的RCT和前瞻性和回顾性研究。删除了重复的文章。选择可能相关研究的全文文章,列出符合纳入标准的试验清单。通过讨论和共识解决了关于研究选择的分歧。

数据提取
以下数据由两位评价者(Kim和Yu)在每项研究中独立提取:纳入和排除标准,人群特征,研究设计,预防性抗生素和剂量类型,抗生素给药方案,随机化方法,分配隐藏RCT和登记患者的随机患者数量在前瞻性和回顾性研究中,辍学,意向治疗分析或按方案分析,SSI,浅表和深部感染。

研究的质量评估
两名研究人员(Kim和Yu)通过评估Cochrane协作网18提供的偏倚检查表的以下风险独立评估RCT的质量:随机序列生成,分配隐藏,参与者和人员致盲,结果评估盲法,结果不完整数据,选择性报告和其他偏见。偏倚风险被评估为高,低和不清楚。 Jadad等人的评分也用于评估荟萃分析中纳入随机研究的质量。在28项RCT中,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42 ,43,44,45,46,47 25项研究22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,39,40,41,42 ,43,44,45,46,47有资格被纳入荟萃分析,高质量的Jadad评分≥3,其他3项研究[20,21,38]是Jadad评分为2的低质量研究。敏感性测试进行评估是否包括三项被归类为低质量的RCT在该荟萃分析中是否合适。

非随机对照试验包括3项前瞻性48,49,50和3项回顾性研究[22,51,52],根据纽卡斯尔 - 渥太华量表进行评估[53],其范围为0至9,“高质量”定义为纽卡斯尔 - 渥太华量表总分≥7。在这项荟萃分析中纳入的6项非随机对照试验中,有2项前瞻性研究被归类为“高质量”。进行敏感性试验以获得汇总数据率。通过讨论和达成共识,解决了对评估的分歧。

统计分析
使用Review Manager version 5.3(Cochrane Collaboration)进行统计学分析。在二分变量分析中,干预的影响大小由风险比(RR)和95%置信区间(CI)表示,并计算连续变量。应用随机效应模型来计算在存在显著异质性时估计的合并事件率,当I2值> 50%或Cochrane Q检验的p值<0.1时确定。评估发表偏倚以通过漏斗图检测“小研究效应”.54将RCT和前瞻性和回顾性研究分开合并以最小化偏倚。进行敏感性分析以评估纳入非随机研究或低质量研究是否适合本荟萃分析

结果
研究选择
2018年7月,作者通过电子数据库使用作者的搜索策略筛选了总共1472项研究。通过手工搜索发现了1096篇文章。在对标题和摘要进行调查后,筛选了239篇文章。对63篇文章的全文进行了审查并评估了其资格,34项研究包括28项RCT和3项前瞻性和3项回顾性试验,均纳入本荟萃分析。二十九篇全文物品55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76, 77,78,79,80,81,82,83,84被排除在外,原因如下:入选标准未得到满足,83次不当干预,55,57,70,77,84不合适比较,56,58,59不足报告的数据,60,61,63,65,66,67,68,69,71,72,73,74,75,76,78,80,81,82和数据重复.62,64研究程序选择总结在PRISMA流程图中(图1)。

1.jpg
图1
用于研究搜索的PRISMA流程图。
研究特色
这项荟萃分析纳入了12121名接受腹腔镜胆囊切除术的患者,这些患者接受了符合条件的28项随机对照试验(7770例患者),3项前瞻性研究(3123名患者)和3项回顾性研究(1228名患者)。表2显示了1995年至2018年间发表的纳入研究的特征摘要,包括出版年份,国家,语言,研究设计,干预,样本量,数据收集分析类型,随访天数和结果。 RCT中包括的大多数患者被归类为术后感染的低风险。大多数RCT的排除标准是ASA身体状况分类III或更高,手术后7天内使用抗生素,过敏,急性胆囊炎复杂胆结石,胆总管结石或胰腺炎,既往胆道手术,转为开腹胆囊切除术,糖尿病,免疫抑制,妊娠,人工心脏瓣膜,严重合并症如儿童C肝硬化或终末期肾病,体重指数> 30,年龄> 70岁或<14岁。然而,在高风险患者的定义中,ASA评分,BMI和老年的标准在纳入研究中并不完全相同。

表2
纳入研究的特点
t2.jpg
RCT,随机对照试验; SSI,手术部位感染; NA,不可用; PP,按协议分析; ITT,意向治疗分析

本荟萃分析中包含的随机对照试验的偏倚风险和Jadad评分总结在表3和表44中,显示了本评价中包含的非随机对照试验的纽卡斯尔 - 渥太华量表。 在随机对照试验中,只有12项研究21,22,28,32,36,38,40,42,43,44,45,47显示了意向治疗分析的数据,其他16项研究[20,23,24,25] ,26,27,29,30,31,33,34,35,37,39,41,46显示了来自每个方案分析的数据。

表3
包括随机对照试验的偏倚风险和Jadad评分
t3.jpg
+,偏见风险低;  - ,偏见风险高; ?,不明确的偏倚风险

表4
纽卡斯尔 - 渥太华纳入非随机研究的量表
t4.jpg
手术部位感染
包括浅表和深SSI在内的SSI亚组分析采用28项随机对照试验,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36, 37,38,39,40,41,42,43,44,45,46,47 3前瞻性研究,48,49,50和3项回顾性研究.22,51,52在28项RCT中,83项(2.07%)预防性抗生素组4018例患者中SSI发生率高于无预防组3752例患者中的119例(3.17%)。预防性抗生素组SSI发生率低于对照组(RR 0.70,95%CI [0.53-0.94],p = 0.02),无明显异质性(p = 0.96,I2 = 0%)。在3项前瞻性研究中,预防性抗生素组1831例患者中有3例(0.16%)发生SSI,而无预防组1292例患者中有22例(1.70%)发生SSI。预防性抗生素组患者的SSI发生率低于对照组(RR 0.12 [0.04-0.37],p = 0.0002)。在纳入的前瞻性研究中未发现显著的异质性(p = 0.48,I2 = 0%)。在3项回顾性研究中,预防性抗生素组717例患者中有15例(2.09%)发生SSI,而无预防组511例患者中5例(0.98%)发生SSI。预防性抗生素组与对照组之间SSI发生率无显著差异(RR 1.59,95%CI [0.30-8.32],p = 0.58),纳入的前瞻性研究中无明显异质性(p = 0.58,I2 = 47%)。在包括28项随机对照试验和3项前瞻性研究以及3项回顾性研究的整体汇总事件发生率中,预防性抗生素组6566例患者中101例(1.54%)发生SSI,而无预防组5555例患者中有146例(2.63%)发生SSI。 。预防性抗生素组患者SSI发生率低于对照组(RR 0.67,95%CI [0.51-0.88],p = 0.003)。纳入的研究中没有显著的异质性(p = 0.47,I2 = 0%)(图2)。

2.jpg
图2
接受选择性腹腔镜胆囊切除术的低风险患者手术部位感染的森林情节。 Mantel-Haenszel固定效应模型用于荟萃分析。风险比率显示为95%置信区间。
浅表手术部位感染
浅表SSI的发生率在22项RCT中有描述,21,22,23,26,28,29,30,31,32,33,34,35,36,37,38,40,41,42,43,45在22项随机对照试验中,预防性抗生素组3508例患者中59例(1.68%)发生浅表性SSI,而3258例患者中有96例(2.95%)发生浅表性SSI,52例患者进行了前瞻性研究,49,50例和1例进行了回顾性研究。没有预防组。预防性抗生素组患者的表面SSI发生率低于对照组患者(RR 0.59,95%CI [0.43-0.82],p = 0.001),纳入研究之间没有显著的异质性(p = 0.91,I2 = 0%)。在2项前瞻性研究中,预防性抗生素组143例患者中0例(0%)发生表浅SSI,而无预防组97例患者中1例(1.03%)发生表浅SSI。两组间的结果无差异(RR 0.35 95%CI [0.01-8.40],p = 0.52)。在一项回顾性研究中,预防性抗生素组279例患者中有5例(1.79%)发生SSI,而无预防组192例患者中有3例(1.56%)发生SSI。在包括22项随机对照试验,2项前瞻性研究和1项回顾性研究的整体汇总事件发生率中,预防性抗生素组3930例患者中64例(1.63%)发生表浅SSI,而3547例患者中则为100例(2.81%)。预防组。预防性抗生素组的表面SSI发生率低于对照组(RR 0.61,95%CI [0.45-0.83],p = 0.002)。在纳入研究中未发现显著的异质性(p = 0.94,I2 = 0%)(图3)。

3.jpg
图3
用于选择性腹腔镜胆囊切除术的低风险患者的浅表手术部位感染的森林图。 Mantel-Haenszel固定效应模型用于荟萃分析。风险比率显示为95%置信区间。
深部手术部位感染
深度SSI的发生率在19项随机对照试验中有所描述,21,23,25,26,28,29,30,31,32,33,34,35,36,40,42,43,45,46 2研究,49,50和一项回顾性研究[52]。在19项随机对照试验中,预防性抗生素组2890例患者中有10例(0.35%)发生深SSI,而无预防组2637例患者中有10例(0.38%)。与对照组相比,预防性抗生素并未降低深SSI的发生率(RR 1.01,95%CI [0.46-2.21],p = 0.98)。在纳入研究中未发现显著的异质性(p = 0.77,I2 = 0%)。在2项前瞻性研究中,预防性抗生素组143例患者中0例(0.00%)发生深SSI,而无预防组97例患者中0例(0.00%)。在一项回顾性研究中,预防性抗生素组中279例患者中有0例(0.00%)发生SSI,而无预防组192例患者中有0例(0.00%)。在包括19项随机对照试验,2项前瞻性研究和1项回顾性研究的整体汇总事件发生率中,预防性抗生素组3312例患者中10例(0.30%)发生深SSI,而无预防组中2926例患者中10例(0.34%)发生了SSI。组。两组之间的结果没有差异(RR 1.01,95%CI [0.46-2.21],p = 0.98),纳入研究之间没有显著的异质性(p = 0.77,I2 = 0%)(图4)。

4.jpg
图4
在接受选择性腹腔镜胆囊切除术的低风险患者中深部手术部位感染的森林情节。 Mantel-Haenszel固定效应模型用于荟萃分析。 风险比率显示为95%置信区间。
灵敏度测试
通过排除所有低质量研究(包括3项RCTs20,21,38,Jadad评分≤2)和4项非随机研究[22,50,51,52],Newcastle-Ottawa评分≤6,进行敏感性测试。 在所有亚组的敏感性测试中,结果与汇总效应大小和异质性的主要荟萃分析结果相似。 表5显示了子组的所有灵敏度测试。 为了确定个体研究的效果,还进行了一次排除一项研究的灵敏度分析。 在SSI的亚组分析中,去除包括2883名患者在内的最大研究[48]并未影响结果的实质性变化(RR 0.74,95%CI [0.56-0.97],p = 0.03)。

表5
敏感性分析
t5.jpg
SSIs,手术部位感染; RCT,随机对照试验; RR,风险比; CI,置信区间。

出版偏见
纳入研究的漏斗图显示不对称,表明SSI亚组分析中的发表偏倚(图5)。

5.jpg
图5
用于确定所有纳入研究中SSI亚组分析中发表偏倚的漏斗图。 RR,风险比; SE,标准错误。

讨论
该系统评价和荟萃分析共纳入来自28个RCT中7770名患者的12121名患者,3项前瞻性研究中的3123名患者和3项回顾性研究中的1228名患者。该研究得出结论,在接受选择性腹腔镜胆囊切除术的低风险患者中使用预防性抗生素可以预防除SSI以外的SSI和浅表SSI。之前的荟萃分析3,4,5,6,7,8,9,10,11,12,13仅基于RCT的数据,并得出结论,预防性抗生素在低风险选择性腹腔镜胆囊切除术中无法有效预防术后SSI ,除了两项研究.10,12

在此前几个关于该主题的荟萃分析中,仅包括RCT以确定总体效果率。因此,这些荟萃分析以相对较小的样本量进行,并且在统计学上是不足的。为了克服该研究的局限性,仅包括样本量较小的RCT,该荟萃分析共包括来自RCT和非RCT的12121名患者,以在SSI,浅表SSI和深SSI的亚组分析中获得适当的统计学效力。 此外,本研究中使用了所有尚未以英语发表的RCT和非RCT来减少语言偏差。尽管通过将RCT与非RCT相结合可能诱导显著的异质性,但在所有亚组分析中,单独RCT与RCT和非RCT之间的结果没有显著差异。

该系统评价和荟萃分析有一些局限性。首先,在28项随机对照试验中,有3项试验质量较低且Jadad评分较低。此外,在6项非随机对照试验中,有4项研究是按纽卡斯尔 - 渥太华量表评估的“低质量”。因此,进行灵敏度测试以获得合并的数据速率。其次,SSI亚组分析中非随机对照试验存在显著的异质性。第三,很少有随机对照试验提供有关糖尿病,类固醇或免疫抑制治疗,胆道梗阻,黄疸,手术前7天抗生素摄入,紧急胆囊切除术,手术前6周急性或慢性胆囊炎以及开放转换的高风险患者的数据手术。因此,预防性抗生素是否在高危腹腔镜胆囊切除术中发挥作用仍不清楚。第四,纳入研究中的患者数量不足以避免II型错误,因为在这项荟萃分析中,大多数试验(包括RCT和非随机对照试验)显示SSI发病率相对较低,发病率差异很小。预防性抗生素组与对照组之间。第五,通过漏斗图评估的发表偏倚显示出不对称性,这表明报告阴性结果的小样本研究尚未公布。第六,本评价中大多数纳入的RCT均按照方案分析而非强度治疗分析进行,导致误导性结果.85

此外,这项荟萃分析的一个重要考虑因素是纳入研究中纳入标准的不一致性。苏格兰校际指南网络1和美国健康系统药剂师协会指南2提出术中胆囊破裂,开放转换,急性胆囊炎,黄疸,免疫抑制,妊娠和假体植入植入是SSI的高危因素。苏格兰校际指南网络1还包括糖尿病,急诊手术,手术时间长,ASA评分为3或更高,手术前30天内最近发生绞痛,年龄> 70岁为SSI的高危人群。然而,一些研究23,25,26,27,28,46包括ASA评分为3或ASA评分的患者未在几项RCT中纳入入选标准.22,32,38,40,43因此,未来的研究需要根据为SSI定义低风险或高风险群体的指南,提供一套一致的纳入标准。

总之,来自现有数据(包括RCT,前瞻性研究和回顾性研究)的这项荟萃分析的总体汇总数据支持在低风险患者选择性腹腔镜胆囊切除术之前使用预防性抗生素来预防SSI和表面SSI。 为了评估抗生素预防对腹腔镜胆囊切除术的确切有益效果,需要更多精心设计的多中心RCT,其具有大样本量,不同人群和高风险患者的足够统计学效力,因为关于该主题的大多数试验都集中于 特别是低至中度风险的患者。 此外,最近的随机对照试验和非随机对照试验还需要进行亚组分析,包括总体感染,腹腔外感染和术后住院时间。

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