2022十二指肠镜相关感染的风险及对策（全文）
导 读：
内镜手术中的外源性感染风险往往被认为可以忽略不计。然而，近日一篇发表在Endoscopy上的一项前瞻性随机研究显示，荷兰ERCP实践过程的十二指肠镜相关感染（DAI）的预估风险是之前报告风险的180倍。来自德国Evangelisches Krankenhaus的Horst Neuhaus对该研究发表了以下评论。
Duodenoscope-associated infections: risks and countermeasures
十二指肠镜相关感染：风险及对策
Introduction
介绍
The exact number of endoscopic retrograde cholangiopancreatography (ERCP) procedures performed worldwide each year is not known; the estimate for the United States is up to 70
bacterium0 000 cases. The high case volume implies that even infrequent adverse events are clinically and economically relevant. These events include procedure-related infections, which occur in 0.5 %–3 % of cases. Such infections are likely to be predominantly induced endogenously by translocation of oral or intestinal bacteria.
全世界每年进行的经内镜逆行性胰胆管造影（ERCP）手术的确切数量是未可知的，美国的预估手术量高达70万台。如此高的手术数量，意味着即使是罕见的不良事件也具有临床意义和经济意义。这些不良事件包括手术相关感染，发生率为0.5%-3%。此类感染可能主要是由口腔细菌或肠道细菌的转移导致的内源性感染。
The extent to which infections are caused by exogenous bacteria is not well known, as these are rarely considered in clinical practice. However, recent reports on outbreaks of duodenoscope-associated infections (DAIs) have led to an increased awareness of this device-related risk. Most of these outbreaks were caused by multidrug-resistant organisms (MDROs) transmitted through contaminated duodenoscopes as proven by molecular typing. Such organisms can cause serious and life-threatening infections.
目前对于外源性细菌引起感染的了解较少，因为在临床实践中很少会考虑这些感染。然而，最近关于十二指肠镜相关感染（DAI）事件暴发的报告引起了对这一器械相关风险的广泛关注。暴发的大多数事件是通过污染的十二指肠镜（由分子分型证实）传播的多重耐药菌（MDRO）引起。此类细菌可导致严重且致命的感染。
Until recently, only reusable duodenoscopes could be used for ERCP. Optimal cleaning, disinfection, and even more so sterilization, are difficult because of the complex mechanical features incorporated into the distal tip of the device. A recent postmarket surveillance report on culturing results showed that up to 5.4 % of properly collected samples from reprocessed duodenoscopes tested positive for organisms of high concern. Supplemental measures such as routine or periodic microbiologic culturing of duodenoscopes and reprocessing with repeat high-level disinfection (HLD), ethylene oxide sterilization after HLD, or liquid chemical sterilization (LCS) have been recommended.
至今，还是只有可重复使用的十二指肠镜可以用于ERCP。由于其远尖端结构复杂，很难
进行最佳清洗、消毒，甚至难以进行灭菌。最近一份关于细菌培养结果的上市后监测报告显示，在从再处理的十二指肠镜上适当采集的样本中，细菌培养阳性率高达5.4%。建议采取补充措施，如常规或定期对十二指肠镜进行细菌培养，并通过重复高水平消毒（HLD）、HLD后环氧乙烷灭菌或液体化学灭菌（LCS）进行再处理。
Randomized study
随机研究
HLD and LCS were recently compared in a prospective randomized study including 878 post-reprocessing surveillance cultures performed in a high-volume center. Cultures were positive for any organism in 1.9 % of cases, with no significant difference between the two methods. Although the culture positivity rate is low, the study results indicate that even the best manual cleaning protocol applied cannot achieve eradication of all potential pathogens and eliminate the potential for human error.
近期的一项前瞻性随机研究对HLD和LCS进行了比较，该研究纳入了在高手术量中心进行
的878例再处理后的监测培养。细菌培养阳性率为1.9%，两种方法之间无显著差异。虽然培养阳性率较低，但研究结果表明，即使采用最佳人工清洗方案也无法根除所有的潜在病原体，并消除出现人为错误的可能性。
A first nationwide study recently showed a high prevalence rate of digestive bacteria in duodenoscopes in the Netherlands. Overall, 92 % of the 73 national centers sampled 745 sites of 155 duodenoscopes from three distinct manufacturers. In more than one third of the participating institutions, at least one patient-ready duodenoscope was identified as contaminated. Furthermore, 15 % of the duodenoscopes harbored microorganisms that indicated residual organic material from previous patients. Contamination occurred with all types of duodenoscopes.
最近，首项在荷兰全国范围内开展的研究显示，十二指肠镜中消化细菌污染率很高。73家国家研究中心中的92%对155条十二指肠镜上的745部位进行取样，这些十二指肠镜来自三家不同的制造商。在三分之一以上的参与机构中，发现至少有1条可重复使用的十二指肠镜存在污染。此外，在15%的含有微生物污染的十二指肠镜中，发现存在来自之前患者的残留有机物质。所有类型的十二指肠镜均存在污染。
The procedural risk of developing infections with different degrees of severity related to contaminated duodenoscopes has so far been rated as very low. A historical 1993 position paper from the American Society for Gastrointestinal Endoscopy (ASGE) suggested a prevalence of 1 in 1.8 million endoscopies. No risk calculation specifically for DAIs has been reported; however, data are urgently needed for strategic planning of DAI prevention.

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