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Abstract：
Background: Procalcitonin (PCT), an important biomarker, can be used for the guidance of antibiotic therapy in respiratory infection. However, it has been a problem that some patients might need antibiotic therapy restart because of infection recurrence after antibiotic discontinuation. To date, there are very few literature on the study of risk factors accounting for infection recurrence. Purpose of this clinical study: 1) To study on antibiotic discontinuation in ventilator-associated pneumonia (VAP) under the guidance of PCT; 2) To evaluate the possible risk factors leading to infection recurrence and antibiotic reuse. Methods: Antibiotic discontinuation was performed when patients met the following criteria: (i) serum PCT<0.5 μg/L, (ii) temperature<38.5℃ and (iii) leukocyte count<15×109/L. Next, the patients were divided into infection recurrence group (infection recurring within 7 days after antibiotic discontinuation) or infection controlled group (no infection recurring after antibiotic discontinuation). Possible risk factors accounting for infection recurrence were evaluated using logistic regression analysis. Results: Of the eligible 51 patients with VAP, 20 patients suffered infection recurrence. Clinical pulmonary infection score (CPIS) and characteristics of tracheal secretions were the independent risk factors (P=0.045 and P=0.041, respectively), accounting for infection recurrence. Simplified CPIS≥5 served a certain predictive value for infection recurrence in VAP when physicians considered antibiotic discontinuation (The area under the receiver operating characteristic curve 0.781, specificity 90.3%, sensitivity 55.0%, positive predictive value 78.6% and negative predictive value 75.7%). At the time of antibiotic discontinuation, differences between the two groups were not statistically significant in the proportion of patients with a tracheotomy and in the culture results of endotracheal aspirates (including semi-quantitative results and whether pathogens were multidrug-resistant [MDR] strains). Conclusion: Simplified CPIS and characteristics of tracheal secretions can be used to predict infection recurrence following PCT-guided antibiotic discontinuation in VAP. These findings are important because physicians may not need to put too much care on semi-quantitative culture results of endotracheal aspirates and whether pathogens are MDRstrains. Trial registration: The registration number of this clinical trial is: ChiCTR-OPC-17011228 (Trial registry name: Chinese Clinical Trial Registry; URL: http://www.chictr.org.cn).
摘要：
背景：降钙素原（PCT），一个重要的生物标志物，可用于指导呼吸道感染的抗生素治疗。然而,一些患者由于抗生素停药后感染复发，可能需要重新开始抗生素治疗。迄今为止,很少有文献研究感染复发的危险因素。本临床研究的目的：1）在PCT指导下研究呼吸机相关性肺炎（VAP）停用抗生素的情况；2）评估导致感染复发和抗生素重复使用的可能危险因素。方法：当患者符合以下标准时，进行抗生素停药：（i）血清PCT<0.5μg/L，(ii)温度<38.5℃和(iii)白细胞计数<15×109/L接下来,将患者分为感染复发组(抗生素停药后7天内感染复发)和感染对照组(抗生素停药后无感染复发).使用logistic回归分析评估了导致感染复发的可能危险因素。结果：在符合条件的51例VAP患者中，20例感染复发。临床肺部感染评分(CPIS)和气管分泌物特征是其独立危险因素(分别为P=0.045和P=0.041)。考虑感染复发。当医生认为抗生素停药时，简化的CPIS≥5对VAP的感染复发具有一定的预测价值（接受者工作特征曲线下面积0.781，特异性90.3％，灵敏度55.0%，阳性预测值78.6%，阴性预测值75.7%)。抗生素停药时,两组间的气管切开患者比例和气管内抽吸物培养结果(包括半定量结果和病原体是否为多重耐药[MDR]菌株)差异无统计学意义.结论：简化的CPIS和气管分泌物特征可用于预测PCT指导的VAP抗生素停药后感染复发。这些发现很重要，因为医生可能不需要太在意气管内抽吸物的半定量培养结果以及病原体是否是MDR菌株。试验注册:本临床试验的注册编号为:ChiCTR-OPC-17011228(试验注册名称:中国临床试验注册中心;网址:http://www。chictr.org.cn)。
