Dixon Giles, Lama-Lopez Adriana, Bintcliffe Oliver J, Morley Anna J, Hooper Clare E, Maskell Nick A
Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, BS10 5NB, UK.
North Bristol Lung Centre, North Bristol NHS Trust, Bristol, UK.
Respir Res. 2017 Feb 3;18(1):30. doi: 10.1186/s12931-017-0501-5.
Bacterial pleural infection requires prompt identification to enable appropriate investigation and treatment. In contrast to commonly used biomarkers such as C-reactive protein (CRP) and white cell count (WCC), which can be raised due to non-infective inflammatory processes, procalcitonin (PCT) has been proposed as a specific biomarker of bacterial infection. The utility of PCT in this role is yet to be validated in a large prospective trial. This study aimed to identify whether serum PCT is superior to CRP and WCC in establishing the diagnosis of bacterial pleural infection.
Consecutive patients presenting to a tertiary pleural service between 2008 and 2013 were recruited to a well-established pleural disease study. Consent was obtained to store pleural fluid and relevant clinical information. Serum CRP, WCC and PCT were measured. A diagnosis was agreed upon by two independent consultants after a minimum of 12 months. The study was performed and reported according to the STARD reporting guidelines.
80/425 patients enrolled in the trial had a unilateral pleural effusion secondary to infection. 10/80 (12.5%) patients had positive pleural fluid microbiology. Investigations for viral causes of effusion were not performed. ROC curve analysis of 425 adult patients with unilateral undiagnosed pleural effusions showed no statistically significant difference in the diagnostic utility of PCT (AUC 0.77), WCC (AUC 0.77) or CRP (AUC 0.85) for the identification of bacterial pleural infection. Serum procalcitonin >0.085 μg/l has a sensitivity, specificity, negative predictive value and positive predictive value of 0.69, 0.80, 0.46 and 0.91 respectively for the identification of pleural infection. The diagnostic utility of procalcitonin was not affected by prior antibiotic use (p = 0.80).
The study presents evidence that serum procalcitonin is not superior to CRP and WCC for the diagnosis of bacterial pleural infection. The study suggests routine procalcitonin testing in all patients with unilateral pleural effusion is not beneficial however further investigation may identify specific patient subsets that may benefit.
The trial was registered with the UK Clinical Research Network ( UKCRN ID 8960 ). The trial was approved by the South West Regional Ethics Committee (Ethical approval number 08/H0102/11).
细菌性胸膜感染需要迅速识别,以便进行适当的检查和治疗。与常用的生物标志物如C反应蛋白(CRP)和白细胞计数(WCC)不同,它们可能因非感染性炎症过程而升高,降钙素原(PCT)已被提议作为细菌感染的特异性生物标志物。PCT在这一作用中的效用尚未在大型前瞻性试验中得到验证。本研究旨在确定血清PCT在诊断细菌性胸膜感染方面是否优于CRP和WCC。
2008年至2013年期间连续就诊于三级胸膜服务机构的患者被纳入一项成熟的胸膜疾病研究。获得了储存胸水和相关临床信息的同意。检测血清CRP、WCC和PCT。至少12个月后,由两名独立的顾问达成诊断共识。该研究按照STARD报告指南进行并报告。
试验纳入的425例患者中,80例有继发于感染的单侧胸腔积液。80例患者中有10例(12.5%)胸水微生物学检查呈阳性。未对积液的病毒病因进行检查。对425例单侧未确诊胸腔积液的成年患者进行的ROC曲线分析显示,PCT(AUC 0.77)、WCC(AUC 0.77)或CRP(AUC 0.85)在识别细菌性胸膜感染的诊断效用方面无统计学显著差异。血清降钙素原>0.085μg/l用于识别胸膜感染的敏感性、特异性、阴性预测值和阳性预测值分别为0.69、0.80、0.46和0.91。降钙素原的诊断效用不受先前使用抗生素的影响(p = 0.80)。
该研究提供的证据表明,血清降钙素原在诊断细菌性胸膜感染方面并不优于CRP和WCC。该研究表明,对所有单侧胸腔积液患者进行常规降钙素原检测并无益处,不过进一步研究可能会确定可能受益的特定患者亚组。
该试验在英国临床研究网络注册(UKCRN ID 8960)。该试验获得了西南地区伦理委员会的批准(伦理批准号08/H0102/11)。