Cipriani Paola, Berardicurti Onorina, Masedu Francesco, D'Onofrio Francesca, Navarini Luca, Ruscitti Piero, Maruotti Nicola, Margiotta Domenico Paolo Emanuele, Liakouli Vasiliki, Di Benedetto Paola, Carubbi Francesco, Valenti Marco, Cantatore Francesco Paolo, Afeltra Antonella, Giacomelli Roberto
Rheumatology Division, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Delta 6 Building, PO Box 67100, L'Aquila, Italy.
Division of Medical Statistic Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Clin Rheumatol. 2017 Feb;36(2):251-260. doi: 10.1007/s10067-016-3444-1. Epub 2016 Oct 25.
Since the introduction of biologics, many concerns about the increased risk of infections have been reported and, to date, the real impact of infections on the daily practice in the rheumatologic centers is still largely unknown. In this work, we evaluated the infection rates associated with the use of biologics in a large cohort of patients. A prospective study, between January 2010 and December 2013, enrolling 731 rheumatic patients, was performed. Demographic and disease characteristics, therapies, comorbidities, and infectious events were recorded and statistically analyzed by multivariate analysis. Two-hundred thirty-five infectious episodes were observed in 28.4 % of patients. About total infections, bacteria were identified in 70.6 % of total cases and viruses in 18.3 %. The most common site of not-serious infection was the urinary tract. Duration of disease, longer follow-up, concomitant steroid therapy, and comorbidities were significantly associated with not-serious infection. In our cohort, 17 episodes fulfilled the criteria of serious infection and occurred in 17 different patients (2.3 %), the majority involving the lower respiratory tract. Serious infections were associated with the beginning of biologics in older age. Our prospective, observational study showed that, in daily practice, a lesser rate of serious as well as not-serious infections may be observed in rheumatic patients treated with biologics than those reported in previous papers. The most common sites of not-serious infections are both the urinary and the respiratory tracts, and for serious infections, the respiratory tract. When pathogens were isolated, we did not find any multidrug-resistant organism.
自从生物制剂问世以来，已有许多关于感染风险增加的担忧被报道，而迄今为止，感染对风湿病中心日常医疗实践的实际影响仍很大程度上未知。在这项研究中，我们评估了一大群患者使用生物制剂相关的感染率。我们进行了一项前瞻性研究，时间跨度为2010年1月至2013年12月，纳入了731名风湿病患者。记录了患者的人口统计学和疾病特征、治疗方法、合并症以及感染事件，并通过多变量分析进行了统计分析。在28.4%的患者中观察到235次感染发作。在所有感染中，70.6%的病例鉴定出细菌，18.3%鉴定出病毒。非严重感染最常见的部位是尿路。疾病持续时间、更长的随访时间、同时使用类固醇治疗以及合并症与非严重感染显著相关。在我们的队列中，17次发作符合严重感染标准，发生在17名不同患者中（2.3%），大多数累及下呼吸道。严重感染与老年患者开始使用生物制剂有关。我们的前瞻性观察性研究表明，在日常医疗实践中，使用生物制剂治疗的风湿病患者中观察到的严重和非严重感染发生率可能低于先前论文报道的发生率。非严重感染最常见的部位是尿路和呼吸道，而严重感染的部位是呼吸道。当分离出病原体时，我们未发现任何多重耐药菌。
