Cioni Giorgio, Viale Pierluigi, Frasson Stefania, Cipollini Francesco, Menichetti Francesco, Petrosillo Nicola, Brunati Sergio, Spigaglia Patrizia, Vismara Chiara, Bielli Alessandra, Barbanti Fabrizio, Landini Giancarlo, Panigada Grazia, Gussoni Gualberto, Bonizzoni Erminio, Gesu Giovanni Pietro
Department of Internal Medicine, Pavullo nel Frignano Hospital, Modena, Italy.
Infectious Diseases Unit, Teaching Hospital "Policlinico S. Orsola Malpighi", Alma Mater Studiorum University of Bologna, Bologna, Italy.
BMC Infect Dis. 2016 Nov 8;16(1):656. doi: 10.1186/s12879-016-1961-9.
Clostridium difficile (CD) is a leading cause of diarrhoea among hospitalized patients. The objective of this study was to evaluate the rate, the optimal diagnostic work-up, and outcome of CD infections (CDI) in Internal Medicine (IM) wards in Italy.
PRACTICE is an observational prospective study, involving 40 IM Units and evaluating all consecutive patients hospitalized during a 4-month period. CDI were defined in case of diarrhoea when both enzyme immunoassay for GDH, and test for A/B toxin were positive. Patients with CDI were followed-up for recurrences for 4 weeks after the end of therapy.
Among the 10,780 patients observed, 103 (0.96 %) showed CDI, at admission or during hospitalization. A positive history for CD, antibiotics in the previous 4 weeks, recent hospitalization, female gender and age were significantly associated with CDI (multivariable analysis). In-hospital mortality was 16.5 % in CD group vs 6.7 % in No-CD group (p < 0.001), whereas median length of hospital stay was 16 (IQR = 13) vs 8 (IQR = 8) days (p < 0.001) among patients with or without CDI, respectively. Rate of CD recurrences was 14.6 %. As a post-hoc evaluation, 23 out of 34 GDH+/Tox- samples were toxin positive, when analysed by molecular method (a real-time PCR assay). The overall CD incidence rate was 5.3/10,000 patient-days.
Our results confirm the severity of CDI in medical wards, showing high in-hospital mortality, prolonged hospitalization and frequent short-term recurrences. Further, our survey supports a 2-3 step algorithm for CD diagnosis: EIA for detecting GDH, A and B toxin, followed by a molecular method in case of toxin-negative samples.
艰难梭菌（CD）是住院患者腹泻的主要病因。本研究的目的是评估意大利内科病房中艰难梭菌感染（CDI）的发生率、最佳诊断方法及预后。
PRACTICE是一项观察性前瞻性研究，涉及40个内科病房，评估4个月期间所有连续住院的患者。当GDH酶免疫测定和A/B毒素检测均为阳性时，腹泻患者被定义为CDI。CDI患者在治疗结束后随访4周以观察复发情况。
在观察的10780例患者中，103例（0.96%）在入院时或住院期间出现CDI。CD阳性病史、前4周内使用抗生素、近期住院、女性性别和年龄与CDI显著相关（多变量分析）。CD组的院内死亡率为16.5%，非CD组为6.7%（p<0.001），而有或无CDI患者的中位住院时间分别为16天（IQR=13）和8天（IQR=8）（p<0.001）。CD复发率为14.6%。作为事后评估，通过分子方法（实时PCR检测）分析时，34份GDH+/毒素阴性样本中有23份毒素呈阳性。CD总体发病率为5.3/10000患者日。
我们的结果证实了内科病房中CDI的严重性，显示出高院内死亡率、延长的住院时间和频繁的短期复发。此外，我们的调查支持CD诊断采用2-3步算法：通过酶免疫测定检测GDH、A和B毒素，毒素阴性样本则采用分子方法。
