Yücel Nedim, Lefering Rolf, Maegele Marc, Max Martin, Rossaint Rolf, Koch Andrea, Schwarz Rosemarie, Korenkov Michael, Beuth Josef, Bach Alfons, Schierholz Jörg, Pulverer Gerhard, Neugebauer Edmund A M
2nd Department of Surgery, Klinikum Merheim, Germany.
J Antimicrob Chemother. 2004 Dec;54(6):1109-15. doi: 10.1093/jac/dkh483. Epub 2004 Nov 10.
Central venous catheters (CVC) are a major cause of nosocomial bloodstream infections. Catheters modified with miconazole and rifampicin that constantly and slowly release antimicrobial substances are assumed to be beneficial in reducing rates of colonization and catheter-related infections.
Prospective controlled non-blinded randomized clinical trial in two German university hospitals.
223 adult inpatients with CVC between October 2000 and February 2002. Baseline characteristics, APACHE II score and therapeutic interventions were comparable.
Randomization to receive either a miconazole and rifampicin modified catheter (n=118) or a standard triple-lumen CVC (n=105). MEASUREMENTS, DEFINITIONS: Microbiological evaluation was done after CVC removal. A catheter was considered colonized if growth of > or =15 cfu was found by semi-quantitative roll-plate technique from a proximal or distal catheter segment. A catheter-related infection (CRI) was defined as a colonized catheter with local signs of inflammation. A catheter-related bloodstream infection (CR-BSI) was defined as a colonized catheter with isolation of the same organism from the patient's blood with accompanying clinical signs of infection.
A colonization of CVC was observed in six patients (5.1%) with a modified catheter and 38 patients (36.2%) with a standard catheter (P < 0.001). Five patients in the modified group (4.2%) and 18 in the standard group (17.1%) developed CRI (P=0.002). One assumed CR-BSI was detected in the standard group, with none in the modified group. No adverse effects related to the modified catheters and no antimicrobial resistance were observed.
CVC supersaturated with miconazole and rifampicin were associated with a significantly lower risk for catheter colonization and catheter-related infections compared to standard catheters.
中心静脉导管（CVC）是医院血流感染的主要原因。用咪康唑和利福平修饰并能持续缓慢释放抗菌物质的导管被认为有助于降低定植率和导管相关感染率。
在两家德国大学医院进行的前瞻性对照非盲随机临床试验。
2000年10月至2002年2月间223例置入CVC的成年住院患者。基线特征、急性生理与慢性健康状况评分系统（APACHE II）评分及治疗干预措施具有可比性。
随机分组，分别接受咪康唑和利福平修饰导管（n = 118）或标准三腔CVC（n = 105）。测量、定义：CVC拔除后进行微生物学评估。采用半定量滚涂平板技术，若在导管近端或远端节段发现菌落形成单位（cfu）≥15，则认为导管定植。导管相关感染（CRI）定义为定植导管伴有局部炎症体征。导管相关血流感染（CR-BSI）定义为定植导管且从患者血液中分离出相同微生物并伴有感染临床体征。
使用修饰导管的6例患者（5.1%）发生CVC定植，使用标准导管的38例患者（36.2%）发生定植（P < 0.001）。修饰组5例患者（4.2%）发生CRI，标准组18例患者（17.1%）发生CRI（P = 0.002）。标准组检测到1例疑似CR-BSI，修饰组未检测到。未观察到与修饰导管相关的不良反应及抗菌药物耐药性。
与标准导管相比，用咪康唑和利福平超饱和处理的CVC发生导管定植和导管相关感染的风险显著降低。
