Ruschulte Heiner, Franke Matthias, Gastmeier Petra, Zenz Sebastian, Mahr Karl H, Buchholz Stefanie, Hertenstein Bernd, Hecker Hartmut, Piepenbrock Siegfried
Department of Anaesthesiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
Ann Hematol. 2009 Mar;88(3):267-72. doi: 10.1007/s00277-008-0568-7. Epub 2008 Aug 5.
The objective of the study was to evaluate the effectiveness of chlorhexidine-impregnated sponges for reducing catheter-related infections of central venous catheters inserted for cancer chemotherapy. The method used was a randomized, prospective, open, controlled clinical study (three-step group sequential analysis protocol). The patients were from two high dependency units at a university hospital undergoing chemotherapy for haematological or oncological malignancies requiring central venous catheters (CVCs) expected to remain in place for at least 5 days. Six hundred and one patients with 9,731 catheterization days were studied between January 2004 and January 2006. Patients admitted for chemotherapy received chlorhexidine and silver sulfadiazine-impregnated triple-lumen CVCs under standardized conditions and were randomized to the groups receiving a chlorhexidine gluconate-impregnated wound dressing or a standard sterile dressing. Daily routine included clinical assessment of the insertion site (swelling, pain, redness), temperature, white blood count and C-reactive protein. Catheters remained in place until they were no longer needed or when a CVC-related infection was suspected. Infection was confirmed with blood cultures via the catheter lumina and peripheral blood cultures according to the time-to-positivity method. Six hundred and one patients were included. The groups were comparable with respect to demographic and clinical data. The incidence of CVC-related infections were 11.3% (34 of 301) and 6.3% (19 of 300) in the control and chlorhexidine-impregnated wound dressing groups, respectively (p=0.016, relative risk 0.54; confidence interval 0.31-0.94). Especially, catheter-related infections at internal jugular vein insertions could be reduced (p=0.018). No adverse effects related to the intervention were observed. The use of chlorhexidine-impregnated wound dressings significantly reduced the incidence of CVC-related infections in patients receiving chemotherapy.
本研究的目的是评估洗必泰浸渍海绵对降低癌症化疗患者中心静脉导管相关感染的有效性。所采用的方法是一项随机、前瞻性、开放、对照临床研究（三步组序贯分析方案）。患者来自一所大学医院的两个高依赖病房，因血液系统或肿瘤性恶性疾病接受化疗，需要留置中心静脉导管（CVC）至少5天。2004年1月至2006年1月期间，对601例患者进行了研究，导管插入天数共计9731天。接受化疗的患者在标准化条件下接受洗必泰和磺胺嘧啶银浸渍的三腔CVC，并随机分为接受葡萄糖酸氯己定浸渍伤口敷料组或标准无菌敷料组。日常工作包括对插入部位进行临床评估（肿胀、疼痛、发红）、测量体温、检测白细胞计数和C反应蛋白。导管一直留置到不再需要或怀疑发生CVC相关感染时。根据阳性时间法，通过导管腔血培养和外周血培养确诊感染。纳入601例患者。两组在人口统计学和临床数据方面具有可比性。对照组和洗必泰浸渍伤口敷料组的CVC相关感染发生率分别为11.3%（301例中的34例）和6.3%（300例中的19例）（p=0.016，相对风险0.54；置信区间0.31-0.94）。特别是，颈内静脉插入部位的导管相关感染发生率可降低（p=0.018）。未观察到与干预相关的不良反应。使用洗必泰浸渍伤口敷料可显著降低接受化疗患者的CVC相关感染发生率。
