La Quaglia M P, Caldwell C, Lucas A, Corbally M, Heller G, Steinherz L, Brown A E, Groeger J, Exelby P R
Department of Surgery (Pediatric Surgery), Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
J Pediatr Surg. 1994 Jun;29(6):742-5. doi: 10.1016/0022-3468(94)90359-x.
The incidence of Hickman catheter sepsis is 10% to 40%, with resultant catheter loss in one third of infections. Urokinase causes dissolution of colonized intracatheter fibrin thrombi and may improve salvage.
To evaluate the efficacy of 12-hour-interval slow-push urokinase infusion in addition to standard antibiotic therapy in the treatment of catheter sepsis in a pediatric oncology population.
A two-arm randomized double-blind trial was undertaken, with catheter salvage rate as the end point. Patients with Hickman catheter sepsis were randomized after culture data confirmed the diagnosis. The study drug was administered by a slow intravenous push and given at 12-hour intervals for a total of four doses. The catheters were aspirated after 1 hour.
The trial was stopped after 41 patients were entered into the study; 18 patients received a placebo, and 23 received the urokinase. In the placebo group, six catheters were lost; in the urokinase group, eight were lost. The rate of bacterial clearance was equivalent for both. After administration of the study drug, each group had three episodes of fever and chills; two of these resulted in hypotension (one in each group). The authors conclude that slow-push urokinase infusion during established Hickman catheter sepsis does not result in improved catheter salvage or bacterial clearance. Slow intravenous push infusions in this setting may provoke hemodynamic instability even after initiation of antibiotics.
希克曼导管败血症的发生率为10%至40%，三分之一的感染会导致导管丢失。尿激酶可溶解导管内定植的纤维蛋白血栓，可能有助于提高导管挽救率。
评估在标准抗生素治疗基础上，每12小时缓慢推注尿激酶治疗儿科肿瘤患者导管败血症的疗效。
进行双臂随机双盲试验，以导管挽救率作为终点指标。在培养数据确诊后，将希克曼导管败血症患者随机分组。研究药物通过静脉缓慢推注给药，每12小时给药一次，共给药四剂。1小时后抽吸导管。
在41名患者进入研究后，试验停止；18名患者接受安慰剂，23名患者接受尿激酶治疗。在安慰剂组中，6根导管丢失；在尿激酶组中，8根导管丢失。两组的细菌清除率相当。给药后，每组均有3次发热和寒战发作；其中2次导致低血压（每组各1次）。作者得出结论，在已发生的希克曼导管败血症期间缓慢推注尿激酶并不能提高导管挽救率或细菌清除率。在这种情况下，即使在开始使用抗生素后，缓慢静脉推注也可能引发血流动力学不稳定。
