庆大霉素封管预防透析导管相关性菌血症的随机对照研究

A randomized controlled study on prevention of catheter-related bacteremla with gentamicinheparin lock solution

目的探讨庆大霉素和肝素混合液封管在预防导管相关性菌血症中的临床应用安全性和有效性。方法将本中心2004年11月至2005年3月新置Cuff—tunneled导管的43例慢性肾衰竭患者随机分成试验组和对照组，分别使用庆大霉素（4g／L）．肝素（45g／L）混合液和肝素液（对照组45g／L）封管，比较两组透析导管相关性菌血症的发生率及相关微炎症和安全性指标。结果试验组（23例）导管平均使用日为114．13±34．39（31—200）d；对照组（20例）为（127．40±32．85）（40～196）d，累积导管使用日分别为2625d及2548d。对照组发生2例导管相关性菌血症（CRB），试验组无1例发生，但差异无统计学意义。试验组血清庆大霉素谷浓度和峰浓度2周时分别为（0．23±0．12）mg／L和（0．53±0．29）mg／L，12周时为（0．26±0．15）mg／L和（0．67±0．32）mg／L，2周和12周的谷浓度和峰浓度相比差异无统计学意义。两组患者随着透析时间延长血CRP和IL-6呈降低趋势，试验组16周和基线时的CRP比较有显著性下降（P〈0．05），而对照组两时间点差异无统计学意义。两组患者残肾功能在随访期间均有下降，但试验组和对照组各时间点相比，差异无统计学意义。16周时庆大霉紊耐药的大肠埃希菌检验阳性率＋试验组和对照组分别为23．6％及21．4％，两组差异无统计学意义，大便培养均未发现其他耐药菌株或真菌。结论庆大霉素4g/L-肝素45g／L的混合液是一种安全、方便、有良好抗凝效果的封管液，对透析导管相关性菌血症有一定的预防作用。

Objective To evaluate the efficacy of catheter-restricted filling using the gentamicin-heparin mixed solution in the prevention for catheter-related bacteremia （CRB）. Methods Forty-three patients in our center were enrolled from Nov. 2004 to Mar. 2005 in this s tudy, and were randomly assigned to receive either heparin lock solution （H group, heparin 45 g/L, 23 patients） or gentamicin-heparin mixed solution （GH group, gentamicin 4 g/L, heparin 45 g/L, 20 patients） as the catheter lock solution during the interdialytic period. The obsorvative indicators included the incidence of CRB, the concentration of gentamicin in peripheral blood, the residual kidney function （RKF）, the side effect of gentamicin, and the change of blood levels of CRP and [L-6. Results Mean CRB-free catheter survival days was 114.13±34.39 （31-200） in GH group and 127.40±32.85 （40-196） in H group. Accumulative catheter day of 2625 day was gained in GH group and 2548 in H group. CRB developed in two patients in the H group whereas none of the patients developed CRB in GH group, however the incidence of CRB between two groups was not significantly different. The trough and peak concentrations of gentamicin in GH group were （0.23±0.12） mg/L and （0.53±0.29） mg/L respectively after two weeks, and（0.26±0.15） mg/L and （0.67±0.32） mg/L after twelve weeks, and no statistical difference was found. The levels of CRP and IL-6 decreased in both groups. At the 16th week, the level of CRP decreased significantly compared to baseline in GH group （P 〈 0.05）, but such difference was not found in H gruop. The RKF decreased in both groups, but the significant differences were not found between two groups. At the 16 weeks, the positive rate of gentamicin-fast E. Coli was 23.6% in GH group and 21.4% in H group respectively, with no significant difference. There were no other antibiotic-resistant bacteria or fungus found in stool culture. Conclusions The gentamicin-heparin mixed solution （4 g/L-45 g/L） is a good catheter lock regimen that has better safety and convenience, and its anticoagulative efficacy is definite. It may be a beneficial means of reducing the CRB rate in hemodialysis oatients with cuff-tunneled catheter.