Abstract：
OBJECTIVE: Little is known about efficacy and safety of ethanol lock therapy (ELT) to treat totally implantable venous access device (TIVAD) infections. The objective of this trial was to evaluate the effectiveness and safety profile of a local treatment with ELT without removal for TIVAD infection due to coagulase-negative staphylococci.
METHODS: We performed a prospective, multicenter, double-blind, randomized clinical trial comparing the efficacy of 40% ELT versus vancomycin lock therapy (VLT) in TIVAD infections due to coagulase-negative staphylococci, complicated or not by bloodstream infection.
RESULTS: Thirty-one patients were assigned to the ELT group and 30 to the VLT arm. Concomitant bacteremia was present in 41 patients (67.2%). Treatment success was 58.1 % (18 of 31) for the ELT arm and 46.7% (14 of 30) for the VLT arm (p = 0.37). The overall treatment success was 52.5% (32). The risk of treatment failure due to uncontrolled infections, superinfections, and mechanical complications did not differ significantly between participants receiving ELT (13 out of 31 [42%]) and those receiving VLT (16 out of 30 [53%]) with a hazard ratio of 0.70 (p = 0.343; 95% CI [0.34-1.46], Cox model). Catheter malfunctions were significantly more frequent in the ELT arm (11 patients versus 2 in the VLT group, p = 0.01).
CONCLUSIONS: We found an overall high rate of treatment failure that did not differ between the ELT arm and the VLT arm. TIVAD removal must be prioritized to prevent complications (uncontrolled infections, superinfections, and catheter malfunctions) except in exceptional situations.
METHODS: We performed a prospective, multicenter, double-blind, randomized clinical trial comparing the efficacy of 40% ELT versus vancomycin lock therapy (VLT) in TIVAD infections due to coagulase-negative staphylococci, complicated or not by bloodstream infection.
RESULTS: Thirty-one patients were assigned to the ELT group and 30 to the VLT arm. Concomitant bacteremia was present in 41 patients (67.2%). Treatment success was 58.1 % (18 of 31) for the ELT arm and 46.7% (14 of 30) for the VLT arm (p = 0.37). The overall treatment success was 52.5% (32). The risk of treatment failure due to uncontrolled infections, superinfections, and mechanical complications did not differ significantly between participants receiving ELT (13 out of 31 [42%]) and those receiving VLT (16 out of 30 [53%]) with a hazard ratio of 0.70 (p = 0.343; 95% CI [0.34-1.46], Cox model). Catheter malfunctions were significantly more frequent in the ELT arm (11 patients versus 2 in the VLT group, p = 0.01).
CONCLUSIONS: We found an overall high rate of treatment failure that did not differ between the ELT arm and the VLT arm. TIVAD removal must be prioritized to prevent complications (uncontrolled infections, superinfections, and catheter malfunctions) except in exceptional situations.
摘要：
目的：关于乙醇锁定疗法（ELT）治疗完全植入式静脉接入装置（TIVAD）感染的疗效和安全性知之甚少。该试验的目的是评估不去除ELT的局部治疗因凝固酶阴性葡萄球菌引起的TIVAD感染的有效性和安全性。
方法：我们进行了前瞻性，多中心，双盲,比较40％ELT与万古霉素锁定疗法（VLT）在凝固酶阴性葡萄球菌引起的TIVAD感染中的疗效的随机临床试验，复杂或不复杂的血液感染。
结果：31名患者被分配到ELT组，30名患者被分配到VLT组。41例患者（67.2％）合并菌血症。ELT组的治疗成功率为58.1%（31个中的18个），VLT组为46.7%（30个中的14个）（p=0.37）。总体治疗成功率为52.5%(32)。不受控制的感染导致治疗失败的风险，超感染,接受ELT的参与者（31人中有13人[42%]）和接受VLT的参与者（30人中有16人[53%]）之间的机械并发症没有显着差异，风险比为0.70（p=0.343;95％CI[0.34-1.46]，考克斯模型)。ELT组导管故障明显更频繁(VLT组11例患者与2例患者相比,p=0.01)。
结论：我们发现ELT臂和VLT臂之间的治疗失败率总体很高。必须优先清除TIVAD以防止并发症（不受控制的感染，超感染,和导管故障)，特殊情况除外。
方法：我们进行了前瞻性，多中心，双盲,比较40％ELT与万古霉素锁定疗法（VLT）在凝固酶阴性葡萄球菌引起的TIVAD感染中的疗效的随机临床试验，复杂或不复杂的血液感染。
结果：31名患者被分配到ELT组，30名患者被分配到VLT组。41例患者（67.2％）合并菌血症。ELT组的治疗成功率为58.1%（31个中的18个），VLT组为46.7%（30个中的14个）（p=0.37）。总体治疗成功率为52.5%(32)。不受控制的感染导致治疗失败的风险，超感染,接受ELT的参与者（31人中有13人[42%]）和接受VLT的参与者（30人中有16人[53%]）之间的机械并发症没有显着差异，风险比为0.70（p=0.343;95％CI[0.34-1.46]，考克斯模型)。ELT组导管故障明显更频繁(VLT组11例患者与2例患者相比,p=0.01)。
结论：我们发现ELT臂和VLT臂之间的治疗失败率总体很高。必须优先清除TIVAD以防止并发症（不受控制的感染，超感染,和导管故障)，特殊情况除外。
