Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan.
PLoS One. 2021 Nov 19;16(11):e0259641. doi: 10.1371/journal.pone.0259641. eCollection 2021.
Prophylactic administration of antibiotics within 24 hours of surgery is recommended to reduce the risk of infection. We conducted a prospective study to compare the efficacy of single administration of antibiotics with a historical control of continuous administration of antibiotics for radiofrequency ablation (RFA) of malignant liver tumors.
Between February 1, 1999 and November 30, 2010, a total of 6,763 RFA treatments were performed in 2,355 patients, using a protocol with continuous administration of prophylactic antibiotics. On December 1, 2010, we began using a revised protocol with a single administration of prophylactic antibiotics, while continuing to use the old continuous administration protocol for patients who declined the new protocol. Interim analysis was performed to assess the safety of the single administration protocol. Thereafter, from April 1, 2012, all patients were treated using the new protocol. Risk factors for infectious complications of RFA were assessed using logistic regression.
From December 2010 to March 2012, 766 RFA treatments were performed in 663 patients using the new antibiotic protocol. Infectious complications were observed following 4 of these treatments (0.52%). As the upper limit of the confidence interval (CI) resulting from a one-sided binomial test was exactly the prespecified limit of 1.0%, from April 2012 onwards, we treated all patients using the new protocol with single administration of prophylactic antibiotics. A total of 3,547 RFA treatments were performed using the single administration protocol. Univariable logistic regression indicated that prior transcatheter arterial chemoembolization (TACE) and maximal tumor diameter were significant risk factors for infectious complications (P = 0.04 and P < 0.001, respectively). Multivariable analysis indicated that the adjusted hazard ratio of single vs. continuous administration of antibiotics was 1.20 (95% CI: 0.53-2.75; P = 0.66).
The rate of infectious complications related to RFA was acceptably low. Single administration of prophylactic antibiotics did not significantly increase the rate of infectious complications related to RFA, compared with a more intensive antibiotic protocol.
建议在手术 24 小时内预防性使用抗生素以降低感染风险。我们进行了一项前瞻性研究,比较了单次使用抗生素与射频消融(RFA)恶性肝肿瘤连续使用抗生素的历史对照的疗效。
1999 年 2 月 1 日至 2010 年 11 月 30 日,对 2355 例患者共进行了 6763 次 RFA 治疗,采用连续使用预防性抗生素的方案。2010 年 12 月 1 日,我们开始使用一种新的方案,即单次使用预防性抗生素,同时继续对拒绝新方案的患者使用旧的连续使用方案。进行了中期分析以评估单次使用方案的安全性。此后,自 2012 年 4 月 1 日起,所有患者均采用新方案进行治疗。使用逻辑回归评估 RFA 感染性并发症的危险因素。
2010 年 12 月至 2012 年 3 月,采用新抗生素方案对 663 例患者进行了 766 次 RFA 治疗。其中 4 次治疗后出现感染性并发症(0.52%)。由于单侧二项式检验的置信区间(CI)上限正好是预定的 1.0%的上限,因此自 2012 年 4 月起,我们对所有患者均采用新方案进行单次预防性抗生素治疗。采用单次给药方案共进行了 3547 次 RFA 治疗。单变量逻辑回归表明,先前的经导管动脉化疗栓塞(TACE)和最大肿瘤直径是感染性并发症的显著危险因素(P=0.04 和 P<0.001)。多变量分析表明,与连续给药相比,单次与连续给药的抗生素调整后的危险比为 1.20(95%CI:0.53-2.75;P=0.66)。
RFA 相关感染并发症的发生率可接受较低。与更密集的抗生素方案相比,单次预防性使用抗生素并未显著增加 RFA 相关感染并发症的发生率。