Uruno Takashi, Masaki Chie, Suzuki Akifumi, Ohkuwa Keiko, Shibuya Hiroshi, Kitagawa Wataru, Nagahama Mitsuji, Sugino Kiminori, Ito Koichi
Department of Surgery, Ito Hospital, 4-3-6 Jingumae, Shibuya-ku, Tokyo, 150-8308, Japan,
World J Surg. 2015 May;39(5):1282-7. doi: 10.1007/s00268-014-2932-1.
The effectiveness of antimicrobial prophylaxis (AMP) in the prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. The objective of this prospective randomized controlled trial (Ito-RCT1) was to assess the effectiveness of AMP in clean neck surgery performed to treat thyroid and parathyroid disease.
Participants comprised patients scheduled for clean neck surgery for thyroid and parathyroid disease at Ito Hospital. Patients whose surgery included sternotomy or resection of the trachea, larynx, pharynx, or esophagus were excluded. AMP consisted of 2 g of piperacillin (PIPC) (group A, n = 541) or 1 g of cefazolin (CEZ) (group B, n = 541) administered intravenously immediately after endotracheal intubation. Patients in the control group (Group C, n = 1,082) did not receive AMP.
Statistical analysis was performed to compare the AMP group (Group A + Group B) with the control group (Group C). Drug-induced acute reactions correlated to PIPC or CEZ did not occur in the AMP group. No significant differences in the postoperative incidence of liver or renal dysfunction were seen between the AMP and control groups. Postoperative incidence of urinary tract infection was significantly higher in the control group (p = 0.002). The incidence of SSI events was very low, with only 1 event (0.09 %) in the AMP group and 3 events (0.28 %) in the control group, and this difference between groups was not significant (p = 0.371).
AMP is not necessary to prevent SSI after clean thyroid or parathyroid surgery.
甲状腺和甲状旁腺手术后抗菌药物预防(AMP)在预防手术部位感染(SSI)方面的有效性仍不确定。这项前瞻性随机对照试验(Ito-RCT1)的目的是评估AMP在治疗甲状腺和甲状旁腺疾病的颈部清洁手术中的有效性。
参与者包括计划在伊藤医院进行甲状腺和甲状旁腺疾病颈部清洁手术的患者。手术包括胸骨切开术或气管、喉、咽或食管切除术的患者被排除。AMP由气管插管后立即静脉注射2克哌拉西林(PIPC)(A组,n = 541)或1克头孢唑林(CEZ)(B组,n = 541)组成。对照组(C组,n = 1082)的患者未接受AMP。
进行统计分析以比较AMP组(A组+B组)与对照组(C组)。AMP组未发生与PIPC或CEZ相关的药物性急性反应。AMP组和对照组术后肝肾功能障碍的发生率无显著差异。对照组术后尿路感染的发生率显著更高(p = 0.002)。SSI事件的发生率非常低,AMP组仅有1例(0.09%),对照组有3例(0.28%),两组之间的差异不显著(p = 0.371)。
在清洁的甲状腺或甲状旁腺手术后预防SSI无需使用AMP。