Avenia Nicola, Sanguinetti Alessandro, Cirocchi Roberto, Docimo Giovanni, Ragusa Mark, Ruggiero Roberto, Procaccini Eugenio, Boselli Carlo, D'Ajello Fabio, Barberini Francesco, Parmeggiani Domenico, Rosato Lodovico, Sciannameo Francesco, De Toma Giorgio, Noya Giuseppe
Endocrine Surgical Unit, University of Perugia, Italy.
General Surgical Unit, University of Perugia, Italy.
Ann Surg Innov Res. 2009 Aug 5;3:10. doi: 10.1186/1750-1164-3-10.
Post-operatory wound infections are a very uncommon finding after thyroidectomy. For these reasons international guidelines do not routinely recommend systemic antibiotic prophylaxis. The benefits of this antibiotic prophylaxis is not supported by clinical evidence in the literature. We have conducted a multicentric randomized double-blind trial on 500 patients who had undergone thyroidectomy for goitre or thyroid carcinoma. The 500 patients enrolled in the study (mean age 47 years) were randomized in two subgroups of 250 patients. 250 patients were treated with standard antibiotic prophylaxis with sulbactam/ampicillin 1 fl (3 gr.) 30 min before surgery. No antibiotic prophylaxis was instituted in the remainder 250 patients. Our RCT showed that prophylactic antibiotic treatment is not beneficial in patients younger than eighty years old, with no concomitant metabolic, infective and hematologic disease, with no cardiac valvulopathies, not under steroidal or immunosuppressive treatment, and not severely obese. Our study should be regarded only as a preliminary RCT, and should be followed by a study in which a larger number of patients should be enrolled so that statistically significant data can be obtained.
甲状腺切除术后手术伤口感染是一种非常罕见的情况。基于这些原因，国际指南并不常规推荐全身性抗生素预防。文献中的临床证据并不支持这种抗生素预防的益处。我们对500例因甲状腺肿或甲状腺癌接受甲状腺切除术的患者进行了一项多中心随机双盲试验。纳入研究的500例患者（平均年龄47岁）被随机分为两个亚组，每组250例。250例患者在手术前30分钟接受标准抗生素预防，使用舒巴坦/氨苄西林1fl（3克）。其余250例患者未进行抗生素预防。我们的随机对照试验表明，预防性抗生素治疗对年龄小于80岁、无合并代谢性、感染性和血液学疾病、无心脏瓣膜病、未接受类固醇或免疫抑制治疗且非严重肥胖的患者并无益处。我们的研究仅应被视为一项初步随机对照试验，后续应进行一项纳入更多患者的研究，以便获得具有统计学意义的数据。
