Department of Surgery, Mora Hospital, Mora Lasarett, 79285 Mora, Sweden.
J Gastrointest Surg. 2010 Feb;14(2):329-34. doi: 10.1007/s11605-009-1056-7. Epub 2009 Nov 10.
In the absence of randomized controlled trials with sufficient power to assess the effectiveness of prophylactic antibiotics (PA), the best evidence is provided by large population-based register studies.
The Swedish Register of Gallstone Surgery and ERCP (GallRiks) started in May 2005 and reached 75% national coverage in 2007. During 2006 and 2007, a total of 16,400 operations were registered in GallRiks. In the present study, all elective procedures performed in 2006-2007 in units performing at least 25 operations annually were included in an analysis of the risk for postoperative infectious complications
Altogether 10,927 procedures were performed 2006-2007. Univariate logistic regression analysis revealed a paradoxical increase in postoperative infectious complications requiring antibiotic treatment and postoperative abscess if PA were given (p < 0.05). This increase disappeared in multivariate analysis with adjustment for age, gender, presence of cholecystitis, accidental gallbladder perforation, and presence of bile duct stones.
No benefit from PA was seen in this study on elective cholecystectomy. Although a randomized controlled trial could possibly show a reduction in the risk for postoperative infectious complications not detected in this study, such a reduction must be weighed against the risk of promoting drug resistance by the widespread use of PA.
在缺乏足够效力的随机对照试验来评估预防性抗生素（PA）的有效性的情况下，最大的证据来自于基于人群的大型登记研究。
瑞典胆囊结石手术和 ERCP 登记研究（GallRiks）于 2005 年 5 月启动，2007 年达到 75%的全国覆盖率。在 2006 年和 2007 年期间，GallRiks 共登记了 16400 例手术。在本研究中，对每年至少进行 25 例手术的单位进行的所有择期手术进行了分析，以评估术后感染性并发症的风险。
总共进行了 10927 例手术。单因素逻辑回归分析显示，如果给予 PA，则术后需要抗生素治疗和术后脓肿的感染性并发症呈反常增加（p<0.05）。经年龄、性别、胆囊炎、胆囊意外穿孔、胆管结石存在情况等因素调整的多因素分析后，这种增加消失了。
本研究中，PA 对择期胆囊切除术没有益处。虽然随机对照试验可能会显示出降低本研究未发现的术后感染性并发症的风险，但必须权衡这种降低风险与广泛使用 PA 促进耐药性的风险。
