Sanabria Alvaro, Dominguez Luis C, Valdivieso Eduardo, Gomez Gabriel
Department of Surgery, School of Medicine-Universidad de La Sabana, Fundación Abood Shaio, Campus Puente del Comun km 21 via Chia, Chia, Cundinamarca, Colombia.
Cochrane Database Syst Rev. 2010 Dec 8(12):CD005265. doi: 10.1002/14651858.CD005265.pub2.
Cholecystectomy is a common surgical procedure. In the open cholecystectomy area, antibiotic prophylaxis showed beneficial effects, but it is not known if its benefits and harms are similar in laparoscopic cholecystectomy. Some clinical trials suggest that antibiotic prophylaxis may not be necessary in laparoscopic cholecystectomy.
To assess the beneficial and harmful effects of antibiotic prophylaxis versus placebo or no prophylaxis for patients undergoing elective laparoscopic cholecystectomy.
We searched the The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 3, 2010), MEDLINE (1985 to August 2010), EMBASE (1985 to August 2010), SCI-EXPANDED (1985 to August 2010), LILACS (1988 to August 2010) as well as reference lists of relevant articles.
Randomised clinical trials comparing antibiotic prophylaxis versus placebo or no prophylaxis in patients undergoing elective laparoscopic cholecystectomy.
Our outcome measures were all-cause mortality, surgical site infections, extra-abdominal infections, adverse events, and quality of life. All outcome measures were confined to within hospitalisation or 30 days after discharge. We summarised the outcome measures by reporting odds ratios and 95% confidence intervals (CI), using both the fixed-effect and the random-effects models.
We included eleven randomised clinical trials with 1664 participants who were mostly at low anaesthetic risk, low frequency of co-morbidities, low risk of conversion to open surgery, and low risk of infectious complications. None of the trials had low risk of bias. We found no statistically significant differences between antibiotic prophylaxis and no prophylaxis in the proportion of surgical site infections (odds ratio (OR) 0.87, 95% CI 0.49 to 1.54) or extra-abdominal infections (OR 0.77, 95% CI 0.41 to 1.46). Heterogeneity was not statistically significant.
AUTHORS' CONCLUSIONS: This systematic review shows that there is not sufficient evidence to support or refute the use of antibiotic prophylaxis to reduce surgical site infection and global infections in patients with low risk of anaesthetic complications, co-morbidities, conversion to open surgery, and infectious complications, and undergoing elective laparoscopic cholecystectomy. Larger randomised clinical trials with intention-to-treat analysis and patients also at high risk of conversion to open surgery are needed.
胆囊切除术是一种常见的外科手术。在开腹胆囊切除术领域，抗生素预防显示出有益效果，但在腹腔镜胆囊切除术中其利弊是否相似尚不清楚。一些临床试验表明，腹腔镜胆囊切除术中可能无需使用抗生素预防。
评估抗生素预防与安慰剂或不预防对接受择期腹腔镜胆囊切除术患者的有益和有害影响。
我们检索了Cochrane肝胆疾病组对照试验注册库、Cochrane图书馆（2010年第3期）中的Cochrane对照试验中心注册库（CENTRAL）、MEDLINE（1985年至2010年8月）、EMBASE（1985年至2010年8月）、SCI-EXPANDED（1985年至2010年8月）、LILACS（1988年至2010年8月）以及相关文章的参考文献列表。
比较抗生素预防与安慰剂或不预防对接受择期腹腔镜胆囊切除术患者的随机临床试验。
我们的结局指标包括全因死亡率、手术部位感染、腹部外感染、不良事件和生活质量。所有结局指标均限于住院期间或出院后30天内。我们使用固定效应模型和随机效应模型，通过报告比值比和95%置信区间（CI）来总结结局指标。
我们纳入了11项随机临床试验，共1664名参与者，这些参与者大多麻醉风险低、合并症发生率低、转为开腹手术的风险低且感染并发症风险低。没有一项试验的偏倚风险低。我们发现，在手术部位感染比例（比值比（OR）0.87，95%CI 0.49至1.54）或腹部外感染比例（OR 0.77，95%CI 0.41至1.46）方面，抗生素预防与不预防之间无统计学显著差异。异质性无统计学显著性。
本系统评价表明，对于麻醉并发症、合并症、转为开腹手术及感染并发症风险低且接受择期腹腔镜胆囊切除术的患者，没有足够证据支持或反驳使用抗生素预防来降低手术部位感染和总体感染。需要开展更大规模的意向性分析随机临床试验，纳入转为开腹手术风险也高的患者。
