Gurusamy Kurinchi Selvan, Koti Rahul, Fusai Giuseppe, Davidson Brian R
Department of Surgery, Royal Free Campus, UCL Medical School, London, UK.
Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD008370. doi: 10.1002/14651858.CD008370.pub3.
Pancreatic resections are associated with high morbidity (30% to 60%) and mortality (5%). Synthetic analogues of somatostatin are advocated by some surgeons to reduce complications following pancreatic surgery; however, their use is controversial.
To determine whether prophylactic somatostatin analogues should be used routinely in pancreatic surgery.
We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 1), MEDLINE, EMBASE and Science Citation Index Expanded to February 2013.
We included randomised controlled trials comparing prophylactic somatostatin or one of its analogues versus no drug or placebo during pancreatic surgery (irrespective of language or publication status).
Two review authors independently assessed trials for inclusion and independently extracted data. We analysed data with both the fixed-effect and random-effects models using Review Manager (RevMan). We calculated the risk ratio (RR), mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) based on an intention-to-treat or available case analysis. When it was not possible to perform either of the above, we performed a per protocol analysis.
We identified 21 trials (19 trials of high risk of bias) involving 2348 people. There was no significant difference in the perioperative mortality (RR 0.80; 95% CI 0.56 to 1.16; n = 2210) or the number of people with drug-related adverse effects between the two groups (RR 2.09; 95% CI 0.83 to 5.24; n = 1199). Quality of life was not reported in any of the trials. The overall number of participants with postoperative complications was significantly lower in the somatostatin analogue group (RR 0.70; 95% CI 0.61 to 0.80; n = 1903) but there was no significant difference in the re-operation rate (RR 1.26; 95% CI 0.58 to 2.70; n = 687) or hospital stay (MD -1.29 days; 95% CI -2.60 to 0.03; n = 1314) between the groups. The incidence of pancreatic fistula was lower in the somatostatin analogue group (RR 0.66; 95% CI 0.55 to 0.79; n = 2206). The proportion of these fistulas that were clinically significant was not mentioned in most trials. On inclusion of trials that clearly distinguished clinically significant fistulas, there was no significant difference between the two groups (RR 0.69; 95% CI 0.38 to 1.28; n = 292).
AUTHORS' CONCLUSIONS: Somatostatin analogues may reduce perioperative complications but do not reduce perioperative mortality. Further adequately powered trials with low risk of bias are necessary. Based on the current available evidence, somatostatin and its analogues are recommended for routine use in people undergoing pancreatic resection.
胰腺切除术的发病率（30%至60%）和死亡率（5%）都很高。一些外科医生主张使用生长抑素的合成类似物来减少胰腺手术后的并发症；然而，其使用存在争议。
确定胰腺手术中是否应常规使用预防性生长抑素类似物。
我们检索了Cochrane上消化道和胰腺疾病组试验注册库、Cochrane对照试验中央注册库（CENTRAL）（《Cochrane图书馆》2013年第1期）、MEDLINE、EMBASE和科学引文索引扩展版，检索截至2013年2月。
我们纳入了比较胰腺手术期间预防性使用生长抑素或其类似物之一与不使用药物或安慰剂的随机对照试验（无论语言或发表状态如何）。
两位综述作者独立评估试验是否纳入并独立提取数据。我们使用Review Manager（RevMan）软件，采用固定效应模型和随机效应模型对数据进行分析。我们基于意向性分析或可用病例分析计算风险比（RR）、平均差（MD）或标准化平均差（SMD）及其95%置信区间（CI）。当无法进行上述任何一种分析时，我们进行符合方案分析。
我们识别出21项试验（19项试验存在高偏倚风险），涉及2348人。两组之间围手术期死亡率（RR 0.80；95%CI 0.56至1.16；n = 2210）或药物相关不良反应人数无显著差异（RR 2.09；95%CI 0.83至5.24；n = 1199）。所有试验均未报告生活质量。生长抑素类似物组术后并发症参与者的总数显著更低（RR 0.70；95%CI 0.61至0.80；n = 1903），但两组之间再次手术率（RR 1.26；95%CI 0.58至2.70；n = 687）或住院时间（MD -1.29天；95%CI -2.60至0.03；n = 1314）无显著差异。生长抑素类似物组胰瘘发生率更低（RR 0.66；95%CI 0.55至0.79；n = 2206）。大多数试验未提及这些胰瘘中具有临床意义的比例。纳入明确区分具有临床意义的胰瘘的试验后，两组之间无显著差异（RR 0.69；95%CI 0.38至1.28；n = 292）。
生长抑素类似物可能减少围手术期并发症，但不能降低围手术期死亡率。有必要进行进一步的、偏倚风险低且样本量充足的试验。基于当前可得证据，推荐生长抑素及其类似物在接受胰腺切除术的患者中常规使用。
