Gurusamy Kurinchi Selvan, Koti Rahul, Fusai Giuseppe, Davidson Brian R
University Department of Surgery, Royal Free Hospital and University College School of Medicine, 9th Floor, Royal Free Hospital, Pond Street, London, UK, NW3 2QG.
Cochrane Database Syst Rev. 2010 Feb 17(2):CD008370. doi: 10.1002/14651858.CD008370.
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 2009, issue 4), MEDLINE, EMBASE and Science Citation Index Expanded to November 2009.
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 authors independently assessed trials for inclusion and independently extracted data. We analysed data with both the fixed-effect and the 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 per protocol analysis.
We identified 17 trials (of high risk of bias) involving 2143 patients. The overall number of patients with postoperative complications was lower in the somatostatin analogue group (RR 0.71; 95% CI 0.62 to 0.82) but there was no difference in the perioperative mortality, re-operation rate or hospital stay between the groups. The incidence of pancreatic fistula was lower in the somatostatin analogue group (RR 0.64; 95% CI 0.53 to 0.78). 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 difference between the two groups (RR 0.69; 95% CI 0.34 to 1.41). Subgroup analysis revealed a shorter hospital stay in the somatostatin analogue group than the controls for patients with malignant aetiology (MD -7.57; 95% CI -11.29 to -3.84).
AUTHORS' CONCLUSIONS: Somatostatin analogues reduce perioperative complications but do not reduce perioperative mortality. In those undergoing pancreatic surgery for malignancy, they shorten hospital stay. 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 patients undergoing pancreatic resection for malignancy. There is currently no evidence to support their routine use in pancreatic surgeries performed for other indications.
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。
确定预防性生长抑素类似物是否应在胰腺手术中常规使用。
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》2009年第4期）、MEDLINE、EMBASE和科学引文索引扩展版至2009年11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一种类似物与不使用药物或安慰剂的随机对照试验（不论语言或发表状态）。
两位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）、均值差（MD）或标准化均值差（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17项（偏倚风险高）涉及2143例患者的试验。生长抑素类似物组术后并发症的总体患者数量较少（RR 0.71；95%CI 0.62至0.82），但两组之间围手术期死亡率、再次手术率或住院时间无差异。生长抑素类似物组胰瘘发生率较低（RR 0.64；95%CI 0.53至0.78）。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，两组之间无差异（RR 0.69；95%CI 0.34至1.41）。亚组分析显示，病因恶性的患者中，生长抑素类似物组的住院时间比对照组短（MD -7.57；95%CI -11.29至-3.84）。
生长抑素类似物可减少围手术期并发症，但不能降低围手术期死亡率。对于因恶性肿瘤接受胰腺手术的患者，它们可缩短住院时间。有必要进行进一步的、偏倚风险低且样本量充足的试验。基于目前可得的证据，推荐生长抑素及其类似物在因恶性肿瘤接受胰腺切除术的患者中常规使用。目前没有证据支持其在因其他适应证进行的胰腺手术中常规使用。
