Poropat Goran, Giljaca Vanja, Hauser Goran, Štimac Davor
Department of Gastroenterology, Clinical Hospital Centre Rijeka, Kresimirova 42, Rijeka, Croatia, 51000.
Cochrane Database Syst Rev. 2015 Mar 23;2015(3):CD010605. doi: 10.1002/14651858.CD010605.pub2.
Acute pancreatitis is a common and potentially lethal disease with increasing incidence. Severe cases are characterised by high mortality, and despite improvements in intensive care management, no specific treatment relevantly improves clinical outcomes of the disease. Meta-analyses suggest that enteral nutrition is more effective than conventional treatment consisting of discontinuation of oral intake with use of total parenteral nutrition. However, no systematic review has compared different enteral nutrition formulations for the treatment of patients with acute pancreatitis.
To assess the beneficial and harmful effects of different enteral nutrition formulations in patients with acute pancreatitis.
We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Specialised Register of Clinical Trials, the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 7), MEDLINE (from inception to 20 August 2013), EMBASE (from inception to 2013, week 33) and Science Citation Index-Expanded (from 1990 to August 2013); we conducted full-text searches and applied no restrictions by language or publication status.
We considered randomised clinical trials assessing enteral nutrition in patients with acute pancreatitis. We allowed concomitant interventions if they were received equally by all treatment groups within a trial.
Two review authors independently assessed trials for inclusion and extracted data. We performed the analysis using Review Manager 5 (Review Manager 2013) and both fixed-effect and random-effects models. We expressed results as risk ratios (RRs) for dichotomous data, and as mean differences (MDs) for continuous data, both with 95% confidence intervals (CIs). Analysis was based on an intention-to-treat principle.
We included 15 trials (1376 participants) in this review. We downgraded the quality of evidence for many of our outcomes on the basis of high risk of bias. Low-quality evidence suggests that immunonutrition decreases all-cause mortality (RR 0.49, 95% CI 0.29 to 0.80). The effect of immunonutrition on other outcomes from a subset of the included trials was uncertain. Subgrouping trials by type of enteral nutrition did not explain any variation in effect. We found mainly very low-quality evidence for the effects of probiotics on the main outcomes. One eligible trial in this comparison reported a higher rate of serious adverse events leading to increased organ failure and mortality due to low numbers of events and low risk of bias. When we excluded this study as a post hoc sensitivity analysis, risks of mortality (RR 0.30, 95% CI 0.10 to 0.84), organ failure (RR 0.74, 95% CI 0.59 to 0.92) and local septic complications (RR 0.40, 95% CI 0.22 to 0.72) were lower with probiotics. In one trial assessing immunonutrition with probiotics and fibres, no deaths occurred, but hospital stay was shorter with immunonutrition (MD -5.20 days, 95% CI -8.73 to -1.67). No deaths were reported following semi-elemental enteral nutrition (EN), and the effect on length of hospital stay was small (MD 0.30 days, 95% CI -0.82 to 1.42). Fibre-enriched formulations reduced the number of other local complications (RR 0.52, 95% CI 0.32 to 0.87) and length of hospital stay (MD -9.28 days, 95% CI -13.21 to -5.35) but did not significantly affect all-cause mortality (RR 0.23, 95% CI 0.03 to 1.84) and other outcomes. Very low-quality evidence from the subgroup of trials comparing EN versus no intervention showed a decrease in all-cause mortality with EN (RR 0.50, 95% CI 0.29 to 0.86).
AUTHORS' CONCLUSIONS: We found evidence of low or very low quality for the effects of immunonutrition on efficacy and safety outcomes. The role of supplementation of enteral nutrition with potential immunomodulatory agents remains in question, and further research is required in this area. Studies assessing probiotics yielded inconsistent and almost contrary results, especially regarding safety and adverse events, and their findings do not support the routine use of EN enriched with probiotics in routine clinical practice. However, further research should be carried out to try to determine the potential efficacy or harms of probiotics. Lack of trials reporting on other types of EN assessed and lack of firm evidence regarding their effects suggest that additional randomised clinical trials are needed. The quality of evidence for the effects of any kind of EN on mortality was low, and further studies are likely to have an impact on the finding of improved survival with EN versus no nutritional support. Evidence remains insufficient to support the use of a specific EN formulation.
急性胰腺炎是一种常见且可能致命的疾病,发病率呈上升趋势。重症病例的特点是死亡率高,尽管重症监护管理有所改善,但尚无特异性治疗方法能显著改善该病的临床结局。荟萃分析表明,肠内营养比包括禁食并使用全胃肠外营养的传统治疗更有效。然而,尚无系统评价比较不同肠内营养制剂对急性胰腺炎患者的治疗效果。
评估不同肠内营养制剂对急性胰腺炎患者的有益和有害影响。
我们检索了Cochrane上消化道和胰腺疾病组临床试验专门注册库、Cochrane对照试验中央注册库(CENTRAL)(2013年第7期)、MEDLINE(从创刊至2013年8月20日)、EMBASE(从创刊至2013年第33周)和科学引文索引扩展版(从1990年至2013年8月);我们进行了全文检索,且未对语言或出版状态设限。
我们纳入评估急性胰腺炎患者肠内营养的随机临床试验。如果一项试验中的所有治疗组均同等接受伴随干预措施,则允许纳入。
两位综述作者独立评估纳入试验并提取数据。我们使用Review Manager 5(Review Manager 2013)以及固定效应和随机效应模型进行分析。对于二分法数据,我们将结果表示为风险比(RRs),对于连续数据,表示为均值差(MDs),两者均伴有95%置信区间(CIs)。分析基于意向性分析原则。
本综述纳入了15项试验(1376名参与者)。基于高偏倚风险,我们对许多结局的证据质量进行了降级。低质量证据表明,免疫营养可降低全因死亡率(RR 0.49,95%CI 0.29至0.80)。免疫营养对纳入试验子集的其他结局的影响尚不确定。按肠内营养类型对试验进行亚组分析未解释任何效应差异。我们发现关于益生菌对主要结局影响的证据质量主要非常低。该比较中的一项合格试验报告称,由于事件数量少且偏倚风险低,严重不良事件发生率较高,导致器官衰竭和死亡率增加。当我们将该研究作为事后敏感性分析排除后,使用益生菌时死亡率(RR 0.30,95%CI 0.10至0.84)、器官衰竭(RR 0.74,95%CI 0.59至0.92)和局部感染并发症(RR 0.40,95%CI 0.22至0.72)的风险较低。在一项评估含益生菌和纤维的免疫营养的试验中,未发生死亡,但免疫营养组的住院时间较短(MD -5.20天,95%CI -8.73至-1.67)。半要素肠内营养(EN)后未报告死亡,对住院时间的影响较小(MD 0.30天,95%CI -0.82至1.42)。富含纤维的制剂减少了其他局部并发症的数量(RR 0.52,95%CI 0.32至0.87)和住院时间(MD -9.28天,95%CI -13.21至-5.35),但未显著影响全因死亡率(RR 0.23,95%CI 0.03至1.84)和其他结局。比较EN与不干预的试验亚组的极低质量证据表明,EN可降低全因死亡率(RR 0.50,95%CI 0.29至0.86)。
我们发现免疫营养对疗效和安全性结局影响的证据质量低或非常低。肠内营养补充潜在免疫调节因子的作用仍存在疑问,并需要在该领域进行进一步研究。评估益生菌的研究结果不一致且几乎相反,尤其是在安全性和不良事件方面,其结果不支持在常规临床实践中常规使用含益生菌的EN。然而,应开展进一步研究以确定益生菌的潜在疗效或危害。缺乏关于评估的其他类型EN的试验报告以及其影响的确凿证据表明,需要更多随机临床试验。任何类型的EN对死亡率影响的证据质量低,进一步研究可能会影响EN与无营养支持相比改善生存的研究结果。证据仍不足以支持使用特定的EN制剂。