Gomes Claudio A R, Andriolo Régis B, Bennett Cathy, Lustosa Suzana A S, Matos Delcio, Waisberg Daniel R, Waisberg Jaques
Department of Gastroenterological Surgery, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, São Paulo, Brazil.
Cochrane Database Syst Rev. 2015 May 22;2015(5):CD008096. doi: 10.1002/14651858.CD008096.pub4.
A number of conditions compromise the passage of food along the digestive tract. Nasogastric tube (NGT) feeding is a classic, time-proven technique, although its prolonged use can lead to complications such as lesions to the nasal wing, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia. Another method of infusion, percutaneous endoscopy gastrostomy (PEG), is generally used when there is a need for enteral nutrition for a longer time period. There is a high demand for PEG in patients with swallowing disorders, although there is no consistent evidence about its effectiveness and safety as compared to NGT.
To evaluate the effectiveness and safety of PEG compared with NGT for adults with swallowing disturbances.
We searched The Cochrane Library, MEDLINE, EMBASE, and LILACS from inception to January 2014, and contacted the main authors in the subject area. There was no language restriction in the search.
We planned to include randomised controlled trials comparing PEG versus NGT for adults with swallowing disturbances or dysphagia and indications for nutritional support, with any underlying diseases. The primary outcome was intervention failure (e.g. feeding interruption, blocking or leakage of the tube, no adherence to treatment).
We used standard methodological procedures expected by The Cochrane Collaboration. For dichotomous and continuous variables, we used risk ratio (RR) and mean difference (MD), respectively with the random-effects statistical model and 95% confidence interval (CI). We assumed statistical heterogeneity when I² > 50%.
We included 11 randomised controlled studies with 735 participants which produced 16 meta-analyses of outcome data. Meta-analysis indicated that the primary outcome of intervention failure, occurred in lower proportion of participants with PEG compared to NGT (RR 0.18, 95% CI 0.05 to 0.59, eight studies, 408 participants, low quality evidence) and this difference was statistically significant. For this outcome, we also subgrouped the studies by endoscopic gastrostomy technique into pull, and push and not reported. We observed a significant difference favouring PEG in the pull subgroup (RR 0.07, 95% CI 0.01 to 0.35, three studies, 90 participants). Thepush subgroup contained only one clinical trial and the result favoured PEG (RR 0.05, 95% CI 0.00 to 0.74, one study, 33 participants) techniques. We found no statistically significant difference in cases where the technique was not reported (RR 0.43, 95% CI 0.13 to 1.44, four studies, 285 participants).There was no statistically significant difference between the groups for meta-analyses of the secondary outcomes of mortality (RR 0.86, 95% CI 0.58 to 1.28, 644 participants, nine studies, very low quality evidence), overall reports of any adverse event at any follow-up time point (ITT analysis, RR 0.83, 95% CI 0.51 to 1.34), 597 participants, 6 studies, moderate quality evidence), specific adverse events including pneumonia (aspiration) (RR 0.70, 95% CI 0.46 to 1.06, 645 participants, seven studies, low quality evidence), or for the meta- analyses of the secondary outcome of nutritional status including weight change from baseline, and mid-arm circumference at endpoint, although there was evidence in favour of PEG for meta-analyses of mid-arm circumference change from baseline (MD 1.16, 95% CI 1.01 to 1.31, 115 participants, two studies), and levels of serum albumin were higher in the PEG group (MD 6.03, 95% CI 2.31 to 9.74, 107 participants).For meta-analyses of the secondary outcomes of time on enteral nutrition, there was no statistically significant difference (MD 14.48, 95% CI -2.74 to 31.71; 119 participants, two studies). For meta-analyses of quality of life measures (EuroQol) outcomes in two studies with 133 participants, for inconvenience (RR 0.03, 95% CI 0.00 to 0.29), discomfort (RR 0.03, 95% CI 0.00 to 0.29), altered body image (RR 0.01, 95% CI 0.00 to 0.18; P = 0.001) and social activities (RR 0.01, 95% CI 0.00 to 0.18) the intervention favoured PEG, that is, fewer participants found the intervention of PEG to be inconvenient, uncomfortable or interfered with social activities. However, there were no significant differences between the groups for pain, ease of learning to use, or the secondary outcome of length of hospital stay (two studies, 381 participants).
AUTHORS' CONCLUSIONS: PEG was associated with a lower probability of intervention failure, suggesting the endoscopic procedure may be more effective and safe compared with NGT. There is no significant difference in mortality rates between comparison groups, or in adverse events, including pneumonia related to aspiration. Future studies should include details of participant demographics including underlying disease, age and gender, and the gastrostomy technique.
多种情况会影响食物在消化道中的通过。鼻胃管(NGT)喂养是一种经典且经过时间验证的技术,尽管长期使用可能会导致诸如鼻翼损伤、慢性鼻窦炎、胃食管反流和吸入性肺炎等并发症。另一种输注方法,即经皮内镜下胃造口术(PEG),通常在需要较长时间肠内营养时使用。吞咽障碍患者对PEG的需求很高,尽管与NGT相比,其有效性和安全性尚无一致证据。
评估PEG与NGT相比对吞咽障碍成人患者的有效性和安全性。
我们检索了Cochrane图书馆、MEDLINE、EMBASE和LILACS,检索时间从数据库建立至2014年1月,并联系了该领域的主要作者。检索无语言限制。
我们计划纳入比较PEG与NGT用于有吞咽障碍或吞咽困难且有营养支持指征的成年患者的随机对照试验,患者可患有任何基础疾病。主要结局是干预失败(例如喂养中断、管道堵塞或渗漏、不依从治疗)。
我们采用了Cochrane协作网期望的标准方法程序。对于二分变量和连续变量,我们分别使用风险比(RR)和均值差(MD),采用随机效应统计模型和95%置信区间(CI)。当I²>50%时,我们假定存在统计学异质性。
我们纳入了11项随机对照研究,共735名参与者,对结局数据进行了16项荟萃分析。荟萃分析表明,与NGT相比,PEG组干预失败的主要结局发生比例较低(RR 0.18,95%CI 0.05至0.59,8项研究,408名参与者,低质量证据),且该差异具有统计学意义。对于该结局,我们还按内镜下胃造口术技术将研究分为牵拉法、推注法和未报告技术的亚组。我们观察到牵拉法亚组中PEG具有显著优势(RR 0.07,95%CI 0.01至0.35,3项研究,90名参与者)。推注法亚组仅包含1项临床试验,结果显示PEG有优势(RR 0.05,95%CI 0.00至0.74,1项研究,33名参与者)。在未报告技术的情况下,我们未发现统计学显著差异(RR 0.43,95%CI 0.13至1.44,4项研究,285名参与者)。两组在死亡率的次要结局荟萃分析(RR 0.86,95%CI 0.58至1.28,644名参与者,9项研究,极低质量证据)、任何随访时间点任何不良事件的总体报告(意向性分析,RR 0.83,95%CI 0.51至1.34,597名参与者,6项研究,中等质量证据)、包括肺炎(吸入性)在内的特定不良事件(RR 0.70,95%CI 0.46至1.06,645名参与者,7项研究,低质量证据)方面,或在营养状况的次要结局荟萃分析(包括自基线起的体重变化和终点时的上臂围)方面,均未发现统计学显著差异,尽管有证据表明在自基线起上臂围变化的荟萃分析中PEG有优势(MD 1.16,95%CI 1.01至I.31,115名参与者,2项研究),且PEG组血清白蛋白水平更高(MD 6.03,95%CI 2.31至9.74,107名参与者)。在肠内营养时间的次要结局荟萃分析中,未发现统计学显著差异(MD 14.48,95%CI -2.74至31.71;119名参与者,2项研究)。在两项共133名参与者的研究中,对于生活质量测量(欧洲五维度健康量表)结局的荟萃分析,在不便(RR 0.03,95%CI 0.00至0.29)、不适(RR 0.03,95%CI 0.00至0.29)、身体形象改变(RR 0.01,95%CI 0.00至0.18;P = 0.001)和社交活动(RR 0.01,95%CI 0.00至0.18)方面,干预措施更倾向于PEG,即较少参与者认为PEG干预不便、不舒服或干扰社交活动。然而,在疼痛、学习使用的难易程度或住院时间的次要结局方面,两组之间无显著差异(2项研究,381名参与者)。
PEG与干预失败概率较低相关联,表明与NGT相比,内镜手术可能更有效且更安全。比较组之间的死亡率以及包括与吸入相关的肺炎在内的不良事件方面无显著差异。未来的研究应纳入参与者人口统计学细节,包括基础疾病、年龄和性别,以及胃造口术技术。