Gou Shanmiao, Yang Zhiyong, Liu Tao, Wu Heshui, Wang Chunyou
Crit Care. 2014 Mar 31;18(2):R57. doi: 10.1186/cc13809.
Necrotic tissue infection can worsen the prognosis of severe acute pancreatitis (SAP), and probiotics have been shown to be beneficial in reducing the infection rate in animal experiments and primary clinical trials. However, the results of multicenter randomized clinical trials have been contradictory. Our aim in this study was to systematically review and quantitatively analyze all randomized controlled trials with regard to important outcomes in patients with predicted SAP who received probiotics.
A systematic literature search of the PubMed, Embase and Cochrane Library databases was conducted using specific search terms. Eligible studies were randomized controlled trials that compared the effects of probiotic with placebo treatment in patients with predicted SAP. Mean difference (MD), risk ratio (RR) and 95% confidence interval (95% CI) were calculated using the Mantel-Haenszel fixed- and random-effects models. A meta-analysis on the use of probiotics in the treatment of critically ill patients was also performed to serve as a reference.
In this study, 6 trials comprising an aggregate total of 536 patients were analyzed. Significant heterogeneities were observed in the type, dose, treatment duration and clinical effects of probiotics in these trials. Systematic analysis showed that probiotics did not significantly affect the pancreatic infection rate (RR = 1.19, 95% CI = 0.74 to 1.93; P = 0.47), total infections (RR = 1.09, 95% CI = 0.80 to 1.48; P = 0.57), operation rate (RR = 1.42, 95% CI = 0.43 to 3.47; P = 0.71), length of hospital stay (MD = 2.45, 95% CI = -2.71 to 7.60; P = 0.35) or mortality (RR = 0.72, 95% CI = 0.42 to 1.45; P = 0.25).
Probiotics showed neither beneficial nor adverse effects on the clinical outcomes of patients with predicted SAP. However, significant heterogeneity was noted between the trials reviewed with regard to the type, dose and treatment duration of probiotics, which may have contributed to the heterogeneity of the clinical outcomes. The current data are not sufficient to draw a conclusion regarding the effects of probiotics on patients with predicted SAP. Carefully designed clinical trials are needed to validate the effects of particular probiotics given at specific dosages and for specific treatment durations.
坏死组织感染会使重症急性胰腺炎(SAP)的预后恶化,在动物实验和初步临床试验中,已证明益生菌有助于降低感染率。然而,多中心随机临床试验的结果却相互矛盾。本研究的目的是系统回顾并定量分析所有关于接受益生菌治疗的预测性SAP患者重要结局的随机对照试验。
使用特定检索词对PubMed、Embase和Cochrane图书馆数据库进行系统文献检索。符合条件的研究为比较益生菌与安慰剂治疗对预测性SAP患者疗效的随机对照试验。采用Mantel-Haenszel固定效应和随机效应模型计算平均差(MD)、风险比(RR)和95%置信区间(95%CI)。还对益生菌用于治疗重症患者进行了荟萃分析作为参考。
本研究分析了6项试验,共纳入536例患者。这些试验中益生菌的类型、剂量、治疗持续时间和临床效果存在显著异质性。系统分析表明,益生菌对胰腺感染率(RR = 1.19,95%CI = 0.74至1.93;P = 0.47)、总感染率(RR = 1.09,95%CI = 0.80至1.48;P = 0.57)、手术率(RR = 1.42,95%CI = 0.43至3.47;P = 0.71)、住院时间(MD = 2.45,95%CI = -2.71至7.60;P = 0.35)或死亡率(RR = 0.72,95%CI = 0.42至1.45;P = 0.25)均无显著影响。
益生菌对预测性SAP患者的临床结局既无有益影响也无不良影响。然而,在所回顾的试验中,益生菌的类型、剂量和治疗持续时间存在显著异质性,这可能导致了临床结局的异质性。目前的数据不足以得出益生菌对预测性SAP患者影响的结论。需要精心设计的临床试验来验证特定剂量和特定治疗持续时间的特定益生菌的效果。