不可吸收双糖与安慰剂/无干预、乳果糖与乳醇预防和治疗肝硬化患者肝性脑病的比较
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Gluud LL, Vilstrup H, Morgan m
不可吸收双糖与安慰剂/无干预、乳果糖与乳醇预防和治疗肝硬化患者肝性脑病的比较
Cochrane Database system Rev. 2016 5月6日;(5):CD003044。cd003044.pub4 doi: 10.1002/14651858.。
- PubMed ID
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27153247 (PubMed视图]
- 摘要
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背景:不可吸收的双糖(乳果糖和乳醇)被推荐作为肝性脑病的一线治疗。本综述的前一个(第二)版本包括10项随机临床试验(rct)，评估不可吸收双糖与安慰剂/无干预的疗效，8项随机临床试验评估乳果糖与乳醇对肝硬化和肝性脑病患者的疗效。该综述没有发现支持或反对使用不可吸收双糖的证据，乳果糖和乳醇之间也没有差异。目的:评估在肝硬化和肝性脑病患者中，1)不可吸收双糖与安慰剂/无干预和2)乳果糖与乳醇的有益和有害影响。必威国际app检索方法:我们对Cochrane肝胆对照试验注册库、Cochrane中央对照试验注册库(Central 2015，第10期)、MEDLINE、EMBASE和Science Citation Index(扩展至2015年10月19日)进行了电子检索;手工检索会议和必威国际app会议记录;查阅书目;以及与调查人员和制药公司的通信。选择标准:我们纳入随机对照试验，不论其发表状态、语言或盲法。数据收集和分析:两名独立工作的综述作者从已发表的报告和与研究者的通信中检索数据。 The primary outcomes were mortality, hepatic encephalopathy, and serious adverse events. We presented the results of meta-analyses as risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI). We assessed the quality of the evidence using 'Grading of Recommendations Assessment Development and Evaluation' (GRADE) and bias control using the Cochrane Hepato-Biliary Group domains. Our analyses included regression analyses of publication bias and other small study effects, Trial Sequential Analyses to detect type 1 and type 2 errors, and subgroup and sensitivity analyses. MAIN RESULTS: We included 38 RCTs with a total of 1828 participants. Eight RCTs had a low risk of bias in the assessment of mortality. All trials had a high risk of bias in the assessment of the remaining outcomes. Random-effects meta-analysis showed a beneficial effect of non-absorbable disaccharides versus placebo/no intervention on mortality when including all RCTs with extractable data (RR 0.59, 95% CI 0.40 to 0.87; 1487 participants; 24 RCTs; I(2) = 0%; moderate quality evidence) and in the eight RCTs with a low risk of bias (RR 0.63, 95% CI 0.41 to 0.97; 705 participants). The Trial Sequential Analysis with the relative risk reduction (RRR) reduced to 30% confirmed the findings when including all RCTs, but not when including only RCTs with a low risk of bias or when we reduced the RRR to 22%. Compared with placebo/no intervention, the non-absorbable disaccharides were associated with beneficial effects on hepatic encephalopathy (RR 0.58, 95% CI 0.50 to 0.69; 1415 participants; 22 RCTs; I(2) = 32%; moderate quality evidence). Additional analyses showed that non-absorbable disaccharides can help to reduce serious adverse events associated with the underlying liver disease including liver failure, hepatorenal syndrome, and variceal bleeding (RR 0.47, 95% CI 0.36 to 0.60; 1487 participants; 24 RCTs; I(2) = 0%; moderate quality evidence). We confirmed the results in Trial Sequential Analysis. Tests for subgroup differences showed no statistical differences between RCTs evaluating prevention, overt, or minimal hepatic encephalopathy. The evaluation of secondary outcomes showed a potential beneficial effect of the non-absorbable disaccharides on quality of life, but we were not able to include the data in an overall meta-analysis (very low quality evidence). Non-absorbable disaccharides were associated with non-serious (mainly gastrointestinal) adverse events (very low quality evidence). None of the RCTs comparing lactulose versus lactitol evaluated quality of life. The review found no differences between lactulose and lactitol for the remaining outcomes (very low quality evidence). AUTHORS' CONCLUSIONS: This review includes a large number of RCTs evaluating the prevention or treatment of hepatic encephalopathy. The analyses found evidence that non-absorbable disaccharides may be associated with a beneficial effect on clinically relevant outcomes compared with placebo/no intervention.
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