Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Am J Gastroenterol. 2023 Feb 1;118(2):284-293. doi: 10.14309/ajg.0000000000002008. Epub 2022 Aug 22.
Patients with hepatic encephalopathy (HE) suffer from significant symptoms and impaired quality of life. Improved understanding on the potential benefits of first-line HE therapies may aid patient-provider discussions regarding expected benefits of HE treatments. We aimed to perform a systematic review to assess the effects of lactulose and rifaximin on patient-reported outcomes (PROs).
We searched MEDLINE, EMBASE, and Cochrane Library databases for randomized trials or prospective cohort studies using lactulose and/or rifaximin for the management of HE and assessing changes in PRO using PRO instruments. Physician reviewers independently reviewed titles, abstracts, and full texts and extracted data independently. We performed random-effects meta-analyses to examine the effects of lactulose and rifaximin on PROs.
We identified 16 studies representing 1,376 patients that met inclusion criteria. Most studies assessed treatment of covert HE. In patients with covert HE, lactulose significantly improved overall patient-reported health-related quality of life measured by the Sickness Impact Profile with an estimated pooled mean difference of 6.92 (95% confidence interval: 6.66-7.18) and showed improvements in several subscales. Conversely, rifaximin demonstrated a nonstatistically significant mean difference in the total Sickness Impact Profile of 4.76 (95% confidence interval: -4.23 to 13.76), with strong evidence of heterogeneity between these studies. Studies examining other PRO instruments showed improvements in overall health-related quality of life, social functioning, and sleep from both lactulose and rifaximin.
Patients with HE treated with lactulose or rifaximin reported improvements in important PROs. These results may inform provider-patient communication and help manage patient expectations regarding the potential benefits of HE therapies.
肝性脑病（HE）患者会出现明显症状和生活质量受损。对一线 HE 治疗潜在获益的深入了解，可能有助于患者与医务人员讨论 HE 治疗的预期获益。我们旨在进行系统评价，评估乳果糖和利福昔明对患者报告结局（PRO）的影响。
我们检索了 MEDLINE、EMBASE 和 Cochrane 图书馆数据库，纳入了使用乳果糖和/或利福昔明治疗 HE 并使用 PRO 工具评估 PRO 变化的随机试验或前瞻性队列研究。由两位医师独立审查标题、摘要和全文，并独立提取数据。我们进行了随机效应荟萃分析，以评估乳果糖和利福昔明对 PRO 的影响。
我们确定了 16 项研究，共纳入了 1376 名符合纳入标准的患者。大多数研究评估了隐匿性 HE 的治疗。在隐匿性 HE 患者中，乳果糖显著改善了整体患者报告的健康相关生活质量，表现在 Sickness Impact Profile 上的估计合并均差为 6.92（95%置信区间：6.66-7.18），并在几个亚量表中显示出改善。相比之下，利福昔明在 Sickness Impact Profile 总分上的平均差异无统计学意义，为 4.76（95%置信区间：-4.23 至 13.76），且这些研究之间存在高度异质性。研究其他 PRO 工具的研究显示，乳果糖和利福昔明均可改善整体健康相关生活质量、社会功能和睡眠。
接受乳果糖或利福昔明治疗的 HE 患者报告 PRO 有显著改善。这些结果可能为医患沟通提供信息，并有助于管理患者对 HE 治疗潜在获益的期望。
