Tandon Puneeta, Rowe Brian H, Vandermeer Ben, Bain Vincent G
Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
Am J Gastroenterol. 2007 Jul;102(7):1528-36. doi: 10.1111/j.1572-0241.2007.01200.x. Epub 2007 Mar 31.
The objective of this review was to evaluate the efficacy and safety of rifampin, opioid antagonists, or bile acid binding agents in the treatment of cholestasis-related pruritus (CAP) from available randomized controlled trial evidence.
In addition to a comprehensive gray literature search, the Cochrane Library, MEDLINE, EMBASE, PubMed, and Web of Science were searched. Only full-text RCTs in participants (>75% adult) with CAP on at least one of the three medications were included. The primary outcome was change in pruritus score, recorded as a continuous or dichotomous outcome. Two independent reviewers performed trial selection and quality assessment.
From 487 citations, 12 RCTs were included. Rifampin (standardized mean difference [SMD]-1.62, 95% CI -3.05 to -0.18) and opioid antagonists (SMD -0.68, 95% CI -1.19 to -0.17) significantly reduced CAP. The two cholestyramine studies were too heterogeneous to pool. Although cholestyramine (P= 0.35) and rifampin (P= 0.96) were not associated with greater side effects compared with placebo, opioid antagonists were (number needed to harm = 2.6, 95% CI 1.4-25).
The available RCTs are small, few in number, and use varying scales for measuring pruritus. Although both opioid antagonists and rifampin demonstrated a reduction in pruritus, there were insufficient data to judge the efficacy of cholestyramine. Opioid antagonists were associated with transient side effects in a significant proportion of patients. A longer well-designed randomized controlled trial is needed to confirm the efficacy of bile acid binding agents and accurately assess adverse events.
本综述的目的是根据现有随机对照试验证据，评估利福平、阿片类拮抗剂或胆汁酸结合剂治疗胆汁淤积相关瘙痒（CAP）的疗效和安全性。
除了全面检索灰色文献外，还检索了Cochrane图书馆、MEDLINE、EMBASE、PubMed和Web of Science。纳入的研究仅为至少使用三种药物之一治疗CAP的参与者（>75%为成年人）的全文随机对照试验。主要结局为瘙痒评分的变化，记录为连续或二分结局。两名独立的评审员进行试验筛选和质量评估。
从487篇文献中，纳入了12项随机对照试验。利福平（标准化均数差[SMD]-1.62，95%CI-3.05至-0.18）和阿片类拮抗剂（SMD-0.68，95%CI-1.19至-0.17）显著减轻了CAP。两项考来烯胺研究异质性太大，无法合并。虽然与安慰剂相比，考来烯胺（P=0.35）和利福平（P=0.96）与更多副作用无关，但阿片类拮抗剂却有关（伤害所需人数=2.6，95%CI 1.4-25）。
现有的随机对照试验规模小、数量少，且使用不同的量表来测量瘙痒。虽然阿片类拮抗剂和利福平均显示瘙痒减轻，但考来烯胺疗效的数据不足。相当一部分患者中，阿片类拮抗剂会出现短暂的副作用。需要进行一项设计更完善的长期随机对照试验，以确认胆汁酸结合剂的疗效并准确评估不良事件。
