考来维仑治疗胆汁酸性腹泻有效性和安全性的Meta分析-东南大学学报医学版

考来维仑治疗胆汁酸性腹泻有效性和安全性的Meta分析

单位：1. 东南大学医学院, 江苏南京 210009;
2. 东南大学附属中大医院消化内科, 江苏南京 210009

分类号：R574.62

出版年·卷·期（页码）：2020·39·第六期（806-811）

摘要：

目的：对新一代胆汁酸螯合剂考来维仑治疗胆汁酸性腹泻（BAD）的有效性和安全性进行Meta分析，并对比考来维仑和考来烯胺在剂型、剂量、不良反应、价格等方面的优劣。方法：在PubMed、Web of Science、Medline、EMBASE、Cochrane library、CNKI和万方等数据库检索文献，纳入使用考来维仑治疗BAD的相关资料。应用Stata 14.0计算考来维仑治疗有效率和不良反应发生率。根据非随机对照研究偏倚风险评估工具ROBINS-I的标准，对纳入研究进行偏倚风险评估。结果：纳入研究中考来维仑初始或二线治疗患者总计94例，有效63例，考来维仑治疗BAD的初始治疗总有效率为61.2%，二线治疗总有效率为53.3%，森林图合并有效率为60%（95%CI为0.34~0.86；I²=86.57%，P<0.05，存在异质性）。汇总考来维仑不良反应发生率为6%（95%CI为0.00~0.18；I²=51.74%，P=0.13，存在异质性）。结论：考来维仑对BAD，包括考来烯胺治疗失败后的BAD治疗安全有效。目前由于成本因素等，临床上多将考来维仑用于二线治疗，其有效性和安全性需要更多临床试验研究观察。

Objective: To analyze and evaluate the efficacy and safety of colesevelam, a new generation of bile acid sequestrant for treating bile acid diarrhea(BAD), by Meta-analysis; to assess the differences between colesevelam and cholestyramine in four aspects:drug form, dosage, adverse drug reaction(ADR) and price. Methods: Studies were collected from PubMed, Web of science, Medline, EMBASE, Cochrane library, CNKI and WanFang Data., and papers studying patients with bile acid diarrhea using colesevelam were included. We calculated the overall response rate and the incidence of ADR of colesevelam based on meta-analysis by Stata 14.0. The risk of bias of the included studies was evaluated with ROBINS-I, a tool designed for assessing the risk of bias in nonrandomized studies of interventions. Results: A total of 94 patients in 4 studies who received the first-line or second-line treatment of colesevelam were included. 63 patients had a positive response to colesevelam. The overall response rate was 60%(95%CI 0.34-0.86) with substantial heterogeneity(I²=86.6%, P<0.05). The overall incidence of ADR was 6%(95%CI 0.00-0.18) with substantial heterogeneity(I²=51.74%, P=0.13). Conclusion: Colesevelam is effective in patients with BAD, including those who failed in the therapy of cholestyramine. However, colesevelam is often used as the second-line treatment nowadays due to its high cost. It is necessary to carry out more clinical trials to demonstrate its efficacy and safety.

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