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在血液透析高磷血症患者中使用替纳诺治疗的疗效和安全性:一项随机安慰剂对照试验的系统评价和荟萃分析。

Efficacy and safety of tenapanor in hemodialysis patients with hyperphosphatemia: A systematic review and meta-analysis of randomized placebo-controlled trials.

机构信息

Department of Radiology, Cheng du First People's Hospital, Chengdu, Sichuan, China.

Department of Critical Care Medicine, The General Hospital of Western Theater Command, Chengdu, Sichuan, China.

出版信息

Ther Apher Dial. 2023 Oct;27(5):839-847. doi: 10.1111/1744-9987.14028. Epub 2023 Jun 22.

Abstract

BACKGROUND

The effects of tenapanor in reducing serum phosphorus in hemodialysis patients with hyperphosphatemia are uncertain and no relevant meta-analysis has been conducted. We performed a meta-analysis of randomized placebo-controlled trials to evaluate the efficacy and safety of tenapanor.

METHODS

All randomized controlled trials of tenapanor were searched up to 1 August 2022. The primary endpoint was the change in serum phosphorus level from baseline with tenapanor and placebo. Data on drug-related adverse events (AEs), gastrointestinal AEs and diarrhea were collected to determine the safety of tenapanor.

RESULTS

There were 533 patients throughout five trials that were eligible. Tenapanor significantly lowered blood phosphorus level by 1.79 mg/dl in the mean difference than the placebo. Diarrhea, gastrointestinal AEs, and drug-related AEs were more severe than placebo.

CONCLUSIONS

This meta-analysis showed that although drug side effects were common, tenapanor significantly reduced serum phosphorus level in hemodialysis patients.

摘要

背景

目前对于特立帕肽降低高磷血症血液透析患者血清磷的效果尚不确定,且尚无相关的荟萃分析。我们对随机安慰剂对照试验进行了荟萃分析,以评估特立帕肽的疗效和安全性。

方法

检索截至 2022 年 8 月 1 日的所有特立帕肽随机对照试验。主要终点为特立帕肽和安慰剂治疗后血清磷水平从基线的变化。收集与药物相关的不良事件(AE)、胃肠道 AE 和腹泻的数据,以确定特立帕肽的安全性。

结果

共有 5 项试验的 533 名患者符合条件。与安慰剂相比,特立帕肽的平均差异使血磷水平降低了 1.79mg/dl。腹泻、胃肠道 AE 和与药物相关的 AE 比安慰剂更严重。

结论

本荟萃分析表明,尽管药物副作用常见,但特立帕肽可显著降低血液透析患者的血清磷水平。

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