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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.

DOI:10.1111/1744-9987.14028
PMID:37349983
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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引用本文的文献

1
Efficacy and safety of tenapanor vs placebo in treating CKD patients on dialysis and with hyperphosphatemia: a systematic review and meta-analysis of 2251 patients.替那帕诺与安慰剂治疗透析及高磷血症慢性肾脏病患者的疗效与安全性:对2251例患者的系统评价与荟萃分析
Int Urol Nephrol. 2025 Jun;57(6):1835-1850. doi: 10.1007/s11255-024-04316-x. Epub 2024 Dec 19.
2
Efficacy and safety of tenapanor in end-stage renal disease patients with hyperphosphatemia: a systematic review and meta-analysis.终末期肾病高磷血症患者使用替纳普仑的疗效和安全性:系统评价和荟萃分析。
Ren Fail. 2024 Dec;46(2):2410389. doi: 10.1080/0886022X.2024.2410389. Epub 2024 Oct 1.
3
Hyperphosphatemia in Chronic Kidney Disease: The Search for New Treatment Paradigms and the Role of Tenapanor.
慢性肾脏病中的高磷血症:寻找新的治疗模式及替那帕诺的作用
Int J Nephrol Renovasc Dis. 2024 May 28;17:151-161. doi: 10.2147/IJNRD.S385826. eCollection 2024.