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依卡替班对血管紧张素转化酶抑制剂诱导血管性水肿的影响:一项随机对照试验的荟萃分析。

Effect of icatibant on angiotensin-converting enzyme inhibitor-induced angioedema: A meta-analysis of randomized controlled trials.

机构信息

School of Pharmacy, Sungkyunkwan University, Suwon, Korea.

Department of Pharmacy, National Cancer Center Hospital, Goyang, Korea.

出版信息

J Clin Pharm Ther. 2019 Oct;44(5):685-692. doi: 10.1111/jcpt.12997. Epub 2019 Jul 9.

Abstract

WHAT IS KNOWN AND OBJECTIVE

Angioedema (AE) caused by angiotensin-converting enzyme inhibitors (ACEIs) requires prompt and appropriate management, but current treatment options are limited to symptomatic treatment. Icatibant is a bradykinin receptor antagonist approved for hereditary AE treatment. Some recent studies showed a potential role for icatibant on ACEI-induced AE while others have shown no promising effect. This meta-analysis of randomized controlled trials (RCTs) was conducted to provide evidence for the use of icatibant in the treatment of ACEI-induced AE.

METHODS

Relevant RCTs that examined the effects of icatibant for ACEI-induced AE were retrieved from EMBASE, PubMed and Cochrane Library (Central). Included articles for the meta-analysis were assessed using the Cochrane risk of bias tool. For meta-analysis, the pooled mean differences (MD) with 95% CIs and the pooled relative risk (RR) with 95% CIs were calculated using RevMan 5.3. The systematic review was performed in accordance with the PRISMA statement.

RESULTS AND DISCUSSION

A total of 234 records were identified after searching the databases. In total, three RCTs involving 179 patients were included in the meta-analysis. The three RCTs had a low risk of bias and the characteristics of the participants and the outcome measures were similar among the RCTs. Treatment with icatibant shortened the time to achieve complete resolution of ACEI-induced AE symptoms compared to placebo or conventional treatments. However, the difference was not statistically significant (MD: -7.77 hours; 95% CI: -25.18-9.63 hours). There were no differences between groups in terms of drug-related adverse effects, apart from the reactions at the site of injection (RR: 1.35; 95% CI: 0.53-3.45).

WHAT IS NEW AND CONCLUSION

This meta-analysis evaluated the effectiveness and tolerability of icatibant therapy for ACEI-induced AE, but the benefit of icatibant therapy over placebo or conventional treatment strategies could not be shown.

摘要

已知和目的

血管紧张素转换酶抑制剂(ACEI)引起的血管性水肿(AE)需要及时和适当的治疗,但目前的治疗选择仅限于对症治疗。艾替班特是一种获批用于遗传性 AE 治疗的缓激肽受体拮抗剂。一些最近的研究表明,艾替班特可能对 ACEI 引起的 AE 有作用,而其他研究则没有显示出有希望的效果。本项随机对照试验(RCT)的荟萃分析旨在为艾替班特治疗 ACEI 引起的 AE 提供证据。

方法

从 EMBASE、PubMed 和 Cochrane Library(中央)检索了研究艾替班特对 ACEI 引起的 AE 影响的相关 RCT。对纳入荟萃分析的文章使用 Cochrane 偏倚风险工具进行评估。对于荟萃分析,使用 RevMan 5.3 计算合并均数差(MD)及其 95%置信区间(CI)和合并相对风险(RR)及其 95%CI。系统评价符合 PRISMA 声明。

结果和讨论

在数据库搜索后共确定了 234 条记录。共有 3 项 RCT 纳入了 179 名患者,共纳入荟萃分析。这 3 项 RCT 偏倚风险低,且 RCT 参与者特征和结局指标相似。与安慰剂或常规治疗相比,艾替班特治疗可缩短 ACEI 引起的 AE 症状完全缓解的时间。但差异无统计学意义(MD:-7.77 小时;95%CI:-25.18-9.63 小时)。除注射部位反应外,各组之间在药物相关不良反应方面无差异(RR:1.35;95%CI:0.53-3.45)。

创新和结论

本荟萃分析评估了艾替班特治疗 ACEI 引起的 AE 的有效性和耐受性,但未能证明艾替班特治疗与安慰剂或常规治疗策略相比有获益。

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