利奥西呱治疗肺动脉高压：系统评价和荟萃分析。

Riociguat therapy for pulmonary hypertension: a systematic review and meta-analysis.

机构信息

Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China; Department of Pediatric Respiratory Medicine, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China; NHC Key Laboratory of Chronobiology (Sichuan University), West China Second University Hospital, Sichuan University, Chengdu, China; The Joint Laboratory for Lung Development and Related Diseases, West China Second University Hospital, Sichuan University, Chengdu, China.

Department of Pediatrics, The Affiliated Hospital of Southwest Medical University, Luzhou, China; Sichuan Clinical Research Center for Birth Defects, Luzhou, China.

出版信息

Ann Palliat Med. 2021 Oct;10(10):11117-11128. doi: 10.21037/apm-21-2656.

DOI:10.21037/apm-21-2656

PMID:34763472

Abstract

BACKGROUND

Riociguat therapy has been recommended for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), and it might have therapeutic significance for other types of pulmonary hypertension (PH). Our purpose was to evaluate the specific impact of riociguat on all types of PH.

METHODS

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing the safety and efficacy of riociguat treatment for PH through databases of the Cochrane Library, PubMed, Embase, and Web of Science from inception to the present. Duplicate publications, studies with no full text, incomplete information or inability to extract data, animal experiments and reviews, and systematic reviews were excluded. The software RevMan 5.4 was used for data synthesis.

RESULTS

There were 8 RCTs included in our study, involving 1,606 participants. For PAH and CTEPH patients, riociguat treatment extended 6-minute walk distance (6MWD) by 39.84 meters, decreased mean pulmonary arterial pressure (PAP) by 4.20 mmHg, lowered pulmonary vascular resistance (PVR) by 218.76 dynes/sec/cm-5, cut down right atrial pressure (RAP) by 0.9 mmHg, increased cardiac index (CI) by 0.49 L/min/m2, improved cardiac output (CO) by 0.89 L/min, reduced N-terminal pro-type B natriuretic peptide (NT-proBNP) by 436.21 pg/mL, and decreased adverse events and clinical worsening as compared with placebo. For other types of PH including PH due to left heart disease and PH due to lung disease, riociguat was reported as having improved CI by 0.42 L/min/m2 and CO was increased by 0.92 L/min compared with placebo. Other efficacy outcomes and safety outcomes did not attain statistical difference in other types of PH.

CONCLUSIONS

For PAH and CTEPH, riociguat treatment is safe and effective, but for other types of PH, it can only improve some hemodynamic parameters.

摘要

背景

利奥西呱治疗已被推荐用于肺动脉高压（PAH）和慢性血栓栓塞性肺动脉高压（CTEPH），并且可能对其他类型的肺动脉高压（PH）具有治疗意义。我们的目的是评估利奥西呱对所有类型 PH 的具体影响。

方法

我们通过 Cochrane 图书馆、PubMed、Embase 和 Web of Science 数据库对比较利奥西呱治疗 PH 的安全性和疗效的随机对照试验（RCT）进行了系统评价和荟萃分析，检索时间从建库至本研究。排除重复发表、无全文、信息不全或无法提取数据、动物实验和综述以及系统评价。使用 RevMan 5.4 软件进行数据合成。

结果

本研究纳入 8 项 RCT，涉及 1606 名参与者。对于 PAH 和 CTEPH 患者，利奥西呱治疗使 6 分钟步行距离（6MWD）延长了 39.84 米，平均肺动脉压（PAP）降低了 4.20mmHg，肺血管阻力（PVR）降低了 218.76 dynes/sec/cm-5，右心房压（RAP）降低了 0.9mmHg，心指数（CI）增加了 0.49L/min/m2，心输出量（CO）增加了 0.89L/min，N 末端 pro 型 B 利钠肽（NT-proBNP）降低了 436.21pg/mL，与安慰剂相比，不良反应和临床恶化减少。对于包括左心疾病引起的 PH 和肺部疾病引起的 PH 在内的其他类型 PH，利奥西呱报告与安慰剂相比，CI 增加了 0.42L/min/m2，CO 增加了 0.92L/min。其他疗效指标和安全性指标在其他类型 PH 中没有达到统计学差异。