School of Nursing, Huzhou University, Huzhou Central Hospital, Huzhou, China.
School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, China.
BMJ Open. 2020 Jan 21;10(1):e033448. doi: 10.1136/bmjopen-2019-033448.
Aliskiren is a newly developed medicine. As one of the effective renin-angiotensin-aldosterone system inhibitors, its role in lowering blood pressure has been recognised. However, its safety and tolerability still remain controversial. The aim of the paper is to systematically summarise the published studies about the clinical efficacy and side effects of aliskiren monotherapy.
A comprehensive review of PubMed, Embase and Cochrane Library databases published from inception until June 2019 will be conducted. The selected articles are meta-analyses that integrated the randomised controlled studies, which evaluated efficacy, safety and tolerability of aliskiren monotherapy. Two people will select eligible articles and extract data independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the AMSTAR 2 tool. Study selection process will be presented using a flowchart. We will re-analyse each outcome with the random effect methods if necessary. If possible, we will also calculate 95% prediction intervals for each random effect estimate, by using Egger's test to evaluate if the reporting bias existed.
Ethical approval is not required for the study, as we only collected data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion.
CRD42019142141.
阿利吉仑是一种新开发的药物。作为有效的肾素-血管紧张素-醛固酮系统抑制剂之一，其降压作用已得到认可。然而，其安全性和耐受性仍存在争议。本文旨在系统总结已发表的关于阿利吉仑单药治疗的临床疗效和副作用的研究。
将对 PubMed、Embase 和 Cochrane Library 数据库从建库起至 2019 年 6 月发表的文献进行全面综述。选择的文章是整合了随机对照研究的荟萃分析，评估了阿利吉仑单药治疗的疗效、安全性和耐受性。两人将独立选择合格的文章并提取数据。任何争议将通过讨论或第三方仲裁解决。使用 AMSTAR 2 工具评估报告证据的质量。将使用流程图展示研究选择过程。如果需要，我们将使用 Egger 检验来评估是否存在报告偏倚，用随机效应方法重新分析每个结局。如果可能，我们还将通过计算每个随机效应估计值的 95%预测区间来进行分析。
该研究不需要伦理批准，因为我们只从已发表的可用材料中收集数据。完成后，本综述将提交给同行评议期刊发表。
PROSPERO 注册号：CRD42019142141。
