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帕金森病随机对照试验安慰剂组报告的心血管不良事件。

Cardiovascular Adverse Events Reported in Placebo Arm of Randomized Controlled Trials in Parkinson's Disease.

机构信息

Serviço de Medicina III, Hospital Pulido Valente, CHULN, Lisbon, Portugal.

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.

出版信息

J Parkinsons Dis. 2020;10(2):641-651. doi: 10.3233/JPD-191907.

DOI:10.3233/JPD-191907
PMID:32116264
Abstract

BACKGROUND

Parkinson's disease and cardiovascular disease are highly prevalent conditions in the elderly. Evidence shows inconsistent findings regarding the association between Parkinson's disease and cardiovascular events.

OBJECTIVE

We sought to evaluate the proportion of cardiovascular adverse events among Parkinson's disease patients included in the placebo arm of randomized controlled trials.

METHODS

For this systematic review and meta-analysis, we searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to February 2017. Randomized, placebo-controlled trials in Parkinson's disease were included. The primary outcome was the proportion of major cardiovascular adverse events, defined as myocardial infarction, stroke, peripheral artery disease, and sudden death. A random-effects meta-analysis was performed to derive pooled estimates of the proportion of adverse events and corresponding 95% confidence intervals (CIs).

RESULTS

236 randomized controlled trials were included, 80% (n = 189; 14704 patients) of which reported data on cardiovascular adverse events. The pooled proportion of major cardiovascular events ranged from 0.00% to 0.06% and the proportion of all cardiovascular adverse events was 3.33% (95% CI: 2.14, 4.70%), and ranged from 1.71% in de novo Parkinson's disease patients to 4.56% in patients receiving levodopa as their only antiparkinsonian medication. The most common adverse events were hypertension and orthostatic hypotension.

CONCLUSIONS

These results suggest that the proportion of major cardiovascular adverse events is low and that blood pressure abnormalities are the most frequent cardiovascular adverse event.

摘要

背景

帕金森病和心血管疾病在老年人中高发。有证据表明,帕金森病与心血管事件之间的关联存在不一致的结果。

目的

我们旨在评估纳入随机对照试验安慰剂组的帕金森病患者中心血管不良事件的比例。

方法

本系统评价和荟萃分析检索了 MEDLINE、EMBASE 和 Cochrane 对照试验中心从建库至 2017 年 2 月的数据。纳入了帕金森病的随机、安慰剂对照试验。主要结局为主要心血管不良事件的比例,定义为心肌梗死、卒中和外周动脉疾病及猝死。采用随机效应荟萃分析得出不良事件比例及其相应 95%置信区间(CI)的合并估计值。

结果

纳入了 236 项随机对照试验,其中 80%(n=189;14704 例患者)报告了心血管不良事件的数据。主要心血管事件的合并比例范围为 0.00%至 0.06%,所有心血管不良事件的比例为 3.33%(95%CI:2.14,4.70%),从新发帕金森病患者的 1.71%到仅接受左旋多巴作为抗帕金森病药物的患者的 4.56%不等。最常见的不良事件是高血压和直立性低血压。

结论

这些结果表明,主要心血管不良事件的比例较低,且血压异常是最常见的心血管不良事件。

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