泡腾对乙酰氨基酚与血压关系的评估：临床试验

Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial.

作者信息

Benitez-Camps Mencia, Vinyoles-Bargalló Ernest, Rebagliato-Nadal Oriol, Morros-Pedrós Rosa, Pera-Pujadas Helena, Dalfó-Baqué Antoni, López-Pavón Ignacio, Roca-Sánchez Carlos, Coma-Carbó Rosa Maria, De La Figuera Von Wichmann Mariano, Mengual-Martínez Lucas, Yuste-Marco Carmen, Teixidó-Colet Montserrat, Pepió i Vilaubí Josep M, Ciurana-Tost Riera, Pou-Vila Rosa, Vila-Coll Ma Antònia, Bordas-Julve Josep Maria, Aragonès-Forès Rosa, Pelegrina-Rodríguez Francisco Javier, Agudo-Ugena Josep, Blanco-Mata Carlos, de la Iglesia Berrojalbiz Jon, Burgos-Alonso Natalia, Gómez-Fernández Maria Cruz

机构信息

CAP Gòtic, Institut Català de la Salut, Barcelona, Spain.

CAP La Mina, Institut Català de la Salut, Barcelona, Spain.

出版信息

BMC Cardiovasc Disord. 2015 Dec 10;15:167. doi: 10.1186/s12872-015-0161-7.

DOI:10.1186/s12872-015-0161-7

PMID:26654907

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4676099/

Abstract

BACKGROUND

Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients.

METHODS/DESIGN: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundació Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held.

DISCUSSION

Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practice.

TRIAL REGISTRATION

NCT 02514538.

摘要

背景

对乙酰氨基酚通过添加碳酸氢盐、碳酸盐或柠檬酸盐形式的钠盐来实现其溶解性。由于盐与高血压之间的关系众所周知，因其钠含量引发了一种可能干扰该风险因素控制的假设。因此，本研究的目的是评估与非泡腾型对乙酰氨基酚相比，泡腾型对乙酰氨基酚对高血压患者血压的影响。

方法/设计：这是一项IV期多中心临床试验方案，为随机、对照、交叉、开放试验，将比较两种不同剂型的对乙酰氨基酚（泡腾型或非泡腾型）对高血压患者血压的影响，并进行为期七周的随访。将纳入49例血压得到控制的高血压患者（临床血压低于150/95 mmHg，糖尿病患者或有心血管事件病史的患者低于135/85 mmHg，日间动态血压测量低于140/90 mmHg）且有轻至中度疼痛（视觉模拟评分在1至4分之间）。该研究已获得Fundació Jordi Gol i Gurina伦理委员会批准，并遵循良好临床实践标准。主要终点将是24小时动态血压监测中收缩压的变化，非泡腾型和泡腾型制剂治疗组之间差异达2 mmHg或更多则视为有显著差异。将进行意向性分析和符合方案分析。