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丹红注射液对冠心病心绞痛患者心功能及血脂的影响:一项随机、双盲、安慰剂对照的临床试验方案。

Effects of Danhong injection on cardiac function and blood lipid in patients with angina pectoris of coronary heart disease: A protocol for randomized, double-blind, placebo-controlled clinical trial.

机构信息

The People's Hospital of Dazu, Chongqing Dazu, Chongqing Province, China.

出版信息

Medicine (Baltimore). 2021 Oct 29;100(43):e27479. doi: 10.1097/MD.0000000000027479.

DOI:10.1097/MD.0000000000027479
PMID:34713825
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8556048/
Abstract

BACKGROUND

Angina pectoris of coronary heart disease is the leading cause of death worldwide. Danhong injection is a supplement for angina pectoris of coronary heart disease. A large number of studies have confirmed its efficacy and safety. However, there is no rigorous clinical study to evaluate the effects of Danhong injection on cardiac function and blood lipid in patients with angina pectoris of coronary heart disease.

METHODS

This is a prospective, randomized, double-blind, placebo-controlled trial to study the effects of Danhong injection on cardiac function and lipid profile in patients with angina pectoris of coronary heart disease. Participants will be randomly divided into treatment group and control group. The treatment group will be treated with Danhong injection and the control group will be treated with placebo under basic treatment according to recommended guideline, and followed up for 3 months after 14 consecutive days of treatment. Outcomes include: cardiac function (left ventricular end-diastolic diameter); left ventricular end-systolic diameter; left ventricular ejection fraction, blood lipid levels (total cholesterol; triacylglycerol; low density lipoprotein cholesterol; high density lipoprotein cholesterol), the number of angina attacks per week, total amount of nitroglycerin tablets, and adverse reactions.

DISCUSSION

This study will evaluate the efficacy of Danhong injection in improving cardiac function and blood lipid in patients with angina pectoris of coronary heart disease. The results of this study will provide reference for clinical use of Danhong injection to improve cardiac function and blood lipid in patients with angina pectoris of coronary heart disease.Trial registration: OSF Registration number: DOI 10.17605/OSF.IO/TPZJ5.

摘要

背景

冠心病心绞痛是全球范围内主要的致死病因。丹红注射液是一种冠心病心绞痛的辅助治疗药物,大量研究已经证实了其疗效和安全性。然而,目前还没有严格的临床研究来评估丹红注射液对冠心病心绞痛患者心功能和血脂的影响。

方法

这是一项前瞻性、随机、双盲、安慰剂对照试验,旨在研究丹红注射液对冠心病心绞痛患者心功能和血脂谱的影响。参与者将被随机分为治疗组和对照组。治疗组在基础治疗上给予丹红注射液治疗,对照组则给予安慰剂治疗,疗程为 14 天,随后随访 3 个月。主要结局指标包括:心功能(左室舒张末期直径)、左室收缩末期直径、左室射血分数;血脂水平(总胆固醇、三酰甘油、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇);每周心绞痛发作次数、硝酸甘油片总用量;不良反应。

讨论

本研究将评估丹红注射液改善冠心病心绞痛患者心功能和血脂的疗效。该研究结果将为丹红注射液改善冠心病心绞痛患者心功能和血脂提供临床参考。

试验注册

OSF 注册号:DOI 10.17605/OSF.IO/TPZJ5。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61a7/8556048/bc58783f0ee4/medi-100-e27479-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61a7/8556048/bc58783f0ee4/medi-100-e27479-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61a7/8556048/bc58783f0ee4/medi-100-e27479-g001.jpg

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