“急性心肌梗死中西医结合临床路径研究”研究方案

A study protocol for clinical pathways based on integrative medicine for patients with acute myocardial infarction

背景：急性心肌梗死（acute myocardial infarction,AMI）是严重危害人类健康的心血管疾病。临床路径（clinical pathway,CP）可以按病种设计最佳的医疗和护理方案,根据病情合理安排住院时间和费用。本研究通过构建AMI的中西医结合临床路径,进行路径的有效性和安全性评价,为AMI的中西医结合治疗提供优化诊治方案。方法与设计：通过AMI中医证候演变规律研究、文献调研和专家咨询,构建AMI中西医结合临床路径;通过多中心（2010年1月~2010年10月入住广东省中医院及各分中心医院的ST段抬高型心肌梗死患者）的非随机、历史对照（2008年1月~2009年12月入住广东省中医院及各分中心医院的ST段抬高型心肌梗死患者）研究,观察临床路径实施前后患者住院时间、费用和住院期间主要心血管事件发生率的变化,对临床路径的有效性和安全性进行评价。讨论：本研究在全国中医院中率先开展中西医结合临床路径的研究工作,建立AMI中西医结合临床路径制定的方法和关键技术,具有方法学指导和行业示范作用,为探索医疗体制改革下的单病种管理模式的改革提供借鉴。临床试验注册号：ChiCTR-TNRC-10000753。

Background：Acute myocardial infarction（AMI）is one of the most common cardiovascular diseases.The clinical pathway is the therapeutic program for disease-specific treatment and its implementation may reduce both the duration and cost of the hospital stay.This study aims to construct and evaluate the efficacy of clinical pathways（CPs）based on integrated traditional Chinese and Western medicine for patients with AMI.Methods and design：The clinical pathway of integrative medicine for AMI was constructed on the basis of syndrome evolvement surveys,literature research and expert consultation.Then,a non-randomized controlled,multicenter trial was designed to evaluate the efficacy and safety of the clinical pathway around the length of hospital stay,hospital expenses and the incidence of major cardiovascular events.This also allowed further exploration into the efficacy and safety of the clinical pathway for AMI based on traditional Chinese and Western medicine.Discussion：The study firstly researched CPs based on the integrative medicine in hospitals of Chinese medicine and set up the key methods and skills for the construction of CPs of integrative medicine.This study will provide a powerful reference and direction for single-disease management reform under the healthcare system and set a good example for the improvement of integrative treatments.Trial registration number：ChiCTR-TNRC-10000753.