真实世界研究在慢性伤口领域的研究进展

Research advances of real world study in the field of chronic wound

近年来,作为随机对照试验(RCT)的有力补充手段,真实世界研究(RWS)得到越来越多的关注。但是在慢性伤口领域,大多数患者的病情复杂,RCT的严格纳入和排除标准缺乏实际应用价值。RWS在临床医疗实践、药物与医疗器械监管和卫生技术评估等方面提供了更接近真实医疗环境的数据,但RWS也存在一些待解决的问题,如诊断标准未统一、研究终点不清等。此外,我国慢性伤口领域的RWS似乎还未真正开始,各级机构需要共同努力以推进RWS的发展。

In recent years,as a powerful supplement to the randomized controlled trial(RCT),real world study(RWS)has received more and more attention.However,in the field of chronic wounds,most of the patients have complex condition,and the strict inclusion and exclusion criteria of RCT were lack of practical application values.The RWS provides data closer to the real medical environment in clinical medical practice,drug and medical device supervision,and health technology evaluation.However,RWS has some problems that need to be resolved,such as inconsistent diagnostic criteria and unclear research endpoints.In addition,RWS in chronic wound research in China seems to have not really started yet,and institutions at all levels need to work together to promote the development of RWS.