中国临床试验注册中心急性肺损伤/急性呼吸窘迫综合征项目特征分析

Characterization of acute lung injury/acute respiratory distress syndrome programs in Chinese clinical trial registries

目的探析注册于中国临床试验注册中心的急性肺损伤(ALI)/急性呼吸窘迫综合征(ARDS)项目特征。方法检索自中心成立至2021年6月30日注册的ALI/ARDS临床试验并统计信息。结果筛选项目96项,主要研究单位以山东、上海居多(各12.50%),79.17%为单中心试验。92项明确样本量的项目共预计招募23310例患者,样本量区间为9~5000例。研究类型多为观察性研究(47.92%)、干预性随机对照试验(42.71%),盲法使用、随机化隐藏等注册信息仍有待完善。44项(45.83%)研究涉及合并症。干预措施涉及中西医结合治疗、西药治疗、非药物治疗等方面,采集标本以血液、支气管肺泡灌洗液为主,观测指标包含临床相关指标、理化检查、评分量表等内容。结论部分项目注册信息填写存在缺失,尚需进一步提高注册质量;针对ALI/ARDS多种合并症及多样化干预手段,多中心、大样本量的临床研究仍亟须开展;结局指标丰富而分散,可关注核心指标集的研制与应用,以促进高质量循证依据的产生,从而助力临床诊疗的完善,为该领域未来研究方向提供参考。

Objective To explore the characteristics of acute lung injury(ALI)/acute respiratory distress syndrome(ARDS)programs registered in Chinese clinical trial registries.Methods Clinical trials of ALI/ARDS registered from the inception of the center to June 30,2021 were retrieved and the information was counted.Results Ninety-six projects were screened,with the majority of major research units in Shandong and Shanghai(12.50%each),and 79.17%were single-center trials.The 92 projects with defined sample sizes were expected to recruit a total of 23310 patients,with a sample size range of 9 to 5000 patients.The types of studies were mostly observational studies(47.92%),interventional randomized controlled trials(42.71%),and registration information such as blinded use and randomization concealment still needs to be improved.44(45.83%)studies involved comorbidities.The interventions involved combined Chinese and western medicine treatment,western medicine treatment and non-pharmaceutical treatment,etc.The specimens collected were mainly blood and bronchoalveolar lavage fluid,and the observation indexes included clinically relevant indexes,physical and chemical examinations,and scoring scales.Conclusion There is a lack of registration information in some projects,and the quality of registration needs to be further improved;multi-center and large sample size clinical studies are still needed for a variety of comorbidities and diverse interventions in ALI/ARDS;outcome indicators are abundant and scattered,and attention can be paid to the development and application of core indicator sets to promote the generation of high-quality evidence-based evidence to help improve clinical diagnosis and treatment,and provide reference for future research directions in this field.