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

doi:10.20047/j.issn1673-7210.2022.31.36

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Abstract 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 23 310 patients, with a sample size range of 9 to 5 000 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.

Key words： Acute lung injury Acute respiratory distress syndrome Clinical trial Registration Characteristics

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	CHEN Yifan LI Yan GUO Nan LIU Jin ZENG Yanpeng CHEN Yu

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CHEN Yifan LI Yan GUO Nan LIU Jin ZENG Yanpeng CHEN Yu. Characterization of acute lung injury/acute respiratory distress syndrome programs in Chinese clinical trial registries[J]. 中国医药导报, 2022, 19(31): 154-158.

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https://www.yiyaodaobao.com.cn/EN/10.20047/j.issn1673-7210.2022.31.36 OR https://www.yiyaodaobao.com.cn/EN/Y2022/V19/I31/154

[1] Fan E，Brodie D，Slutsky AS. Acute respiratory distress syndrome：advances in diagnosis and treatment [J]. JAMA，2018，319（7）：698-710.
[2] Ranieri VM，Rubenfeld GD，Thompson BT，et al. Acute respiratory distress syndrome：the Berlin Definition [J]. JAMA，2012，307（23）：2526-2533.
[3] Riviello ED，Kiviri W，Twagirumugabe T，et al. Hospital incidence and outcomes of the acute respiratory distress syndrome using the kigali modification of the Berlin definition [J]. Am J Respir Crit Care Med，2016，193（1）：52-59.
[4] Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome：consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference [J]. Pediatr Crit Care Med，2015，16（5）：428-439.
[5] 郭静雨，陈龙，史源.2017年新生儿急性呼吸窘迫综合征蒙特勒诊断标准解读[J].中华儿科杂志，2018，56（8）：571- 574.
[6] 吴泰相，米娜瓦尔·阿不都，郝园，等.中国临床试验注册10年：现状与问题[J].中国循证医学杂志，2018，18（6）：522-525.
[7] 徐伟娟，孙激.我国高影响因子医学期刊临床试验注册和发表机制实施现状分析[J].中国科技期刊研究，2020， 31（12）：1424-1430.
[8] 蔡青青，沈赟，李晓宇，等.基于改良Jadad量表评价注射用胸腺法新超说明书用药的合理性[J].中国临床药学杂志，2020，29（4）：278-281.
[9] 陈一凡，李雁，李昕，等.中国临床试验注册中心虚拟现实、增强现实及混合现实项目特征分析[J].重庆医学，2022，51（4）：697-701.
[10] 杨毅，邱海波.急性呼吸窘迫综合征救治：需要遵循的十大原则[J].中华重症医学电子杂志，2015，1（1）：33- 38.
[11] 石颖，左祥荣，曹权.急性呼吸窘迫综合征的表型及内型研究进展[J].中华重症医学电子杂志（网络版），2020， 6（2）：215-222.
[12] Sevransky JE，Martin GS，Shanholtz C，et al. Mortality in sepsis versus non-sepsis induced acute lung injury [J]. Crit Care，2009，13（5）：R150.
[13] Fan E，Del Sorbo L，Goligher EC，et al. An official American Thoracic Society/ European Society of Intensive Care Medicine/ Society of Critical Care Medicine clinical practice guideline：Mechanical ventilation in adult patients with acute respiratory distress syndrome [J]. Am J Respir Crit Care Med，2017，195（9）：1253-1263.
[14] Matthay MA，McAuley DF，Ware LB. Clinical trials in acute respiratory distress syndrome：challenges and opportunit- ies [J]. Lancet Respir Med，2017，5（6）：524-534.
[15] 陈加宝，刘华.急性肺损伤/急性呼吸窘迫综合征的药物治疗研究进展[J].广东药科大学学报，2021，37（3）：135-140.
[16] 万茂婷.中西医结合治疗急性呼吸窘迫综合征临床疗效的系统评价[D].北京：北京中医药大学，2017.
[17] 张松.中西医综合方案治疗ARDS的多中心、前瞻性、随机对照及动物实验研究[D].成都：成都中医药大学，2020.
[18] 程璐.通腑泻肺方治疗脓毒症相关急性呼吸窘迫综合征的临床及实验研究[D].南京：南京中医药大学，2020.
[19] Porter ME. What is value in health care? [J]. N Engl J Med，2010，363（26）：2477-2481.
[20] Williamson PR，Altman DG，Bagley H，et al. The COMET Handbook：version 1.0 [J]. Trials，2017，18（Suppl 3）：280.
[21] Kirkham JJ，Gorstts，Altman DG，et al. COSSTAR：a reporting guideline for studies developing core outcome sets （protocol） [J]. Trials，2015，16：373.
[22] 张英，陈红，孙亚男，等.临床疗效评价结局指标的理论框架概述[J].中国医药导报，2021，18（18）：183-188.
[23] 苏娴.ICH管委会成员国药物临床试验质量管理规范相关法规启示[J].中国医药科学，2020，10（24）：251-253.
[24] 吴泰相，李幼平，刘关键，等.中国临床试验注册中心及中国循证医学中心提高我国临床试验质量的策略和措施[J].中国循证医学杂志，2010，10（11）：1243-1248.
[25] 周江华，董碧蓉.通过推进注册提升临床试验研究质量[J].现代临床医学，2016，42（6）：469-470.
[26] 吴泰相，米娜瓦尔·阿不都，卞兆祥，等.基于临床试验注册信息调查影响我国临床试验质量的因素[J].中国循证医学杂志，2018，18（6）：526-531.