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几十年来随机对照试验中弥散性血管内凝血标准及目标患者的转变:一项范围综述

The transition of the criteria for disseminated intravascular coagulation and the targeted patients in randomized controlled trials over the decades: a scoping review.

作者信息

Matsuoka Tadashi, Yamakawa Kazuma, Umemura Yutaka, Homma Koichiro, Iba Toshiaki, Sasaki Junichi

机构信息

Department of Emergency and Critical Care Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan.

Department of Emergency and Critical Care Medicine, Osaka Medical and Pharmaceutical University, 2-7 Daigakumachi, 569-8686, Takatsuki, Osaka, Japan.

出版信息

Thromb J. 2024 Dec 23;22(1):112. doi: 10.1186/s12959-024-00681-w.

DOI:10.1186/s12959-024-00681-w
PMID:39716150
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11665092/
Abstract

BACKGROUND

Disseminated intravascular coagulation (DIC) is a severe complication in septic patients. The Japanese Ministry of Health and Welfare (JMHW)-DIC criteria, the first DIC criteria, were established in 1983, and several other criteria have been proposed since then, including the International Society on Thrombosis and Haemostasis (ISTH)-overt DIC criteria and the Japanese Association for Acute Medicine (JAAM) DIC criteria. This study aimed to look into the transition of DIC criteria used in randomized controlled trials (RCTs) for sepsis-induced DIC.

METHODS

We searched PubMed, Scopus, and the Cochrane Central Register of Controlled Trials for English-language studies published through September 30, 2023. Two reviewers looked through citations that assessed the DIC criteria used in RCTs and their secondary analyses. Data on DIC diagnostic criteria, patient characteristics, interventions, and results were gathered.

RESULTS

Twenty-one studies (thirteen RCTs: JMHW-DIC in 5, JAAM-DIC in 4, the sepsis-induced coagulopathy (SIC) in 2; and eight secondary analyses: ISTH-overt DIC in 3, single parameter in 5) were eligible for inclusion. Most RCTs were conducted in Japan, using the criteria of JMHW-DIC, which were followed by JAAM-DIC. Recently, SIC has been used in international RCTs. Meanwhile, other countries tended to conduct RCTs that focused on sepsis, with secondary analyses for DIC using the ISTH-overt DIC criteria.

CONCLUSIONS

The criteria used in RCTs have changed over decades, from the JMHW-DIC to the JAAM-DIC criteria, and the ISTH-overt DIC criteria were retained in the secondary analysis. Based on these findings, additional research is needed to determine the best criterion for diagnosing septic patients.

摘要

背景

弥散性血管内凝血(DIC)是脓毒症患者的一种严重并发症。日本厚生省(JMHW)-DIC标准是首个DIC标准,于1983年制定,此后又提出了其他一些标准,包括国际血栓与止血学会(ISTH)-显性DIC标准和日本急性医学协会(JAAM)DIC标准。本研究旨在探讨脓毒症诱导的DIC随机对照试验(RCT)中使用的DIC标准的转变情况。

方法

我们检索了PubMed、Scopus和Cochrane对照试验中心注册库,查找截至2023年9月30日发表的英文研究。两名评审员查阅了评估RCT中使用的DIC标准及其二次分析的文献。收集了关于DIC诊断标准、患者特征、干预措施和结果的数据。

结果

21项研究(13项RCT:5项使用JMHW-DIC标准,4项使用JAAM-DIC标准,2项使用脓毒症诱导的凝血病(SIC)标准;8项二次分析:3项使用ISTH-显性DIC标准,5项使用单一参数标准)符合纳入标准。大多数RCT在日本进行,采用JMHW-DIC标准,其次是JAAM-DIC标准。最近,SIC已在国际RCT中使用。与此同时,其他国家倾向于开展专注于脓毒症的RCT,并使用ISTH-显性DIC标准对DIC进行二次分析。

结论

几十年来,RCT中使用的标准已从JMHW-DIC标准转变为JAAM-DIC标准,ISTH-显性DIC标准则保留在二次分析中。基于这些发现,需要进一步研究以确定诊断脓毒症患者的最佳标准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/468a/11665092/6ae1535cb0bf/12959_2024_681_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/468a/11665092/97e351484e70/12959_2024_681_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/468a/11665092/6ae1535cb0bf/12959_2024_681_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/468a/11665092/97e351484e70/12959_2024_681_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/468a/11665092/6ae1535cb0bf/12959_2024_681_Fig2_HTML.jpg

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