中药静脉制剂治疗急性心力衰竭的证据图谱研究OA
An evidence map of intravenous traditional Chinese medicine preparations for acute heart failure
目的 应用证据图谱方法,系统检索与梳理中药静脉制剂治疗急性心力衰竭(心衰)的临床研究文献,展现该领域的证据分布情况.方法 检索中国生物医学文献数据库(CBM)、维普数据库、中国知网(CNKI)、万方数据库、Cochrane图书馆、美国国立医学图书馆PubMed数据库、荷兰医学文摘Embase数据库和科学网(Web of Science),检索时间自数据库建立至 2023 年 2 月,纳入中药静脉制剂治疗急性心衰的临床研究、系统评价以及指南路径研究,运用证据图谱研究方法,采用文字描述结合表格、气泡图等分析证据分布特征,针对纳入文献用AMSTAR 2 量表进行方法学质量评价.结果 ① 共纳入临床研究 343 篇,系统评价 9 篇,指南、共识 2 篇.② 多以小样本(60~100 例)、单中心、短时程(干预时长多为 14 d)的随机对照试验(RCT)为主.③ 结局指标选择种类较多,以心功能指标、总有效率、安全性指标最为多见,但尚无规范统一的核心结局指标,未能充分体现中医特色优势,亦缺乏远期疗效证据.④纳入的系统评价方法学质量整体偏低,AMSTAR 2 等级仅为低级和极低级,7 项显示证据有效,2 项证据有潜在疗效;RCT研究质量有待提高,且多数研究难以给出确定有效的临床证据.⑤ 尚缺乏完善的相应诊疗指南.结论 中药静脉制剂在治疗急性心衰的临床有效性和安全性方面具有一定的优势,但相关研究证据质量整体较低.未来中医药研究需规范临床用药选择,体现中医治疗的关键优势,完善结局指标的选择,提高系统评价的质量,多进行大样本、多中心、方法学质量高的临床研究,产出高质量的循证证据,充分发挥中医治疗急性心衰的特色优势.
Objective To apply an evidence mapping approach to systematically retrieve and sort clinical literature regarding intravenous traditional Chinese medicine preparations for acute heart failure,so as to visualize the distribution of relevant clinical evidence.Methods The China Biology Medicine(CBM),VIP Database,China National Knowledge Infrastructure(CNKI),Wanfang Data,the Cochrane Library,PubMed,Embase,and Web of Science were searched from database inception to February 2023.Clinical studies,systematic reviews,and guideline pathway research on the treatment of acute heart failure with Chinese medicine intravenous preparation were included.The evidence map research method was employed,combining textual descriptions with tables,bubble charts,and other analyses to characterize evidence distribution.The AMSTAR 2 scale was used to assess the methodological quality of the included literature.Results ① A total of 343 clinical studies,9 systematic reviews,and 2 guidelines and consensus articles were included.② The majority of randomized controlled trials(RCT)are small sample(60-100 cases),single center,and short-term(intervention duration is mostly 14 days).③ There are many types of outcome indicators to choose from,with cardiac function indicators,total effective rate,and safety indicators being the most common.However,there is no standardized and unified core outcome indicator,which fails to fully reflect the advantages of traditional Chinese medicine and lacks evidence of long-term efficacy.④ The overall quality of the methodology included in the systematic review is low,with AMSTAR 2 rating only at low and very low levels.Seven items show evidence of effectiveness,and two items have potential therapeutic effects;The quality of RCT research needs to be improved,and most studies are difficult to provide definitive and effective clinical evidence.⑤ There is still a lack of comprehensive diagnostic and treatment gu idelines.Conclusions Traditional Chinese medicine intravenous preparations have certain advantages in the clinical efficacy and safety of treating acute heart failure,but the overall quality of related research evidence is relatively low;In the future research of traditional Chinese medicine,it is necessary to standardize the selection of clinical drugs,reflect the key advantages of traditional Chinese medicine treatment,improve the selection of outcome indicators,improve the methodological quality of systematic reviews,conduct more large-scale,multi center,and high-quality clinical studies,produce high-quality evidence-based research,and fully leverage the unique advantages of traditional Chinese medicine in treating acute heart failure.
王云姣;范鹿;李艳阳;张军平;刘学政;吕仕超
天津中医药大学第一附属医院/中医国家临床医学研究中心,天津 300193天津中医药大学第一附属医院/中医国家临床医学研究中心,天津 300193天津医科大学肿瘤医院,天津 300060天津中医药大学第一附属医院/中医国家临床医学研究中心,天津 300193天津中医药大学第一附属医院/中医国家临床医学研究中心,天津 300193天津中医药大学第一附属医院/中医国家临床医学研究中心,天津 300193
急性心力衰竭中药静脉制剂证据图谱临床研究
Acute heart failureIntravenous traditional Chinese medicine preparationEvidence mappingClinical research
《中国中西医结合急救杂志》 2026 (3)
299-305,7
世界中医药科技专项资助(WFCMS2024007)天津市中医药重点领域科研课题(2024002)天津市教委科研计划项目(2023ZD029、2022ZD044)World Special Fund for Science and Technology of Chinese Medicine(WFCMS2024007)Tianjin Key Research Projects in Traditional Chinese Medicine(2024002)The Science&Technology Development Fund of Tianjin Education Commission for Higher Education(2022ZD044,2023ZD029)
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