基于文献计量学分析升降散治疗脓毒症的临床试验研究现状

Quality Assessment of Clinical Trials About Shengjiang Powder in the Treatment of Sepsis Based on Bibliometrics

目的:对现有使用升降散治疗脓毒症的临床研究进行质量评价,为相关临床研究的设计和实施提供参考。方法:在Web of Science、PubMed、Embase、Cochrane Library、CNKI、WanFang Data、SinoMed、VIP数据库中检索纳入符合要求的随机对照试验(RCT),使用Cochrane风险偏倚评估工具进行质量评估,双人平行提取信息并评估质量。结果:检索到423篇文献,最终纳入25篇中文文献。10篇(40.0%)文献为硕士或博士学位论文,13篇(52.0%)文献声明有基金资助。研究选取的主要结局指标是急性生理与慢性健康评分(APACHEⅡ)、中医证候积分、有效率等。对照组为西医治疗,试验组在对照组基础上加服升降散。在25个自述RCT的研究中,未提及随机化过程、分配隐匿和未阐述盲法的文献比例为40.0%(10/25)、96.0%(24/25)、88.0%(22/25)。仅设置了一个对照组且结局为有效率的13项研究中,10篇(76.9%)样本量不足。只有11项(44.0%)研究关注了不良反应结局。结论:围绕升降散治疗脓毒症开展的临床研究较少且质量不高,反映出目前中医临床医生对方法学知识掌握不足,期刊对文章的方法学、安全性评估等方面要求低等问题。亟需政府、期刊、研究者共同努力,提高中医药研究质量。

Objective:To evaluate the quality of existing clinical studies of Shengjiang Powder for the treatment of sepsis,trying to provide a reference for the design and implementation of relevant clinical studies.Methods:Web of Science,PubMed,Embase,Cochrane Library,CNKI,Wan Fang database,VIP,and SinoMed were searched from inception to April 17 th 2021,using“Shengjiang Powder”and“sepsis”as keywords both in Chinese and in English,qualified randomized controlled trials(RCTs)were included The Cochrane Collaboration’s tool for assessing the risk of bias was used for quality assessment.The data extraction and evaluation were conducted independently by two reviewers.Results:Within 423 initially identified records,25 trials in Chinese were included in our review.Of which,10(40.0%)were Master’s thesis,and 13(52.0%)stated funding support.The main outcome indicators were APACHEⅡscore,TCM syndrome score,effective rate and so on.In addition,among 25 trials claimed to be RCTs,the proportion for not mentioning the process of randomization,allocation concealment,and blindness was 40.0%(10/25),96.0%(24/25),and 88.0%(22/25).Ten of the 13 trials(76.9%)with one control group and the effective rate outcome had an insufficient sample size.Only 11 trials(44.0%)mentioned adverse reactions.Conclusion:Only a few clinical studies with relatively low quality were related to sepsis treatment with Shengjiang Powder,which reflected the lack of methodological knowledge of traditional Chinese medicine clinicians and the low requirements of journals on the methodology and safety assessment on articles.Therefore,to improve the quality of TCM researches,efforts from the government,journals,and clinicians are urgently needed.