中国医院用药评价与分析2026，Vol.26Issue(1)：14-18,24,6.DOI:10.14009/j.issn.1672-2124.2026.01.002
2012年1月至2025年6月脓毒症和脓毒症休克患者随机对照试验的对照组药物选择分析
Analysis of Drug Selection for Control Group in Randomized Controlled Trials of Patients with Sepsis and Septic Shock from Jan.2012 to Jun.2025
摘要
Abstract
OBJECTIVE:To evaluate the rationality of drug selection for control group in randomized controlled trials(RCT)of patients with sepsis and septic shock.METHODS:WHO ICTRP and PubMed databases were retrieved to collect RCTs of fluid resuscitation or antimicrobial treatment in patients with sepsis or septic shock from Jan.2012 to Jun.2025.Key information including registration time,sample size,study phase,study status,study design,drugs administered in the control and intervention groups,and results were extracted.Relevant sections of different versions of the global Surviving Sepsis Campaign Guidelines(hereinafter referred to as the"SSC Guidelines")were systematically reviewed to assess the rationality of drug selection for control group in RCT.RESULTS:A total of 58 RCTs were included,among which 16 RCTs were indicated as completed in terms of study status.Seven-teen studies had publicly released data on the outcomes,categorized by intervention type into 13 fluid resuscitation studies and 4 antimicrobial treatment studies.The data from 41 RCTs were not made public.Among the 13 fluid resuscitation studies with published data,12 were sourced from PubMed,and 1 was from the report of the clinical study website.Among the 58 RCTs,7 exhibited flaws in their control group design,including 6 studies on fluid resuscitation and 1 on antimicrobial therapy.Of the 3 RCTs that showed statistical significance in the primary outcomes,all were in the field of fluid resuscitation.Six studies were cited by the SSC guidelines,including 5 fluid resuscitation studies and 1 antimicrobial treatment study.CONCLUSIONS:Overall,the selection of interventions in control group of RCT investigating fluid resuscitation in patients with sepsis or septic shock has some irrational phenomenon.Existing RCTs have not clearly elucidated the correlation between intervention selection and clinical outcomes,and the number of RCT cited in the SSC guidelines remains limited.More well-designed RCTs need to be conducted to provide support for clinical treatment and evidence-based practice.关键词
重症/脓毒症/脓毒症休克/随机对照试验/拯救脓毒症运动指南Key words
Critical ill/Sepsis/Septic shock/Randomized controlled trial/Surviving Sepsis Campaign Guidelines分类
医药卫生引用本文复制引用
赵以览,马思楠,杨婷,王佳甜,龚黄鑫,陈柯宇,王娜,王岩..2012年1月至2025年6月脓毒症和脓毒症休克患者随机对照试验的对照组药物选择分析[J].中国医院用药评价与分析,2026,26(1):14-18,24,6.基金项目
国家自然科学基金资助项目(No.72274153) （No.72274153）
