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OA
Analysis of Drug Selection for Control Group in Randomized Controlled Trials of Patients with Sepsis and Septic Shock from Jan.2012 to Jun.2025
目的:评价脓毒症和脓毒症休克患者进行随机对照试验(RCT)时对照组药物的选择合理性.方法:检索WHO ICTRP和PubMed数据库,搜索 2012 年 1 月至 2025 年 6 月脓毒症和脓毒症休克患者液体复苏或抗感染治疗的临床研究,提取注册时间、样本量、研究阶段、状态、设计、对照组和研究组药物以及研究结果等相关信息.查阅全球性的《拯救脓毒症运动指南》(以下简称"SSC指南")不同年份版本的相关内容,对RCT中对照组所选择药物的合理性进行评价.结果:该研究共纳入 58 项RCT,其中16 项RCT的研究状态为已完成.17 项RCT公开发表了主要结果指标的数据,其中液体复苏研究 13 项,抗感染治疗研究 4 项;41 项RCT未公开发表研究数据.13 项公布数据的液体复苏研究中,有 12 项来自PubMed,1 项来自研究国临床研究网站.58 项RCT中存在对照组设计缺陷的有 7 项,其中液体复苏研究 6 项,抗感染治疗研究 1 项.3 项RCT的主要结局具有统计学意义,全部为液体复苏研究.6 项RCT被SSC引用,其中液体复苏研究 5 项,抗感染治疗研究 1 项.结论:在涉及液体复苏的脓毒症和脓毒症休克RCT中,对照组的药物选择需改进.现有RCT未能明确治疗药物选择与临床结果之间的相关性,且SSC指南中引用的RCT较少.未来需开展更多设计严谨的RCT,为临床治疗和循证提供支持.
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.
赵以览;马思楠;杨婷;王佳甜;龚黄鑫;陈柯宇;王娜;王岩
西安交通大学第二附属医院药学部,西安 710114西安交通大学第二附属医院药学部,西安 710114西安交通大学第二附属医院药学部,西安 710114西安交通大学第二附属医院药学部,西安 710114西安交通大学第二附属医院药学部,西安 710114西安交通大学第二附属医院药学部,西安 710114西安交通大学第二附属医院药学部,西安 710114西安交通大学第二附属医院药学部,西安 710114
医药卫生
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
Critical illSepsisSeptic shockRandomized controlled trialSurviving Sepsis Campaign Guidelines
《中国医院用药评价与分析》 2026 (1)
14-18,24,6
国家自然科学基金资助项目(No.72274153)
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