Traditional Chinese medicine (TCM) is effective in the treatment of sepsis-induced acute lung injury (ALI) /acute respiratory distress syndrome (ARDS). However, the lack of standard and uniform outcome indicators in the design of most published clinical trials makes it difficult to combine and compare the results of similar studies, causing the impossibility of generating high-quality evidence to guide clinical decision-making.

To analyze the use of outcome indicators in randomized controlled trials on TCM for sepsis-induced ALI/ARDS from 2017 to 2022.

CNKI, Wanfang Data, SinoMed, PubMed, Embase, Web of Science and Cochrane Library were searched for RCTs on sepsis-induced ALI/ARDS, with the intervention group treated with TCM combined with other drugs or conventional treatment, and no restrictions in the control group. The ROB.2 tool of the Cochrane Review Group was used to assess the quality of literature and the classification of outcome indicators was summarized.

39 papers were included after screening, including 1 (2.56%) with low risk of bias, 3 (7.69%) with high risk of bias and 35 (89.74%) with concerns of bias. The outcome indicators in 5 RCTs were reported with a quality score of ≥5, indicating the complete reporting of outcome indicators. A total of 106 outcome indicators were reported and used for 443 times, including physicochemical testing outcome (55 types, 51.89%), TCM syndrome/sign outcome (2 types, 1.89%), symptom and syndrome outcome (13 types, 12.26%), long-term prognosis outcome (19 types, 17.92%), quality of life outcome (7 types, 6.60%), safety event outcome (8 types, 7.55%) and economic evaluation outcome (2 types, 1.89%). There were four outcome indicators with utilization rate>50%, including oxygenation index (82.05%), Acute Physiology and Chronic Health Evaluation Scoring System (58.97%), mechanical ventilation duration (51.28%) and interleukin-6 (51.28%). The composite outcome indicators of effective rate or TCM syndrome efficacy were used in 21 papers, involving a total of 12 times of effective rate, TCM syndrome score of 8 times and TCM symptom efficacy of 6 times. The total 106 outcome indicators were summarized and categorized sequentially including overall evaluation indicators (36 types, 33.96%), common indicators (36 types, 33.96%) and different focus indicators (34 types, 32.08%) .

At present, the selection of outcome indicators in RCTs on TCM for sepsis-induced ALI/ARDS is still nonstandard, mainly manifests in unclear differentiation between primary and secondary outcome indicators, trivialization of endpoint indicators, lack of follow-up data and characteristic indicators of TCM. A core outcome set of TCM outcome indicators for septic induced ALI/ARDS should be constructed to promote the high-quality development of TCM in the future.

中医药治疗脓毒症性急性肺损伤（ALI）/急性呼吸窘迫综合征（ARDS）的疗效确切，但大多数已发表的临床试验设计中缺乏标准、统一的结局指标，造成同类研究结果难以合并、对比，无法产生高质量的循证证据指导临床决策。

分析2017—2022年中医药治疗脓毒症性ALI/ARDS临床试验结局指标的使用情况。

检索中国知网（CNKI）、万方数据知识服务平台、中国生物医学文献服务系统、PubMed、Web of Science、Embase、Cochrane Library数据库中有关脓毒症性ALI或ARDS的随机对照试验，其中干预组措施为中医药联合其他药物或常规治疗方案，对照组不做限制。采用Cochrane研发的ROB.2工具进行文献质量评价并总结结局指标分类情况。

经筛选后纳入39篇文献，其中文献偏倚风险评估为低风险1篇（2.56%），高风险3篇（7.69%），可能存在风险35篇（89.74%）。5篇（12.82%）文献结局指标报告质量评分≥5分，为结局指标报告完整。共报告106种结局指标，累计使用443次，包括理化检测（55种，51.89%）、中医症状/证候（2种，1.89%）、症状/体征（13种，12.26%）、远期预后（19种，17.92%）、生活质量（7种，6.60%）、安全性事件（8种，7.55%）和经济学评估（2种，1.89%）。使用率>50%的结局指标有4个，分别是氧合指数（82.05%）、急性生理与慢性健康状况评分系统Ⅱ（58.97%）、机械通气时间（51.28%）和白介素6（51.28%）。21篇文献使用有效率和/或中医证候疗效的复合结局指标，包括总有效率12次，中医证候积分8次和中医症状疗效6次。由于各结局指标差异较大，对106种指标进行合并和依次归类，最终总结出3个大类，分别为：整体评价指标（36种，33.96%）、共性指标（36种，33.96%）及不同关注重点指标（34种，32.08%）。

目前中医药治疗脓毒症性ALI/ARDS临床试验结局指标的选择尚不规范，主要表现为主次结局指标区分不明确、复合结局指标标准不统一、轻视终点指标、缺少随访数据和中医特色指标等。未来应构建脓毒症性ALI/ARDS的中医药核心结局指标集，推动中医药的高质量发展。