Grounded in the traditional Chinese medicine (TCM) theory of visceral outward manifestation describing the Lung and Large Intestine being Externally-Internally Related (Zang-Fu Xiang Guan), previous research has revealed that a self-formulated TCM prescription Qingfei Huayu Tongfu Formula positively treats sepsis-related acute respiratory distress syndrome (ARDS). However, the effect of the therapeutic timing of Qingfei Huayu Tongfu Formula on the clinical outcomes and prognosis of sepsis-related ARDS remains unclear.

To explore the optimal timing of the Qingfei Huayu Tongfu Formula in the treatment of sepsis-associated ARDS and its impact on the treatment efficacy and prognosis.

A total of 208 patients with sepsis-associated ARDS diagnosed in the Intensive Care Unit, Affiliated Hospital of Nanjing University of Chinese Medicine from 2021 to 2023, and treated with Qingfei Huayu Tongfu Formula were retrospectively recruited. According to the time of the first application of TCM decoction, those who took Qingfei Huayu Tongfu Formula within 48 hours of the diagnosis of sepsis-associated ARDS were included the early intervention group (n=109), and patients who took Qingfei Huayu Tongfu Formula after 48 hours were included in the late intervention group (n=85). Fourteen patients were lost to follow-up. Clinical outcomes and prognosis were compared between groups.

The 28-day all-cause mortality rate in the early intervention group was significantly lower than that of the late intervention group (13.8% vs. 29.4%, P=0.001 4). The risk of death in the late intervention group was 2.11 times that of the early intervention group (HR=2.11, 95%CI=1.13-3.91, P=0.019). The median duration of mechanical ventilation was 12 (8, 23) days in the early intervention group, which was significantly shorter than 27 (13, 35) days in the late intervention group (P=0.035). Intra-group comparisons showed improvements in oxygen index for both groups post-treatment (P<0.001). C-reactive protein (CRP), procalcitonin (PCT), and white blood cell counts post-treatment were all significantly reduced in both groups compared to pre-treatment levels (P<0.05). After the intervention, the mean oxygen index in the early intervention group was significantly higher than that of the late intervention group[ (319.87±95.32) vs. (259.55±99.72), P<0.001]. After the intervention, the median CRP in the early intervention group was significantly lower than that of the late intervention group[19.39 (8.16, 44.47) mg/L vs. 38.01 (17.53, 86.05) mg/L, P<0.001]. Similarly, the median PCT concentration post-treatment in the early intervention group was significantly lower than that of the late intervention group[0.175 (0.089, 0.750) ng/mL vs. 0.460 (0.143, 1.850) ng/mL, P=0.004].

Early administration (within 48 hours after diagnosis) of the TCM formula Qingfei Huayu Tongfu Formula to treat sepsis-related ARDS can reduce the 28-day mortality and the length of mechanical ventilation, improve the oxygenation index, and reduce inflammatory responses.

根据中医藏象学说中"肺与大肠相表里"理论，前期研究发现自拟中药清肺化瘀通腑方对脓毒症相关急性呼吸窘迫综合征（ARDS）具有积极治疗作用，但目前关于清肺化瘀通腑方治疗时机对脓毒症相关ARDS患者临床疗效及预后影响的研究较少。

探索中药方剂清肺化瘀通腑方治疗脓毒症相关ARDS的最佳切入时机及其对治疗效果和预后的影响。

回顾性选择2021—2023年南京中医药大学附属医院重症医学科诊断为脓毒症相关ARDS且治疗过程中联合中药汤剂清肺化瘀通腑方治疗的208例患者。按照中药首次使用时间，确诊脓毒症相关ARDS 48 h内（包括48 h）开始服用清肺化瘀通腑方患者为早期干预组；48 h后开始服用清肺化瘀通腑方患者为晚期干预组。最终早期干预组109例，晚期干预组85例，失访患者14例。比较两组患者的临床疗效及预后。

早期干预组28 d全因病死率为13.8%，低于晚期干预组的29.4%（P=0.001 4），且晚期干预组死亡风险为早期干预组的2.11倍（HR=2.11，95%CI=1.13~3.91，P=0.019）。早期干预组机械通气天数为12（8，23）d，少于晚期干预组的27（13，35）d（P=0.035）。两组组内比较，治疗后氧合指数均较治疗前明显改善（P<0.001），C反应蛋白、降钙素原、白细胞计数与本组治疗前比较均下降（P<0.05）。两组治疗后早期干预组氧合指数均数为（319.87±95.32），高于晚期干预组的（259.55±99.72）（P<0.001）。两组治疗后早期干预组C反应蛋白为19.39（8.16，44.47） mg/L，低于晚期干预组的38.01（17.53，86.05） mg/L（P<0.001）。两组治疗后早期干预组降钙素原为0.175（0.089，0.750） ng/mL，低于晚期干预组的0.460（0.143，1.850） ng/mL（P=0.004）。

早期（确诊后48 h内）合理给予中药清肺化淤通腑治疗脓毒症相关ARDS可减少患者28 d全因病死率及机械通气天数，改善患者氧合指数，减轻炎性反应。