Influences of Treatment Timing of the TCM prescription Qingfei Huayu Tongfu Formula on the Therapeutic Effect and Prognosis of Sepsis-related Acute Respiratory Distress Syndrome

Background 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. Objective 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. Methods 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. Results 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]. Conclusion 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.