Qingfeihuayutongfu prescription for intervening fibrosis in patients with sepsis-associated acute respiratory distress syndrome: a prospective single blind randomized controlled clinical trial study / 中华危重病急救医学

ABSTRACT

Objective To investigate the effect of Qingfeihuayutongfu prescription on oxygenation and pulmonary fibrosis in patients with sepsis-associated acute respiratory distress syndrome (ARDS). Methods A prospective randomized controlled trial was performed. Patients with moderate to severe ARDS admitted to intensive care unit (ICU) of Affiliated Hospital of Nanjing University of Chinese Medicine from July 2015 to February 2017 were enrolled, and randomly divided into Qingfeihuayutongfu prescription group (observation group, 200 mL of Qingfeihuayutongfu prescription was given through nasal feeding on the first day after admission, one dose per day for 7 days) and placebo control group. Routine treatment of ARDS in both groups was the same. The oxygenation index (PaO2/FiO2), levels of serum procollagen Ⅲ (PC Ⅲ) and prolidase (PLD) were measured at 1, 3, 7, 14 and 28 days after treatment, duration of mechanical ventilation, the length of ICU stay and 60-day survival rate were recorded. Results A total of 32 patients with ARDS were selected, with 16 in each group, and their baseline data were balanced and comparable. As time went on, PaO2/FiO2in both groups was decreased gradually, and serum levels of PC Ⅲand PLD were increased gradually. Compared with placebo control group, PaO2/FiO2was significantly increased at 14 days and 28 days after treatment in observation group [mmHg (1 mmHg = 0.133 kPa): 185.81±65.07 vs. 137.19±55.72, 250.56±102.72 vs. 178.25±80.97, both P < 0.05], the levels of serum PC Ⅲ were significantly decreased at 14 days and 28 days after treatment (μmol/L: 197.13±26.61 vs. 240.81±45.27, 169.06±36.34 vs. 234.75±46.30, both P < 0.01), the levels of serum PLD was significantly decreased at 28 days after treatment (U/L: 1 166.31±304.84 vs. 1 468.81±387.65, P < 0.05), duration of mechanical ventilation (days: 18.20±5.20 vs. 23.38±7.57) and the length of ICU stay (days: 23.7±5.7 vs. 31.0±7.9 ) were significantly shortened (both P < 0.05). Kaplan-Meier survival curve analysis showed that there was no significant difference in the 60-day survival rate between the observation group and placebo control group [81.25% (13/16) vs. 68.75% (11/16), χ2= 0.667, P = 0.505]. Conclusion The Qingfeihuayutongfu prescription may improve oxygenation of ARDS patients, reduce the levels of serum PC Ⅲ and PLD, and inhibit pulmonary fibrosis, thus improve prognosis.