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ObjectiveTo investigate the risk factors of patients with acute lung injury/acute respiratory distress syndrome (ALI/ARDS) complicated with Yangming Fushi syndrome.Methods A prospective study was conducted. From August 2009 to July 2013, 206 patients with Yangming Fushi syndrome combined with ALI/ARDS were enrolled in the intensive care units ( ICUs ) of the following five hospitals: Tianjin Nankai Hospital, Dongzhimen Hospital Affiliated to Beijing Traditional Chinese Medicine University, General Hospital of Tianjin Medical University, the First Affiliated Hospital of Dalian Medical University, and Wuxi Third People's Hospital in Jiangsu Province. According to the mortality occurring in ICU, the patients were divided into death group and survival group. The gender, age, acute physiology and chronic health evaluation Ⅱ ( APACHE Ⅱ ) score within the first 24 hours after admission, the length of invasive mechanical ventilation, usage of vasoactive agents, ratio of operative intervention, the length of stay in ICU, application of continuous renal replacement therapy ( CRRT ), amount of blood transfusion, the level of C-reactive protein ( CRP ), lactulose/mannitol ( L/M ) ratio, the number of organs with dysfunction, oxygenation index ( PaO2/FiO2 ), levels of lactate and serum creatinine ( SCr ) of both groups were recorded. Logistic regression analysis was used to look for the independent risk factors of death of patients. Results There were 124 cases with severe acute pancreatitis ( SAP ), which was the most common disease with manifestation of Yangming Fushi syndrome combined with ALI/ARDS, accounting for 60.19% of all the patients. During the period of hospitalization in ICU, 171 patients survived and 35 died, and the mortality rate was 16.99%. The risk factors of the two groups were analyzed by variable analysis, and it was shown that compared with those in survival group, the age ( years: 57.26±16.23 vs. 48.07±13.48, t = 3.544, P = 0.000 ), APACHE Ⅱ score ( 20.83±9.73 vs. 12.61±6.63, t = 4.777, P = 0.000 ), the length of invasive mechanical ventilation ( days: 10.97±7.71 vs. 6.91±2.48, t = 2.555, P = 0.015 ) and the number of dysfunction organs ( 3.11±1.21 vs. 1.60±1.34, t = 6.222, P = 0.000 ) in death group were significantly higher. The level of PaO2/FiO2 [ mmHg ( 1 mmHg = 0.133 kPa ): 218.56±64.90 vs. 244.58±85.10, t = -2.024, P = 0.044 ] in the death group was significantly lower than that of the survival group, while the length of ICU stay ( days: 14.33±10.81 vs. 9.11±7.37, t = 2.600, P = 0.010 ), the usage rates of CRRT [ 28.57% ( 10/35 ) vs. 15.20% ( 26/171 ), χ2 = 3.968, P = 0.046 ], vasoactive agents [ 28.57% ( 10/35 ) vs. 12.28% ( 21/171 ), χ2 = 6.511, P = 0.011 ], and blood transfusion ratio [ 42.86% ( 15/35 ) vs. 23.39% ( 40/171 ), χ2 = 7.042, P = 0.008 ] were all obviously higher in the death group than those in the survival group. There were no statistically significant differences in gender, number of operation, the levels of CRP, L/M ratio, lactate and SCr between the two groups ( all P > 0.05 ). Multivariate logistic regression analysis showed that age [ odds ratio ( OR ) = 0.938, 95% confidence interval ( 95%CI ) = 0.898-0.980, P = 0.004 ], APACHE Ⅱ score ( OR = 0.914, 95%CI = 0.839-0.996, P = 0.041 ), the number of dysfunction organs ≥ 3 ( OR = 0.223, 95%CI = 0.066-0.754, P = 0.016 ), and the level of PaO2/FiO2 ( OR = 0.990, 95%CI = 0.982-0.998, P = 0.015 ) were independent risk factors for mortality. Conclusions The age, APACHE Ⅱ score, number of dysfunction organs ≥ 3 and the level of PaO2/FiO2 are of significance in predicting the prognosis of patients with Yangming Fushi syndrome combined with ALI/ARDS. Patients with risk factors of high mortality should be more carefully monitored and treated aggressively.