[Clinical research of Dahuang Fuzi decoction in auxiliary treatment of severe acute pancreatitis: a multi-center observation in 206 patients].

OBJECTIVE: To observe the efficacy of Dahuang Fuzi decoction in patients with severe acute pancreatitis (SAP), and to provide valuable medical evidences for a treatment of SAP with combined traditional Chinese and western medicine.
METHODS: A prospective, multi-center, randomized, controlled clinical trial was designed. Two hundred and six adult patients with SAP admitted to intensive care unit (ICU) in three tertiary university teaching hospitals in Dalian from January 2007 to February 2010 were randomly divided into two groups: soapsuds enema control group (control group, n=101) and Dahuang Fuzi decoction enema study group (study group, n=105). The levels of serum amylase, albumin (Alb), D-lactic acid, endotoxin and diamine oxidase (DAO), high-sensitive C-reactive protein (hs-CRP), immunoglobulin (IgG, IgA, IgM), complements (C3, C4), tumour necrosis factor-α (TNF-α), interleukins (IL-6, IL-8) were determined before and after treatment for 2, 4, 7 days. The bowel sound, gastrointestinal function score, the acute physiology and chronic health evaluation II (APACHEII) score and the length of mechanical ventilation (MV), the length of stay in ICU, the mortality rate and average hospital expenses within 28 days were compared.
RESULTS: Compared with control group, in the study group the levels of serum amylase, DAO, D-lactic acid and endotoxin were lowered, the Alb was increased, the levels of TNF-α, IL-6, IL-8, hs-CRP were decreased, the function of body immunity was enhanced, intestinal peristalsis was enhanced, gastrointestinal function score and APACHEII score were improved, the length of MV was reduced, the length of stay in ICU was diminished, the 28-day mortality and average hospital expenses were lowered [4 days amylase (U/L): 357.35±137.54 vs. 492.95±189.42, 2 days DAO (kU/L) : 5.20±0.59 vs. 5.45±0.72, 4 days D-lactic acid (mmol/L): 3.31±0.48 vs. 4.15±0.55, 2 days endotoxin (kEU/L): 0.29±0.11 vs. 0.34±0.14, 4 days Alb (g/L): 34.75±3.56 vs. 32.53±3.44, 2 days TNF-α (ng/L): 3.08±0.45 vs. 3.36±1.11, 2 days IL-6 (ng/L): 298.54±67.82 vs. 313.56±73.91, 4 days IL-8 (ng/L): 30.48±8.56 vs. 45.16±10.81, 2 days hs-CRP (mg/L): 32.56±11.83 vs. 40.42±15.10, 4 days IgG (g/L): 7.05±2.56 vs. 9.53±2.94, 2 days IgA (mg/L): 1 600±170 vs. 1 400±140, 4 days IgM (mg/L): 1 310±280 vs. 1 650±290, 4 days C3 (g/L): 1.11±0.09 vs. 1.50±0.15, 4 days C4 (g/L) : 0.32±0.11 vs. 0.41±0.10, 2 days bowel sound (times/min): 1.26±0.45 vs. 1.15±0.41, 2 days gastrointestinal function score: 2.24±0.98 vs. 2.42±1.05, 4 days APACHEII score: 16.4±6.8 vs. 20.1±7.1, the length of MV (days): 6.5±3.1 vs. 10.1±4.6, the length of stay in ICU (days): 11.3±6.3 vs. 13.8±7.5, mortality: 8.6% vs. 16.8%, average hospital expenses (yuan): 72 thousands vs. 86 thousands, P<0.05 or P<0.01].
CONCLUSION: Dahuang Fuzi decoction may enhance the intestinal peristalsis, protect the gastrointestinal barrier function, reduce the bacteria and endotoxin translocation and the releasing of inflammation mediators, protect the function of body immunity, reduce the length of MV, the length of stay in ICU, and lower the 28-day mortality and average hospital expenses, and it can improve the prognosis of patients with SAP.

RCT Entities:   Population Interventions Outcomes