| Objective:Through continuous observe the peripheral blood concentration of ET, L/M, human leukocyte antigen DR site (HLA-DR) expression rate, the helper T lymphocyte1/2(Thl/Th2), the regulatory T lymphocyte (Treg) expression rate and in different stages of Severe Acute Pancreatitis(SAP) Patients on the basis of Western medicine, to treat Qing fei cheng qi granules, we investigate the effect of Qing fei cheng qi granules on immune response and prognosis in early severe acute pancreatitis (SAP) patients and the infective stage SAP patients.Subjects and methods:Continuous observation patients of severe acute pancreatitis Tianjin Nankai Hospital SICU admitted from February2010to May2013, subject to the following conditions:Chinese Medical Association of Gastroenterology pancreatic diseases study group will develop a "Chinese acute pancreatitis treatment guidelines" diagnostic standards; aged18-70years old; consent of the patient or family consent. There are24males and11females in the systemic inflammatory stage, while32males and12females in the infective stage. The study is a randomized, controlled, double-blind clinical study. Through the China Academy of traditional Chinese medicine clinical evaluation center, we divided patients enrolled in different stages into Western medicine treatment group(Western medicine treatment plus placebo) and Integrative treatment(Western medicine treatment plus Qing fei cheng qi granules). Qing fei cheng qi granules and placebo are provided from the Jiang yin tian jiang pharmaceutical company. Placebo:The morphology similar granules with Qing fei cheng qi granules without pharmacodynamic effects. Drug administration way:Oral/nasogastric plus enema;2times/day for ten days. Complete the study task, We applied for a blind exposure, confirmed which was the experimental agent group and placebo group. The patients were observed and compared in1st,3rd,7th and14th day during treatment changes in immunological parameters. We exam their human leukocyte antigen DR site(HLA-DR) rate, the helper T lymphocyte1/2(Thl/Th2), the regulatory T lymphocyte positive rate, the concentration of ET in the peripheral blood, and L/M.Results:(1) The early stage:Patients die within28days of3cases (8.57%), in which the observer group1deaths (5.56%) in the control group2deaths(11.76%). Compared with the control group, the observer group L/M and ET(EU/ml) were significantly decreased on the7th,14th day. Compared with the observer group patients into groups, on the7th,14th day, L/M and ET(EU/ml) were significantly decreased. Compared with the control group patients into groups, L/M were significantly increased on the3rd,7th,14th day. ET(EU/ml) were significantly increased on the7th,14th day. It shows that Qing fei cheng qi granules can improve intestinal mucosal barrier function and reduce intestinal bacterial and endotoxin translocation. Compared with the control group, the observer group HLA-DR(%)(86.77%±17.39%vs65.46%±28.72%,85.43%±20.36%vs73.32%±29.03%, all P<0.05) were significantly increased on the7th,14th day, Th1/Th2(3.58±3.74vs4.62±2.69,3.54±2.65vs5.64±2.34, P<0.05) were significantly decreased on the7th,14th day, Treg(%) on the1st,3rd day (9.37%±5.61%vs5.65%±3.75%,9.10%±6.86%vs7.09%±4.80%, all P<0.05) were significantly increased. Compared with the observer group patients into groups, on the7th,14th day, HLA-DR(%) were significantly increased, Thl/Th2were significantly decreased, Treg(%) on the1st,3rd day were significantly increased. Compared with the control group patients into groups, on the14th day, HLA-DR(%) were significantly increased. Results show that Qing fei cheng qi granules can enhance SAP early Antigen, enhance the immune response starts, reducing immunosuppression; as well as by over expression of Treg cells to promote Thl to Th2cells, reduce immune intemperate, reduce immune drastic harm to the body.(2) The infective stage:The observation group died2patients(8.33%) within28d while in the control group died4cases(20%). Compared with the control group, the observer group L/M and ET(EU/ml) were significantly decreased on the7th,14th day. Compared with the observer group patients into groups, on the7th,14th day, L/M and ET(EU/ml) were significantly decreased. Compared with the control group patients into groups, L/M were significantly increased on the3rd,7th14th day. ET(EU/ml) were significantly increased on the7th,14th day. It indicates that Qing fei cheng qi granules also can improve intestinal mucosal barrier function, lower intestinal bacterial and endotoxin translocation. The HLA-DR(%), Thl/Th2and Treg(%) have no significantly different on the1st,3rd day. Compared with the control group, the observer group HLA-DR(%), Thl/Th2and Treg(%) have significantly different on the7th day(87.02%±5.94%vs51.01%±33.90%,5.96±6.12vs2.53±1.74and4.58%±3.67%vs8.87%±6.19%, P<0.05). Compared with the observer group patients into groups, on the7th,14th day, HLA-DR(%) were significantly increased, Thl/Th2on the7th day were significantly increased, Treg(%) on the14th day were significantly decreased. Compared with the control group patients into groups, HLA-DR(%) were significantly increased, Treg(%) were significantly increased on the7th day. Results showed that Qing fei cheng qi granules can enhance cellular immune response starts by enhancing the expression of HLA-DR, Treg expression in peripheral blood of patients with reduced to adjust the CD4+T cell differentiation and superiority induced by t-cells into Thl offset, thereby mitigating the negative effects of immune cells, reduce immune suppression, promote immune restoration.Conclusion:The Qing fei cheng qi granules can through improved intestinal mucosa barrier function, reduce intestinal bacteria and the endotoxin translocation, enhance the expression of HLA-DR and signaling between immune cells, then develope the ability of antigen presentation, which enhance the immune response starts to reduce immune suppression and remove pathogens. It also boosts immune balance through adjusting the Thl/Th2and Treg(%), and adjust anti-inflammatory/pro-inflammatory response, improve immunity, promote the recovery of the disease, reduce the mortality of patients with SAP in different stages. |
