Clinical Research On The Treatment Of Qingyi Granula For Severe Acute Pancreatitis

Objectives:To investigate clinical features in the natural course of severe acute pancreatitis (SAP) and tongue, pulse, syndromes for Traditional Chinese Medicine (TCM); To observe the value of Qingyi granule on the treatment for the early period of SAP; To observe the dynamic immunity for patients with SAP and Chinese medicine intervention. Methods:Relying on the national issues of Science and Technology Support Program, we observed all complications for 79 patients with SAP in the acute phase response at all stages of natural course, and tongue, pulse, syndromes for TCM, and the intervention for the natural course with Chinese medicine from July 2007 to December 2009. By using a randomized controlled trial, 79 patients were divided into the Qingyi granules treatment group (treatment group) and the routine treatment group (control group) for mortality, clinical results, severe degree, infection, C-reactive protein (CRP) on admission,1,3,5,7 and 14 d, and economics of treatment. We collected 21 patients with SAP from May 2009 to December 2009, which were divided into the treatment group versus the control group, or the infection group versus the un-infection group, by collecting data from clinic and biochemical data including the percentage of CD3+/ CD4+/CD8+/natural killer (NK) cells/B lymphocytes/HLA-DR and CD4+/CD8+ratio in serum on 1,7, 14 and 28 d. Results:1.15 cases with secondary infection,6 patients died,5 cases entered the recovery period,53 cases with rehabilitation; 50/79 patients with organ dysfunction; the main tongue coating with yellow-white and thick; the main tongue color with red; the main pulse manifestation with wiry. In infection period, nine cases recovered,5 cases entered the recovery period and 1 died; the main tongue coating with yellow and greasy; the main tongue color with crimson; the main pulse manifestation with full. Ten of eighty patients got in the recovery period, the main tongue coating with white and thick; the main tongue color with light red; the main pulse manifestation with feeble. 5/37 patients with complications in the treatment group,15cases with complications in the control group.2. The mortality of the two groups was similar (8.1% versus 9.5%). The total effective rates of the two groups were difference significantly (86.5% versus 69.0%). The severe degree for patients were declined, APACHE-â…¡score in the treatment group was faster on 3,5,7 and 14d, but not for CT score. The infection rates of the two groups were difference significantly (4/37 versus 11/42); the predominant infections were gram-negative bacterium and polyinfection. By compared, serum CRP levels of the treatment group were showed difference on 5,7 and 14d. Comparison of survival patients in the two groups for health economics, time of antibiotic use, hospitalization days and hospital charges in the treatment group were significantly decreased.3. Six patients infected; 9 patients in the treatment group,12 cases in the other. The levels of T-lymphocyte subsets in the treatment group were quite different from the control group, with much more the percentage of CD4+ and the CD4+/CD8+ ratio on 7,14 and 28d, and much less the percentage of CD8+ on 14 and 28d; on 14 and 28d, the levels of NK cells and B lymphocytes were significantly higher in the treatment group; the levels of HLA-DR were significantly decreased in the control group on 7,14 and 28d. The levels of T-lymphocyte subsets and B lymphocytes in the infection group were quite different from the uninfection group, with much lower the percentage of CD4+, B lymphocytes and the CD4+/CD8+ ratio on 7,14 and 28d, and much more the percentage of CD3+ on 14 and 28d; on 14 and 28d, the levels of NK cells were significantly higher in the infection group; the levels of HLA-DR were significantly decreased in the control group on days 14 and 28, in contrast on 1 and 7d. Conclusions:1. For tongue and pulse, the early period of SAP is the stage of qi and blood with depression and closure, manifested as organ dysfunction; the advanced period is the stage of heat and virus formed pus, characterized by intra-abdominal infection; the recovery period is the stage of pathogenic factor removing and positive injury. Qingyi granule can achieve with high recovery rate and cross-phase.2. Qingyi granule can play a good role in control and treatment on the development of SAP, and have a clear economic advantage through multi-link and multi-level.3. The immune dysregulation exists in the progression of SAP, especially in infection. Qingyi granule can upregulate patient's immune and maintain immune balance.