RESUMEN
Objective To develop a scale for evaluating the curative effect of traditional Chinese medicine (TCM) for liver disease under the guidance of the theory of TCM, and to improve the TCM efficacy evaluation standard system for liver disease. Methods According to the TCM theory, the concept model of the liver disease-specific scale was built in combination with the international connotation of QOL and patient-reported outcomes ( PRO). A primary clinical scale was established after item pool screening, field test, culture adaptation and clinical pre-survey by the research staff. Finally, 200 questionnaires were distributed and 198 questionnaires were reclaimed. Statistical analysis was conducted to choose the items. Results All the selected items were analyzed by the different statistical methods, including significance grading, discrete tendency ( coefficient of variation ) method, stepwise regression analysis, discriminatory analysis, Cronbach’s al pha, and principal component analysis and factor analysis. A self-reported subjective scale and a perceived objective scale were developed, including 17 self-reported subjective items and 13 objective items. Conclusion According to the TCM theory and the international connotation of QOL, the scale of assessing curative effect of TCM for liver disease is practical and repeatable. It will be worthy of further evaluation and promotion to clinical application.
RESUMEN
Objective To observe the therapeutic effect of heat-clearing and dampness-removing therapy combined with Bifico for ulcerative colitis ( UC) induced by trinitrobenzene sulfonic acid ( TNBS), and to explore its influence on tumor necrosis factor alpha ( TNF-α) and interleukin-10 ( IL-10) in rats. Methods Forty female adult Sprague-Dawley rats were evenly randomized into five groups, namely normal control group, model group, Bifico (175 mg/kg) group, Chinese medicine group(enema with Changdiqing 3.6/kg and oral use of Changyanling Recipe l) , and Chinese medicine plus Bifico group. After treatment, the damage of colonic mucous membrane was evaluated, and expression levels of IL-10 and TNF-α in colonic mucosa were observed through immunohistochemical assay. Results The degree of colonic mucosal injury was severer and the inflammation was more obvious in the model group than those in the normal control groups ( P<0.01) , and the above changes were relieved to various degrees in the medication group ( P<0.01 compared with those in the model group) . Chinese medicine plus Bifico group had better effect on reducing colonic mucosa damage index ( CMDI) and inflammation, and on promoting the healing of colonic mucosa than Bifico group and Chinese medicine group (P<0.05 ) . The expression level of TNF-α in the colonic mucosa was markedly increased while that of IL-10 was markedly decreased in the model group ( P<0.01 compared with those in the normal control group) . The medication groups could counteract the above changes in the colonic mucosa ( P<0.01 compared with those in the model group) . The combination group and Chinese medicine group had better effect on decreasing TNF-α expression level and on increasing IL-10 expression level than Bifico group ( P<0.05) . Conclusion IL-10 and TNF-α play an important role in the pathogenesis and development of ulcerative colitis. Chinese medicine combined with Bifico has satisfactory therapeutic effect on UC rats, and its mechanism may be related with the increase of IL-10 expression level and with the decrease of TNF-α expression level.