| OBJECTIVES:To observe the clinical therapeutic effect of the modified Wendan Decoction on hyperbilirubinemia induced by viral hepatitis,and explore the mechanism clinically and theoretically.Methods:1.All data were collected from the out-patient and in-patient section of Department of Liver Diseases from March 2006 to December 2007 in Hubei Hospital of Traditional Chinese Medicine.All cases were accorded with both the Scheme in the management of viral hepatitis revised by the Chinese Medical Association Branch Association of Infectious Diseases and Parasiyology and the Branch Association of Hepatology in 2000 and the Guiding principles for clinical research on new drugs (traditional Chinese medicine)issued by the State Food and Drug Administration in 2002.80 cases were involved in the study and randomized into Control Group(n=40) and Treatment Group(n=40)with no statistical difference discovered in age,gender, diagnosis with western medicine and pathogenic diagnosis,so as to be comparable (P＞0.05).2.The Control Group was given routine western medicine treatment as: 150mg/d diammonium glycyrrhizinate,20ml/d potassium magnesium aspartate, 20mg/d vitarnine K1,and symptomatic supportive treatment.The Treatment Group was treated with the above treatment plus the modified Wendan Decoction(Faxia, Zhuru,Chao Zhishi,Chenpi,Sheng Gancao,10g for each,and Fuling15g, Dansheng20g,Chishao30g,decocted with water to 250 ml),one dose a day,twice orally.The two groups were both treated for 30 days,with no other medications were taken during the treatment.3.Common physical examination(e.g.Temperature,Pulse,Respirations,Blood Pressure),routine examinations of blood,urine,feces,and occult blood,kidney function,electrocardiogram and the adverse reaction were conducted before and after treatment,and the safety was evaluated accordingly.We recorded the clinical symptoms,blood serum TBIL,ALT,ALB before and after treatment and worked out the therapeutic evaluation according to the related diagnostic criteria.RESULTS:1.On total efficacy:of the 40 cases in the Treatment Group,21 cases shows remarkably effective,13 effective and 6 ineffective,the total effective rate is 85.00%; of the 40 cases in the Control Group,it is 11 remarkably effective,12 effective and 17 ineffective,with the total effective rate of 57.50%.The statistical analysis of the comparison of the two groups shows a superior effect of Treatment Group to Control Group in total effective rate(P＜0.05),which indicates a better efficacy of clinical overall therapeutic effect in Treatment group than Control group.2.On total score of clinical symptoms:no significant difference was observed in comparing both groups before treatment(P＞0.05);the total score after treatment was obviously different to that of before in both groups(P＜0.01);and the total score of Treatment Group showed an apparent superior improvement to that of Control Group(P＜0.05),this demonstrated a better therapeutic effect of Treatment Group than of Control Group.3.On liver function:①Before treatment,TBIL,ALT,ALB in both groups showed no obvious difference(P＞0.05);②After treatment,the differences were statistically significant(P＜0.01);③The comparison between the two groups after treatment showed significant difference in TBIL(P＜0.05),whereas none in ALT and ALB(P＞0.05).These indicated that both groups had obviously improved the patients' liver function,lowered TBIL,ALT and elevated ALB;and the Treatment Group was superior to Control in lowering TBIL in patients,but similar in lowering ALT and elevating ALB.4.On analysis of symptoms improvement:①Before treatment,the score for clinical symptoms in both groups showed no obvious difference(P＞0.05);②After treatment,the differences were statistically significant(P＜0.01);③When making comparison between the two groups after treatment,the following symptoms were improved significantly in Treatment Group with a superior effect to Control Group: icterus,hypochondriac pain,thoracic stuffiness and abdomen distending,dark urine, anorexia,nausea and vomiting.However,no significant differences were observed on the improvement of thirst,bitter taste and fatigue(P＞0.05).5.On safety comparison:both groups showed no obvious abnormal changes in routine examinations of blood,urine,feces,and occult blood,kidney function, electrocardiogram.And no adverse reaction was seen during the treatment.These all indicates the safety of the combination therapy of modified Wendan Decoction and western medicine on the hyperbilirubinemia induced by viral hepatitis,as well as its efficiency and no side effects.CONCLUSIONS:Our results indicate a better therapeutic effect of the modified Wendan Decoction combined with western medicine than the single use of western medicine on hyperbilirubinemia induced by viral hepatitis.The possible mechanisms for this may include:1.protection of liver cells;2.improvement of the disordered liver function of conjugating and excreting bilirubin;3.improvement of the disordered bile excretion.Therefore,we should give full play to the advantages of the traditional Chinese Medicine and make better application on the combined traditional Chinese and western medicine therapy,enhancing the curative effect on the hyperbilirubinemia induced by viral hepatitis,so as to promote the academic advancement of Chinese medicine and free the pain of the patients with greater efficiency. |
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