Clinical Research Of Chinese Medicine Combined With West Medicine In Treating Chronic Hepatitis B With Syndrome Of Spleen-stomach Dampness-heat And Liver Depression And Spleen Deficiency

ObjectiveObserve clinical efficacy of valid prescription "Hua Shi Bao Gan Fang"," Qi Du Rou Gan Fang" combination with lamivudine in treating chronic hepatitis B with Syndrome of Spleen-stomach Dampness-heat and Liver Depression and Spleen Deficiency and lamivudine-resistant effects of drugs, finding new ways to prevention and treatment of lamivudine-resistant hepatitis B virus, and then the optimal treatment program.MethodsA multicenter, controlled clinical research program,the implementation of integrated traditional Chinese and Western Medicine on chronic hepatitis B with Syndrome of Spleen-stomach Dampness-heat and Liver Depression and Spleen Deficiency in patients with clinical intervention. Each type of syndromes is divided into treatment group and control group, in which:(1) the control group:the use of lamivudine therapy;(2) the treatment group:treated with lamivudine combined with TCM,according to syndrome differentiation "(treatment of Spleen-stomach Dampness-heat syndrome"with"Hua Shi Bao Gan Fang";"Liver Depression and Spleen Deficiency syndrome" with "Qi Du Rou Gan Fang"), treatment for1years.Records of patients with clinical symptoms, signs and tongue changes, to detect the virological, serological and biochemical indexes, and application of gene chip sequencing technology and sequencing analysis software to detecting of hepatitis B virus lamivudine resistance, and using SPSS17.0software for statistical analysis of all measurement, count data.Results (1) Biochemical response:treatment group and the control group of Spleen stomach Dampness-heat syndrome, treatment group and control group of Liver Depression and Spleen Deficiency syndrome,ALT value for0months(before treatment),3months, june, September, December through statistical analysis, had no statistical significance (P>0.05).Spleen-stomach Dampness-heat syndrome group ALT values in0month and March, March and June were statistically significant (P <0.05); the control group ALT values in0months and March were statistically significant (P=0.001). Liver Depression and Spleen Deficiency syndrome group ALT values in0months and March were statistically significant (P=0.000); the control group in0months and March, March and June, June and September was statistically significant (P<0.05). With increasing duration of treatment, ALT value of the treatment group total showed overall downward trend, with0months to March and declined significantly;the control group showed a downward trend overall, with0months to June declined significantly.(2) Viral nucleic acid response:Spleen-stomach Dampness-heat syndrome treatment group and the control group, Liver Depression and Spleen Deficiency syndrome treatment group and control group HBV DNA value for0months (before treatment) March, June, September and December through statistical analysis, had no statistical significance (P>0.05). Spleen-stomach Dampness-heat syndrome group HBV DAN value in0months and March compared was statistically significant (P <0.05); the results of statistical analysis of the control group same with the treatment group. Liver Depression and Spleen Deficiency syndrome group HBV DAN values in0month and March, March and June compared were statistically significant (P<0.05); the control group HBV DNA value in0months and March was statistically significant (P<0.05). With increasing treatment time, HBV DNA value of the treatment group and the control group overall downward trend, between0month and March fell significantly.(3)HBV Lamivudine-resistant:Spleen-stomach Dampness-heat syndrome treatm ent for12months, the treatment group resistance rate1.69%,the control group5.88%, two groups had no statistical significance (P=0.623), the control group began resi stant in March, and the trend was gradually increased, the treatment group began in S eptember, the trend lower than that of the control group. Liver Depression and Splee n Deficiency syndrome treatment group treating for9months,the resistance rate was significantly lower than the control group, treatment in December the resistance rate was7.5%,the control group20%, two groups had nostatistical significance (P=0.236). The total treatment group resistance rate in December4.04%, control group12.50%, two groups had no statistical significance (P=0.623).Drug-resistant mutations mai ly in rtL180M,rtM204V/I, respectively,41.6%,54.1%.(4)TCM symptoms:Spleen-stomach Dampness-heat syndrome group thirsty, Halitosis, yellow sclera, irritability, sighing, lassitude,abdominal distention, stomach discomfort, Smelly stool, yellow urine,red tongue, tongue old, yellow fur, white fur, fur thin,fur thick, greasy moss and slippery pulse. rapid pulse are different with the control group,according to the Statistical Analysis(p<0.05); treatment for3months, the treatment group symptom score was lower than that in the control group, there was significant difference(p=0.04),dropping largely compared with the control group. Liver Depression and Spleen Deficiency syndrome treatment group irritability, sigh, sash pain, thirst, stomach discomfort, abdominal distention, Smelly stool, bowel, tongue pale, tender tongue, sublingual collaterals varicose, white fur, yellow fur, fur thick, greasy moss, pulse string, slippery pulse are statistical different compared with the control group (P<0.05); treatment for3months, the treatment group symptom scores decline largely than the control group, in June, the two groups was statistically significant (P=0.009), the average integral of the treatment group was lower than that of the control group.ConclusionsTreatment of Chinese medicine combined with West medicine can effectively reduce the chronic hepatitis B patients with Spleen-stomach Dampness-heat syndrome and Liver Depression and Spleen Deficiency syndrome ALT value, HBV DNA levels, the ALT value in March declined more than single lamivudine treatment. Treatment of Chinese medicine combined with West medicine can significantly reduce the chronic hepatitis B patients with Spleen-stomach Dampness-heat syndrome and Liver Depression and Spleen Deficiency syndrome Lamivudine resistance rates, and can delay the resistance time. HBV lamivudine resistant mutations mainly in rtL180M and rtM204Ⅴ/Ⅰ.Treatment of Chinese medicine combined with West medicine can effectively improve the clinical symptoms and tongue and pulse of chronic hepatitis B patients with Spleen-stomach Dampness-heat syndrome and Liver Depression and Spleen Deficiency syndrome, is better than a single lamivudine treatment.