Relationship Between TCM Syndrome Types Of HBeAg Negative CHB And Biological Index And The Effect On The Efficacy Of Pegylated Interferon Alpha-2a

Objective: 1.This study was conducted to observe the relationship between clinical biological indicators,including HBsAg negative chronic hepatitis B TCM syndrome type,serum ALT,HBsAg quantification,HBV DNA load,liver tissue inflammation activity(G)and degree of fibrosis(S),to further discuss the biological basis of the HBsAg negative CHB TCM syndrome type,which provides a scientific basis for the judgment of TCM syndrome types.2.To discuss the relationship between HBsAg negative CHB TCM syndrome type and the efficacy index of Pegylated interferon alpha-2a(Peg-IFN?-2a)(ALT normalization rate,HBsAg negative conversion rate,HBV DNA negative conversion rate),in order to evaluate the influence on the efficacy of Peg-IFN?-2a,providing a reference for the treatment of HBeAg-negative CHB by combination of traditional Chinese and western medicine.Methods: Research objects are patients with HBeAg-negative CHB who were treated in the inpatient department of the Hepatology Center of Xiamen Hospital of Traditional Chinese Medicine from November 2016 to December 2017,who were enrolled in a liver biopsy with informed consent and consent form signed.Eligible subjects screened by inclusion criteria were treated with Peg-IFN?-2a antiviral therapy for 48 weeks.The TCM syndromes,age,gender,baseline ALT,HBsAg,HBV DNA,liver tissue inflammation activity degree(G)and fibrosis degree(S)of patients before treatment and ALT normalization,HBsAg negative conversion,HBV DNA negative conversion of the patients after 48 weeks of treatment were recorded.The author uses unordered multinomial Logistic regression analysis to know about the biological basis of TCM syndromes in HBeAg-negative CHB patients and binary Logistic regression analysis to discuss the effects of TCM syndromes and baseline-related indicators on Peg-IFN?-2a.Outcomes:1.General: A total of 116 patients met the inclusion criteria,98 males and 18 females with an average age of 37.40±7.34 years old.Liver-stagnation and spleen-deficiency syndrome(43 cases,39.7%),damp-heat accumulation syndrome(41 cases,33.6%),liver stagnation syndrome(17 cases,13.8%),liver and kidney yin deficiency syndrome(8 cases,6.9%),blood stasis syndrome(7 cases,6.0%).The number of drop-out patients was 8 in total,including 4 patients with Liver-stagnation and spleen-deficiency syndrome,3 patients with damp-heat accumulation syndrome,and 1 patient with liver stagnation syndrome,all of which were included in the statistics according to the last observation value conversion method.(1)The male-female ratio of HBeAg-negative CHB patients with different syndrome types was different,and the difference was statistically significant(P=0.029).(2)The age of liver stagnation syndrome patients was younger than other syndrome types,and the differences were all statistically significant(P<0.05).2.Relationship between TCM syndrome types and baseline biological indicators:(1)The ALT level of damp-heat accumulation syndrome was higher than other syndrome types,and the difference was statistically significant(P<0.05).(2)The HBsAg level and HBV DNA load of liver-stagnation and spleen-deficiency syndrome were lower than other syndrome types,the difference was statistically significant(P<0.05);(3)The composition of liver tissue inflammation activity(G)of damp-heat accumulation syndrome was higher comparing with liver stagnation syndrome.The difference was statistically significant(P=0.005);(4)The degree of liver fibrosis in the blood stasis syndrome was higher than that in other syndromes,and the difference was statistically significant(P<0.05).3.The relationship between efficacy index and baseline biological index:(1)HBV DNA negative conversion rate at 48 th week was higher when ALT was greater than 2 times the upper limit of normal value.The difference was statistically significant(P=0.011).;(2)The ALT normalization rate,HBsAg negative conversion rate and HBV DNA negative conversion rate were high in HBsAg?1 500 IU/mL at 48 th weeks.The differences were statistically significant(P<0.05);(3)HBV DNA negative conversion rate in HBV DNA?6 lg IU/mL at 48 th week was high,the difference was statistically significant(P<0.001);(4)When liver tissue inflammatory activity G>2,ALT normalization rate at 48 th weeks and HBV DNA negative conversion rate are different.The difference was statistically significant(P<0.05).4.Through unordered multinomial Logistic regression analysis,taking the damp-heat accumulation syndrome as the reference class,compared with the damp-heat accumulation syndrome,in the same low level of ALT,the occurrence ratio of liver-stagnation and spleen-deficiency syndrome was 3.387 times higher than that of the damp-heat accumulation syndrome(95%CI:1.113~10.310,P=0.032).The rates of the same low age,low ALT level,low inflammatory activity and liver qi stagnation syndrome were 25.676,12.944,10.370(95% CI 4.328~152.334,2.115~79.234,1.276~84.272,respectively,P<0.001,P=0.006,0.029);In the same male sex,the occurrence ratio of liver and kidney yin deficiency syndrome was 0.037 times higher than that of damp-heat accumulation syndrome(95% CI 0.004~0.316,P<0.003),suggesting that the lliver and kidney yin deficiency syndrome was more common in women and had the same low ALT level.The occurrence ratio of liver and kidney yin deficiency syndrome was 11.176 times higher than that of damp-heat accumulation syndrome(95%CI:1.620~77.099,P=0.014).In the same low fibrosis degree,the occurrence ratio of blood stasis syndrome was 0.027(95%CI 0.002~0.412,P=0.009)of dampness-heat accumulation syndrome,suggesting that blood stasis syndrome with high degree of fibrosis was more common than that of damp-heat accumulation syndrome.Among them,the lower the level of ALT,the more the probability of syndrome type occurrence was liver stagnation qi stagnation syndrome>blood stasis syndrome>liver-stagnation and spleen-deficiency syndrome according to the superiority ratio.5.After binary Logistic regression analysis,adding independent influencing factors of TCM syndrome type of ALT normalization at 48 th week and HBV DNA negative conversion,the odds ratio of ALT normalization at 48 th week of spleen-deficiency syndrome to damp-heat accumulation syndrome at 48 th weeks was 0.097(95% CI: 0.024~0.388,P=0.038),while that of HBV DNA negative conversion at 48 th week was 0.269(95% CI: 0.077~0.942,P=0.040).The odds ratio of liver and kidney yin deficiency syndrome to damp-heat accumulation syndrome on HBV DNA negative conversion at 48 th week was 0.097(95% CI: 0.010~0.978,P=0.048).Conclusion: 1.HBeAg-negative CHB with different TCM syndromes types has certain biological characteristics.2,TCM syndrome type is an independent influencing factor of Peg-IFN?-2a efficacy.The syndrome of accumulation of dampness-heat is better than the syndrome of liver depression and spleen deficiency and the syndrome of deficiency of liver-kidney yin,which has a higher rate of ALT normalization rate and HBV DNA negative conversion.Combined with ALT,HBV DNA and other baseline biological indicators seize the time of treatment in time for Peg-IFN ?-2a antiviral therapy,it is expected to obtain a higher virological response.