Clinical Observation Of Qizhu Huaji Formula In The Treatment Of Precancerous Lesions Of Hepatocellular Carcinoma

Objective: To observe the clinical efficacy and safety of Qizhu Huaji formula in the treatment of precancerous lesions of Hepatocellular carcinoma(liver depression and spleen deficiency,phlegm and blood stasis syndrome).Methods: 64 patients who subsumed the inclusion criteria were available,they were split into two groups: one 34 cases observation group rendered conventional therapy such as etiological treatment and liver protection treatment while the other 30 cases control group received routine treatment combined with Qizhu Huaji formula.The course of treatment was 48 weeks,and the patients were followed up for 48 weeks after drug withdrawal.The changes of symptoms and signs,liver function,tumor marker indexes,lesion length and diameter before and after treatment were observed,the incidence and complications of liver cancer in the cure period and follow-up cycle were surveyed.Results:1.Comparison of TCM syndrome efficacy and syndrome score: the effective rate of TCM syndrome improvement consist of 91.18% observation group and63.33% control group.The effective rate of the observation group exceed the control group,and the discrepancy was statistically significant(P<0.05);There was obvious difference between the two groups: the total integral of TCM syndrome after treatment was ameliorate in comparison with that before treatment,and the difference illustrated statistical significance(P<0.05).Compared between groups,accumulate points of TCM syndrome in the observation group after treatment was lower than that in the control group,and the distinction was statistically significant(P<0.05).2.Comparison of improvement of liver function: the values of ALT,AST,TBIL and GGT in the two groups after treatment were lower than those before treatment,and the discrepancy was statistically significant(P<0.05).The value of ALB in the two groups after remedy overtake that before remedy,and it stated significant statistical difference(P<0.01).The ALP value of observation group in later treatment was lower than that before treatment,and it has evident statistical difference(P<0.01),There was no dramatic difference in ALP value before and after therapy in the control group(P>0.05);After therapy,the AST and ALP values of the observation group were lower than those of the control group,and the difference showed statistically significant(P<0.05).The ALB value of the observation group exceed the control group,and the discrepancy was statistically significant(P<0.05).The target of ALT,TBIL and GGT between the two groups have no obvious difference(P>0.05).3.Changes of tumor markers: the AFP-L3 ratio and DCP level of the observation group after treatment were significantly lower than those before treatment(P<0.01),it demonstrated no significant difference in the AFP level of the observation group in before and after therapy(P>0.05),and the AFP-L3 ratio of the control group was noticeable below those prior treatment(P<0.01),the AFP and DCP level presented that there was no significant difference in the control group during the treatment period(P>0.05).There was no significant difference in AFP,AFP-L3 and DCP between groups after treatment(P>0.05).4.Changes of lesion type and length and diameter:after treatment,the length and diameter of the lesions in the observation group were smaller than those before treatment,and the difference was statistically significant(P<0.01).Among them,3 patients with RN disappeared,while there was no statistical difference in the length and diameter of the lesions in the control group before and after treatment(P>0.05);The two groups after treatment illustrated no significant difference in the lesion length and diameter(P>0.05).The improvement rate and index of stability between two groups demonstrated no significant difference(P>0.05),the total improvement rate of lesions in the observation group was 35.29%,the total stability rate was50%,and the total improvement rate of lesions in the control group was 20%,the total stability rate was 43.33%,and there was no significant difference in general two descriptions of ratio among the two groups(P>0.05).5.Incidence of liver cancer: during the treatment cycle,no patient in the observation group developed liver cancer,and 1 patient in the control group developed liver cancer;During the 48 week follow-up period,3 cases in the observation group progressed to liver cancer and 4 cases in the control group progressed to liver cancer.After the follow-up period,3 cases in the observation group progressed to liver cancer and 5 cases in the control group progressed to liver cancer,The incidence of liver cancer in the observation group was 8.82% and that in the control group was 16.67%.There was no distinct discrepancy between the two groups(P>0.05).6.Incidence of complications: all cases of liver cirrhosis included in this study were patients with compensatory liver cirrhosis,and no decompensated complications occurred in the treatment cycle.After the 48 week follow-up period,it proved that the incidence of complications in the observation group was 8.82% and 30% in the control group.The incidence of complications in the observation group was lower than that in the control group(P<0.05).7.Safety: during the 48 week treatment cycle,there was no abnormal safety index in both groups.Mild adverse reactions occurred in 2 people in the observation group and 3 people in the control group,with no significant difference(P>0.05).Conclusion:Treating precancerous lesions of Hepatocellular Carcinoma(liver depression and spleen deficiency,phlegm and blood stasis syndrome)with Qizhu Huaji formula has a good curative effect in improving TCM syndromes,improving liver function,reducing the incidence of liver cancer and complications of liver cirrhosis,and is worthy of clinical application.