Hepatocellular carcinoma (HCC) is characterized by high morbidity and mortality. Early diagnosis and timely intervention in the precancerous stage can effectively reduce the incidence of HCC, which is of great significance for its prevention and treatment. Modern medical treatment of precancerous lesions of HCC has problems such as difficulties to grasp the timing of intervention and single treatment method, traditional Chinese medicine (TCM) may be a simple and effective new approach to prevent and treat precancerous lesion of HCC.

To observe the clinical efficacy and safety of Qizhuhuaji formula in the treatment of precancerous lesion of HCC (liver-depression and spleen-deficiency, phlegm and blood stasis syndrome) .

Patients with precancerous lesion of HCC who met the TCM syndrome type "liver-depression and spleen-deficiency, phlegm and blood stasis syndrome" admitted in the hepatology clinic of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Weihai Hospital of Traditional Chinese Medicine and Taian Hospital of Traditional Chinese Medicine from October 2019 to March 2020 were included as the study subjects. General information (gender, age, history of HBV-related cirrhosis, family history of HCC, history of alcohol consumption for more than 10 years), the TCM syndrome score, liver function indicators [alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), albumin (ALB), glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) ], tumor marker indexes [alpha-fetoprotein (AFP), alpha-fetoprotein variants-L3 (AFP-L3), des-γ-carboxy-prothrombin (DCP) ], imaging indexes (lesion type, lesion nature, lesion length diameter), safety indexes and adverse reactions were collected. The 64 patients who met the inclusion criteria and completed the study were divided into the observation group (n=34) and the control group (n=30) using the random number tables. The patients in the control group were treated with conventional therapy such as antiviral, anti-inflammatory and liver-protective therapy; the observation group was treated with conventional therapy combined with Qizhuhuaji formula. The treatment course was 48 weeks, and the follow-up period was 48 weeks after drug withdrawal. The incidence of HCC and complications in the treatment cycle and follow-up period of the two group were observed, and the differences in the improvement indexes of TCM syndrome (TCM syndrome scores, total effective rate), liver function indicators, tumor marker indexes, imaging indexes (lesion length diameter, lesion stability rate, lesion improvement rate), and safety index (safety rate) between the two groups before and after treatment.

After treatment, the TCM syndrome scores, ALT, AST, TBIL, GGT, ALP, and AFP-L3 were lower than those before treatment in both groups, and the ALB level was higher than that before treatment (P<0.05) ; the DCP value and lesion length-diameter of patients in the observation group were lower than those before treatment (P<0.05) ; the comparison results between the two groups showed that the TCM syndrome scores, AST, and ALP values in the observation group were lower than those in the control group, and the ALB value was higher than that in the control group (P<0.05). The total effective rate of TCM syndrome in the observation group (91.2%) was higher than that in the control group (63.3%) at the end of the treatment cycle (P<0.05) ; there was no statistically significant differences (P>0.05) in the rates of lesion improvement (35.3%) and lesion stability (50.0%) in the observation group compared with the control group (20.0%, 43.3%). There was no statistically significant difference in the incidence of HCC between the observation group (8.8%) and the control group (16.7%) at the end of the follow-up period (P>0.05) ; the incidence of complications (8.8%) in the observation group was lower than that of the control group (30.0%) (P<0.05). Regarding the safety indexes, 2 cases in the observation group showed mild adverse reactions and 3 cases in the control group showed mild adverse reactions, no abnormal safety indexes were observed in both groups, there was no statistically significant difference (P>0.05) in the safety rate between the observation group (94.1%) and the control group (90.0%) .

The treatment of precancerous lesions of HCC (liver depression and spleen deficiency, phlegm and blood stasis syndrome) with Qizhuhuaji formula has better clinical efficacy and higher safety in improving TCM syndrome, improving liver function, shrinking lesion nodules, reducing the incidence of long-term HCC and complications of liver cirrhosis.