Objective To observe clinical efficacy of Dahuang Zhechong Capsules（大黄■虫胶囊） in the treatment of patients with compensated hepatitis B cirrhosis of syndrome of static blood blocking collaterals with splenomegaly. Methods Based on real-world research methods

a retrospective cohort study was conducted to retrieve the patients with compensated hepatitis B cirrhosis and syndrome of static blood blocking collaterals with splenomegaly in Shuguang Hospital

Shanghai University of Traditional Chinese Medicine from January 2012 to April 2017. Finally

a total of 114 cases were enrolled

and were divided into 61 cases in the control group treated with basic treatment including antiviral therapy and liver protection treatment and 53 cases in the treatment group treated with basic treatment combined with Dahuang Zhechong Capsules orally according to whether oral administration of Dahuang Zhechong Capsules was used. The spleen thickness and length

TCM syndrome score

liver function

blood routine examination

liver fibrosis index

aspartate aminotransferase and platelet ratio index（APRI） of both groups of patients were compared before treatment and 1 year after treatment. And clinical efficacy and safety were evaluated. Results After treatment

the thickness and length of spleen of the patients in the treatment group were significantly shrank than those before treatment（P<0.05）

and the spleen shrinkage was the most obvious in patients with spleen thickness of 50-69 mm and spleen length of less than 100 mm（P<0.05）. After treatment

the TCM syndrome score of patients in the treatment group decreased significantly

and was significantly lower than that in the control group（P<0.05）. Compared with the control group after treatment

white blood cells（WBC）

hemoglobin（Hb）

platelets（PLT）

APRI were increased significantly in the treatment group（P<0.05）. The total effective rate of clinical efficacy in the treatment group was 69.81%

which was significantly higher than the 13.11% in the control group（P<0.05）. Logistic regression analysis showed that age was a related risk factor for decompensated liver cirrhosis and/or liver cancer. Taking Dahuang Zhechong Capsules as the exposure factor

the relative risk value of occurring decompensated liver cirrhosis and/or liver cancer in the exposed and non-exposed was 0.35

95% confidence interval 0.12-1.01

which indicated that the exposure was beneficial. There were no adverse events in both groups. Conclusions Dahuang Zhechong Capsules can significantly reduce the size of spleen in patients with compensated hepatitis B cirrhosis and syndrome of static blood blocking collaterals with splenomegaly

and delay cirrhosis. Dahuang Zhechong Capsules can also improve symptoms of syndrome of blood stasis and has a positive clinical effect and good safety.