OBJECTIVETo assess the clinical efficacy of Xiaozhang Recipe (XR) in treatment of chronic viral hepatitis B patients with compensated liver cirrhosis.

METHODSBased on the anti-viral effects of lamivudine, 84 chronic viral hepatitis B patients with compensated liver cirrhosis were randomly assigned to the treatment group and the control group. Patients in the treatment group were treated with XR (consisting of heterophylla falsestarwort root, large head atractylodes rhizome, tangerine peel, green tangerine peel, water-plantain tuber, bugleweed herb, turtle shell, oyster shell, chicken's gizzard-skin endothelium, areca peel, decocted, one dose daily, twice daily). Patients in the control group took Fuzheng Huayu Capsule (consisting of red sage root, walnut seed, gynostemma pentaphyllum, aweto, magnoliavine fruit; five pills each time, three times daily, 30 min before meals). The therapeutic course for all was 12 months. The changes of the Chinese medicine symptom scores, chronic liver disease questionnaire (CLDQ), the liver function, hepatitis B virus deoxyribonucleic acid (HBV DNA) were compared between before and after treatment in the two groups. Meanwhile, B ultrasound was performed on all patients. Changes of the inner diameter of the portal vein and the splenic vein, the length and the thickness of the spleen were recorded.

RESULTSAfter treatment the Chinese medicine symptom scores and CLDQ obviously decreased in the two groups (P<0.01). Besides, the score in the treatment group decreased more obviously than that in the control group (P<0.05, P<0.01). The Child-Pugh scores obviously decreased in the two groups (P<0.01). However, the comparison between the two groups did not show any statistical significance (P>0.05). The liver function of of the two groups were improved when compared with before treatment (P<0.01), and the treatment group was superior to the control group (P<0.01). The B ultrasound results showed MPV, SPV, the length and the thickness of the spleen obviously decreased in the treatment group (P< 0.01). Only the thickness of the spleen obviously decreased in the control group (P<0.01). The HBV DNA obviously decreased in the two groups (P<0.01), more obviously shown in the treatment group (P<0.01).

CONCLUSIONSXR in combination of lamivudine could improve the liver function of chronic viral hepatitis B patients with compensated liver cirrhosis and HBV DNA, lower their Chinese medicine symptom scores and CLDQ scores, improve their Child-Pugh classification to some extent. It showed favorable effects.