ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction (, YCZFD) in the treatment of acute-on-chronic liver failure caused by hepatitis B virus (HBV-ACLF) with cold pattern in Chinese medicine (CM).</p><p><b>METHODS</b>This is a multi-center randomized controlled trial of integrative treatment of CM and Western medicine (WM) for the management of HBV-ACLF patients. A total of 200 HBV-ACLF patients with cold pattern were equally randomly assigned to receive YCZFD and WM (integrative treatment) or WM conventional therapy alone respectively for 4 weeks. The primary end point was the mortality for HBV-ACLF patients. Secondary outcome measures included Model for End-Stage Liver disease (MELD) score, liver biochemical function, coagulation function and complications. Adverse events during treatment were reported.</p><p><b>RESULTS</b>The mortality was decreased 14.28% in the integrative treatment group compared with WM group (χ(2) =6.156, P=0.013). The integrative treatment was found to signifificantly improve the MELD score (t=2.353, P=0.020). There were statistically signifificant differences in aspartate transaminase, total bilirubin, indirect bilirubin, direct bilirubin and prothrombin time between the two groups (P<0.05 or P<0.01). The complications of ascites (χ(2)=9.033, P=0.003) and spontaneous bacteria peritonitis (χ(2)=4.194, P=0.041) were improved signifificantly in the integrative treatment group. No serious adverse event was reported.</p><p><b>CONCLUSIONS</b>The integrative treatment of CM and WM was effective and safe for HBV-ACLF patients with cold pattern in CM. The Chinese therapeutic principle "treating cold pattern with hot herbs" remains valuable to the clinical therapy. (Trial registration No. ChiCTR-TRC-10000766).</p>
Subject(s)
Adult , Female , Humans , Male , Acute-On-Chronic Liver Failure , Drug Therapy , Mortality , Virology , Ascites , Demography , Drugs, Chinese Herbal , Pharmacology , Therapeutic Uses , Electrolytes , Hepatitis B , Drug Therapy , Mortality , Hepatitis B virus , Physiology , Integrative Medicine , Liver , Pathology , Virology , Liver Function Tests , Peritonitis , Time Factors , Treatment OutcomeABSTRACT
Objective To observe the effect of treating chronic severe hepatitis modified Yinchen Zhufu Decoction.Methods 46 chronic severe hepatitis patients (belonging to Ymhuang syndrome in TCM) were randomly recruited in to a treatment group (26 cases) and a control group (20 cases). Indexes as symptoms, signs, liver functions, prothrombin activity (PTA), prothrombin (ALB) and complications were used for evaluating therapeutic effects. Results After four weeks' treatment, of all 26 cases in the treatment group, 23 cases were effective (occupying 88.5%) and 3 cases were inefficacy (occupying 11.5%); while of all 20 cases in the control group, 11 cases were effective (occupying 55%) and 9 cases were inefficacy (occupying 45%). There was significant difference between the two group in therapeutic effects( P＜0.05 ). TBIL in both groups were decreased after the treatment(P＜ 0.05 ), and the decrease amplitude in the treatment group was much bigger than the control group (P＜0.05). PTA in the treatment group was increased after the treatment (P＜0.05), but this increase amplitude showed no significant difference comparing with the control group (P＞0.05). ALB showed significant difference between the two groups after treatment, with P＜0.05, but complications demonstrated no significant difference between the two groups after treatment, with P＞0.05. Conclusion Modified Yinchen Zhufu Decoction has good therapeutic effects in treating chronic severe hepatitis of yinhuang syndrome.