中国临床药理学杂志2025，Vol.41Issue(17)：2401-2406,6.DOI:10.13699/j.cnki.1001-6821.2025.17.001
多烯磷脂酰胆碱联合替诺福韦对乙肝合并非酒精性脂肪性肝炎患者的临床研究
Clinical trial of polyene phosphatidylcholine combined with tenofovir in patients with hepatitis B complicated with non-alcoholic steatohepatitis
摘要
Abstract
Objective To analyze the clinical efficacy and safety of polyenophosphatidylcholine(PPC)in combination with tenofovir tablets in the treatment of patients with hepatitis B combined with nonalcoholic steatohepatitis(NASH).Methods The patients with hepatitis B complicated with NASH in our hospital were divided into treatment group and control group by random number table method.The control group was treated with tenofovir tablets,25 mg qd,taken during meals.The treatment group was treated with PPC on the basis of the control group.The initial dose was 456 mg tid,taken with warm boiled water,and the daily dose could not exceed 1 368 mg.After 12 weeks of treatment,the dose was reduced to 228 mg tid,according to the immune response,and the dose was maintained.Both groups were treated for 24 weeks,and the treatment group was followed up to 48 weeks after stopping PPC.The negative conversion rates of hepatitis B virus surface antigen(HBsAg)and hepatitis B virus e antigen(HBeAg),hepatitis B virus DNA(HBV-DNA)load,the levels of costimulatory molecule B7 homolog 1(B7-Hl),transforming growth factor β1(TGFβ1),Golgi transmembrane glycoprotein 73(GP73),chitinase 3-like protein 1(CHI3L1)and prothrombin activity(PTA)were compared between the two groups,and the safety was evaluated.Results A total of 95 cases were enrolled and 92 cases were included in statistical analysis,including 46 cases in the treatment group and 46 cases in the control group.After treatment,the total effective rates of the treatment group and the control group were 97.83％(45 cases/46 cases)and 84.78％(39 cases/46 cases),respectively,and the difference was statistically significant(P＜0.05).After 24 weeks of treatment,the HBV-DNA load of the treatment group and the control group were 80.43％and 60.87％,respectively;the HBsAg negative conversion rates were 28.26％and 10.87％,respectively;and the HBeAg negative conversion rates were 30.43％and 13.04％,respectively.The above indicators in the treatment group were statistically significantly different from those in the control group(all P＜0.05).After 48 weeks of treatment,the HBV-DNA load of the treatment group and the control group were 89.13％and 69.57％,respectively;the HBsAg negative conversion rates were 50.00％and 28.26％,respectively;and the HBeAg negative conversion rates were 50.00％and 26.09％,respectively.The above indicators in the treatment group were statistically significantlly different from those in the control group(all P＜0.05).After treatment,the levels of B7-Hl in the treatment group and the control group were 0.40(0.30,0.40)and 0.60(0.50,0.70)ng·mL-1,the levels of TGFβ1 were(269.02±24.36)and(287.64±27.39)ng·mL-1,respectively;and the levels of GP73 were(76.24±8.95)and(87.22±10.03)ng·mL-1,respectively;PTA were(80.02±12.55)％and(65.24±10.24)％,respectively.The treatment group compared with the control group,the differences were statistically significant(all P＜0.05).The main adverse drug reactions during treatment in the treatment group and the control group were nausea and vomiting,headache,rash and abdominal distension.The total incidence of adverse drug reactions in the treatment group was 10.87％(5 cases/46 cases),which was 13.04％(6 cases/46 cases)in the control group,and the difference had no statistically significant(P＞0.05).Conclusion The combined application of PPC and tenofovir tablets in the treatment of hepatitis B patients with NASH can reduce the levels of B7-Hl and TGFβ1,improve the liver function of the body,and has good safety.关键词
多烯磷脂酰胆碱胶囊/替诺福韦片/乙型肝炎/非酒精性脂肪性肝炎Key words
polyene phosphatidylcholine capsule/tenofovir tablet/Hepatitis B/non-alcoholic steatohepatitis分类
药学引用本文复制引用
王智华,李敏,邓俊德,程锐..多烯磷脂酰胆碱联合替诺福韦对乙肝合并非酒精性脂肪性肝炎患者的临床研究[J].中国临床药理学杂志,2025,41(17):2401-2406,6.基金项目
四川省卫生健康委员会2024年第一批科技基金资助项目(24LCYJPT04) （24LCYJPT04）
