富马酸丙酚替诺福韦联合复方鳖甲软肝片治疗乙型肝炎肝硬化患者疗效和安全性评估*

doi:10.3969/j.issn.1672-5069.2024.05.027

摘要/Abstract

摘要： 目的观察富马酸丙酚替诺福韦(TAF)联合复方鳖甲软肝片治疗乙型肝炎肝硬化患者的效果。方法 2021年6月～2023年6月我院收治的乙型肝炎肝硬化患者116例,被随机分为两组,每组58例。给予对照组患者口服TAF治疗,给予观察组TAF联合复方鳖甲软肝片治疗,两组均治疗观察6个月。常规检测血清HBV标记物和HBV DNA载量,采用放射免疫分析法检测血清透明质酸(HA)、层粘连蛋白(LN)、Ⅲ型前胶原(PIIIP)和Ⅳ型胶原(CIV),使用超声检测肝脏剪切波弹性成像(SWE)和门脉指标。结果在治疗6个月末,观察组血清ALT水平为(43.1±6.2)U/L,显著低于对照组【(62.6±7.8)U/L,P＜0.05】,而两组血清TBIL、ALB和INR比较,无显著性差异(P>0.05);两组血清HBV DNA均转阴,但血清HBsAg和HBeAg水平均无变化;观察组血清透明质酸、Ⅲ型前胶原和Ⅳ型胶原水平分别为(82.2±10.3)ng/L、(94.8±11.5)ng/mL和(61.3±7.5)ng/mL,均显著低于对照组【分别为(123.1±11.9)ng/L、(132.1±13.8)ng/mL和(89.7±9.1)ng/mL,P＜0.05】;观察组SWE为(11.2±2.0)kPa,显著低于对照组【(14.1±2.5)kPa,P＜0.05】,而两组门静脉内径和脾静脉内径比较,无显著性差异(P>0.05)。结论应用TAF联合复方鳖甲软肝片治疗乙型肝炎肝硬化患者可加速肝功能指标的恢复,抗肝纤维化作用明显,其长期疗效还有待于进一步观察。

关键词: 肝硬化, 乙型肝炎, 富马酸丙酚替诺福韦, 复方鳖甲软肝片, 肝纤维化, 治疗

Abstract: Objective The purpose of this study was to investigate anti-fibrotic efficacy of tenofovir disoproxil fumarate (TAF) and Fufang Biejia Ruangan tablet, an herbal Compound, in the treatment of patients with hepatitis B-induced liver cirrhosis (LC). Methods 116 patients with hepatitis B-induce LC were encountered in our hospital between June 2021 and June 2023, and we randomly assigned them to receive TAF (control, n=58) or TAF and herbal Compound combination (observation, n=58) for treatment of six months. Serum HBV DNA loads, and HBsAg and HBeAg levels were routinely assayed. Serumhyaluronic acid (HA), laminin (LN), procollagen type III (PIIIP) and collagen type IV (CIV) levels were detected by radioimmunoassay, and portal vein diameter (PVD), splenic vein diameter (SVD), splenic thickness (ST) and splenic length (SL) were detected by ultrasonography. Results By end of six month treatment, serum ALT level in the observation group were (43.1±6.2)U/L, much lower than [(62.6±7.8)U/L, P＜0.05]in the control, and there were no significant differences as respect to total serum bilirubin, serum albumin and INR (P>0.05)between the two groups; serum HBV DNA returned to negative, and serum HBsAg and HBeAg levels didn’t change in all patients in the two groups; serum HA,PIIIP and CIV levels in the observation were (82.2±10.3)ng/L, (94.8±11.5)ng/mL and (61.3±7.5)ng/mL, all significantly lower than [(123.1±11.9)ng/L, (132.1±13.8)ng/mLand (89.7±9.1)ng/mL, respectively, P＜0.05] in the control; SWE was (11.2±2.0)kPa, much lower than [(14.1±2.5)kPa, P＜0.05] in the control, and there were no significant differences respect to portal vein diameters and splenic vein diameters (P>0.05) between the two groups. Conclusion Administration of tenofovir disoproxil fumarate and Compound Fufang Biejia Ruangan tablets combination in the treatment of patients with hepatitis B-induced LC could improve liver function tests normal and have anti-fibrotic efficacy, which needs long-term investigation.

Key words: Liver cirrhosis, Hepatitis B, Tenofovir disoproxil fumarate, Compound Fufang Biejia Ruangan tablets, herbal medicine, Liver fibrosis, Therapy

连作勤, 王世明, 张甲, 李付平. 富马酸丙酚替诺福韦联合复方鳖甲软肝片治疗乙型肝炎肝硬化患者疗效和安全性评估^*[J]. 实用肝脏病杂志, 2024, 27(5): 753-756.

Lian Zuoqin, Wang Shiming, Zhang Jia, et al. Anti-fibrotic efficacy of tenofovir disoproxil fumarate and Compound Fufang Biejia Ruangan tablet in the treatment of patients with hepatitis B-induced liver cirrhosis[J]. Journal of Practical Hepatology, 2024, 27(5): 753-756.

参考文献

[1] Shoraka S, Mohebbi SR, Hosseini SM,et al. Identification of plasma lncRNA-ATB levels in hepatitis B virus-related cirrhosis and non-cirrhotic chronic hepatitis B patients. J Virus Res, 2021, 303:198503.
[2] Meng X, Pan Z, Zhao J,et al. Efficacy and safety of Fufang Biejia Ruangan Tablets as an adjuvant treatment for chronic hepatitis B liver fibrosis: A systematic review and meta-analysis J. Medicine (Baltimore), 2022, 101(46):e31664.
[3] 冯志刚,李涛,赵冰清,等.复方鳖甲软肝片联合恩替卡韦对乙肝肝硬化失代偿期患者疗效、肝功能、免疫功能影响研究.中华中医药学刊,2022,40(1):184-187.
[4] Chen CH, Jeng WJ, Hu TH,et al. HBV relapse rates in patients who discontinue tenofovir disoproxil fumarate with or without switching totenofovir alafenamide J. Dig Liver Dis, 2023, 55(6):771-777.
[5] 中华医学会肝病学分会和感染病学分会.慢性乙型肝炎防治指南(2022年版).实用肝脏病杂志,2023,26(3)S18-39.
[6] Jung CY, Jung HY, Kim HW,et al. Fibrotic burden in patients with hepatitis B virus-related cirrhosis is independently associated with poorer kidney outcomes J. J Infect Dis, 2024, 229(1):108-116.
[7] Tu A, Zhu X, Dastjerdi PZ, et al. Evaluate the clinical efficacy of traditional Chinesemedicine as the neoadjuvant treatment in reducing the incidence of hepatocellular carcinoma in patients with hepatitis B-related cirrhosis: A systematic review and meta-analysis J. Heliyon, 2024, 10(3):e24437.
[8] He J, Guo Y, Zhang Y,et al. Comparison of pegylated interferon alfa therapy in combination with tenofovir alafenamide fumarate or tenofovir disoproxil fumarate for treatment of chronic hepatitis B patients J. Infect Drug Resist, 2023, 16:3929-3941.
[9] 欧阳冰琛,赵权,王晶,等.LC-MS/MS法同时测定复方鳖甲软肝片中9种成分.中成药,2022,44(12):3787-3791.
[10] Schafer JJ, Zimmerman M, Walshe C,et al. Weight changes in patients with sustained viral suppression switching tenofovir disoproxil fumarate to tenofovir alafenamide J. Obesity (Silver Spring), 2022, 30(6):1197-1204.
[11] Sevenler D, Niu X, Dossantos S, et al. Point-of-care semi-quantitative test for adherence to tenofovir alafenamide or tenofovir disoproxil fumarate J. J Antimicrob Chemother, 2022, 77(4):996-999.
[12] Tian X, Dong H, Lai X,et al. TRIM56 impairs HBV infection and replication by inhibiting HBV core promoter activity J. Antiviral Res, 2022, 207:105406.
[13] Li B, Liu Z, Liu X, et al. Efficacy and safety of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in preventing HBV vertical transmission of high maternal viral load J. Hepatol Int, 2021, 15(5):1103-1108.
[14] Akbar SMF, Al Mahtab M, Khan S,et al. Innovative therapies targeting the virus and the host for treating chronic hepatitis B virus infection: from bench to bedside J. Vaccines (Basel), 2022, 10(5):746.
[15] Wang P, Yang Y, Pang G,et al. Hepatocyte-derived MANF is protective for rifampicin-induced cholestatic hepatic injury via inhibiting ATF4-CHOP signal activation J. Free Radic Biol Med, 2021, 162:283-297.
[16] Buchl SC, Hanquier Z, Haak AJ,et al. Traf2 and NCK interacting kinase is a critical regulator of procollagen I trafficking and hepatic fibrogenesis in mice. J Hepatol Commun, 2022, 6(3):593-609.
[17] 熊雪丽,张江春,胡乃毅,等.实时二维剪切波弹性成像对乙型肝炎肝硬化门静脉高压患者曲张静脉出血风险的预测价值分析.中国现代医学杂志,2023,33(1):76-81.
[18] Lin LY, Zeng DW, Liu YR,et al. Diagnostic value of liver stiffness measurement combined with risk scores for esophagogastric variceal bleeding in patients with hepatitis B cirrhosis. JEur J Radiol, 2024, 173:111385.
[19] Vukotic R, Di Donato R, Roncarati G,et al. 5-MTHF enhances the portal pressure reduction achieved with propranolol in patients withcirrhosis: A randomized placebo-controlled trial. J Hepatol, 2023, 79(4):977-988.
[20] Van Welzen BJ, Thielen MAJ, Mudrikova T,et al. Switching tenofovir disoproxil fumarate to tenofovir alafenamide results in a significant decline in parathyroid hormone levels: uncovering the mechanism of tenofovir disoproxil fumarate-related bone loss? J AIDS, 2019, 33(9):1531-1534.

富马酸丙酚替诺福韦联合复方鳖甲软肝片治疗乙型肝炎肝硬化患者疗效和安全性评估^*

Anti-fibrotic efficacy of tenofovir disoproxil fumarate and Compound Fufang Biejia Ruangan tablet in the treatment of patients with hepatitis B-induced liver cirrhosis

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

本文评价

[1]	韦新焕, 柳雅立, 张晶, 贾继东. 代谢相关性脂肪性肝硬化诊疗进展^*[J]. 实用肝脏病杂志, 2024, 27(5): 641-645.
[2]	张志强, 方坚, 李东良. 介入治疗肝硬化门静脉高压症研究进展与挑战^*[J]. 实用肝脏病杂志, 2024, 27(5): 650-653.
[3]	中国医药生物技术协会慢病管理分会肝病学组. 双环醇防治肝脏炎性损伤多学科专家共识[J]. 实用肝脏病杂志, 2024, 27(5): 659-668.
[4]	彭麟, 杨春, 李兴泉. 聚乙二醇干扰素α-2b联合恩替卡韦治疗HBeAg阳性慢性乙型肝炎患者疗效研究^*[J]. 实用肝脏病杂志, 2024, 27(5): 677-680.
[5]	冉书容, 刘洋, 雷兰. 恩替卡韦经治的慢性乙型肝炎患者发生低病毒血症危险因素及转换TAF治疗疗效研究^*[J]. 实用肝脏病杂志, 2024, 27(5): 681-684.
[6]	黎防, 杨宏飞, 张青. 索非布韦联合雷迪帕韦治疗慢性丙型肝炎患者疗效评价^*[J]. 实用肝脏病杂志, 2024, 27(5): 685-688.
[7]	刘雅光, 胡连智, 董一侠, 刘洋. 抗病毒治疗的基因1b型慢性丙型肝炎患者疗效及其血清γ-干扰素和白细胞介素-10水平变化^*[J]. 实用肝脏病杂志, 2024, 27(5): 689-692.
[8]	莫伟斌, 张清友, 黄晓涵, 欧阳婉爱. 达诺瑞韦联合拉维达韦治疗慢性丙型肝炎患者疗效研究^*[J]. 实用肝脏病杂志, 2024, 27(5): 693-696.
[9]	高怡, 沈小雪, 夏素芹, 张洁, 朱先兰. 自身免疫性肝炎和原发性胆汁性胆管炎患者血清胆汁酸成分变化及其对治疗应答的影响^*[J]. 实用肝脏病杂志, 2024, 27(5): 709-712.
[10]	蒋叶舟, 花霞, 陈国飞, 朱青蓝, 蔡明月. 自身免疫性肝炎患者血清瘦素、外周血调节性T细胞和Th17细胞水平变化^*[J]. 实用肝脏病杂志, 2024, 27(5): 713-716.
[11]	朱家瑞, 葛绍锋, 叶桂云, 黄远茂. 自身免疫性肝炎患者外周血NLR和nCD64指数变化及其临床意义探讨^*[J]. 实用肝脏病杂志, 2024, 27(5): 717-720.
[12]	王燕燕, 周桐桐, 卞兆连. 原发性胆汁性胆管炎和原发性胆汁性胆管炎-自身免疫性肝炎重叠综合征患者临床与肝组织病理学特点分析^*[J]. 实用肝脏病杂志, 2024, 27(5): 721-724.
[13]	任艳, 孔明, 徐曼曼, 白丽, 陈煜. 瞬时弹性成像技术和无创诊断模型诊断原发性胆汁性胆管炎患者肝纤维化效能研究^*[J]. 实用肝脏病杂志, 2024, 27(5): 725-728.
[14]	王秀娟, 朱贺, 张茹梦, 常文绘, 刘玉玉. 泼尼松联合硫唑嘌呤治疗自身免疫性肝炎患者不同减量方法的效果研究^*[J]. 实用肝脏病杂志, 2024, 27(5): 729-732.
[15]	信亮亮, 温智. 2D-SWE技术联合FIB-4和血清VEGF水平评估乙型肝炎肝硬化患者食管静脉曲张价值研究^*[J]. 实用肝脏病杂志, 2024, 27(5): 737-740.