目的 分析乙肝解毒胶囊和富马酸替诺福韦二吡呋酯协同治疗慢性乙型肝炎患者的临床效果。方法 纳入沧州市第三医院2024年1月至2025年1月期间收治的慢性乙型肝炎患者102名，按随机数字表法将患者平均分为对照组和治疗组，每组各51例。对照组接受富马酸替诺福韦二吡呋酯片治疗，治疗组在相同用药基础上加服乙肝解毒胶囊，疗程12周。观察两组患者临床疗效，比较治疗前后两组患者典型表现缓解时间，血清乙型肝炎病毒脱氧核糖核酸（HBV DNA），肝功能指标总胆红素（TBIL）、天冬氨酸转氨酶（AST）和丙氨酸转氨酶（ALT）水平，慢性肝病问卷（CLDQ）和HBV感染者生活质量量表（HBQOL）评分，及血小板与淋巴细胞比值（PLR）和血清白球比（A/G）、可溶性血管黏附蛋白1（sVAP-1）、单核细胞趋化蛋白-1（MCP-1）水平。结果 总有效率治疗组vs.对照组（94.12% vs. 80.39%，P＜0.05）。各项症状（肝区不适、乏力等）的缓解时间治疗组都短于对照组（P＜0.05）。治疗后，两组血清HBV DNA、各项肝功能指标（TBIL、AST等）、PLR和血清A/G、sVAP-1、MCP-1水平都低于同组治疗前（P＜0.05）；治疗组低于对照组（P＜0.05）。治疗后，两组CLDQ、HBQOL评分和血清A/G都高于同组治疗前（P＜0.05）；治疗组高于对照组（P＜0.05）。结论 针对慢性乙型肝炎患者，采用乙肝解毒胶囊和富马酸替诺福韦二吡呋酯协同治疗方案，可有效减轻HBV感染程度，抑制肝脏炎症损害与纤维化，促进患者症状及肝功能好转，利于患者机体功能及心理状况改善。

Objective To explore the clinical efficacy of Hepatitis B Jiedu Capsules combined with tenofovir disoproxil fumarate in treatment of chronic hepatitis B. Methods A randomized allocation of 102 chronic hepatitis B patients (treated at Cangzhou Third Hospital from January 2024 to January 2025) were divided into control group and treatment group according to random number table method, with 51 cases in each group. Patients in control group were po administered with Tenofovir Disoproxil Fumarate Tablets, Patients in treatment group were po administered with Hepatitis B Jiedu Capsules on the basis of the control group. The treatment course was 12 weeks. The clinical efficacy of two groups was observed, and the analysis included time to symptomatic improvement, HBV DNA concentrations, TBIL and liver enzyme (AST/ALT) levels, PLR ratios, A/G protein profiles, sVAP-1 and MCP-1 biomarkers, along with CLDQ and HBQOL questionnaire results before and after therapeutic intervention. Results The overall efficacy rate demonstrated a significant difference between the intervention and comparison arms (94.12% versus 80.39%, P < 0.05). Regarding symptom alleviation duration (including hepatic discomfort and fatigue), the experimental cohort showed faster resolution compared to the control group (P < 0.05). Post-intervention analysis revealed notable reductions in multiple parameters: serum HBV DNA levels, hepatic function markers (TBIL, AST, among others), PLR values, along with serum A/G ratio, sVAP-1, and MCP-1 concentrations. These measurements exhibited two key findings significant decreases from baseline values (P < 0.05), more pronounced reductions in the treatment arm relative to controls (P < 0.05). Conversely, improvements were observed in CLDQ and HBQOL assessment scores, as well as serum A/G levels, which demonstrated marked elevation from pretreatment measurements (P < 0.05), superior enhancement in the therapeutic group versus the comparator (P < 0.05). Conclusion The treatment of chronic hepatitis B with Hepatitis B Jiedu Capsules combined with tenofovir dipivurate fumarate can effectively reduce the degree of HBV infection, inhibit the inflammatory damage and fibrosis of the liver, promote the improvement of patients' symptoms and liver function, and improve the patients′ physical function and psychological status.

R978.7

沧州市重点研发计划指导项目（192106002）