[Clinical study on the efficacy of Wuling capsules combined with nucleos(t)ide analogues in the treatment of low-level viremia patients with chronic hepatitis B].

Abstract / Summary

Objective: To comprehensively evaluate the efficacy and safety profile of Wuling capsules combined with nucleos(t)ide analogues in the treatment of low-level viremia in chronic hepatitis B. Methods: A randomized, controlled, multicenter clinical trial was conducted. One hundred patients with low-level viremia in chronic hepatitis B admitted between December 2021 and March 2024 were randomly divided into an experimental group and a control group, with 50 cases in each group. The experimental group received nucleos(t)ide analogues combined with Wuling capsules, while the control group received nucleos(t)ide analogues alone. Of the 100 subjects, 96 in the full analysis set (FAS) (experimental group: 47; control group: 49) were included for statistical analysis. Changes in hepatitis B virus (HBV) DNA levels, serological markers of hepatitis B, liver function parameters, and clinical symptom scores were compared following 180 days of treatment between the two groups. Categorical data were analyzed using the χ2 test, with results expressed as percentages (%). Quantitative data were expressed as mean ± standard deviation (x¯±s) for normally distributed datasets and analyzed using the t-test. The Wilcoxon rank-sum test was used for non-normally distributed data. Results: The HBV DNA seroconversion rate was significantly higher in the experimental group compared to the control group [67.39% (31/46) vs. 48.98% (24/49), χ2=6.65, P<0.05], while HBsAg, HBeAg, and anti-HBc were all lower in the experimental group than the control group (P<0.05) following 180 days of treatment. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin were all significantly higher in the experimental group than in the control group [(24.17±10.07) U/L vs. (30.77±19.00) U/L, (23.70±6.58) U/L vs. (27.66±10.46) U/L, and (12.69±5.72) μmol/L vs. (15.36±5.90) μmol/L, P<0.05]. The normalization rates of ALT, AST, and γ-glutamyl transferase were significantly higher in the treatment group than those in the control group (85.71% vs. 66.67%, 83.33% vs. 60.00%, and 100% vs. 66.67%, P<0.05). The visual analogue scale (VAS) scores and clinical symptom scores were also superior in the treatment group to those in the control group (P<0.01 or P<0.05). The main symptoms of patients, including hypochondriac pain, belching, and anorexia, were significantly improved in the treatment group compared to the control group (P<0.05 or P<0.01). No adverse reactions related to Wuling Capsules were found. Conclusion: Wuling capsules combined with nucleos(t)ide analogues achieved significant efficacy in treating low-level viremia patients with chronic hepatitis B. This treatment significantly improved HBV DNA seroconversion rate, hepatitis B blood markers, liver function levels, and clinical symptoms, with a favorable safety profile. 目的： 全面评估五灵胶囊联合核苷（酸）类似物治疗慢性乙型肝炎低病毒血症的有效性和安全性。 方法： 采取随机、对照、多中心临床试验的方法，将2021年12月至2024年3月收治的100例慢性乙型肝炎低病毒血症患者分为试验组和对照组，每组各50例，试验组给予核苷（酸）类似物联合五灵胶囊治疗，对照组则单独使用核苷（酸）类似物治疗。在100例受试者中，共有96例进入全分析集（FAS）（试验组：47例；对照组：49例），并纳入统计分析。经过180 d治疗后，比较2组间乙型肝炎病毒（HBV）DNA水平、乙型肝炎血清学标志物、肝功能参数及临床症状评分的变化。分类数据采用χ2检验及构成比（%）对比分析，符合正态分布定量数据以均值±标准差（x¯±s）表示，用t检验进行统计分析；若不符合正态分布，则采用Wilcoxon秩和检验。 结果： 治疗180 d后，试验组血清HBV DNA转阴率明显高于对照组［67.39%（31/46）比48.98%（24/49），χ2=6.65，P<0.05］，HBsAg、HBeAg、抗-HBc均低于对照组（P值均<0.05）；天冬氨酶转氨酶（ALT）、丙氨酶转氨酶（AST）、总胆红素改善均明显优于对照组［（24.17±10.07）U/L比（30.77±19.00）U/L，（23.70±6.58）U/L比（27.66±10.46）U/L，（12.69±5.72）μmol/L比（15.36±5.90）μmol/L，P值均<0.05］；ALT、AST、γ-谷氨酰转移酶复常率高于对照组（85.71%比66.67%、83.33%比60.00%、100%比66.67%，P值均<0.05）；治疗组视觉模拟评分法评分及临床症状评分均优于对照组（P<0.01或P<0.05）。治疗组患者的主要症状，包括胁肋胀痛、嗳气、纳呆等均有显著改善（P<0.05或P<0.01）。未发现五灵胶囊相关不良反应。 结论： 五灵胶囊联合核苷（酸）类似物治疗慢性乙型肝炎低病毒载量患者取得显著疗效，该治疗在提高HBV DNA转阴率、改善乙型肝炎血标志物、肝功能水平及临床症状均有显著疗效，且安全性良好。.

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