目的 探讨安络化纤丸联合聚乙二醇干扰素α-2b治疗慢性乙型肝炎的临床疗效。方法 纳入2022年5月—2024年12月青海省第四人民医院收治的94例慢性乙型肝炎患者，按随机数字表法分为对照组和治疗组，每组各47例。对照组采用聚乙二醇干扰素α-2b注射液皮下注射治疗，180 μg/次，1次/周。治疗组在此基础上口服安络化纤丸，1袋/次，2次/d。两组疗程24周。观察两组临床疗效和临床表现改善时间，比较治疗前后血清乙肝表面抗原（HBsAg）、HBV脱氧核糖核酸（HBV DNA）、HBV核糖核酸（HBV RNA）、肝功能指标、淋巴细胞与单核细胞比值（LMR）、血小板计数与中性粒细胞比值（PNR）和外周血T淋巴细胞亚群水平。结果 治疗后，治疗组总有效率是93.62%，较对照组的78.72%更高（P＜0.05）。治疗后，治疗组疲乏、厌油、食欲减退、肝区不适的改善时间短于对照组（P＜0.05）。治疗后两组血清HBsAg、HBV DNA、HBV RNA均降低（P＜0.05）；且治疗组低于对照组（P＜0.05）。两组治疗后ALT、TBIL、AST水平均显著降低（P＜0.05）；治疗组ALT、TBIL、AST低于对照组（P＜0.05）。两组患者治疗后LMR、PNR和CD4⁺、CD4⁺/CD8⁺均增高，而CD8⁺降低（P＜0.05）；治疗后，治疗组LMR、PNR和CD4⁺、CD4⁺/CD8⁺均高于对照组，CD8⁺低于对照组（P＜0.05）。结论 安络化纤丸联合聚乙二醇干扰素α-2b治疗慢性乙型肝炎能有效抑制病毒复制，减轻炎症损伤，调节机体免疫功能，进一步改善患者的临床表现及肝功能。

Objective To investigate the clinical efficacy of Anluo Huaxian Pills combined with peginterferon α-2b in treatment of chronic hepatitis B. Methods A total of 94 patients with chronic hepatitis B admitted to Qinghai Provincial Fourth People’s Hospital from May 2022 to December 2024 were included and divided into control group and treatment group according to random number table method, with 47 cases in each group. Patients in control group were iv administered with Peginterferon α-2b Injection, 180 μg each time, once weekly. Patients in treatment group were po administered with Anluo Huaxian Pills on basis of control group, 1 bag each time, twice daily. The treatment course for both groups was 24 weeks. The clinical efficacy and the improvement time of clinical manifestations of the two groups were observed, and the levels of serum HBsAg, HBV DNA, HBV RNA, liver function indicators, LMR, PNR, and peripheral blood T lymphocyte subsets before and after treatment were compared. Results After treatment, the total effective rate of treatment group was 93.62%, which was higher than 78.72% of control group (P < 0.05). After treatment, the improvement time of fatigue, aversion to oil, loss of appetite and discomfort in the liver area in treatment group was shorter than that in control group (P < 0.05). After treatment, the levels of serum HBsAg, HBV DNA, and HBV RNA in both groups decreased (P < 0.05). And those indicators in treatment group were lower than the control group (P < 0.05). After treatment in both groups, the levels of ALT, TBIL, and AST were significantly decreased (P < 0.05). The levels of ALT, TBIL, and AST in treatment group were lower than those in control group (P < 0.05). After treatment, LMR, PNR, CD4⁺ and CD4⁺/CD8⁺ in both groups of patients increased, but CD8⁺ decreased (P < 0.05). After treatment, LMR, PNR, CD4⁺, and CD4⁺/CD8⁺ in the treatment group were all higher than those in control group, but CD8⁺ was lower than that in control group (P < 0.05). Conclusion Anluo Huaxian Pills combined with peginterferon α-2b in treatment of chronic hepatitis B can effectively inhibit viral replication, reduce inflammatory damage, regulate the immune function of the body, and further improve the clinical manifestations and liver function of patients.

R975

青海省卫生健康系统适宜技术推广项目（2022-wjtg-07）