【目的】观察疏肝健脾化瘀方（逍遥散合膈下逐瘀汤加减化裁）治疗肝郁脾虚夹瘀型慢性乙型肝炎（CHB）患者的临床疗 效。【方法】通过回顾性队列研究，将2023 年9 月至2025 年3 月就诊于广州中医药大学附属宝安中医院（深圳市宝安区中医 院）肝病科门诊的100 例肝功能异常的肝郁脾虚夹瘀型CHB 患者，根据是否接受疏肝健脾化瘀方治疗分为暴露组与对照组， 每组各50 例。对照组给予常规保肝、抗病毒治疗，暴露组在此基础上给予疏肝健脾化瘀方治疗，疗程均为24 周。观察2 组 患者治疗前后中医证候积分、肝脏硬度测量（LSM）值、肝功能指标[谷丙转氨酶（ALT）、谷草转氨酶（AST）、谷氨酰转肽酶 （GGT）]、血清乙型肝炎表面抗原（HBsAg）、乙肝病毒脱氧核糖核酸（HBV-DNA）水平的变化情况，并评价2 组患者的临床疗 效和用药安全性。【结果】（1）疗效方面，治疗24 周后，暴露组的总有效率为98.00%（49/50），对照组为82.00%（41/50），组间 比较（χ2 检验），暴露组的临床疗效明显优于对照组（P＜0.05）。（2）肝功能方面，治疗后，2 组患者的肝功能指标ALT、AST、 GGT 水平均较治疗前明显降低（P＜0.05），且暴露组的降低幅度均明显优于对照组（P＜0.05）。（3）LSM 值方面，治疗后，2 组 患者的LSM 值均较治疗前有降低趋势，但差异均无统计学意义（P＞0.05）；组间比较，暴露组对LSM 值的降低幅度明显优于 对照组（P＜0.05）。（4）中医证候积分方面，治疗后，2 组患者的中医证候积分均较治疗前明显降低（P＜0.05），且暴露组的降 低幅度明显优于对照组（P＜0.05）。（5）血清HBsAg 和HBV-DNA 方面，暴露组与对照组在改善血清HBsAg 和HBV-DNA 水平 方面均无显著性差异（P＞0.05）；但初次抗病毒治疗患者对血清HBsAg 和HBV-DNA 的改善程度均明显优于既往已规律抗病 毒治疗者（P＜0.05）。（6）安全性方面，治疗过程中，2 组患者均无明显不良反应发生，具有较高安全性。【结论】疏肝健脾化 瘀方治疗肝功能异常的肝郁脾虚夹瘀型CHB 患者疗效确切，能显著改善患者的肝功能及临床症状，且在改善LSM 值方面也 有一定效果，其疗效明显优于单纯西医治疗。

Objective To observe the clinical efficacy of the Shugan Jianpi Huayu Formula（modified from Xiaoyao San plus Gezha Zhuyu Decoction）in the treatment of patients with chronic hepatitis B（CHB）presenting with liver depression and spleen deficiency complicated by blood stasis syndrome. Methods A retrospective cohort study was conducted. A total of 100 CHB patients with liver depression and spleen deficiency complicated by blood stasis syndrome and abnormal alanine aminotransferase（ALT）levels，who visited the Hepatology Department outpatient clinic of Bao’an Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine （Shenzhen Bao’an Traditional Chinese Medicine Hospital Group）from September 2023 to March 2025，were divided into an exposure group and a control group based on the treatment with the Shugan Jianpi Huayu Formula， with 50 cases in each group. The control group received conventional liver-protection and antiviral therapy，while the exposure group received the Shugan Jianpi Huayu Formula in addition to the conventional therapy. The treatment course for both groups was 24 weeks. Changes in TCM syndrome scores，liver stiffness measurement （LSM）values，liver function indicators [alanine aminotransferase（ALT），aspartate aminotransferase（AST）， gamma-glutamyl transferase（GGT）]，serum hepatitis B surface antigen（HBsAg），and hepatitis B virus deoxyribonucleic acid（HBV-DNA）levels were observed before and after treatment in both groups，and the clinical efficacy and medication safety were evaluated. Results（1）Regarding efficacy，after 24 weeks of treatment，the total effective rate was 98.00%（49/50）in the exposure group and 82.00%（41/50）in the control group. Intergroup comparison（by chi-square test）showed that the clinical efficacy of the exposure group was significantly superior to that of the control group（P＜0.05）.（2）Regarding liver function，after treatment，the levels of liver function indicators ALT，AST，and GGT were significantly decreased in both groups compared to before treatment（P＜0.05），and the decreases were significantly greater in the exposure group than in the control group（P＜0.05）.（3）Regarding LSM，after treatment，LSM values showed a decreasing trend in both groups compared to before treatment，but the differences were not statistically significant（P＞0.05）；however， intergroup comparison revealed that the reduction in LSM values was significantly greater in the exposure group than in the control group（P＜0.05）.（4）Regarding TCM syndrome scores，after treatment，the scores were significantly decreased in both groups compared to before treatment（P＜0.05），and the decrease was significantly greater in the exposure group than in the control group（P＜0.05）.（5）Regarding serum HBsAg and HBV-DNA levels，there were no significant differences between the exposure group and the control group in improving these parameters（P＞0.05）. However，patients receiving initially antiviral treatment showed significantly greater improvements in serum HBsAg and HBV-DNA levels compared to those who had previously received regular antiviral treatment（P＜0.05）.（6）Regarding safety，during the treatment process，no significant adverse reactions occurred in either group，indicating a favorable safety profile. Conclusion The Shugan Jianpi Huayu Formula demonstrates definitive efficacy in treating CHB patients with liver depression and spleen deficiency complicated by blood stasis syndrome and abnormal liver function. It can significantly improve patients’liver function and clinical symptoms，and also shows some effect in reducing LSM values，with its therapeutic effect being significantly superior to conventional western medicine treatment alone.

R259.126

国家中医药管理局综合司·国家卫生健康委办公厅·中央军委后勤保障部卫生局：强化建设的重大疑难疾病中西医临床协作项目 （编号：ZDYN-2024-B-012）；深圳市“医疗卫生三名工程”资助项目（编号：SZZYSM202311014）