目的 探讨安络化纤丸联合硫普罗宁治疗慢性乙型肝炎肝硬化的临床疗效。方法 选取2021年8月—2023年2月西安市第八医院收治的166例慢性乙型肝炎肝硬化患者，按随机数字表法将所有患者分为对照组和治疗组，每组各83例。对照组静脉滴注注射用硫普罗宁，每次将0.2 g加入0.9%氯化钠注射液250 mL中充分稀释后给药，1次/d。治疗组在对照组治疗基础上口服安络化纤丸，6 g/次，2次/d。两组患者的疗程均为3个月。观察两组临床疗效，比较治疗前后两组肝功能指标[谷丙转氨酶（ALT）、总胆红素（TBiL）、白蛋白与球蛋白比值（A/G）]、谷草转氨酶（AST）与血小板（PLT）比值指数（APRI）评分、肝脏硬度测量（LSM）值、肝/脾CT值比值及血清肝纤维化指标[Ⅲ型前胶原N端肽（PC-Ⅲ）、透明质酸（HA）、Ⅳ型胶原（Ⅳ-C）、层黏连蛋白（LN）]和高迁移率族蛋白B1（HMGB1）、白细胞介素-17（IL-17）、可溶性P选择素（sP-selectin）水平。结果 治疗后，治疗组总有效率为90.36%，显著高于对照组的78.31%（P＜0.05）。治疗后，两组血清ALT、TBiL水平均显著降低，而A/G均显著增高（P＜0.05）；治疗后，治疗组肝功能指标改善优于对照组（P＜0.05）。治疗后，两组APRI评分、LSM值均显著降低，肝/脾CT值比值均显著升高（P＜0.05）；且均以治疗组改善更显著（P＜0.05）。治疗后，两组血清PC-Ⅲ、HA、Ⅳ-C、LN水平均显著下降（P＜0.05）；均以治疗组改善更显著（P＜0.05）。治疗后，两组血清HMGB1、IL-17、sP-selectin水平均显著下降（P＜0.05）；治疗后，治疗组HMGB1、IL-17、sP-selectin水平均低于对照组（P＜0.05）。结论 安络化纤丸联合硫普罗宁治疗慢性乙型肝炎肝硬化能有效提高疗效，改善肝功能和肝纤维化，抑制机体慢性炎症及肝硬化进程，且安全性较佳，值得临床推广。

Objective To explore the clinical efficacy of Anluo Huaxian Pills combined with tiopronin in treatment of liver cirrhosis caused by chronic hepatitis B. Methods A total of 166 patients with chronic hepatitis B cirrhosis admitted to Xi'an Eighth Hospital from August 2021 to February 2023 were selected and divided into control group and treatment group according to random number table method, with 83 cases in each group. Patients in the control group were iv administered with Tiopronin for injection, 0.2 g was added into 0.9% sodium chloride injection 250 mL for full dilution and administration, once daily. Patients in the treatment group were po administered with Anluo Huaxian Pills on the basis of the control group, 6 g/time, twice daily. The treatment course of both groups was 3 months. After treatment, the clinical efficacy was evaluated, and the liver function indexes [alanine transaminase (ALT), total bilirubin (TBiL), albumin to globulin ratio (A/G)], aspartate Transaminase to platelet (PLT) ratio index (APRI) score, liver hardness measurement (LSM) value, and liver/spleen CT value ratio were compared between the two groups before and after treatment. The levels of serum hepatic fibrosis markers [type Ⅲ procollagen N-terminal peptide (PC - Ⅲ), hyaluronic acid (HA), type Ⅳ collagen (Ⅳ-C), Laminin (LN)], High-mobility group protein B1 (HMGB1), interleukin-17 (IL-17), soluble P Selectin (sP selectin)] were also measured. Results After treatment, the total effective rate of the treatment group was 90.36%, which was significantly higher than that of control group (78.31%, P < 0.05). After treatment, serum ALT and TBiL levels were significantly decreased, but A/G were significantly increased in both groups (P < 0.05). After treatment, the improvement of liver function indexes in treatment group was better than that in control group (P < 0.05). After treatment, APRI score and LSM value were significantly decreased, and the ratio of liver/spleen CT value was significantly increased in both groups (P < 0.05). The improvement was more significant in treatment group (P < 0.05). After treatment, the serum levels of PC-Ⅲ, HA, Ⅳ-C and LN in 2 groups were significantly decreased (P < 0.05). The improvement was more significant in treatment group (P < 0.05). After treatment, serum HMGB1, IL-17 and sP-selectin levels in 2 groups were significantly decreased (P< 0.05). After treatment, the levels of HMGB1, IL-17 and sP-selectin in treatment group were lower than those in control group (P < 0.05). Conclusion Anluo Huaxian Pills combined with tiopronin can effectively improve the curative effect in treatment of liver cirrhosis caused by chronic hepatitis B, and can improve liver function and liver fibrosis, inhibit the process of chronic inflammation and cirrhosis of the body with good safety, which is worthy of clinical promotion.

R975

西安市科技计划项目（21YXYJ0063）