【目的】 观察软坚散结丸治疗乙型肝炎（简称乙肝）肝硬化代偿期瘀血阻络证患者的临床疗效。【方法】 将2023年1月至 2024年4月就诊于广州中医药大学附属宝安中医院的80例乙肝肝硬化代偿期瘀血阻络证患者随机分为试验组和对照组，每 组各40例。对照组给予口服恩替卡韦抗乙肝病毒（HBV）治疗，试验组在对照组的基础上加用软坚散结丸治疗，疗程为1年。 观察2组患者治疗前后血常规[白细胞计数（WBC）、血小板计数（PLT）]、肝功能[白蛋白（ALB）、总胆红素（TBIL）、谷丙转氨 酶（ALT）、谷草转氨酶（AST）]、凝血酶原时间（PT）、肝硬度值（LSM）和中医证候积分的变化情况，并评价2组患者的临床疗 效和用药安全性。【结果】（1）脱落情况方面，对照组脱落3例，试验组脱落4例，最终对照组37例、试验组36例纳入疗效统 计。（2）疗效方面，治疗1年后，试验组的总有效率为91.67%（33/36），对照组为67.57%（25/37），组间比较（χ2 检验），试验组 的疗效明显优于对照组（P < 0.05）。（3）血常规方面，治疗后，试验组的 WBC、PLT均较治疗前升高（P < 0.05），而对照组的 WBC、PLT均无明显变化（P > 0.05）；治疗后组间比较，试验组的WBC、PLT均较对照组明显升高（P < 0.05）。（4）肝功能和凝 血功能方面，治疗后，2组患者的ALB均较治疗前升高（P < 0.05），2组患者的PT值和试验组的ALT较治疗前降低（P < 0.05）， 而2组患者的TBIL、AST及对照组的ALT治疗前后比较，差异均无统计学意义（P > 0.05）；组间比较，试验组对PT值的降低 程度明显优于对照组（P < 0.05），而2组患者的ALT、AST、TBIL、ALB比较，差异均无统计学意义（P > 0.05）。（5）肝脏硬度 值方面，治疗后，2组患者的LSM均较治疗前降低（P < 0.05），且试验组的降低程度明显优于对照组（P < 0.05）。（6）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降低（P < 0.05），且试验组的降低程度明显优于对照组（P < 0.05）。 （7）安全性方面，治疗过程中，2组患者均无明显不良反应和不良事件发生。【结论】 软坚散结丸能够改善乙肝肝硬化代偿期 瘀血阻络证患者临床症状，改善凝血功能，降低肝脏硬度，延缓肝硬化进程，其临床疗效及安全性良好。

Objective To observe the clinical efficacy of Ruanjian Sanjie Pills in the treatment of patients with hepatitis B - related cirrhosis in compensatory stage differentiated as blood stasis blocking collaterals syndrome. Methods A total of 80 cases of patients with hepatitis B-related cirrhosis in compensatory stage admitted to Bao'an Hospital of Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine from January 2023 to April 2024 were randomly divided into the trial group and the control group，40 cases in each group. The control group was treated with oral administration of Entecavir for hepatitis B virus（HBV），and the trial group was treated with Ruanjian Sanjie Pills on the basis of treatment for the control group，the course of treatment covering one year. Before and after treatment，the two groups were observed in the changes of routine blood test indicators of white blood cell count（WBC）and platelet count（PLT）， liver function indicators [albumin（ALB）， total bilirubin （TBIL）， alanine transaminase （ALT） and aspartate transaminase （AST）]， prothrombin time （PT）， liver stiffness measurement（LSM），and traditional Chinese medicine（TCM）syndrome scores. After treatment，the clinical efficacy and safety were evaluated. Results（1）There were three cases in the control group and four cases in the trial group fell off，and eventually 37 cases in the control group and 36 cases in the trial group were enrolled in the efficacy statistics.（2）After one year of treatment，the total effective rate of the trial group was 91.67%（33/ 36）and that of the control group was 67.57%（25/37），and the intergroup comparison（tested by chi-square test） showed that the therapeutic efficacy of the trial group was significantly superior to that of the control group（P < 0.05）.（3）After treatment，the routine blood test indicators of WBC and PLT in the trial group were increased compared with those before treatment（P < 0.05），while the WBC and PLT in the control group did not change significantly（P > 0.05）. The post-treatment WBC and PLT in the trial group were significantly higher than those of the control group（P < 0.05）.（4）After treatment，the ALB of patients in the two groups was increased compared with that before treatment（P < 0.05），and the PT value of patients in the two groups and the ALT of the trial group were decreased compared with those before treatment（P < 0.05），but TBIL and AST of the two groups and ALT of the control group did not differ from those before treatment（P > 0.05）. The comparison between the two groups showed that the decrease of PT value in the trial group was significantly superior to that of the control group（P > 0.05）， but no statistically significant differences of ALT， AST， TBIL and ALB were shown between the two groups（P > 0.05）.（5）After treatment，the LSM of patients in the two groups was decreased compared with that before treatment（P < 0.05），and the decrease in the trial group was significantly superior to that in the control group（P < 0.05）.（6）After treatment，the TCM syndrome scores of the two groups of patients were decreased compared with those before treatment（P < 0.05），and the decrease in the trial group was significantly superior to that in the control group（P < 0.05）.（7）There were no significant adverse reactions or adverse events occurring in the two groups during the treatment. Conclusion Ruanjian Sanjie Pills can improve the clinical symptoms of patients with hepatitis B-related cirrhosis in the compensatory stage，improve the coagulation function，reduce the hardness of the liver，and slow down the process of cirrhosis，with satisfactory efficacy and good safety.

R259.752

广东省中医药局科研项目（编号：20201303）；深圳市“医疗卫生三名工程”资助项目（编号：SZZYSM202311014）