目的 探讨舒肝宁注射液联合富马酸替诺福韦二吡呋酯片治疗慢性乙型肝炎肝硬化的临床疗效。方法 选取2019年1月—2020年2月在平煤神马医疗集团总医院就诊的104例慢性乙型肝炎肝硬化患者作为本研究对象，根据随机数字表法将104例患者分为对照组和治疗组，每组各52例。对照组口服富马酸替诺福韦二吡呋酯片，300 mg/次，1次/d。治疗组在对照组治疗的基础上肌肉注射舒肝宁注射液，10 mL/次，1次/d。两组均连续治疗4周后。观察两组患者的临床疗效，比较两组的肝功能指标、淋巴细胞、乙型肝炎病毒的脱氧核糖核酸（HBV-DNA）转阴率、乙型肝炎E抗原（HBeAg）转阴率、乙型肝炎E抗体（HBeAb）转阳率。结果 治疗后，治疗组患者的总有效率为96.15%，对照组总有效率为84.62%，两组对比差异有统计学意义（P<0.05）。治疗后，两组的丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、总胆红素（TBIL）水平显著降低，白蛋白（ALB）水平显著升高（P<0.05）；治疗后治疗组的ALT、AST、TBIL水平低于对照组，ALB水平高于对照组（P<0.05）。治疗后，两组的CD3⁺、CD4⁺、CD4⁺/CD8⁺、NK细胞显著升高（P<0.05）；治疗后治疗组的CD3⁺、CD4⁺、CD4⁺/CD8⁺、自然杀伤（NK）细胞高于对照组（P<0.05）。治疗后，治疗组的HBeAg转阴率、HBeAb转阳率低于对照组（P<0.05），两组的HBV-DNA转阴无明显差异。结论 舒肝宁注射液联合富马酸替诺福韦二吡呋酯片治疗慢性乙型肝炎肝硬化的临床疗效较好，可改善肝功能，调节淋巴细胞的分泌。

Objective To investigate the clinical effect of Shuganning Injection combined with Tenofovir Disoproxil Fumarate Tablets in treatment of chronic hepatitis B cirrhosis. Methods Patients (104 cases) with chronic hepatitis B cirrhosis in Pingmei Shenma Medical Group General Hospital from January 2019 to February 2020 were randomly divided into control and treatment groups, and each group had 52 cases. Patients in the control group were po administered with Tenofovir Disoproxil Fumarate Tablets, 300 mg/time, once daily. Patients in the treatment group were iv administered with Shuganning Injection on the basis of the control group, 10 mL/time, once daily. Patients in two groups were treated for 4 weeks. After treatment, the clinical efficacies were evaluated, and liver function indexes, lymphocyte, HBV-DNA negative rate, HBeAg negative rate, HBeAb positive rate in two groups were compared. Results After treatment, the total effective rate of the treatment group was 96.15%, and that of the control group was 84.62%, and there was difference between two groups (P<0.05). After treatment, the levels of ALT, AST, and TBIL in the two groups were significantly decreased, while the level of ALB in the two groups was significantly increased (P<0.05). After treatment, the levels of ALT, AST, and TBIL in the treatment group were lower than those in the control group, while the level of ALB was higher than those in the control group (P<0.05). After treatment, CD3⁺, CD4⁺, CD4⁺/CD8⁺, and NK cells in two groups were significantly increased (P<0.05). After treatment, CD3⁺, CD4⁺, CD4⁺/CD8⁺, and NK cells in the treatment group were higher than those in the control group (P< 0.05). After treatment, HBeAg negative conversion rate and HBeAb positive conversion rate in the treatment group were lower than those in the control group (P<0.05). There were no significant differences in the negative conversion rate of HBV-DNA between two groups. Conclusion Shuganning Injection combined with Tenofovir Disoproxil Fumarate Tablets has clinical curative effect in treatment of chronic hepatitis B cirrhosis, can improve liver function and regulate the secretion of lymphocytes.

R975

河南省医学科技攻关计划项目（201702338）