目的 探讨复方苦参注射液联合甲磺酸仑伐替尼胶囊治疗原发性肝癌的疗效。方法 选择2023年4月—2025年12月在邯郸市中西医结合医院就诊的94例原发性肝癌患者，使用随机数字表法将全部患者分为对照组和治疗组，每组47例。对照组口服甲磺酸仑伐替尼胶囊，体质量＜60 kg的2粒/次，体质量≥60 kg的3粒/次，1次/d。治疗组在对照组基础上静脉滴注复方苦参注射液，每次20 mL加入200 mL生理盐水稀释，1次/d，持续治疗14 d。3周为1个疗程，两组完成3个疗程。比较两组的总有效率、生活质量、免疫指标、血清肿瘤标志物、肝功能指标和不良反应。结果 治疗组的总有效率为80.85%，对照组的总有效率为61.70%，组间比较差异显著（P＜0.05）。治疗后，两组的肝癌生命质量测定量表（QOL-LC）评分显著升高（P＜0.05），且治疗组QOL-LC评分高于对照组（P＜0.05）。治疗后，两组的脂肪酸结合蛋白5（FABP5）、淋巴细胞/单核细胞比值（LMR）、中性粒细胞与淋巴细胞比值（NLR）均显著降低（P＜0.05），且治疗组FABP5、LMR、NLR明显低于对照组（P＜0.05）。两组治疗后的血清甲胎蛋白（AFP）、糖类抗原242（CA242）、糖类抗原199（CA199）水平明显降低（P＜0.05），且治疗组血清AFP、CA242、CA199水平低于对照组（P＜0.05）。两组治疗后的天冬氨酸转氨酶（AST）、碱性磷酸酶、丙氨酸氨基转移酶（ALT）明显降低（P＜0.05），且治疗组的AST、碱性磷酸酶、ALT低于对照组（P＜0.05）。治疗组患者高血压、腹泻、疲乏、食欲下降、蛋白尿、关节痛/肌痛的发生率明显低于对照组（P＜0.05）。结论 复方苦参注射液联合甲磺酸仑伐替尼胶囊有助于提高原发性肝癌的临床疗效，改善免疫功能和肝功能，降低不良反应的发生。

Objective To investigate the efficacy of Compound Kushen Injection combined with Lenvatinib Mesilate Capsules in treatment of primary liver cancer. Methods 94 Patients with primary liver cancer who visited Handan Hospital of Integrated TCM-WM from April 2023 to December 2025 were divided into control group and treatment group using a random number table method, with 47 patients in each group. The control group took orally Lenvatinib Mesilate Capsules, with 2 capsules/time for body weight < 60 kg and 3 capsules/time for body weight ≥ 60 kg, once daily. The treatment group received intravenous infusion of Compound Kushen Injection on the basis of the control group, with 20 mL diluted with 200 mL physiological saline each time, once daily, and continued treatment for 14 days. One course of treatment was 3 weeks, and the efficacy of the two groups was calculated after completing 3 courses. The total effective rate, quality of life, immune indicators, serum tumor markers, liver function indicators, and adverse reactions were compared between two groups. Results The total effective rate of the treatment group was 80.85%, the total effective rate of the control group was 61.70%, and the difference between two groups was significant (P< 0.05). After treatment, the QOL-LC scores of two groups significantly increased (P < 0.05), and the QOL-LC scores in the treatment group were higher than those in the control group (P < 0.05). After treatment, the levels of fatty acid binding protein 5 (FABP5), lymphocyte/monocyte ratio (LMR), and neutrophil to lymphocyte ratio (NLR) in two groups were significantly reduced (P < 0.05), and the levels of FABP5, LMR, and NLR in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, the serum levels of alpha fetoprotein (AFP), carbohydrate antigen 242 (CA242), and carbohydrate antigen 199 (CA199) in two groups were significantly reduced (P < 0.05), and the serum levels of AFP, CA242, and CA199 in the treatment group were lower than those in the control group (P < 0.05). After treatment, the levels of aspartate aminotransferase (AST), alkaline phosphatase, and alanine aminotransferase (ALT) in two groups were significantly reduced (P < 0.05), and the AST, alkaline phosphatase, and ALT levels in the treatment group were lower than those in the control group (P< 0.05). The incidence of hypertension, diarrhea, fatigue, decreased appetite, proteinuria, and joint/ muscle pain in the treatment group was significantly lower than that in the control group (P < 0.05). Conclusion The combination of Compound Kushen Injection and Lenvatinib Mesylate Capsules can improve the clinical efficacy in treatment of primary liver cancer, enhance immune and liver function, and reduce the occurrence of adverse reactions.

R975

河北中医药管理局项目（2025607）