榄香烯注射液联合仑伐替尼治疗原发性肝癌有效性及安全性研究

Clinical Study of Olive Elemene Injection Combined with Lenvatinib Mesilate Capsules in the Treatment of Primary Liver Cancer

摘要: 目的：探讨榄香烯注射液联合仑伐替尼治疗原发性肝癌临床疗效和安全性。方法：选取我院收治78例晚期原发性肝癌患者，随机分为对照组39例，观察组39例。对照组给予口服仑伐替尼，观察组在对照组基础上给予榄香烯乳状注射液4支加入0.9%氯化钠注射液250 ml，1/次d，静脉滴注。连续使用14 d，3周为1个疗程，共治疗2个疗程。比较两组患者治疗前后近期疗效和生活质量。采用酶联免疫吸附法检测患者治疗前后，血清中肿瘤坏死因子-α (TNF-α)、白细胞介素-6 (IL-6)、白细胞介素-1 (IL-1)、以及血清C反应蛋白(CRP)。采用流式细胞仪检测CD3⁺、CD4⁺细胞率和CD4⁺/CD8⁺变化。观察两组患者用药中不良反应。结果：观察组总有效率为41.03%，对照组总有效率为30.77%，两组相比有统计学意义(P < 0.05)。与对照组相比，观察组生活质量评分明显升高(P < 0.05)；观察组血清中CD3⁺、CD4⁺、CD4⁺/CD8⁺水平明显升高(P < 0.05)；血清中TNF-α、IL-6、IL-1水平明显降低(P < 0.05)。不良反应发生率方面，观察组在体重降低、疲乏、食欲减退不良反应发生率明显低于对照组(P < 0.05)。结论：榄香烯注射液联合仑伐替尼治疗原发性肝癌临床效果较好，能提高生活质量，提高机体免疫力，降低炎症水平和不良反应，值得临床推广使用。

Abstract: Objective: To investigate the clinical efficacy and safety of elemene injection combined with Lenvatinib Mesilate Capsules for primary liver cancer. 78 patients were randomly divided into the control group and the observation group. The control group was given oral lenavatinib, the observation group was given elemene injection (250 ml of 0.9% NS solution) Intrav infusion, once on 1 day, and 1 course for 3 weeks. A total of 2 courses were treatment. To compare the recent efficacy and quality of life before and after treatment. TNF-α, IL-6, IL-1 and CRP were detected by ELISA. CD3⁺, CD4⁺ and CD4⁺/CD8⁺ were determined by flow cytometry. The adverse reactions in both groups was observed. After treatment, the total response rate of the observation group was 41.03% and the control group was 30.77% (P < 0.05). Compared with the control group, the quality of life score increased significantly (P < 0.05); the serum levels of CD3⁺, CD4⁺ and CD4⁺/CD8⁺ in the observation group increased significantly (P < 0.05); and the serum levels of TNF-α, IL-6 and IL-1 were significantly decreased (P < 0.05). In terms of the incidence of adverse reactions, the incidence of adverse reactions in weight loss, fatigue and appetite loss was significantly lower than that of the control group (P < 0.05). Conclusion: elemene injection combined with Lenvatinib Mesilate Capsules for primary liver cancer very well, which could improve quality of life, improving body immunity, reducing inflammatory level and adverse reactions, and being worth clinical promotion and use.