原发性肝癌患者应用索拉菲尼血药浓度与不良反应关系分析

Relationship Between Plasma Sorafenib Concentration and Adverse Reactions in Patients with Primary Liver Cancer

目的:分析原发性肝癌患者应用索拉菲尼进行治疗,血药物浓度与不良反应之间的关系。方法:以该院收治的原发性肝癌患者60例为该试验的研究对象,采用计算机随机分组的方式,分为对照组(n=30)及试验组(n=30)。两组患者均接受同样的方式进行治疗,包括肝动脉栓塞化疗以及口服索拉菲尼,调整药物使用剂量,将对照组患者索拉菲尼血药浓度控制在>4.78μg/mL,将试验组患者的血药浓度控制在≤4.78μg/mL。对所有入组患者不良反应发生情况进行统计、分析及比较。结果:60例研究对象的不良反应发生率为43.33%,其中试验组发生率(23.33%)显著低于对照组(63.33%),差异有统计学意义(χ^(2)=9.773,P=0.002 <0.05);不良反应中,高血压发生占比最高,为13.33%,血液系统相关并发症发生占比最低,为3.33%;常规化疗毒性分级标准(commontoxicity criteria,CTC)分级1~4级分别发生10例、10例、4例、2例。结论:索拉菲尼所致的不良反应与患者血液药物浓度之间有着密切的关系,在不影响治疗效果的前提下,调整药物的使用剂量,降低患者血液药物浓度,可有效降低不良反应的发生率,以提高患者的生存质量。

Objective: To analyze the relationship between blood drug concentration and adverse reactions in patients with primary liver cancer treated with sorafenib. Methods: 60 patients with primary liver cancer were selected in the hospital as the research objects of the trial, they were divided into a control group(n = 30) and a test group(n = 30) by random grouping by computer. Both groups of patients received the same treatment, including hepatic artery embolization chemotherapy and oral sorafenib, adjusted the dosage of the drug, and controlled the sorafenib blood concentration of the control group to more than 4.78 μg/mL, and the test group patient’s blood drug concentration was controlled at ≤ 4.78 μg/mL. The incidence of adverse reactions in all patients were statistically analyzed and compared. Results: The incidence of adverse reactions of 60 subjects was 43. 33%, and the incidence of the experimental group(23.33%) was significantly lower than that of the control group(63.33%), the difference was statistically significant(χ^(2)= 9.773, P = 0.002 < 0.05);Among the adverse reactions, the incidence of hypertension was the highest(13.33%), and the incidence of hematological complications was the lowest(3.33%);There were 10 cases, 10 cases, 4 cases and 2 cases in CTC grade 1-4, respectively. Conclusion: There is a close relationship between the adverse reactions caused by sorafenib and the blood drug concentration of patients. On the premise of not affecting the treatment effect, adjusting the dosage of drugs and reducing the blood drug concentration of patients can effectively reduce the incidence of adverse reactions and improve the quality of life of patients.