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阿帕替尼片联合肝动脉化疗栓塞术治疗中晚期原发性肝癌的临床研究 被引量:40

Clinical trial of apatinib tablets combined with transcatheter arterial chemoembolization in the treatment of advanced primary liver cancer
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摘要 目的观察阿帕替尼片联合肝动脉化疗栓塞术(TACE)治疗中晚期原发性肝癌的临床疗效及安全性。方法将76例中晚期原发性肝癌患者随机分为对照组和试验组,每组38例。对照组予以TACE治疗;试验组在对照组治疗的基础上,于TACE治疗后3 d至下一周期TACE治疗前4 d予以阿帕替尼每次850 mg,qd,口服。2组患者1个周期均为28 d,治疗至肿瘤进展或者无法耐受时终止。比较2组患者的临床疗效,生存情况,细胞免疫功能,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为63. 16%(24例/38例)和36. 84%(14例/38例),1年生存率分别为86. 84%(33例/38例)和65. 79%(25例/38例),2年生存率分别为71. 05%(27例/38例)和52. 63%(20例/38例),差异均有统计学意义(均P <0. 05)。治疗后,试验组和对照组的CD3^+分别为(62. 42±10. 76)%和(56. 75±9. 90)%,CD4^+分别为(39. 39±9. 02)%和(35. 52±4. 62)%,CD8^+分别为(23. 79±2. 87)%和(26. 28±1. 84)%,CD4^+/CD8^+分别为(1. 71±0. 28)和(1. 33±0. 17),差异均有统计学意义(均P <0. 05)。2组患者的药物不良反应均以疼痛、食欲缺乏、恶心呕吐、骨髓抑制和乏力为主,试验组和对照组的总药物不良反应发生率分别为50. 00%和28. 95%,差异有统计学意义(P <0. 05)。结论阿帕替尼片联合TACE治疗中晚期原发性肝癌的临床疗效确切,其能有效地改善细胞免疫功能,延长生存期,但药物不良反应发生率较高。 Objective To observe the clinical efficacy and safety of apatinib tablets combined with transcatheter arterial chemoembolization (TACE) in the treatment of advanced primary liver cancer.Methods A total of 76 patients with advanced primary liver cancer were randomly divided into control and treatment groups,38 cases in each group.Control group was treated with TACE.Treatment group was given apatinib tablets 850 mg per time,qd,orally from 3 days after TACE treatment to 4 days before next TACE treatment,on the basis of control group.Two groups were treated to the tumor progression or intolerable with 28 days per cycle.The clinical efficacy,survival,cellular immunity and adverse drug reactions were compared between two groups.Results After treatment, the total effective rates of treatment and control groups were 63.16% (24 cases /38 cases) and 36.84% (14 cases /38 cases) ,the 1-year survival rates were 86.84% (33 cases /38 cases) and 65.79% (25 cases /38 cases) ,and the 2-year survival rates were 71.05% (27 cases /38 cases) and 52.63% (20 cases /38 cases) ,the differences were statistically significant (all P <0.05) .After treatment,the main indexes of treatment and control groups were compared: CD3^+ were (62.42±10.76) % and (56.75±9.90) %,CD4^+ were (39.39±9.02) % and (35.52±4.62) %,CD8^+ were (23.79±2.87) % and (26.28±1.84) %,CD4^+ /CD8^+ were (1.71±0.28) and (1.33±0.17) ,the differences were statistically significant (all P<0.05) .The adverse drug reactions of two groups were pain,loss of appetite,nausea and vomiting,myelosuppression and fatigue,and the total incidences of adverse reactions in treatment and control groups were 50.00% and 28.95% with significant difference (P<0.05) .Conclusion Apatinib tablets combined with TACE have a definitive clinical efficacy in the treatment of advanced primary liver cancer,which can statistically improve the cellular immunity and prolong survival time,but the incidence of adverse drug reactions is higher.
作者 曾广源 吴龚丽莉 郑文 王家寿 ZENG Guang -yuan;WU Gong -Li li;ZHENG Wen;WANG Jia -shou(Department of Hepatobiliary Surgery,Shangrao People's Hospital, Shangrao 334000,Jiangxi Province, China;Department of Medical,Shangrao People's Hospital, Shangrao 334000,Jiangxi Province, China;Department of Oncology,Shangrao People's Hospital, Shangrao 334000,Jiangxi Province, China;Department of Radiology,Shangrao People's Hospital, Shangrao 334000,Jiangxi Province, China)
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2018年第23期2693-2696,共4页 The Chinese Journal of Clinical Pharmacology
基金 江西省卫生计生委科技计划资助项目(20164065)
关键词 阿帕替尼片 肝动脉化疗栓塞术 中晚期原发性肝癌 安全性评价 apatinib tablet transcatheter arterial chemoembolization advanced primary liver cancer safety evaluation
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