雷替曲塞注射剂联合奥沙利铂注射剂治疗晚期原发性肝癌的临床研究  

Clinical trial of raltitrexed injection combined with oxaliplatin injection in the treatment of advanced primary liver cancer

作　　者：鲁文权 乐凌云[1] 田炳如[1] 邢士超[1] 邵宝儿 林能明[2] LU Wen-quan;LE Ling-yun;TIAN Bing-ru;XING Shi-chao;SHAO Bao-er;LIN Neng -ming(Department of Oncology,Yuyao People's Hospital,Yuyao 315400,Zhejiang Province,China;Department of Oncology,Hangzhou First People's Hospital,Hangzhou 310006,China)

机构地区：[1]余姚市人民医院肿瘤科,浙江余姚315400 [2]杭州市第一人民医院肿瘤科,杭州310006

出　　处：《中国临床药理学杂志》2019年第2期102-105,共4页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省自然科学基金资助项目(Y15H310007)

摘　　要：目的观察雷替曲塞注射剂联合奥沙利铂注射剂治疗晚期原发性肝癌的临床疗效及安全性。方法将148例晚期原发性肝癌患者随机分为对照组和试验组,每组74例。对照组予以85 mg·m^(-2)奥沙利铂,静脉滴注,第1天+200mg·m^(-2)亚叶酸钙,静脉滴注2 h,第1～2天+400 mg·m^(-2)氟尿嘧啶,静脉推注,之后予以600 mg·m^(-2)持续静脉滴注22 h,第1～2天,1个周期为14 d,共治疗3个周期。试验组予以3 mg·m^(-2)雷替曲塞,静脉滴注15 min,第1天+130mg·m^(-2)奥沙利铂,静脉滴注3 h,第1天,1个周期为21 d,共治疗2个周期。比较2组患者的临床疗效、肿瘤标志物水平和药物不良反应的发生情况。结果治疗后,试验组和对照组的疾病控制率分别为56. 76%(42例/74例)和40. 54%(30例/74例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的甲胎蛋白分别为(34. 68±4. 02)和(40. 11±3. 86) ng·mL^(-1),糖链抗原^(-1)99分别为(212. 54±23. 15)和(226. 45±24. 88) U·mL^(-1),组织多肽抗原分别为(308. 95±31. 37)和(361. 48±36. 77) U·L^(-1),癌胚抗原分别为(14. 27±1. 24)和(18. 56±1. 54) ng·mL^(-1),差异均有统计学意义(均P <0. 05)。试验组和对照组的消化道反应发生率分别为39. 19%和72. 97%,肝毒性发生率分别为33. 78%和62. 16%,心脏毒性发生率分别为6. 76%和25. 68%,神经毒性发生率分别为28. 38%和51. 35%,手足综合征发生率分别为10. 81%和48. 65%,差异均有统计学意义(均P <0. 05)。结论雷替曲塞注射剂联合奥沙利铂注射剂治疗晚期原发性肝癌的临床疗效确切,其能有效控制疾病进展,降低肿瘤标志物水平,且安全性较高。Objective To observe the clinical efficacy and safety of raltitrexed injection combined with oxaliplatin injection in the treatment of advanced primary liver cancer. Methods A total of 148 patients with advanced primary liver cancer were randomly divided into control and treatment groups with 74 cases per group. Control group was treated with85 mg·m^-2 oxaliplatin,intravenous drip,day 1 + 200 mg ·m^-2 calcium folate,intravenous drip for 2 h,day 1-2 + 400 mg·m^-2 fluorouracil,intravenous injection,followed by 600 mg·m^-2 continuously intravenous drip for 22 h,day 1-2,and the treatment was 3 cycles with 14 days per cycle. Treatment group was given 3 mg·m^-2 raltitrexed,intravenous drip for 15 min,day 1 + 130 mg·m^-2 oxaliplatin,intravenousdrip for 3 h,day 1,and the treatment was 2 cycles with 21 days per cycle. The clinical efficacy,levels of tumor markers and adverse drug reactions were compared between two groups. Results After treatment,the disease control rates of treatment and control groups were 56. 76%( 42 cases/74 cases) and 40. 54%( 30 cases/74 cases) with significant difference( P < 0. 05). After treatment,the main indexes of treatment and control groups were compared: alpha fetoprotein were( 34. 68 ± 4. 02) and( 40. 11 ± 3. 86) ng·mL^-1,carbohydrate antigen 199 were( 212. 54 ± 23. 15)and( 226. 45 ± 24. 88) U · mL^-1,tissue polypeptide antigen were( 308. 95 ± 31. 37) and( 361. 48 ± 36. 77)U·L^-1,carcinoembryonic antigen were( 14. 27 ± 1. 24) and( 18. 56 ± 1. 54) ng·mL^-1,the differences were statistically significant( all P < 0. 05). Incidences of digestive tract reactions in the treatment and control groups were 39. 19% and 72. 97%,incidences of hepatotoxicity were 33. 78% and 62. 16%,incidences of cardiac toxicity were6. 76% and 25. 68%,incidences of neurotoxicity were 28. 38% and 51. 35%,incidences of hand-foot syndrome were 10. 81% and 48. 65%,the differences were statistically significant( all P < 0. 05). Conclusion Raltitrexed injection combined with oxaliplatin injection has a def

关 键 词：雷替曲塞注射剂 奥沙利铂注射剂 晚期原发性肝癌 安全性评价 

分 类 号：R979.1[医药卫生—药品]