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
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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 definitive clinical efficacy and safety in the treatment of advanced primary liver cancer,which can effectively control the progress of disease,and reduce the levels of tumor markers.
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 definitive clinical efficacy and safety in the treatment of advanced primary liver cancer,which can effectively control the progress of disease,and reduce the levels of tumor markers.
引文
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[8]周丽,李青山.表柔比星+5-氟尿嘧啶、奥沙利铂对人肝癌HepG2细胞增殖及凋亡的影响[J].肝胆外科杂志,2014,22(6):474-476.
[9]吕会来,张丽,温士旺,等.雷替曲塞联合奥沙利铂治疗术后复发转移性食管癌的临床对照研究[J].实用医学杂志,2015,31(22):3781-3783.
[10]王会忠,王震,仲海洋.雷替曲塞联合奥沙利铂治疗晚期胃癌的疗效观察[J].中国肿瘤临床与康复,2015,22(8):940-942.
[2]张晓媛,黄鹏,李燕京,等.晚期原发性肝癌治疗的研究进展[J].现代肿瘤医学,2017,25(10):1655-1659.
[3]刘文稚,李孟考,陈祥明.雷替曲塞联合奥沙利铂治疗结直肠癌肝转移的临床研究[J].中华临床医师杂志:电子版,2015,9(1):146-148.
[4]中华人民共和国卫生部.原发性肝癌诊疗规范(2011年版)[J].中华肝脏病杂志,2012,20(6):929-946.
[5]孙燕.抗癌药急性及亚急性毒性反应分度标准(WHO标准)[J].癌症,1992,11(3):插2.
[6]WATANABE H,OKADA M,KAJI Y,et al.New response evaluation criteria in solid tumours-revised RECIST guideline(version1.1)[J].Eur J Cancer,2009,36(13):2495-2501.
[7]何杨,彭玉珍,吉兆宁.雷替曲塞或5-氟尿嘧啶联合奥沙利铂一线治疗晚期胃癌的对比性研究[J].中国临床药理学与治疗学,2015,20(2):194-198.
[8]周丽,李青山.表柔比星+5-氟尿嘧啶、奥沙利铂对人肝癌HepG2细胞增殖及凋亡的影响[J].肝胆外科杂志,2014,22(6):474-476.
[9]吕会来,张丽,温士旺,等.雷替曲塞联合奥沙利铂治疗术后复发转移性食管癌的临床对照研究[J].实用医学杂志,2015,31(22):3781-3783.
[10]王会忠,王震,仲海洋.雷替曲塞联合奥沙利铂治疗晚期胃癌的疗效观察[J].中国肿瘤临床与康复,2015,22(8):940-942.