贝伐珠单抗注射液治疗晚期结肠癌的临床研究

Clinical trial of bevacizumab injection on advanced colon cancer

目的观察贝伐珠单抗治疗晚期结肠癌患者的临床疗效和安全性。方法将172例晚期结肠癌患者随机分为对照组和试验组,每组各86例。对照组予以甲酰四氢叶酸钙+5氟尿嘧啶+草酸铂(FOLFOX)化疗方案治疗,试验组在FOLFOX化疗前,给予静脉注射贝伐珠单抗注射液5 mg·kg-1,qd。2周为1个疗程,2组患者均治疗5个疗程。比较2组患者的临床疗效、血清癌胚抗原(CEA)、糖类抗原199(CA199)、糖类抗原242(CA242)、糖类抗原125(CA125)、血管内皮生长因子(VEGF)、环氧化酶-2(COX-2)、基质金属蛋白酶-9(MMP-9)、基质金属蛋白酶-2(MMP-2)水平和药物不良反应发生率。结果治疗后,试验组和对照组的总有效率分别为56.98%(49例/86例)和36.05%(31例/86例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血清CEA分别为(42.16±5.44),(53.34±6.64)ng·m L^(-1);CA199分别为(59.96±8.11),(68.57±8.75)U·m L^(-1);CA242分别为(31.18±3.84),(49.63±6.54)U·m L^(-1),CA125指标分别为(25.46±3.08),(36.54±4.34)U·m L^(-1);VEGF分别为(301.18±32.28),(375.36±36.75)pg·m L^(-1);COX-2分别为(325.36±31.57),(515.36±38.64)ng·L^(-1);MMP-9分别为(175.47±20.11),(246.67±25.73)mg·L^(-1);MMP-2分别为(214.87±22.54),(249.46±27.78)mg·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有白细胞减少、胃肠道反应、肝功能异常、神经毒性、高血压,对照组的药物不良反应主要有白细胞减少、胃肠道反应、肝功能异常。试验组和对照组的药物不良反应发生率分别为27.91%(24例/86例)和20.93%(18例/86例),差异无统计学意义(P>0.05)。结论贝伐珠单抗治疗晚期结肠癌的临床疗效确切,安全性高。

Objective To investigate the clinical efficacy and safety of bevacizumab injection on advanced colon cancer. Methods A total of172 patients with advanced colon cancer were randomly assign to either a control group（ n = 86 cases） or a treatment group（ n = 86 cases）. The control group was treated with leucovorin calcium,5 fluorouracil and oxaliplatin（ FOLFOX） chemotherapy regimen,while the treatment group received intravenous injection of bevacizumab at dose of 5 mg · kg^-1 before FOLFOX chemotherapy regimen. Both groups were treated for 5 cycles（ 2 weeks a cycle）. The clinical efficacy, carcinoembryonic antigen（ CEA）, carbohydrate antigen 199（ CA199）, carbohydrate antigen242（ CA242）,carbohydrate antigen125（ CA125）,vascular endothelial growth factor（ VEGF）,cyclooxygenase-2（ COX-2）,matrixmetalloproteinase-9（ MMP-9）,matrix metalloproteinase-2（ MMP-2） and incidence of adverse drug reactions were compared. Results After treatment,the total effective rates of the treatment group and the control group were 56. 98%（ 49 cases/86 cases） and 36. 05%（ 31 cases/86 cases）,the difference were statistically significant（ P〈0. 05）.There were significant differences between the treatment group and the control group in the serum CEA[（ 42. 16 ± 5. 44） ng· m L^-1 vs（ 53. 34 ± 6. 64） ng· m L^-1],CA199 [（ 59. 96 ± 8. 11） U· m L^-1 vs（ 68. 57 ± 8. 75）U· m L^-1],CA242 [（ 31. 18 ± 3. 84） U· m L^-1 vs（ 49. 63 ± 6. 54） U · m L^-1],CA125 [（ 25. 46 ± 3. 08）U· m L^-1 vs（ 36. 54 ± 4. 34） U· m L^-1,VEGF [（ 301. 18 ± 32. 28） pg· m L^-1 vs（ 375. 36 ± 36. 75） pg · m L^-1],COX-2 [（ 325. 36 ± 31. 57） ng· L^-1 vs（ 515. 36 ± 38. 64） ng · L^-1],MMP-9 [（ 175. 47 ± 20. 11） mg· L^-1 vs（ 246. 67 ± 25. 73） mg · L^-1],and MMP-2 [（ 214. 87 ± 22. 54） mg · L^-1 vs（ 249. 46 ± 27. 78） mg · L^-1]（ P〈0. 05）. The adverse drug reactions of the treatment group were leukocyte reduction,gastrointestinal reaction,abnormal liver function,neurotoxicity and hypertension,while those of the control group were leukocyte reduction,gastrointestinal reaction and abnormal liver function. The incidences of adverse drug reactions of the treatment group and the control group were 27. 91%（ 24 cases/86 cases） and 20. 93%（ 18 cases/86 cases）,and there was no significant difference between the two groups（ P〉0. 05）. Conclusion Bevacizumab exerted effective and high safety profile in the treatment of advanced colon cancer.