扶正抗癌方联合GP方案治疗胆囊癌

Fuzheng Kang′ai Prescription Combined with GP Regimen in Treatment of Gallbladder Carcinoma

目的:观察扶正抗癌方联合GP方案治疗胆囊癌的临床疗效。方法:60例胆囊癌患者根据治疗方法随机分为对照组、治疗组各30例。对照组给予GP方案治疗,治疗组在对照组治疗基础上给予扶正抗癌方。比较两组患者有效率、客观缓解率、无疾病进展生存期、不良反应及肿瘤标志物CEA、CA199、CA125及血管内皮生长因子(vascular endothelial growth factor,VEGF)水平。结果:治疗组有效率为83.3%,对照组为60.0%,两组比较,差异有统计学意义(χ~2=4.022,P=0.045)。治疗组、对照组的无疾病进展生存期分别为9.2个月[95%CI(8.002,10.489)个月]和7.6个月[95%CI(6.698,8.525)个月],两组比较,差异有统计学意义(χ~2=4.763,P=0.030)。治疗组可显著改善化疗过程中的骨髓抑制(白细胞、中性粒细胞及血小板),尤其对白细胞的改善显著,其发生率为23.33%vs 56.67%,两组不良反应的发生率比较,差异无统计学意义(P>0.05),治疗过程中,两组尚未出现Ⅳ度毒性反应及药物相关不良事件;治疗组可显著降低肿瘤标志物CEA、CA199、CA125及VEGF水平,差异有显著统计学意义(P<0.01)。结论:扶正抗癌方配合化疗治疗胆囊癌疗效显著,可显著延长患者的无疾病进展生存期,减轻化疗不良反应,降低肿瘤标志物水平,防止肿瘤复发转移。

Objective:To observe the clinical efficacy of Fuzheng Kang′ai Prescription combined with GP regimen in treatment of gallbladder carcinoma.Methods:Sixty patients with gallbladder carcinoma were randomly divided into control group and treatment group according to the treatment method.The control group was given GP regimen,and the treatment group was given Fuzheng Kangfang on the basis of the control group.The effective rate,objective response rate,disease-free survival(no disease progression survival),adverse reactions and tumor markers CEA,CA199,CA125 and vascular endothelial growth factor(VEGF)levels were compared between the two groups.Results:The effective rate was 83.3%in the treatment group and 60.0%in the control group.The difference was statistically significant(χ~2=4.022,P=0.045).The progression-free survival of the treatment group and the control group were 9.2 months(95%CI:8.02-10.489 months)and 7.6 months(95%CI:6.698-8.525 months),respectively.Learning significance(χ~2=4.763,P=0.030).The treatment group can significantly improve myelosuppression(white blood cells,neutrophils and platelets)during chemotherapy,especially for leukocytes,with an incidence of 23.33%vs.56.67%,but in nausea and vomiting,diarrhea and peripheral neurotoxicity.The incidence of toxic side effects was not statistically significant.During the treatment,there were no IV toxicity and drug-related adverse events in the two groups.The treatment group significantly reduced the levels of tumor markers CEA,CA199,CA125 and VEGF.The difference was statistically significant(P<0.01).Conclusion:Fuzheng Kang′ai Prescription combined with chemotherapy in treatment of gallbladder cancer has significant curative effect,which can significantly prolong the progression of disease-free survival,reduce the adverse reactions of chemotherapy,reduce the level of tumor markers,and prevent tumor recurrence and metastasis.