参附注射液配合密集化疗治疗进展期胃癌临床研究

【作者】 李天传； 杨建伟；

【机构】 福建省肿瘤医院内科；

【摘要】 目的:剂量密集化疗作为一种新的化疗方法在胃癌中广泛应用。然而,剂量密集化疗在提高进展期胃癌疗效的同时,降低了进展期胃癌患者的生存质量。本研究以参附注射液配合密集化疗治疗30例进展期胃癌,并与30例单纯密集化疗组(对照组)作比较,探讨参附注射液配合密集化疗治疗进展期胃癌对提高生存质量的影响。方法:应用参附注射液配合密集化疗治疗进展期胃癌。治疗组(剂量密集化疗+参附注射液),化疗方案采用CF200mg／m2静滴连用2天(D1,2),5一FU 1．0g／m2 持续静脉滴注46小时(D1,2),Taxol 135 mg／m2静滴1天(D1)。每14天为一个周期,两周期为一个疗程。治疗组在常规每个周期化疗的同时每天静脉滴注5％GS注射液250ml+参附注射液(主要由红参、附子组成,深圳三九雅安制药有限公司生产)50ml,第1-7天。对照组单用剂量密集化疗治疗。化疗二个周期后评价其近期疗效、生存质量、临床症状、体重、免疫指标变化。结果:2004, 2—2005,12入选60例合格病例,分为治疗组与对照组,对照组1例因严重的化疗反应中断治疗、 1例治疗1周期就进展出组。58例接受了至少两个周期治疗,58例可评价疗效。在近期疗效方面: 治疗组有效率63．33％,对照组有效率为60．71％,两组无显著差异(P>0．05)。在临床症状总改善率方面:治疗组优于对照组(83．33％与57．14％,P<0．05)。在生存质量评分方面:治疗组治疗后比治疗前明显提高(48．08±7．32vs43．76±8．32,P<0．05),而对照组治疗后比治疗前降低 (39．02±7．63vs43．98±8．18,P<0．05)。体重变化:治疗组治疗后体重减轻率23．33％,对照组体重减轻率46．43％。治疗组在防止体重减轻方面有一定的优势,但从统计学上作两组比较,差异无统计学意义(P>0．05)。在免疫功能变化方面:治疗组治疗后与治疗前比较T淋巴细胞亚群无叫显差异(P>0．05)．而对照组治疗后与治疗前比较CD3,CD4,CD4／CD8明显降低(P<0．05),CD8明显升高 (P<0．05)．两组治疗后比较,治疗组治疗后CD3,CD4／CD8明显升高(P<0．05),CD4虽无明显变化 (P>0．05),但其均数值也有改善,CD8降低(P<0．05)．说明参附注射液具有防止进展期胃癌密集化疗后细胞免疫功能下降的作用。在安全性方面:参附注射液治疗病人中有1例出现烦躁不安,1例出现皮疹等不良反应,予对症处理后均缓解,接受参附注射液治疗的患者心、肝、肾功能未见异常。临床使用较安全。结论:参附注射液配合密集化疗可以改善进展期胃癌的临床症状、提高生存质量、防止免疫功能下降。另外,参附注射液无明显毒副作用,临床用药较安全。是配合密集化疗治疗进展期胃癌较理想药物。更多还原

【Abstract】 (OBJECT) The chemotherapy of dose-dense have been extensive applied in gastric cancer as a new chemotherapy method.However, The chemotherapy of dose-dense decrease the quality of life.while elevate therapeutic effect .This prospective controlled study was to compare the efficacy of quality of life of dose-dense chemotherapy plus ShenFu injection and dose-dense chemotherapy. (METHOD) Sixty patients with advanced gastric cancer were divided into treating group and control group. Each group 30 patients, to the treating group ,in the same time of applying chemotherapy,50ml of ShenFu injection was given intravenously by dissolving in 250ml of glucose injection per day for 7 successive days,while to the control group,only chemotherapy was given, chemotherapy regimen was:CF200mg/m2 ivgtt (D1, 2) ,5-FU 1.0g/m2 civ for46h,Taxol 135 mg/m2 ivgtt (D1) ,every 2 weeks for 1 cycle ,and 2 cycle for 1 course of treatment .the local control rate> quality of life, weight, clinical symptomwere evaluated. (RESULT) A total of 60 patients were enrolled from February,2004 to december,2005.of 60 patients , 2 patients exit treatment for severity toxicities in control group.58 patients received 2 cycles of chemotherapy.treating outcomes of 58 patients were evaluable.The local control rate and extenuation rate of weight was similar among two group (63.33%vs60.71%;23.33%vs46.43%,P>0.05). The improving rate of clinical symptom was significant higher in the treating group than in the control group(83.33%vs57.14%).The total scores of quality of life was 43.76±8.32 for prior treatment and 48.08±7.32 for posttreatment in the treating group, respectively was 43.98±8.18vs39.02±7.63 in the control group,the difference was significant(P<0.05). In immunity function aspect,the numerical value of CD3、CD4、CD8、CD4/CD8 was similar among prior treatment and posttreatment in the treating group(P>0.05),But in control group, the numerical value of CD3、CD4、CD8、CD4/CD8 was significant lower in the posttreatment than in the prior treatment (P<0.05).In the side effect,l patient occur fantod and restlessness and 1 patient occur skin rash in treating group,these symptom relieve after treating it. (CONCLUSION) ShenFu injection combined with dose-dense chemotherapy may improve clinical symptom and quality of life、strength immunity function、increase weight of patient.but ShenFu injection cannot increase local control rate.It is an ideal drug that ShenFu injection combined with dose-dense chemotherapy for patients with advanced gastric cancer.更多还原