荣筋方联合谷胱甘肽防治结直肠癌奥沙利铂累积性外周神经毒性随机平行对照研究

The Random Parallel Control Study of Protective Effect of Rongjin Fang on Oxaliplatin-induced Chronic Neurotoxicity in treating colorectal cancer

[目的]观察荣筋方联合谷胱甘肽防治结直肠癌奥沙利铂累积性外周神经毒性疗效。[方法]使用随机平行对照方法,将60例住院患者按随机数字表法分为两组,每组30例。治疗期间避免饮食冷物、呼吸较冷空气、接触冷物体及金属等,防止诱发或加重神经毒性症状。均采用FOLFOX4化疗方案,化疗6周期(奥沙利铂85mg/(m2·d),静滴2h,d1;亚叶酸钙200mg/(m2·d),静滴2h,d 1、2;氟尿嘧啶400mg/(m2·d),静推d 1、2,600mg/(m2·d),静滴持续22h,d 1、2。每2周重复1次,2次为1周期)。对照组谷胱甘肽1500mg/m2,静滴,1次/d。治疗组荣筋方(炙黄芪30g,桂枝、白芍各15g,鸡血藤20g,白术、川芎、当归各15g,细辛3g,醋延胡索10g,全蝎3g,醋青皮、木瓜、怀牛膝各15g,甘草3g),水煎200mL,早晚口服,1剂/d,每次化疗结束后2天开始,连续5剂。若消化道反应明显,延至反应减轻再开始服用;谷胱甘肽使用同对照组。连续治疗24周为1疗程。观测慢性神经毒性分级、不良反应。治疗1疗程,判定疗效。[结果]治疗组Ⅰ级10例,Ⅱ级15例,Ⅲ级5例。对照组Ⅰ级3例,Ⅱ级16例,Ⅲ级11例。奥沙利铂化疗后神经毒性治疗组低于对照组(P<0.05)。[结论]荣筋方联合谷胱甘肽防治结直肠癌奥沙利铂累积性外周神经毒性,疗效满意。

[ Objective ] To observe the efficacy of Rongjin Fang （ RJF ）combined with reduced glutathione （ GSH ） for preventing the chronic neurotoxicity induced by oxaliplatin in the treatment of colorectal cancer. [ Methods ] Using random parallel control method, 60 hospitalized patients were divided randomly into two groups according to random number table method, 30 in each droup.During the treatment eating cold things, breathing the cold air , exposure to cold and metal objects, etc were avoided, to prevent or exacerbate neurotoxicity induced symptoms.The patients in both groups were treated with FOLFOX4 chemotherapy regimenfor 6 cycles （ oxaliplatin 85mg/ （ m2 . d ）, intravenous drip 2h, dl ;folic acid and calcium 200mg/ （ m2 . d ）, intravenous drip 2h, dl, 2 ; fluorouraeil 400mg/ （ m2. d ）, intravenous injection dl, 2, 600mg/ （ m2 . d ）, continuous static drop 22h, dl, 2, repeated 1 time every 2 weeks, 2 times to 1 cycle ） .The patients in the control group received infusion Of 1500 mg/m2 of GSH intravenously during chemotherapy with oxaliplatin, 1 time/d, while the patients in the treatment group additionally received RJF （ The roasted root of remembranous milk vetch 30g, Cassia twig 15g, Radix paeoniae alba 15g, Caulis spatholobi 20g, Large-headed atractylodes 15g, Rhizoma ligustiei wallichii 15g, angelica 15g, asarum 3g, Vinegar rhizoma eorydalis 10g, scorpion 3g, Vinegar green husk 15g, papaya 15g, Radix aehyranthis bidentatae 15g, licorice 3g ） 2 days after chemotherapy with oxaliplatin, boiling down to 200ml of decoction, once daily for 5 days. If the digestive tract response is obvious, RJF＇was postponed until the response was reduced. The application of glutathione was the same as the control group . 24 weeks continuous treatment was as 1 treatment course, then to observe the severity of oxaliplatin--induced chronic neurotoxicity and the adverse respones, then to judge the curative effects after 1 treatment course. [Results ]In the treatment group Ⅰ level 10 cases, Ⅱ level 15 cases, Ⅲ level 5 cases. In the control groupⅠ level 3 cases,Ⅱ level 16 cases, Ⅲ level 11 cases. The severity of oxaliplatin--induced chronic neurotoxieity in the treatment group is lower than the control group （ P〈0.05 ） . [ Conclusion ] RJF combined with GSH is effective in preventing the chronic neurotoxicity induced by oxaliplatin in the treatment of colorectal cancer.