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作 者:杨国旺[1] 王皓[1] 韩磊[2] 初玉平[3] 周爱军[4] 张侠[5] 朱建华[6] 富琦[1] 张青[1] 韩燕[1] 王笑民[1]
机构地区:[1]首都医科大学附属北京中医医院 [2]首都医科大学大兴区医院 [3]首都医科大学附属北京朝阳医院 [4]北京市昌平区医院 [5]北京军区总医院 [6]中国人民解放军总医院第一附属医院
出 处:《中医杂志》2014年第3期209-213,共5页Journal of Traditional Chinese Medicine
基 金:首都医学发展基金联合攻关课题(SF-2007-Ⅰ-08)
摘 要:目的观察基于"证候要素和应证组合"指导思想的中医辨证论治方案联合化疗治疗晚期非小细胞肺癌(NSCLC)患者的临床疗效。方法采用前瞻性随机对照临床研究,将符合研究标准的晚期(ⅢB和Ⅳ期)NSCLC患者204例随机分为治疗组104例和对照组100例,在化疗同时治疗组给予中医辨证汤剂口服,而对照组给予贞芪扶正胶囊口服,两组均21天为1个疗程,共治疗2个疗程。观察两组患者临床疗效及无进展生存期(PFS)、生存期(OS)、毒副反应。结果治疗组和对照组的肿瘤缓解率分别为36.3%和28.1%,疾病控制率分别为89.0%和76.4%,两组疾病控制率比较差异有统计学意义(P<0.05)。治疗组和对照组的中位PFS分别为21周和17周,OS分别为64周和56周,两组比较差异无统计学意义(P>0.05)。治疗组白细胞下降、血小板下降和恶心、呕吐发生情况较对照组为轻(P<0.05)。结论中医辨证论治方案能够对化疗晚期NSCLC患者起到增效减毒作用,在提高肺癌远期生存方面具有一定优势。Objective To obsmwe the therapeutic effect of TCM differential treatment combined with dlemotherapy for advanced nun-small cell lung cancer (NSCLC). Methods A prospective randomized controlled clinical study was conducted. Totally 204 eases of advanced NSCI,C were randomized into the treatment group and control group, with 104 and 100 in each. Both groups were given chemothe,'apy. The treatment group was added with TCM deco~'- tions according to pattern differentiation. The control group was added with Zheuqi Fuzheng Capsules [ capsules o[' Nvzhenzi (Fructus Ligustri Lucidi 7~ta~,~:') and Huangqi (Radix AstragMi ~) to st,'engthen the body resistance] Both groups were treated for 2 treatment courses (42 days). The therapeutic effect, progression-free survival ( PFS), overall survival (OS) and toxicity in both groups was observed. Results The tumor remission rate in the treatment group and control group was 36. 3% and 28. 1% respectively. The disease control rate in the treatment group and control group was 89.0% and 76.4% respectively, with a significant difference between groups ( P 〈 0.05). The median PFS in the treatment group and control group was 21 weeks and 17 weeks respectively, and the median OS was 64 weeks and 56 weeks respectively, with no significant difference between groups (P 〉0.05). Comparing the control group, the incidence of leukopenia, thrombocytopenia, nausea and vomiting in the treatment group was significantly decreased (P 〈0. 05). Conclusion TCM differential treatment has a synergistic and attenuated effect for advanced NSCLC patients undergoing chemotherapy with an improvement of long-term survival.
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