抗瘤增效方联合化疗对中晚期非小细胞肺癌患者肿瘤标志物影响的随机对照研究  

Effects of chemotherapy combined with Chinese herbal medicine Kangliu Zengxiao Decoction on tumor markers of patients with advanced non-small-cell lung cancer:a randomized,controlled trial

作　　者：严桂英[1] 徐振晔[2] 邓海滨[2] 万智勇[1] 张磊[1] 朱娇玉[3] 

机构地区：[1]上海市浦东新区浦南医院肿瘤科,上海200125 [2]上海中医药大学龙华医院肿瘤科,上海200032 [3]上海市中西医结合医院急诊科,上海200082

出　　处：《中西医结合学报》2011年第5期525-530,共6页Journal of Chinese Integrative Medicine

基　　金：上海市卫生局科研课题(No.2010224)

摘　　要：背景:某些肿瘤标志物在临床上广泛应用并成为判断肺癌疾病进展情况的一个重要观察指标,中医药与化疗联合治疗肺癌能否改善肿瘤标志物水平也成为临床医生逐渐关注的一个问题。目的:探讨抗瘤增效方对中晚期非小细胞肺癌(non-small-cell lung cancer,NSCLC)化疗患者血清糖类抗原50(carbohydrate antigen50,CA50)、细胞角蛋白19片段(cytokeratin 19 fragment,CYFRA21-1)、癌胚抗原(carcinoembryonic antigen,CEA)的影响及其与临床疗效的关系。设计、场所、对象和干预措施:所有患者均为2008年10月～2009年12月在上海中医药大学附属龙华医院肿瘤科及上海市浦东新区浦南医院肿瘤科治疗的住院患者,采用前瞻性、随机、对照的临床研究方法,将74例中晚期NSCLC患者分为治疗组(抗瘤增效方+化疗)、对照组(单纯化疗)各37例,均采用NP方案(诺维本+顺铂)化疗2个疗程,治疗组在化疗同时口服中药抗瘤增效方。主要结局指标:检测治疗前后NSCLC患者CA50、CYFRA21-1、CEA水平并观察疗效、中医症状、生活状态评分(Karnofsky评分),探讨疗效与CA50、CYFRA21-1、CEA水平变化的关系。结果:两组患者均未达到完全缓解。治疗组近期稳定率(部分缓解+稳定)为89.20%(33/37),优于对照组的70.30%(26/37)(P<0.05)。治疗组治疗后血清CA50、CYFRA21-1、CEA水平均较对照组明显下降(P<0.05),稳定患者治疗后血清CA50、CYFRA21-1、CEA水平也下降,对照组变化不明显,甚至有升高趋势。此外,治疗组治疗后中医证候改善率为51%(19/37),优于对照组的11%(4/37)(P<0.05)。而生活质量的变化,治疗组总有效率为91.89%(34/37),优于对照组的56.76%(21/37)(P<0.01)。结论:中药抗瘤增效方结合化疗治疗中晚期NSCLC可以获得较好的局部病灶稳定缓解,降低肿瘤标志物水平,同时明显改善伴随症状,提高生活质量。Tumor markers are widely used in clinical practice and have become important indicators in assessing cancer progress. There is increasing concern that chemotherapy combined with traditional Chinese medicine has effects in decreasing the level of tumor markers.Objective：To investigate the effects of chemotherapy combined with Kangliu Zengxiao Decoction （KLZX）,a compound Chinese herbal drug,on tumor markers carbohydrate antigen 50 （CA 50）,cytokeratin 19 fragment （CYFRA21-1） and carcinoembryonic antigen （CEA） in patients with advanced non-small-cell lung cancer （NSCLC） and to explore the relationships between clinical efficacy and tumor markers.Design,setting,participants and interventions：Patients were included from Punan Hospital of Shanghai Pudong New District and Longhua Hospital between October 2008 and December 2009. Seventy-four subjects with advanced NSCLC were randomly assigned into treatment group （n=37） and control group （n=37）. Patients in the control group were treated with chemotherapy alone while patients in the treatment group were treated with chemotherapy combined with KLZX. Chemotherapy of NP （vinorelbine ＋ cisplatin） was given for two cycles and patients in the treatment group were administered with KLZX during chemotherapy.Main outcome measures：Levels of CA50,CYFRA21-1 and CEA before and after treatment were evaluated and the relationship between changes in levels of tumor makers and tumor size,clinical symptoms and living condition score （Karnofsky score） was analyzed.Results：No patients achieved a complete remission. The disease control rates （complete remission （CR）＋partial remission （PR）＋no change （NC）） were 89.20% （33/37） and 70.30% （26/37） in the treatment and control group respectively （P0.05）. The levels of CA50,CYFRA21-1 and CEA were clearly decreased in the treatment group after treatment （P0.05） while also decreased in the patients without progression of disease. There were no obvious changes of CA50,CYF

关 键 词：非小细胞肺癌 抗肿瘤联合化疗方案 中草药 肿瘤标志 生物学 抗原 肿瘤相关 碳水化合物 随机对照试验 前瞻性研究 

分 类 号：R734.2[医药卫生—肿瘤]