Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (5): 525-530.doi: 10.3736/jcim20110509

• Original Clinical Research • Previous Articles     Next Articles

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

Gui-ying Yan1, Zhen-ye Xu2(),Hai-bin Deng2, Zhi-yong Wan1, Lei Zhang1, Jiao-yu Zhu3   

  1. 1. Department of Oncology, Punan Hospital of Pudong New District, Shanghai 200125, China
    2. Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    3. Department of Emergency, Shanghai TCM-integrated Hospital, Shanghai 200082, China
  • Received:2010-12-14 Accepted:2011-02-15 Online:2011-05-20 Published:2011-05-15
  • Contact: Xu Zhen-ye

Background: 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 (P<0.05). The levels of CA50, CYFRA21-1 and CEA were clearly decreased in the treatment group after treatment (P<0.05) while also decreased in the patients without progression of disease. There were no obvious changes of CA50, CYFRA21-1 and CEA in the control group, and there was even a trend of increase. Furthermore, the improvement rates of clinical syndrome were 51% (19/37) vs 11% (4/37) (P<0.05) in the treatment group and control group respectively. The total response rates of quality of life were 91.89% (34/37) vs 56.76% (21/37) (P<0.01) in the treatment and control group respectively.
Conclusion: Combined chemotherapy with KLZX in treating advanced NSCLC can acquire better stabilizing tumor foci, decrease levels of tumor markers and improve the clinical symptoms and Karnofsky score.

Key words: carcinoma,non-small cell lung, antineoplastic combined chemotherapy protocols, drugs,Chinese herbal, tumor markers,biological, antigen,tumor-related,carbohydrate, randomized controlled trial, prospective study


Figure 1

Flow diagram of this randomized trial"





[1] Li CH . Strengthen the establishment and evaluation of tumor makers[J]. Zhonghua Jian Yan Yi Xue Za Zhi, 2000,23(1):6-8
doi: 10.3760/j:issn:1009-9158.2000.01.002
李春海 . 加强肿瘤生物学标志的研究和评价[J]. 中华检验医学杂志, 2000,23(1):6-8
doi: 10.3760/j:issn:1009-9158.2000.01.002
[2] Chen W, Sun YL, Xi Y . Correlation between serum tumor marker level and stage, therapeutic response and survival in patients with lung cancer[J]. Biao Ji Mian Yi Fen Xi Yu Lin Chuang, 2008,15(4):209-211, 221
doi: 10.3969/j.issn.1006-1703.2008.04.006
陈武, 孙艳丽, 席妍 . 肿瘤标志物水平与肺癌分期、近期疗效及生存时间的相关性的临床观察[J]. 标记免疫分析与临床, 2008,15(4):209-211, 221
doi: 10.3969/j.issn.1006-1703.2008.04.006
[3] Le Cesne A, Arriagada R, Grunenwald D, Baldeyrou P, Girard P, Bretel JJ, Le Chevalier T . New therapeutic strategies and current research in inoperable locally advanced non-small-cell lung cancers(stage ⅢB)[J]. Bull Cancer, 1997,84(4):413-419
[4] Xu ZY, Yang YF. Integrated traditional Chinese and Western medicine in lung cancer[M]. Beijing: People's Medical Publishing House,2002:451- 456, 815-816
徐振晔, 杨宇飞 . 肺癌中西医综合治疗[M]. 北京: 人民卫生出版社,2002:451- 456, 815-816
[5] Zheng XY. Guidelines for clinical research on Chinese herbal medicines(trail implementation)[M]. Beijing: China Medical Science Press, 2002: 216-221
郑筱萸 . 中药新药临床研究指导原则(试行)[M]. 北京: 中国医药科技出版社, 2002: 216-221
[6] Zha RJ, He CQ, Zeng DW, Huang XM. Diagnosis and treatment of lung cancer in modern times [M]. Beijing: People's Military Medical Press, 1999,( 2nd ed):414-417
查人俊, 何长清, 曾逖闻, 黄孝迈 . 现代肺癌诊断与治疗 [M]. 北京: 人民军医出版社, 1999,( 第2版):414-417
[7] Shi YH, Lu XL . Application of serum CA-50 in diagnosis and treatment of tumor[J]. Jiangsu Yi Yao, 1998,24(2):139
石寅皓, 陆雪龙 . 肿瘤标志物在CA-50在肿瘤诊治中的应用[J]. 江苏医药, 1998,24(2):139
[8] Xue QP, Qiu XH, Yang MN . Application of serum tumor specific growth factor, CA-50 and CA19-9 in diagnosis[J]. Nanjing Yi Ke Da Xue Xue Bao Zi Ran Ke Xue Ban, 2001,21(3):270-271
doi: 10.3969/j.issn.1007-4368.2001.03.037
薛绮萍, 仇晓华, 杨美南 . 肿瘤特异性生长因子及肿瘤标志物CA-50、CA19-9在诊断中的应用[J]. 南京医科大学学报: 自然科学版, 2001,21(3):270-271
doi: 10.3969/j.issn.1007-4368.2001.03.037
[9] Hatzakis KD, Froudarakis ME, Bouros D, Tzanakis N, Karkavitsas N, Siafakas NM . Prognostic value of serum tumor markers in patients with lung cancer[J]. Respiration, 2002,69(1):25-29
doi: 10.1159/000049366
[10] Li H, Wan ZF . Clinical value of combined determination of serum CEA and CYFRA21-1 levels for diagnosis of NSCLC[J]. Fang She Mian Yi Xue Za Zhi, 2006,19(5):432-433
doi: 10.3969/j.issn.1008-9810.2006.05.052
李红, 万自芬 . 肿瘤标志物CEA、CYFRA21-1联检在非小细胞肺癌中的诊断价值[J]. 放射免疫学杂志, 2006,19(5):432-433
doi: 10.3969/j.issn.1008-9810.2006.05.052
[11] Carpelan-Holmstrom M, Louhimo J, Stenman UH, Alfthan H, Jarvinen H, Haglund C . CEA, CA 242, CA 19-9, CA 72-4 and hCGbeta in the diagnosis of recurrent colorectal cancer[J]. Tumour Biol, 2004,25(5-6):228-234
doi: 10.1159/000081385
[12] Foa P, Fornier M, Miceli R, Seregni E, Santambrogio L, Nosotti M, Cataldo I, Sala M, Caldiera S, Bombardieri E . Tumour markers CEA, NSE, SCC, TPA and CYFRA 21.1 in resectable non-small cell lung cancer[J]. Anticancer Res, 1999,19(4C):3613-3618
pmid: 10629660
[13] Du TX, Wang ZZ, Tian R . Changes of NSE, CYFRA21-1 and CEA observed by RIA in patients with lung tumor[J]. Zhong Liu Fang Zhi Yan Jiu, 2000,27(3):172-174
doi: 10.3971/j.issn.1000-8578.1682
杜同信, 王自正, 田韧 . 肺癌患者NSE、CYFRA21-1、CEA RIA水平变化的分析研究[J]. 肿瘤防治研究, 2000,27(3):172-174
doi: 10.3971/j.issn.1000-8578.1682
[14] Gao WH, Zhao XD, Zhou CC . Application value of serum tumour markers in chemotherapy for non-small-cell lung cancer[J]. Lin Chuang Fei Ke Za Zhi, 2002,7(2):41-42
高卫红, 赵向东, 周彩存 . 肿瘤标记物在非小细胞肺癌化疗中的应用价值[J]. 临床肺科杂志, 2002,7(2):41-42
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[3] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[4] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[5] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[6] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[7] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[8] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[9] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[10] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[11] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[12] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[13] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
[14] Maria Sousa Cláudia, Coimbra Daniela, Machado Jorge, J. Greten Henry. Effects of self-administered exercises based on Tuina techniques on musculoskeletal disorders of professional orchestra musicians: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(5): 314-318.
[15] Marco Gemma, Elisa Nicelli, Luigi Gioia, Elena Moizo, Luigi Beretta, Maria Rosa Calvi. Acupuncture accelerates recovery after general anesthesia: A prospective randomized controlled trial. Journal of Integrative Medicine, 2015, 13(2): 99-104.
Full text



[1] Hong Liu , Guo-liang Zhang, Li Shen , Zhen Zeng, Bao-luo Zhou, Cheng-hai Liu, Guang Nie . Application and evaluation of a pseudotyped virus assay for screening herbs for anti-H5Nl avian influenza virus. Journal of Chinese Integrative Medicine, 2010, 8(11): 1036-1040
[2] Veena Sharma , Pracheta Janmeda , Ritu Paliwal , Shatruhan Sharma. Antihepatotoxic activity of Euphorbia neriifolia extract against N-nitrosodiethylamine-induced hepatocarcinogenesis in mice. Journal of Chinese Integrative Medicine, 2012, 10(11): 1303-1309
[3] Ji Chen, Qin Pan, Li-shuang Ye, Jia-ling Huang. English translation of cultural aspects of the titles of traditional Chinese medicine classics based on the skopos theory. Journal of Chinese Integrative Medicine, 2012, 10(11): 1316-1320
[4] Li-ke Guo, Chao-xian Zhang, Xiao-feng Guo. Acupuncture combined with Chinese herbal medicine Plantain and Senna Granule in treatment of functional constipation: A randomized, controlled trial. Journal of Chinese Integrative Medicine, 2011, 9(11): 1206-1214
[5] Mei-jun Lü, Hui-yong Zhang, Zhe Zhang, Guan-lin Yang. Measurement of health-related quality of life in coronary heart disease: A review. Journal of Chinese Integrative Medicine, 2011, 9(12): 1277-1285
[6] Se-Der Wu, Jen-Tzer Gau, Yuh-Hai Wang. Ryodoraku as a tool monitoring the effects of walking exercise. Journal of Chinese Integrative Medicine, 2011, 9(12): 1319-1325
[7] Guang Ji, Jian-gao Fan, Jian-jie Chen, Lun-gen Lu, Lian-jun Xing, Pei-yong Zheng, Hong-gang Gu, Hua-feng Wei, Sheng-fu You, Pei-ting Zhu. Effectiveness of Danning Tablet in patients with non-alcoholic fatty liver of damp-heat syndrome type: A multicenter randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(2): 128-133
[8] Hui Li, Xiao-qing Liu, Bing Zhang, Li Ni, Zhi-jian Ling. Effects of active component in Cichorii on lipid metabolism of rat with hypertriglyceridemia complicated by hyperuricemia and hyperglycemia. Journal of Chinese Integrative Medicine, 2008, 6(2): 157-162
[9] Yong-hong Li, Zong-wen Huang, Ping Xue, Jia Guo, Fu-qian He, Zheng You, Zheng-rong Wang. Effects of Chaiqin Chengqi Decoction on activation of nuclear factor-κB in pancreas of rats with acute necrotizing pancreatitis. Journal of Chinese Integrative Medicine, 2008, 6(2): 180-184
[10] Li Cai-hong, Qiu Qing-hua, Wu Xing-wei, Gong Yuan-yuan, Xie Zheng-gao, Song Yi, Gu Qing. Chinese herbal medicine Lingqi Huangban Granule protects retinal pigment epithelial cells against oxidative stress-induced injury in vitro. Journal of Chinese Integrative Medicine, 2012, 10(1): 85-90