Effectiveness and Safety of Kanglaite Combined with Gemcitabine for Advanced Non-small Cell Lung Cancer: A Meta-Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 ZENGLin-miao ¹ , ZHENGHai-lun ¹ , PENGJin-yun ¹ , XIAOJian-hong ¹ , PANWei-piao ² , WUDong-mei ¹

1. Mindong Hospital Affiliated to Fujian Medical University, Fu'an 355000, China;
2. Fujian Medical University, Fuzhou 350108, China;

Corresponding author：

Keywords：

Kanglaite; Gemcitabine; Non-small-cell lung cancer; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20140138

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Objective To systematically review the effectiveness and safety of Kanglaite combined with gemcitabine in treating patients with advanced non-small cell lung cancer (NSCLC). Methods The randomized controlled trials (RCTs) about Kanglaite ombined with gemcitabine treating advanced NSCLC was retrieved in PubMed, EMbase, The Cochrane Library (Issue 9, 2013), CBM, CNKI, VIP, and WanFang Data from the dates of their establishment to September 2013. Literature screening according to the inclusion and exclusion criteria, data extraction and methodological quality assessment were completed by two reviewers independently. Meta-analysis was then conducted using RevMan 5.2 software. Results A total of seven RCTs involving 506 patients were finally included. The results of meta-analysis indicated that:a) Kanglaite injection combined with gemcitabine chemotherapy increased short-term effectiveness (OR=1.85, 95%CI 1.29 to 2.65, P=0.000 8), patients' quality of life (OR=3.02, 95%CI 1.90 to 4.78, P < 0.000 1), and immune function (MD=0.64, 95%CI 0.31 to 0.97, P=0.000 1); and reduced the incidences of leukopenia decrease (OR=0.30, 95%CI 0.19 to 0.47, P < 0.000 01), nausea and vomiting (OR=0.49, 95%CI 0.34 to 0.73, P=0.000 3), bone marrow suppression (OR=0.27, 95%CI 0.16 to 0.45, P < 0.000 01), and liver and renal impairments (OR=0.43, 95%CI 0.28 to 0.68, P=0.000 3), all with significant differences. b) Both groups were alike in reducing thrombocytopenia (OR=0.67, 95%CI 0.40 to 1.14, P=0.14) without significant differences. Conclusion Applying Kanglaite injection combined with gemcitabine in treating patients with advanced NSCLC could increase short-term effectiveness, improve patients' quality of life and immune function; and reduce the incidences of adverse reaction caused by chemotherapy. However, it has no obvious advantage in reducing thrombocytopenia. Due to the limited quantity and quality of the included studies, more larger sample size, multicenter, high quality RCT are needed to verify the above conclusion.

Citation： ZENGLin-miao, ZHENGHai-lun, PENGJin-yun, XIAOJian-hong, PANWei-piao, WUDong-mei. Effectiveness and Safety of Kanglaite Combined with Gemcitabine for Advanced Non-small Cell Lung Cancer: A Meta-Analysis. Chinese Journal of Evidence-Based Medicine, 2014, 14(7): 827-834. doi: 10.7507/1672-2531.20140138 Copy

1.	王道英, 李征, 杨克虎, 等.放疗联合热疗治疗局部晚期非小细胞肺癌疗效与安全性的系统评价.中国循证医学杂志, 2012, 12(10):1203-1208.
2.	过为, 李健华, 王峰, 等.奈达铂联合化疗治疗晚期非小细胞肺癌疗效和安全性的Meta分析.中国循证医学杂志, 2013, 13(1):47-54.
3.	徐少华, 王伟, 柳相珍, 等.国产吉西他滨联合卡铂治疗老年晚期非小细胞肺癌的临床观察.中国肿瘤临床, 2006, 33(1):35-37.
4.	Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin, 2009, 59(4):225-249.
5.	钱桂生, 余时沧.肺癌流行病学最新资料与启示.中华结核和呼吸杂志, 2012, 35(2):86-89.
6.	王廷贤.泽菲治疗非小细胞肺癌的临床疗效观察.中国社区医师(医学专业), 2012, 14(9):45-46.
7.	刘睿, 郭姗, 闵婕, 等.高温联合顺铂及多西他赛对肺腺癌A549细胞体外作用的研究.现代肿瘤医学, 2010, 18(5):857-861.
8.	朱小生, 胡晓文, 操乐杰, 等.化疗联合恩度治疗非小细胞肺癌临床观察.临床肺科杂志, 2009, 14(2):194-195.
9.	Zhan YP, Huang XE, Cao J, et al. Clinical safety and efficacy of Kanglaite^® (Coix Seed Oil) injection combined with chemotherapy in treating patients with gastric cancer. Asian Pac J Cancer Prev, 2012, 13(10):5319-5321.
10.	Higgins JP, Green S. Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0).[cited 2012 Jan 5]. Available at:http://www.cochrane-handbook.org.
11.	车曙华, 罗超, 刘瑛, 等.康莱特注射液联合GP方案治疗晚期非小细胞肺癌的临床观察.肿瘤药学, 2012, 2(4):286-289.
12.	管燕, 郭其森, 宋洁, 等.康莱特联合GP方案治疗老年晚期非小细胞肺癌临床观察.中国老年保健医学, 2010, 8(1):5-7.
13.	刘军强, 尚立群, 李学昌, 等.康莱特联合GP方案治疗晚期非小细胞肺癌的疗效观察.现代肿瘤医学, 2011, 19(10):1974-1976.
14.	黄振步, 朱春雅, 吴式琇.康莱特联合化疗治疗晚期非小细胞肺癌的疗效观察.中国药房, 2010, 21(20):1860-1861.
15.	练祖平, 陆运鑫, 侯恩存, 等.康莱特联合化疗治疗中晚期非小细胞肺癌.中国肺癌杂志, 2006, 9(1):74-77.
16.	佟倩.康莱特联合吉西他滨治疗老年晚期非小细胞肺癌的临床研究.中国医药指南, 2012, 10(8):31-33.
17.	邓曙光, 文石兵, 陈安丽, 等.康莱特联合健择、卡铂治疗中晚期非小细胞肺癌的临床观察.浙江实用医学, 2006, 11(4):234-236.
18.	张特, 刘大海, 王斌, 等.恩度联合吉西他滨和顺铂二线方案治疗晚期非小细胞肺癌的近期疗效及安全性.中国全科医学, 2009, 12(11):969-971.
19.	Rosell R, Cobo M, Isla D, et al. Pharnkacogenomics and gemcitabine. Ann Oncol, 2006, 17 (Suppl 5):v13-16.
20.	高庆, 王福元, 余宏, 等.吉西他滨联合卡铂或紫杉醇与紫杉醇联合卡铂治疗晚期非小细胞肺癌的随机对照研究.中华肿瘤杂志, 2011, 33(11):874-876.
21.	Cho KH, Song YB, Choi IS, et al, A phase II study of single agent gemcitabine as a second-1ine treatment in advanced non-small cell lung cancer. JPN J Clin Oncol, 2006, 36:50-54.
22.	Genestreti G, Giovannini N, Frizziero M, et al. Carboplatin and gemcitabine in first-1ine treatment of elderly patients with advanced non-small cell 1ung cancer:data from a retrospective study. J Chemother, 201l, 23:232-237.
23.	施勋, 余新民, 张沂平, 等.培美曲塞或吉西他滨联合卡铂一线治疗老年晚期非小细胞肺癌的疗效和安全性.中华肿瘤杂志, 2013, 35(3):221-224.
24.	赵文英, 陈冬云.伊立替康联合顺铂与吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的随机对照研究.中华肿瘤杂志, 2012, 34(10):775-779.
25.	陈建强.香菇多糖联合化疗对非小细胞肺癌的疗效观察.苏州大学学报(医学版), 2008, 28(2):306-307.
26.	张明, 谢可, 陈淋, 等.康莱特注射液改善晚期肿瘤患者食欲和生存质量的临床观察.肿瘤防治杂志, 2003, 10(12):1298-1298, 1304.
27.	包三裕, 张洪.康莱特注射液作用机理及临床应用研究.长春中医药大学学报, 2011, 27(1):139-140.
28.	李大鹏.康莱特注射液抗癌作用机理研究进展.中药新药与临床药理, 2001, 12(2):122-124.
29.	吴岩, 潘沛, 王彧杰, 等.康莱特注射液对Lewis肺癌小鼠免疫功能的影响.上海交通大学学报(医学版), 2009, 29(12):1455-1458.
30.	谭煌英, 李园, 于莉莉, 等.康莱特对大鼠的镇痛作用及其对促炎细胞因子的影响.中国中西医结合外科杂志, 2007, 13(2):152-155.

1. 王道英, 李征, 杨克虎, 等.放疗联合热疗治疗局部晚期非小细胞肺癌疗效与安全性的系统评价.中国循证医学杂志, 2012, 12(10):1203-1208.
2. 过为, 李健华, 王峰, 等.奈达铂联合化疗治疗晚期非小细胞肺癌疗效和安全性的Meta分析.中国循证医学杂志, 2013, 13(1):47-54.
3. 徐少华, 王伟, 柳相珍, 等.国产吉西他滨联合卡铂治疗老年晚期非小细胞肺癌的临床观察.中国肿瘤临床, 2006, 33(1):35-37.
4. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin, 2009, 59(4):225-249.
5. 钱桂生, 余时沧.肺癌流行病学最新资料与启示.中华结核和呼吸杂志, 2012, 35(2):86-89.
6. 王廷贤.泽菲治疗非小细胞肺癌的临床疗效观察.中国社区医师(医学专业), 2012, 14(9):45-46.
7. 刘睿, 郭姗, 闵婕, 等.高温联合顺铂及多西他赛对肺腺癌A549细胞体外作用的研究.现代肿瘤医学, 2010, 18(5):857-861.
8. 朱小生, 胡晓文, 操乐杰, 等.化疗联合恩度治疗非小细胞肺癌临床观察.临床肺科杂志, 2009, 14(2):194-195.
9. Zhan YP, Huang XE, Cao J, et al. Clinical safety and efficacy of Kanglaite^® (Coix Seed Oil) injection combined with chemotherapy in treating patients with gastric cancer. Asian Pac J Cancer Prev, 2012, 13(10):5319-5321.
10. Higgins JP, Green S. Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0).[cited 2012 Jan 5]. Available at:http://www.cochrane-handbook.org.
11. 车曙华, 罗超, 刘瑛, 等.康莱特注射液联合GP方案治疗晚期非小细胞肺癌的临床观察.肿瘤药学, 2012, 2(4):286-289.
12. 管燕, 郭其森, 宋洁, 等.康莱特联合GP方案治疗老年晚期非小细胞肺癌临床观察.中国老年保健医学, 2010, 8(1):5-7.
13. 刘军强, 尚立群, 李学昌, 等.康莱特联合GP方案治疗晚期非小细胞肺癌的疗效观察.现代肿瘤医学, 2011, 19(10):1974-1976.
14. 黄振步, 朱春雅, 吴式琇.康莱特联合化疗治疗晚期非小细胞肺癌的疗效观察.中国药房, 2010, 21(20):1860-1861.
15. 练祖平, 陆运鑫, 侯恩存, 等.康莱特联合化疗治疗中晚期非小细胞肺癌.中国肺癌杂志, 2006, 9(1):74-77.
16. 佟倩.康莱特联合吉西他滨治疗老年晚期非小细胞肺癌的临床研究.中国医药指南, 2012, 10(8):31-33.
17. 邓曙光, 文石兵, 陈安丽, 等.康莱特联合健择、卡铂治疗中晚期非小细胞肺癌的临床观察.浙江实用医学, 2006, 11(4):234-236.
18. 张特, 刘大海, 王斌, 等.恩度联合吉西他滨和顺铂二线方案治疗晚期非小细胞肺癌的近期疗效及安全性.中国全科医学, 2009, 12(11):969-971.
19. Rosell R, Cobo M, Isla D, et al. Pharnkacogenomics and gemcitabine. Ann Oncol, 2006, 17 (Suppl 5):v13-16.
20. 高庆, 王福元, 余宏, 等.吉西他滨联合卡铂或紫杉醇与紫杉醇联合卡铂治疗晚期非小细胞肺癌的随机对照研究.中华肿瘤杂志, 2011, 33(11):874-876.
21. Cho KH, Song YB, Choi IS, et al, A phase II study of single agent gemcitabine as a second-1ine treatment in advanced non-small cell lung cancer. JPN J Clin Oncol, 2006, 36:50-54.
22. Genestreti G, Giovannini N, Frizziero M, et al. Carboplatin and gemcitabine in first-1ine treatment of elderly patients with advanced non-small cell 1ung cancer:data from a retrospective study. J Chemother, 201l, 23:232-237.
23. 施勋, 余新民, 张沂平, 等.培美曲塞或吉西他滨联合卡铂一线治疗老年晚期非小细胞肺癌的疗效和安全性.中华肿瘤杂志, 2013, 35(3):221-224.
24. 赵文英, 陈冬云.伊立替康联合顺铂与吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的随机对照研究.中华肿瘤杂志, 2012, 34(10):775-779.
25. 陈建强.香菇多糖联合化疗对非小细胞肺癌的疗效观察.苏州大学学报(医学版), 2008, 28(2):306-307.
26. 张明, 谢可, 陈淋, 等.康莱特注射液改善晚期肿瘤患者食欲和生存质量的临床观察.肿瘤防治杂志, 2003, 10(12):1298-1298, 1304.
27. 包三裕, 张洪.康莱特注射液作用机理及临床应用研究.长春中医药大学学报, 2011, 27(1):139-140.
28. 李大鹏.康莱特注射液抗癌作用机理研究进展.中药新药与临床药理, 2001, 12(2):122-124.
29. 吴岩, 潘沛, 王彧杰, 等.康莱特注射液对Lewis肺癌小鼠免疫功能的影响.上海交通大学学报(医学版), 2009, 29(12):1455-1458.
30. 谭煌英, 李园, 于莉莉, 等.康莱特对大鼠的镇痛作用及其对促炎细胞因子的影响.中国中西医结合外科杂志, 2007, 13(2):152-155.

Chinese Journal of Evidence-Based Medicine

Effectiveness and Safety of Kanglaite Combined with Gemcitabine for Advanced Non-small Cell Lung Cancer: A Meta-Analysis

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