Protective Effects of Decoction Plus Radiotherapy on Nasopharyngeal Carcinoma: A Meta-analysis of Randomized Controlled Trials_West China Medical Journal

Authors：

QIAO Bei ^1,2 , YUAN Weili ¹ , ZHANG Ying ¹ , FENG Min ³ , QIAN Ying ³ , ZOU Linling ³ ,  ZHANG Ruiming ¹

1. Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China; 2. Department of Clinical Medicine, Medical College, Tibet University, Lhasa, Tibetan 850000, P. R. China; 3. Institute of Drug Clinical Trial ? GCP Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

ZHANG Ruiming, Email: 364711073@qq.com

Keywords：

鼻咽癌; 放射治疗; 中医药; 益气养阴; 清热活血; 随机对照试验; Meta分析

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【摘要】　目的　评价中药复方（益气养阴、清热活血方Yiqi Yangyin Qingre Huoxue decoction，YYQHD）联合放射疗法治疗鼻咽癌在减毒增效方面的疗效。　方法　采用Cochrane系统评价方法，电子检索Cochrane图书馆临床对照试验资料库（Cochrane Central Register of Controlled Trials，CENTRAL）、PubMed、EMBASE、中国生物医学文献数据库（CBM）、中文科技期刊全文数据库（CNKI）和中国期刊全文数据库（VIP）以及万方数据库等数据库2010年3月前所发表的相关文献。同时互联网检索Current Controlled Trial、Clinical Trials和中国临床试验注册网。手工检索部分肿瘤类核心期刊。采用Cochrane协作网推荐的 “偏倚风险评估”工具，评估纳入研究的质量，使用RevMan 5.0.23.0软件对纳入的研究进行定量系统评价。　结果　最终纳入符合标准的中文文献9篇共795例患者。定量分析结果显示:与单纯常规放射治疗相比较，中药复方（YYQHD）联合常规放射治疗能显著提高肿瘤近期疗效、生存率，并且能显著减少放射治疗常见毒副反应的发生，从而提高放射治疗按时完成率确保放射治疗疗效、改善患者生存质量。　结论　虽现有研究尚不能得出可以将中药复方（YYQHD）作为标准治疗手段辅助放射治疗的结论，但提示益气养阴、清热活血类中药联合放射治疗治疗鼻咽癌是值得继续探索的研究方向，期待设计科学合理、高质量的多中心、大样本、双盲、随机对照临床试验以进一步验证其疗效。
【Abstract】　Objective　 To compare the efficacy of traditional Chinese medicine (TCM) plus radiotherapy (RT) with RT alone on nasopharyngeal carcinoma (NPC) by Yiqi Yangyin Qingre Huoxue decoction (YYQHD) through a meta-analysis of all available randomized controlled trials.　Methods　 Literature retrieval was conducted using the Cochrane Library, PubMed, EMBASE, CBMdisk, CNKI, VIP, and Wanfang Database electronically. Relevant journals and conference proceedings were also hand-searched until March 31, 2010. The quality of included studies was assessed according to the criteria recommended by the Cochrane handbook, and the Meta-analysis was performed for homogeneous studies using RevMan 5.0.23.0 Software.　Results　 Basing on our search criteria, we found nine trials (795 patients) which all published in Chinese. Our results showed that TCM (YYQHD) plus RT compared with RT alone, improved immediate tumor response, survival, completion rate of RT, quality of life, and alleviation of adverse effect of patients with NPC.　Conclusions　 Considering the limitations related to this Meta-analysis, it nevertheless presents credible evidence that TCM (YYQHD) plus RT is worthy of additional study. Therefore, further large-scale, muti-center, randomized, and double-blind trials are warranted.

Citation： QIAO Bei,YUAN Weili,ZHANG Ying,FENG Min,QIAN Ying,ZOU Linling,ZHANG Ruiming. Protective Effects of Decoction Plus Radiotherapy on Nasopharyngeal Carcinoma: A Meta-analysis of Randomized Controlled Trials. West China Medical Journal, 2011, 26(3): 391-398. doi: Copy

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3.	Lee AW, Foo W, Mang O, et al. Changing epidemiology of nasopharyngeal carcinoma in Hong Kong over a 20-year period (1980-99): an encouraging reduction in both incidence and mortality[J]. Int J Cancer, 2003, 103(5): 680-685.
4.	Wei WI, Sham JS. Nasopharyngeal carcinoma[J]. Lancet, 2005, 365(9476): 2041-2054.
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6.	周小军, 田道法. 鼻咽癌古文献研究[J]. 中华医史杂志, 2001, 31(4): 115-118.
7.	Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions[M]. Version5. 0. 2. [updated September 2009]. http: //www. cochrane-handbook. org/.
8.	徐伯平, 胡丕丽, 陈勇, 等. 养阴清热方防治急性放射性反应的研究[J]. 癌症, 1999, 18(4): 457-464.
9.	王炳胜, 刘秀芳, 王涛, 等. 活血益气养阴方防治急性放射损伤的研究[J]. 中国中西医结合杂志, 2000, 20(3): 180-182.
10.	刘城林, 刘健雄, 刘丽萍, 等. 养阴活血方对鼻咽癌放疗减毒增效的临床观察[J]. 中国中西医结合杂志, 2002, 22(12): 918-920.
11.	文先惠, 刘嘉, 伍伟景. 益气养阴化瘀解毒法配合放射治疗复发性鼻咽癌65例总结[J]. 中国医师杂志, 2003, 5(5): 712-714.
12.	张红. 导赤散加味配合放疗治疗鼻咽癌40例[J]. 湖南中医学院学报, 2003, 23(2): 34-35.
13.	金红, 吴湘玮. 养阴解毒法减低鼻咽癌放射反应24例疗效观察[J]. 山东中医杂志, 2005, 24(1): 17-19.
14.	张支农, 张剑, 陈红云, 等. 中西医结合治疗晚期鼻咽癌46例总结[J]. 湖南中医杂志, 2006, 22(1): 1-2.
15.	袁国荣, 卢丽琴, 钦志泉, 等. 加味清营汤对鼻咽癌放疗增效减毒的临床研究[J]. 中医药学刊, 2006, 24(4): 670-671.
16.	何福根, 陈晓钟, 章红燕. 养阴生津协定方改善鼻咽癌患者放疗毒副反应59例疗效观察[J]. 福建中医药, 2008, 39(5): 13-14.
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21.	Thomas J, Beinhorn C, Norton D, et al. Managing radiation therapy side effect with complementary medicine[J]. J Soc Integr Oncol, 2010, 8(2): 65-80.
22.	Hsiao WL, Liu L. The role of traditional Chinese herbal medicines in cancer therapy-from TCM therapy to mechanistic insights[J]. Planta Med, 2010, 76(11): 1118-1131.
23.	Li QF, Shi SL, Liu QR, et al. Anticancer effects of ginsenoside Rg1, cinnamic acid, and tanshinoneⅡA in osteosarcoma MG-63 cells: nuclear matrix downregulation and cytoplasmic trafficking of nucleophosmin[J]. Int J Biochem Cell Biol, 2008, 40(9): 1918-1929.
24.	Chen LZ, Feng XW, Zhou JH. Effect of rehmannia glutinosa polysaccharide b on T-lymphocytes in mice bearing sarcoma 180[J]. Acta Pharmacol Sin, 1995, 16(4): 337-340.
25.	Cho WC, Leung KN. In vitro and in vivo anti-tumor effects of astragalus membranaceus[J]. Cancer Lett, 2007, 252(1): 43-54.
26.	Gupta S, Zhang D, Yi J, et al. Anticancer activities of oldenlandia diffusa[J]. J Herb Pharmacother, 2004, 4(1): 21-33.
27.	Chu Q, Satoh K, Kanamoto T, et al. Antitumor potential of three herbal extracts against human oral squamous cell lines[J]. Anticancer Res, 2009, 29(8): 3211-3219.
28.	Xie CH, Zhang MS, Zhou YF, et al. Chinese medicine angelica sinensis suppresses radiation-induced expression of TNF-alpha and TGF-betal in mice[J]. Oncol Rep, 2006, 15(6): 1429-1436.
29.	Hui MK, Wu WK, Shin VY, et al. Polysaccharides from the root of angelica sinensis protect bone marrow and gastrointestinal tissues against the cytotoxicity of cyclophosphamide in mice[J]. Int J Med Sci, 2006, 3(1): 1-6.
30.	Bao YX, Wong CK, Leung SF, et al. Clinical studies of immunomodulatory activities of yunzhi-danshen in patients with nasopharyngeal carcinoma[J]. J Alter Complement Med, 2006, 12(8): 771-776.
31.	Dai AW, Li ZY, Wang LH, et al. Effect of yangyin humo decoction on oral mucomembranous reaction to radiotherapy[J]. Chin J Integr Med, 2009, 15(4): 303-306.
32.	陈俏妍, 夏纪严, 韩凌, 等. 滋阴清热法防治阴虚内热证急性放射性口腔炎临床研究[J]. 中国中西医结合杂志, 2010, 30(7): 694-698.
33.	李廷谦, 刘雪梅, 张鸣明, 等. 中文期刊发表的中医药系统评价/Meta分析现状调查[J]. 中国循证医学杂志, 2007, 7(3): 180-188.
34.	吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范(征求意见稿) [J]. 中国循证医学杂志, 2007, 7(8): 601-605.
35.	胡丹, 康德英, 洪旗. 中医药系统评价中的异质性分析与处理[J]. 中国循证医学杂志, 2010, 10(4): 488-491.
36.	Wang G, Mao B, Xiong ZY, et al. The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China[J]. Clin Ther, 2007, 29(7): 1456-1467.
37.	Hewitt C, Hahn S, Torgerson DJ, et al. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals[J]. BMJ, 2005, 330 (7499): 1057-1058.
38.	Llorca J, Martinez-Sanz F, Prieto-Salceda D, et al. Quality of controlled clinical trials on glaucoma and intraocular high pressure[J]. J Glaucoma, 2005, 14(3): 190-195.

1. 　Boyle P, Levin B. World Cancer Report 2008[M]. Lyon: International Agency for Research on Cancer, 2008: 380-384.
2. 　Jia WH, Huang QH, Liao J, et al. Trends in incidence and mortality of nasopharyngeal carcinoma over a 20-25 year period (1978/1983-2002) in Sihui and Cangwu counties in southern China[J]. BMC Cancer, 2006, 6(1-8): 178.
3. 　Lee AW, Foo W, Mang O, et al. Changing epidemiology of nasopharyngeal carcinoma in Hong Kong over a 20-year period (1980-99): an encouraging reduction in both incidence and mortality[J]. Int J Cancer, 2003, 103(5): 680-685.
4. 　Wei WI, Sham JS. Nasopharyngeal carcinoma[J]. Lancet, 2005, 365(9476): 2041-2054.
5. 　NCCN头颈部肿瘤临床实践指南(中国版)2010年[M/OL]. http: //www. nccn-asia. org/cn/Adaptation.aspx? Cator ID=51&KoID=13&Opsition=2010.
6. 　周小军, 田道法. 鼻咽癌古文献研究[J]. 中华医史杂志, 2001, 31(4): 115-118.
7. 　Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions[M]. Version5. 0. 2. [updated September 2009]. http: //www. cochrane-handbook. org/.
8. 　徐伯平, 胡丕丽, 陈勇, 等. 养阴清热方防治急性放射性反应的研究[J]. 癌症, 1999, 18(4): 457-464.
9. 　王炳胜, 刘秀芳, 王涛, 等. 活血益气养阴方防治急性放射损伤的研究[J]. 中国中西医结合杂志, 2000, 20(3): 180-182.
10. 　刘城林, 刘健雄, 刘丽萍, 等. 养阴活血方对鼻咽癌放疗减毒增效的临床观察[J]. 中国中西医结合杂志, 2002, 22(12): 918-920.
11. 　文先惠, 刘嘉, 伍伟景. 益气养阴化瘀解毒法配合放射治疗复发性鼻咽癌65例总结[J]. 中国医师杂志, 2003, 5(5): 712-714.
12. 　张红. 导赤散加味配合放疗治疗鼻咽癌40例[J]. 湖南中医学院学报, 2003, 23(2): 34-35.
13. 　金红, 吴湘玮. 养阴解毒法减低鼻咽癌放射反应24例疗效观察[J]. 山东中医杂志, 2005, 24(1): 17-19.
14. 　张支农, 张剑, 陈红云, 等. 中西医结合治疗晚期鼻咽癌46例总结[J]. 湖南中医杂志, 2006, 22(1): 1-2.
15. 　袁国荣, 卢丽琴, 钦志泉, 等. 加味清营汤对鼻咽癌放疗增效减毒的临床研究[J]. 中医药学刊, 2006, 24(4): 670-671.
16. 　何福根, 陈晓钟, 章红燕. 养阴生津协定方改善鼻咽癌患者放疗毒副反应59例疗效观察[J]. 福建中医药, 2008, 39(5): 13-14.
17. 　Trotti A, Bellm LA, Epstein JB, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review[J]. Radiother Oncol, 2003, 66(3): 253-262.
18. 　McQuestion M. Evidence-based skin care management in radiation therapy[J]. Semin Oncol Nurs, 2006, 22(3): 163-173.
19. 　Fang FM, Chiu HC, Kuo WR, et al. Health-related quality of life for nasopharyngeal carcinoma patients with cancer-free survival after treatment[J]. Int J Radiat Oncol Biol Phys, 2002, 53(4): 959-968.
20. 　Pajak TF, Laramore GE, Marcial VA, et al. Elapsed treatment days-a critical item for radiotherapy quality control review in head and neck trials: RTOG report[J]. Int J Radiat Oncol Biol Phys, 1991, 20(1): 13-20.
21. 　Thomas J, Beinhorn C, Norton D, et al. Managing radiation therapy side effect with complementary medicine[J]. J Soc Integr Oncol, 2010, 8(2): 65-80.
22. 　Hsiao WL, Liu L. The role of traditional Chinese herbal medicines in cancer therapy-from TCM therapy to mechanistic insights[J]. Planta Med, 2010, 76(11): 1118-1131.
23. 　Li QF, Shi SL, Liu QR, et al. Anticancer effects of ginsenoside Rg1, cinnamic acid, and tanshinoneⅡA in osteosarcoma MG-63 cells: nuclear matrix downregulation and cytoplasmic trafficking of nucleophosmin[J]. Int J Biochem Cell Biol, 2008, 40(9): 1918-1929.
24. 　Chen LZ, Feng XW, Zhou JH. Effect of rehmannia glutinosa polysaccharide b on T-lymphocytes in mice bearing sarcoma 180[J]. Acta Pharmacol Sin, 1995, 16(4): 337-340.
25. 　Cho WC, Leung KN. In vitro and in vivo anti-tumor effects of astragalus membranaceus[J]. Cancer Lett, 2007, 252(1): 43-54.
26. 　Gupta S, Zhang D, Yi J, et al. Anticancer activities of oldenlandia diffusa[J]. J Herb Pharmacother, 2004, 4(1): 21-33.
27. 　Chu Q, Satoh K, Kanamoto T, et al. Antitumor potential of three herbal extracts against human oral squamous cell lines[J]. Anticancer Res, 2009, 29(8): 3211-3219.
28. 　Xie CH, Zhang MS, Zhou YF, et al. Chinese medicine angelica sinensis suppresses radiation-induced expression of TNF-alpha and TGF-betal in mice[J]. Oncol Rep, 2006, 15(6): 1429-1436.
29. 　Hui MK, Wu WK, Shin VY, et al. Polysaccharides from the root of angelica sinensis protect bone marrow and gastrointestinal tissues against the cytotoxicity of cyclophosphamide in mice[J]. Int J Med Sci, 2006, 3(1): 1-6.
30. 　Bao YX, Wong CK, Leung SF, et al. Clinical studies of immunomodulatory activities of yunzhi-danshen in patients with nasopharyngeal carcinoma[J]. J Alter Complement Med, 2006, 12(8): 771-776.
31. 　Dai AW, Li ZY, Wang LH, et al. Effect of yangyin humo decoction on oral mucomembranous reaction to radiotherapy[J]. Chin J Integr Med, 2009, 15(4): 303-306.
32. 　陈俏妍, 夏纪严, 韩凌, 等. 滋阴清热法防治阴虚内热证急性放射性口腔炎临床研究[J]. 中国中西医结合杂志, 2010, 30(7): 694-698.
33. 　李廷谦, 刘雪梅, 张鸣明, 等. 中文期刊发表的中医药系统评价/Meta分析现状调查[J]. 中国循证医学杂志, 2007, 7(3): 180-188.
34. 　吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范(征求意见稿) [J]. 中国循证医学杂志, 2007, 7(8): 601-605.
35. 　胡丹, 康德英, 洪旗. 中医药系统评价中的异质性分析与处理[J]. 中国循证医学杂志, 2010, 10(4): 488-491.
36. 　Wang G, Mao B, Xiong ZY, et al. The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China[J]. Clin Ther, 2007, 29(7): 1456-1467.
37. 　Hewitt C, Hahn S, Torgerson DJ, et al. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals[J]. BMJ, 2005, 330 (7499): 1057-1058.
38. 　Llorca J, Martinez-Sanz F, Prieto-Salceda D, et al. Quality of controlled clinical trials on glaucoma and intraocular high pressure[J]. J Glaucoma, 2005, 14(3): 190-195.

West China Medical Journal

Protective Effects of Decoction Plus Radiotherapy on Nasopharyngeal Carcinoma: A Meta-analysis of Randomized Controlled Trials

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