喬蓓 1,2 , 袁維利 1 , 張穎 1 , 馮敏 3 , 錢瑛 3 , 鄒林玲 3 , 張瑞明 1
  • 1 四川大學(xué)華西醫(yī)院中西醫(yī)結(jié)合科（成都，610041）;2 西藏大學(xué)醫(yī)學(xué)院臨床醫(yī)學(xué)系;3 四川大學(xué)華西醫(yī)院臨床藥理基地?GCP中心;

【摘要】　目的　 評(píng)價(jià)中藥復(fù)方（益氣養(yǎng)陰、清熱活血方Y(jié)iqi Yangyin Qingre Huoxue decoction，YYQHD）聯(lián)合放射療法治療鼻咽癌在減毒增效方面的療效。　方法　 采用Cochrane系統(tǒng)評(píng)價(jià)方法，電子檢索Cochrane圖書館臨床對(duì)照試驗(yàn)資料庫(kù)（Cochrane Central Register of Controlled Trials，CENTRAL）、PubMed、EMBASE、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)（CBM）、中文科技期刊全文數(shù)據(jù)庫(kù)（CNKI）和中國(guó)期刊全文數(shù)據(jù)庫(kù)（VIP）以及萬(wàn)方數(shù)據(jù)庫(kù)等數(shù)據(jù)庫(kù)2010年3月前所發(fā)表的相關(guān)文獻(xiàn)。同時(shí)互聯(lián)網(wǎng)檢索Current Controlled Trial、Clinical Trials和中國(guó)臨床試驗(yàn)注冊(cè)網(wǎng)。手工檢索部分腫瘤類核心期刊。采用Cochrane協(xié)作網(wǎng)推薦的 “偏倚風(fēng)險(xiǎn)評(píng)估”工具，評(píng)估納入研究的質(zhì)量，使用RevMan 5.0.23.0軟件對(duì)納入的研究進(jìn)行定量系統(tǒng)評(píng)價(jià)。　結(jié)果　 最終納入符合標(biāo)準(zhǔn)的中文文獻(xiàn)9篇共795例患者。定量分析結(jié)果顯示:與單純常規(guī)放射治療相比較，中藥復(fù)方（YYQHD）聯(lián)合常規(guī)放射治療能顯著提高腫瘤近期療效、生存率，并且能顯著減少放射治療常見(jiàn)毒副反應(yīng)的發(fā)生，從而提高放射治療按時(shí)完成率確保放射治療療效、改善患者生存質(zhì)量。　結(jié)論　 雖現(xiàn)有研究尚不能得出可以將中藥復(fù)方（YYQHD）作為標(biāo)準(zhǔn)治療手段輔助放射治療的結(jié)論，但提示益氣養(yǎng)陰、清熱活血類中藥聯(lián)合放射治療治療鼻咽癌是值得繼續(xù)探索的研究方向，期待設(shè)計(jì)科學(xué)合理、高質(zhì)量的多中心、大樣本、雙盲、隨機(jī)對(duì)照臨床試驗(yàn)以進(jìn)一步驗(yàn)證其療效。
【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.

引用本文： 喬蓓,袁維利,張穎,馮敏,錢瑛,鄒林玲,張瑞明. 中藥復(fù)方聯(lián)合放射療法治療鼻咽癌療效的Meta分析. 華西醫(yī)學(xué), 2011, 26(3): 391-398. doi: 復(fù)制

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頭頸部腫瘤臨床實(shí)踐指南(中國(guó)版)2010年[M/OL]. http: //www. nccn-asia. org/cn/Adaptation.aspx? Cator ID=51&KoID=13&Opsition=2010.
6. 　周小軍, 田道法. 鼻咽癌古文獻(xiàn)研究[J]. 中華醫(yī)史雜志, 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, 胡丕麗, 陳勇, 等. 養(yǎng)陰清熱方防治急性放射性反應(yīng)的研究[J]. 癌癥, 1999, 18(4): 457-464.
9. 　王炳勝, 劉秀芳, 王濤, 等. 活血益氣養(yǎng)陰方防治急性放射損傷的研究[J]. 中國(guó)中西醫(yī)結(jié)合雜志, 2000, 20(3): 180-182.
10. 　劉城林, 劉健雄, 劉麗萍, 等. 養(yǎng)陰活血方對(duì)鼻咽癌放療減毒增效的臨床觀察[J]. 中國(guó)中西醫(yī)結(jié)合雜志, 2002, 22(12): 918-920.
11. 　文先惠, 劉嘉, 伍偉景. 益氣養(yǎng)陰化瘀解毒法配合放射治療復(fù)發(fā)性鼻咽癌65例總結(jié)[J]. 中國(guó)醫(yī)師雜志, 2003, 5(5): 712-714.
12. 　張紅. 導(dǎo)赤散加味配合放療治療鼻咽癌40例[J]. 湖南中醫(yī)學(xué)院學(xué)報(bào), 2003, 23(2): 34-35.
13. 　金紅, 吳湘瑋. 養(yǎng)陰解毒法減低鼻咽癌放射反應(yīng)24例療效觀察[J]. 山東中醫(yī)雜志, 2005, 24(1): 17-19.
14. 　張支農(nóng), 張劍, 陳紅云, 等. 中西醫(yī)結(jié)合治療晚期鼻咽癌46例總結(jié)[J]. 湖南中醫(yī)雜志, 2006, 22(1): 1-2.
15. 　袁國(guó)榮, 盧麗琴, 欽志泉, 等. 加味清營(yíng)湯對(duì)鼻咽癌放療增效減毒的臨床研究[J]. 中醫(yī)藥學(xué)刊, 2006, 24(4): 670-671.
16. 　何福根, 陳曉鐘, 章紅燕. 養(yǎng)陰生津協(xié)定方改善鼻咽癌患者放療毒副反應(yīng)59例療效觀察[J]. 福建中醫(yī)藥, 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. 　陳俏妍, 夏紀(jì)嚴(yán), 韓凌, 等. 滋陰清熱法防治陰虛內(nèi)熱證急性放射性口腔炎臨床研究[J]. 中國(guó)中西醫(yī)結(jié)合雜志, 2010, 30(7): 694-698.
33. 　李廷謙, 劉雪梅, 張鳴明, 等. 中文期刊發(fā)表的中醫(yī)藥系統(tǒng)評(píng)價(jià)/Meta分析現(xiàn)狀調(diào)查[J]. 中國(guó)循證醫(yī)學(xué)雜志, 2007, 7(3): 180-188.
34. 　吳泰相, 李幼平, 卞兆祥, 等. 中醫(yī)藥臨床隨機(jī)對(duì)照試驗(yàn)報(bào)告規(guī)范(征求意見(jiàn)稿) [J]. 中國(guó)循證醫(yī)學(xué)雜志, 2007, 7(8): 601-605.
35. 　胡丹, 康德英, 洪旗. 中醫(yī)藥系統(tǒng)評(píng)價(jià)中的異質(zhì)性分析與處理[J]. 中國(guó)循證醫(yī)學(xué)雜志, 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. 1. 　Boyle P, Levin B. World Cancer Report 2008[M]. Lyon: International Agency for Research on Cancer, 2008: 380-384.
  2. 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. 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. 4. 　Wei WI, Sham JS. Nasopharyngeal carcinoma[J]. Lancet, 2005, 365(9476): 2041-2054.
  5. 5. 　NCCN頭頸部腫瘤臨床實(shí)踐指南(中國(guó)版)2010年[M/OL]. http: //www. nccn-asia. org/cn/Adaptation.aspx? Cator ID=51&KoID=13&Opsition=2010.
  6. 6. 　周小軍, 田道法. 鼻咽癌古文獻(xiàn)研究[J]. 中華醫(yī)史雜志, 2001, 31(4): 115-118.
  7. 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. 8. 　徐伯平, 胡丕麗, 陳勇, 等. 養(yǎng)陰清熱方防治急性放射性反應(yīng)的研究[J]. 癌癥, 1999, 18(4): 457-464.
  9. 9. 　王炳勝, 劉秀芳, 王濤, 等. 活血益氣養(yǎng)陰方防治急性放射損傷的研究[J]. 中國(guó)中西醫(yī)結(jié)合雜志, 2000, 20(3): 180-182.
  10. 10. 　劉城林, 劉健雄, 劉麗萍, 等. 養(yǎng)陰活血方對(duì)鼻咽癌放療減毒增效的臨床觀察[J]. 中國(guó)中西醫(yī)結(jié)合雜志, 2002, 22(12): 918-920.
  11. 11. 　文先惠, 劉嘉, 伍偉景. 益氣養(yǎng)陰化瘀解毒法配合放射治療復(fù)發(fā)性鼻咽癌65例總結(jié)[J]. 中國(guó)醫(yī)師雜志, 2003, 5(5): 712-714.
  12. 12. 　張紅. 導(dǎo)赤散加味配合放療治療鼻咽癌40例[J]. 湖南中醫(yī)學(xué)院學(xué)報(bào), 2003, 23(2): 34-35.
  13. 13. 　金紅, 吳湘瑋. 養(yǎng)陰解毒法減低鼻咽癌放射反應(yīng)24例療效觀察[J]. 山東中醫(yī)雜志, 2005, 24(1): 17-19.
  14. 14. 　張支農(nóng), 張劍, 陳紅云, 等. 中西醫(yī)結(jié)合治療晚期鼻咽癌46例總結(jié)[J]. 湖南中醫(yī)雜志, 2006, 22(1): 1-2.
  15. 15. 　袁國(guó)榮, 盧麗琴, 欽志泉, 等. 加味清營(yíng)湯對(duì)鼻咽癌放療增效減毒的臨床研究[J]. 中醫(yī)藥學(xué)刊, 2006, 24(4): 670-671.
  16. 16. 　何福根, 陳曉鐘, 章紅燕. 養(yǎng)陰生津協(xié)定方改善鼻咽癌患者放療毒副反應(yīng)59例療效觀察[J]. 福建中醫(yī)藥, 2008, 39(5): 13-14.
  17. 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. 18. 　McQuestion M. Evidence-based skin care management in radiation therapy[J]. Semin Oncol Nurs, 2006, 22(3): 163-173.
  19. 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. 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. 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. 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. 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. 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. 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. 26. 　Gupta S, Zhang D, Yi J, et al. Anticancer activities of oldenlandia diffusa[J]. J Herb Pharmacother, 2004, 4(1): 21-33.
  27. 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. 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. 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. 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. 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. 32. 　陳俏妍, 夏紀(jì)嚴(yán), 韓凌, 等. 滋陰清熱法防治陰虛內(nèi)熱證急性放射性口腔炎臨床研究[J]. 中國(guó)中西醫(yī)結(jié)合雜志, 2010, 30(7): 694-698.
  33. 33. 　李廷謙, 劉雪梅, 張鳴明, 等. 中文期刊發(fā)表的中醫(yī)藥系統(tǒng)評(píng)價(jià)/Meta分析現(xiàn)狀調(diào)查[J]. 中國(guó)循證醫(yī)學(xué)雜志, 2007, 7(3): 180-188.
  34. 34. 　吳泰相, 李幼平, 卞兆祥, 等. 中醫(yī)藥臨床隨機(jī)對(duì)照試驗(yàn)報(bào)告規(guī)范(征求意見(jiàn)稿) [J]. 中國(guó)循證醫(yī)學(xué)雜志, 2007, 7(8): 601-605.
  35. 35. 　胡丹, 康德英, 洪旗. 中醫(yī)藥系統(tǒng)評(píng)價(jià)中的異質(zhì)性分析與處理[J]. 中國(guó)循證醫(yī)學(xué)雜志, 2010, 10(4): 488-491.
  36. 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. 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. 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.