• 1. 四川大學(xué)華西醫(yī)院腫瘤中心（成都 610041）2. 四川大學(xué)華西醫(yī)院循證醫(yī)學(xué)與臨床流行病學(xué)中心（成都 610041）;

目的 　系統(tǒng)評價(jià)拓?fù)涮婵翟谛〖?xì)胞肺癌治療中的臨床療效和安全性, 一線及二線治療中的地位, 不同給藥方式的療效及其毒副作用。
方法 　采用Cochrane系統(tǒng)評價(jià)方法，檢索Cochrane圖書館臨床對照試驗(yàn)庫、MEDLINE、EMbase、Cancerlit、CBM、CNKI和VIP等電子數(shù)據(jù)庫，并輔以手工檢索和附加檢索。檢索時(shí)間截至2006年。由2名評價(jià)者獨(dú)立評價(jià)并交叉核對納入研究質(zhì)量，對同質(zhì)研究采用RevMan 4.2.8軟件進(jìn)行Meta分析。
結(jié)果 　共納入14個(gè)研究，2 099例小細(xì)胞肺癌患者，所有研究均報(bào)道采用了隨機(jī)方法，均未詳細(xì)報(bào)道隨機(jī)方案的隱藏情況及是否采用盲法。Meta分析結(jié)果表明，TP 方案（拓?fù)涮婵担樸K）與EP方案（足葉乙甙＋順鉑）的反應(yīng)率相似 [OR 0.83, 95%CI (0.63,1.09)]，但具有相對高的致血小板下降的骨髓毒性；單藥拓樸替康與CE方案（足葉乙甙＋卡鉑）的反應(yīng)率相似 [OR 0.59, 95%CI (0.22,1.60)]；TEP方案（拓?fù)涮婵担闳~乙甙＋順鉑）與EP方案的反應(yīng)率相似 [OR 1.37, 95%CI (0.82,2.28)]，TEP方案致化療后重度白細(xì)胞下降、重度血小板下降、重度血紅蛋白下降均高于EP方案；口服拓?fù)涮婵蹬c靜脈滴注拓?fù)涮婵档幕熀蠓磻?yīng)率 [OR 0.97, 95％CI (0.60,1.57)]、中位疾病進(jìn)展期 [WMD –2.32, 95％CI ( –5.72, 1.09)]、中位生存期 [WMD –1.65, 95％CI (–7.13,3.83)] 相似，口服拓?fù)涮婵祷熀笾囟戎行粤＜?xì)胞下降明顯低于靜脈滴注拓?fù)涮婵?。所有研究共?bào)道了45例治療相關(guān)性死亡。
結(jié)論 　拓?fù)涮婵抵委熜〖?xì)胞肺癌有確切臨床療效，無論是單藥還是與其他藥物的聯(lián)合用藥均具有與當(dāng)前一線經(jīng)典方案相當(dāng)?shù)寞熜?，但具有相對高的致白?xì)胞和血小板下降的骨髓毒性，已被認(rèn)為是治療化療敏感的小細(xì)胞肺癌患者復(fù)發(fā)的二線推薦藥物，但是作為一線用藥仍然需要更多的實(shí)踐來證實(shí)。但由于納入的研究存在選擇性偏倚和測量性偏倚的高度可能性，勢必影響結(jié)果的論證強(qiáng)度，期待更多高質(zhì)量的隨機(jī)雙盲對照試驗(yàn)提供高質(zhì)量的證據(jù)。

引用本文： 王曉珊,吳泰相,侯梅. 拓?fù)涮婵抵委熜〖?xì)胞肺癌的系統(tǒng)評價(jià). 中國循證醫(yī)學(xué)雜志, 2007, 07(3): 189-203. doi: 復(fù)制

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  1. 1. Chinese Society of Clinical Oncology. 2006. http://www.csco.net.cn. (Updated yearly).
  2. 2. Tang ZY, Zhu SN, Cao SL. Editor-in-Chief. Modern Oncology. 2nd Edition. Shanghai: Publishing Company of Shanghai Medical University, 2000. 876.
  3. 3. Kang P, Yu QT, Li ZG. Clinical observation of topotecan and cisplatin combination chemotherapy for small cell lung cancer. Guangxi Medical Journal, 2002, 24(10): 1541–1542.
  4. 4. Liu W, Liu Y, Gu ZP, et al. Comparative study on topotecan plus cisplatin as preoperative neoadjuvant chemotherapy for small cell lung cancer. Chinese Journal of Misdiagnostics, 2004, 4(11): 1790–1792.
  5. 5. Gao YJ, Liu JW, Ban LY, et al. Clinical study of domestic topotecan hydrochloride in the treatment of small cell lung cancer. Chinese Journal of Current Practical Medicine, 2004, 3(16): 11–12.
  6. 6. Li R, Yang J, Li EX, et al. Phase Ⅱ clinical trial of domestic TPT (topotecan) hydrochloride. Chinese New Drugs Journal, 2001, 10(10): 760–763.
  7. 7. Su YQ, Chou JR, Liu Lk, et al. Clinical observation of topotecan and etoposide plus cisplatin in treating small cell lung cancer. Chinese Clinical Oncology, 2004, 9(1): 5–7.
  8. 8. Qi YE, Liu YH, Zheng MZ, et al. Clinical comparative study of topotecan/etoposide vs. etoposide/cisplatin as first-line treatment in patients with small cell lung cancer. Journal of China Medical University, 2005, 34(3): 269–270.
  9. 9. Ma SR. Topotecan hydrochloride in combination with Cisplatin in patients with small cell lung cancer. Journal of Medical Forum, 2003, 24(6): 41.
  10. 10. Shi HL, Zhu YZ, Liu Z, et al. Study on topotecan in the treatment of small-cell lung cancer. Beijing Medical Journal, 2002, 24(4): 251–253.
  11. 11. Xu JH, J Zhou JT, Zhou WW, et al. Clinical study of topotecan plus cisplatin in patients with small cell lung cancer. Cancer Research and Clinic, 2005, 17(1): 35–36.
  12. 12. American Cancer Society: Cancer Facts and Figures 2006. Atlanta, Ga; American Cancer Society, 2006. [2006-08-07]. http://www.cancer.org,Last accessed August 7, 2006.
  13. 13. 中國抗癌協(xié)會臨床腫瘤學(xué)協(xié)作專業(yè)委員會. 2006年. http://www.csco.net.cn. (常規(guī)每年更新).
  14. 14. 湯釗猷, 朱世能, 曹世龍. 主編. 現(xiàn)代腫瘤學(xué). 第2版. 上海: 上海醫(yī)科大學(xué)出版社, 2000. 876.
  15. 15. Okuno SH, Jett JR. Small cell lung cancer: current therapy and promising new regimens. The Oncologist, 2002, 7: 234–238.
  16. 16. Schiller JH. Current standards of care in small-cell and non-small-cell lung cancer. Oncology, 2001, 61(Suppl 1): 3–13.
  17. 17. von Pawel J. The role of topotecan in treating small cell lung cancer: second-line treatment. Lung Cancer, 2003, 41(Suppl 4): S3–S8.
  18. 18. Topotecan. An Oncologist’ View.Centre Francois Baclesse, Centre Régional de Lutte Contre le Cancer, Caen, France. The Oncologist, 1998, 3: 390–402.
  19. 19. Depierre A, von Pawel J, Hans K, et al. Evaluation of topotecan (Hycam-tin(TM)) in relapsed small cell lung cancer (SCLC). A multicentre phase II study. Lung Cancer, 1997, 18(Suppl 1): 35.
  20. 20. Ardizzoni A, Hansen H, Dombernowsky P, et al. Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: a phase II study in patients with refractory and sensitive disease. The European Organization for Research and Treatment of Cancer Early Clinical Stud-ies Group and New Drug Development Office, and the Lung Cancer Cooperative Group. J Clin Oncol, 1997, 15: 2090–2096.
  21. 21. Perez-Soler R, Glisson BS, Lee JS, et al. Treatment of patients with small-cell lung cancer refractory to etoposide and cisplatin with the topoisomer-ase I poison topotecan. J Clin Oncol, 1996, 14: 2785–2790.
  22. 22. Sandler AB. Chemotherapy for small cell lung cancer. Semin Oncol, 2003, 30: 9–25.
  23. 23. Ardizzoni A, Hansen H, Dombernowsky P, et al. Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: a phase II study in patients with refractory and sensitive disease. The European Organization for Research and Treatment of Cancer Early Clinical Studies Group and New Drug Development Office, and the Lung Cancer Cooperative Group. J Clin Oncol, 1997, 15: 2090–2096.
  24. 24. Depierre A, von Pawel J, Hans K, et al. Evaluation of topotecan in relapsed small cell lung cancer (SCLC). A (Hycamtin multicentre phase II study. Lung Cancer, 1997, 18(Suppl 1): 35.
  25. 25. Eckardt J, Gralla R, Palmer MC, et al. Topotecan (T) as secondline therapy in patients (Pts) with small cell lung cancer(SCLC): a phase II study. Ann Oncol, 1996, 7(Suppl 5): 107.
  26. 26. von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol, 1999, 17: 658–667.
  27. 27. Korfel A, Oehm C, von Pawel J, et al. Response to topotecan of symptomatic brain metastases of small-cell lung cancer also after whole-brain irradiation: a multicentre phase II study. Eur J Cancer, 2002, 38: 1724–1729.
  28. 28. Wong ET, Berkenblit A. The role of topotecan in the treatment of brain metastases. The Oncologist, 2004, 9: 68–79.
  29. 29. Bahadori HR, Green MR, Catapano CV. Synergistic interaction between topotecan and microtubule-interfering agents. Cancer Chemother Pharmacol, 2001, 48: 188–196.
  30. 30. Nagourney RA, Sommers BL, Harper SM, et al. Ex vivo analysis of topotecan: advancing the application of laboratory-based clinical therapeutics. Br J Cancer, 2003, 89: 1789–1795.
  31. 31. Jonsson E, Fridborg H, Nygren P, et al. Synergistic interactions of combinations of topotecan with standard drugs in primary cultures of human tumor cells from patients. Eur J Clin Pharmacol, 1998, 54: 509–514.
  32. 32. Greco FA. Topotecan as first-line therapy for small cell lung cancer. Lung Cancer, 2003, 41(Suppl 4): S9–S16.
  33. 33. Alderson P, Green S, Higgins JPT, editors. Cochrane Reviewer’s Handbook 4.2.2 (updated March 2004). The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd, 2004.
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