• 四川大學(xué)華西醫(yī)院中國循證醫(yī)學(xué)中心 （成都 610041）;

目的　 系統(tǒng)評(píng)價(jià)與其它藥物比較，青蒿琥酯注射劑與栓劑治療重癥瘧疾是否能降低患者病死率和改善其他臨床結(jié)局。
方法　 計(jì)算機(jī)檢索Cochrane圖書館（2007年第3期）、MEDLINE（1966～2007.4）、EMbase（1988～2007.4）、CBMweb（1978～2007.4）、VIP（1989～2007.4）和CNKI（1994～2007.4）數(shù)據(jù)庫，收集所有青蒿琥酯注射劑與栓劑治療重癥瘧疾的隨機(jī)對(duì)照試驗(yàn)（RCT），使用Cochrane系統(tǒng)評(píng)價(jià)方法，評(píng)價(jià)納入研究的方法學(xué)質(zhì)量并提取有效數(shù)據(jù)進(jìn)行分析。
結(jié)果　 共納入11個(gè)RCT，共2?269例患者。根據(jù)Cochrane圖書館推薦的RCT質(zhì)量評(píng)價(jià)標(biāo)準(zhǔn)，各納入研究的方法學(xué)質(zhì)量均較高，6篇為A級(jí)，5篇為B級(jí)。其中6個(gè)RCT比較靜脈注射用青蒿琥酯與靜脈注射用奎寧的療效，結(jié)果顯示病死率差異有統(tǒng)計(jì)學(xué)意義［RR 0.65，95%CI（0.52，0.80），P lt;0.0001］，靜脈注射用青蒿琥酯的療效優(yōu)于靜脈注射用奎寧。3個(gè)RCT比較了靜脈注射用青蒿琥酯與青蒿素栓的療效，結(jié)果顯示病死率差異無統(tǒng)計(jì)學(xué)意義，其RR及95%CI分別為0.94（0.35，2.56），0.58（0.19，1.74）和2.00（0.39，10.26）。2個(gè)RCT比較靜脈注射和肌肉注射用青蒿琥酯的療效，差異無統(tǒng)計(jì)學(xué)意義［RR 1.50，95%CI（0.52，4.31），P=0.45］。靜脈注射用青蒿琥酯與靜脈注射用氯喹、蒿甲醚等其它藥物比較，其病死率差異均無統(tǒng)計(jì)學(xué)意義。9個(gè)RCT報(bào)告了治療后的不良反應(yīng)，主要為輕微胃腸道反應(yīng)，惡心、嘔吐等。
結(jié)論　 奎寧比較，注射用青蒿琥酯更有效且副作用發(fā)生率明顯降低；靜脈用青蒿琥酯與肌肉用青蒿琥酯比較，以及靜脈用青蒿琥酯與青蒿素栓比較，在病死率方面差異均無統(tǒng)計(jì)學(xué)意義。

引用本文： 原志芳,孫鑫,孟月,敬媛媛,毛秀,李幼平. 青蒿琥酯治療重癥瘧疾隨機(jī)對(duì)照試驗(yàn)的系統(tǒng)評(píng)價(jià). 中國循證醫(yī)學(xué)雜志, 2007, 07(11): 794-801. doi: 復(fù)制

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2. Liu GJ. The application of bio-statistical method in Evidence-based Medicine. In: Li YP, Editor-in-Chief. Evidence-based Medicine. Beijing: Higher Education Press, 2003. 50-66.
3. Disease information. http://www.who.int/tdr/diseases/malaria/diseaseinfo.htm.
4. 2006 Guidelines for the treatment of malaria. http://www.who.int/malaria/docs/TreatmentGuidelines2006.pdf.
5. 周自永, 主編. 新編常用藥物手冊. 第2版. 北京: 金庸出版社, 1992. 526-527.
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9. Tjitra E, Suprianto S, Dyer M, et al. Field Evaluation of the ICT Malaria P.f/P.v immunochromatographic test for detection of Plasmodium falciparum and Plasmodium vivax in patients with a presumptive clinical diagnosis of Malaria in eastern indonesia. J Clin Microbiol, 1999, 37: 2412-2417.
10. World Health Organization. Severe and complicated malaria (World Health Organization Malaria Action Programme). Trans R Soc Trop Med Hyg,1986,80(Suppl):3-50.
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12. Turato G, Zuin R, Monti S. Celluar and structual changes in peripheral airways of subjects with severe COPD. Eur Respir J, 2001, 91: 662.
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17. Dondorp A, Nosten F, Stepniewska K, et al. Artesunate versus quinine for treatment of severe falciparum malaria: A randomised trial. Lancet, 2005, 366: 717-725.
18. Hien TT, Phu NH, Mai NT, et al. An open randomized comparison of intravenous and intramuscular artesunate in severe falciparum malaria. Trans R Soc Trop Med Hyg, 1992, 86(6): 584-585.
19. Haroon N, Amichandwala K, Solu MG. Comparative efficacy of quinine and artesunate in the treatment of severe malaria: a randomized controlled trial. JK Science, 2005, 7: 32-35.
20. Hien TT, Arnold K, Vinh H, et al. Comparison of artemisinin suppositories with intravenous artesunate and intravenous quinine in the treatment of cerebral malaria. Trans R Soc Trop Med Hyg, 1992, 86(6): 582-583.
21. Cao XT, Bethell DB, Pham TP, et al. Comparison of artemisinin suppositories, intramuscular artesunate and intravenous quinine for the treatment of severe childhood malaria. Trans R Soc Trop Med Hyg, 1997, 91(3): 335-342.
22. Goka BQ, Adabayeri V, Ofori-Adjei E, et al. Comparison of chloroquine with artesunate in the treatment of cerebral malaria in Ghanaian children. J Trop Pediatr, 2001, 47(3): 165-169.
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24. Newton PN, Angus BJ, Chierakul W, et al. Randomized comparison of artesunate and quinine in the treatment of severe falciparum malaria. Clin Infect Dis, 2003, 37(1): 7-16.
25. Ha V, Nguyen NH, Tran TB, et al. Severe and complicated malaria treated with artemisinin, artesunate or artemether in Viet Nam. Trans R Soc Trop Med Hyg, 1997, 91(4): 465-467..
26. Mohanty AK, Rath BK, Mohanty R, et al. Randomized control trial of quinine and artesunate in complicated malaria. Indian J Pediatr, 2004, 71(4): 291-295.
27. Peter B. Bloland.Drug resistance in malaria. http://www.who.int/csr/resources/publications/drugresist/malaria.pdf.
28. Pradines B. Antimicrobial agents and chemotherapy. Trop Med Parasitol, 1999, 43(2): 418 - 420.
  1. 1. Zhou ZY, editor-in-chief. Handbook of Materia Medica. 2nd ed. Beijing: Jin Yong Publishing House, 1992. 526-527.
  2. 2. Liu GJ. The application of bio-statistical method in Evidence-based Medicine. In: Li YP, Editor-in-Chief. Evidence-based Medicine. Beijing: Higher Education Press, 2003. 50-66.
  3. 3. Disease information. http://www.who.int/tdr/diseases/malaria/diseaseinfo.htm.
  4. 4. 2006 Guidelines for the treatment of malaria. http://www.who.int/malaria/docs/TreatmentGuidelines2006.pdf.
  5. 5. 周自永, 主編. 新編常用藥物手冊. 第2版. 北京: 金庸出版社, 1992. 526-527.
  6. 6. What is the best treatment against malaria?http://www.who.int/features/qa/26/en/index.html.
  7. 7. McIntosh HM, Olliaro P. Artemisinin derivatives for treating severe malaria. Cochrane Database Syst Rev, 2000, (2): CD000527.
  8. 8. Jones KL, Donegan S, Lalloo DG. Artesunate versus quinine for treating severe malaria. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD005967. DOI: 10.1002/14651858.CD005967.pub2.
  9. 9. Tjitra E, Suprianto S, Dyer M, et al. Field Evaluation of the ICT Malaria P.f/P.v immunochromatographic test for detection of Plasmodium falciparum and Plasmodium vivax in patients with a presumptive clinical diagnosis of Malaria in eastern indonesia. J Clin Microbiol, 1999, 37: 2412-2417.
  10. 10. World Health Organization. Severe and complicated malaria (World Health Organization Malaria Action Programme). Trans R Soc Trop Med Hyg,1986,80(Suppl):3-50.
  11. 11. Warrell DA, Molyneux ME, Beales PF. Severe and complicated malaria. Trans R Soc Trop Med Hyg, 1990, 84(suppl 2):1-65.
  12. 12. Turato G, Zuin R, Monti S. Celluar and structual changes in peripheral airways of subjects with severe COPD. Eur Respir J, 2001, 91: 662.
  13. 13. Cochrane Reviewer, Handbook 4.2. The Cochrane Collaboration, 2006.
  14. 14. Schulz KF, Chalmers I, Hayes RJ. Empirical evidence of bias. JAMA, 1995, 273: 408 - 421.
  15. 15. 劉關(guān)鍵. 統(tǒng)計(jì)學(xué)方法在循證醫(yī)學(xué)中的應(yīng)用. 見: 李幼平, 主編. 循證醫(yī)學(xué). 第1版. 北京: 高等教育出版社, 2003. 49-57.
  16. 16. Karunajeewa, HA, Reeder J, Lorry K, et al. Artesunate suppositories versus intramuscular artemether for treatment of severe malaria in children in Papua New Guinea. Antimicrob Agents Chemother, 2006, 50(3): 968-974.
  17. 17. Dondorp A, Nosten F, Stepniewska K, et al. Artesunate versus quinine for treatment of severe falciparum malaria: A randomised trial. Lancet, 2005, 366: 717-725.
  18. 18. Hien TT, Phu NH, Mai NT, et al. An open randomized comparison of intravenous and intramuscular artesunate in severe falciparum malaria. Trans R Soc Trop Med Hyg, 1992, 86(6): 584-585.
  19. 19. Haroon N, Amichandwala K, Solu MG. Comparative efficacy of quinine and artesunate in the treatment of severe malaria: a randomized controlled trial. JK Science, 2005, 7: 32-35.
  20. 20. Hien TT, Arnold K, Vinh H, et al. Comparison of artemisinin suppositories with intravenous artesunate and intravenous quinine in the treatment of cerebral malaria. Trans R Soc Trop Med Hyg, 1992, 86(6): 582-583.
  21. 21. Cao XT, Bethell DB, Pham TP, et al. Comparison of artemisinin suppositories, intramuscular artesunate and intravenous quinine for the treatment of severe childhood malaria. Trans R Soc Trop Med Hyg, 1997, 91(3): 335-342.
  22. 22. Goka BQ, Adabayeri V, Ofori-Adjei E, et al. Comparison of chloroquine with artesunate in the treatment of cerebral malaria in Ghanaian children. J Trop Pediatr, 2001, 47(3): 165-169.
  23. 23. Nealon C, Dzeing A, Müller-Römer U, et al. Intramuscular bioavailability and clinical efficacy of artesunate in gabonese children with severe malaria. Antimicrob Agents Chemother, 2002, 46(12): 3933-3939.
  24. 24. Newton PN, Angus BJ, Chierakul W, et al. Randomized comparison of artesunate and quinine in the treatment of severe falciparum malaria. Clin Infect Dis, 2003, 37(1): 7-16.
  25. 25. Ha V, Nguyen NH, Tran TB, et al. Severe and complicated malaria treated with artemisinin, artesunate or artemether in Viet Nam. Trans R Soc Trop Med Hyg, 1997, 91(4): 465-467..
  26. 26. Mohanty AK, Rath BK, Mohanty R, et al. Randomized control trial of quinine and artesunate in complicated malaria. Indian J Pediatr, 2004, 71(4): 291-295.
  27. 27. Peter B. Bloland.Drug resistance in malaria. http://www.who.int/csr/resources/publications/drugresist/malaria.pdf.
  28. 28. Pradines B. Antimicrobial agents and chemotherapy. Trop Med Parasitol, 1999, 43(2): 418 - 420.