• 1.四川大學(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）2.四川大學(xué)華西臨床醫(yī)學(xué)院（成都 610041）3.四川大學(xué)華西臨床醫(yī)學(xué)院教務(wù)部;

目的 　系統(tǒng)評價單獨(dú)應(yīng)用齊多夫定（zidovudine，ZDV）阻斷HIV母嬰傳播的有效性和安全性。
方法 　采用Cochrane系統(tǒng)評價方法，計算機(jī)檢索Cochrane圖書館（2007第1期）、PubMed、EMbase、CINAHL、AIDSearch、AIDSLINE、AIDSTRIALS、AIDSDRUGS、AIDSinfo、CRD（center of review and dissemination）、CBMdisc，VIP和CNKI等數(shù)據(jù)庫，以及全球或地區(qū)性AIDS相關(guān)的會議論文集、政府或非政府組織的相關(guān)文件等，檢索日期截至2007年4月30日，全面收集全球抗艾滋病病毒藥物預(yù)防HIV母嬰傳播的隨機(jī)對照試驗。由兩名評價員獨(dú)立篩查文獻(xiàn)、評價質(zhì)量和提取資料，然后交叉核對，若遇分歧則征求第三方意見討論解決。使用RevMan軟件進(jìn)行Meta分析。
結(jié)果 　共納入8個RCT，包括24篇全文和13篇摘要，其方法學(xué)質(zhì)量的Jadad評分≥3分。Meta分析顯示：① ZDV與安慰劑比較共納入4個RCTs（2385例），無論長短療程、母乳或非母乳喂養(yǎng)人群，ZDV預(yù)防HIV母嬰傳播的效果均優(yōu)于安慰劑組，降低HIV母嬰傳播風(fēng)險43%～50%，且兩組死產(chǎn)率、嬰兒死亡率、母親死亡率、早產(chǎn)、低體重兒、出生缺陷、母嬰不良反應(yīng)發(fā)生率和母親產(chǎn)前、產(chǎn)時和產(chǎn)后并發(fā)癥發(fā)生率差異均無統(tǒng)計學(xué)意義（P gt;0.05）。② 1個大樣本RCT（1437例）比較了ZDV不同療程的效果，結(jié)果顯示ZDV“長–長療程”（從孕28周開始到產(chǎn)后6周）比“短–短療程”（從孕35周開始到分娩后3天）降低HIV母嬰傳播風(fēng)險61%［RR=0.39，95%CI（0.19，0.82）］。長–長療程與長–短療程（從孕28周開始到產(chǎn)后3天）及短-長療程（從孕35周開始到產(chǎn)后6周）比較，其預(yù)防HIV母嬰傳播的效果差異均無統(tǒng)計學(xué)意義（P  gt;0.05）。各組死產(chǎn)、新生兒死亡、1年內(nèi)嬰兒死亡、母親死亡、早產(chǎn)、低體重兒、出生缺陷、母嬰不良反應(yīng)發(fā)生率相似（P gt;0.05）。③ 1個大樣本RCT（1 200例）顯示：人工喂養(yǎng)+短程ZDV預(yù)防HIV母嬰傳播的效果優(yōu)于母乳喂養(yǎng)+長程ZDV，可降低嬰兒HIV感染風(fēng)險的35%～39%，但提高了嬰兒7個月時的死亡率（9.3% vs 4.9%；P=0.003）；兩組嬰兒早產(chǎn)率、低體重兒出生率、出生缺陷率、不良反應(yīng)發(fā)生率相似（P gt;0.05）。④ 2個直接比較短程或超短程ZDV與單劑量奈韋拉平（Nevirapine，NVP）預(yù)防HIV母嬰傳播效果的RCT（702例）顯示，NVP可降低HIV母嬰傳播風(fēng)險的44%～48%，兩組死產(chǎn)、6月內(nèi)嬰兒死亡、母親死亡、低體重兒、母嬰不良反應(yīng)發(fā)生率相似（P gt;0.05）。
結(jié)論 　無論長短療程、母乳或非母乳喂養(yǎng)人群，ZDV預(yù)防HIV母嬰傳播的效果均優(yōu)于安慰劑，且其妊娠結(jié)局和不良反應(yīng)發(fā)生情況相似。ZDV“長–長療程”比“短–短療程”預(yù)防HIV母嬰傳播效果更好，但長–長療程與長–短療程、短–長療程預(yù)防HIV母嬰傳播的效果相似；各組安全性相似。人工喂養(yǎng)+短程ZDV預(yù)防HIV母嬰傳播的效果優(yōu)于母乳喂養(yǎng)+長程ZDV，但提高了嬰兒7個月時的死亡率。單劑量NVP預(yù)防HIV母嬰傳播效果優(yōu)于短程和超短程ZDV，且安全性相似。

引用本文： 王莉,孟月,毛秀,彭麗華,姚巡,劉關(guān)鍵,敬媛媛,文進(jìn),原志芳,李幼平. 齊多夫定單用預(yù)防HIV母嬰傳播的有效性與安全性的系統(tǒng)評價. 中國循證醫(yī)學(xué)雜志, 2007, 07(5): 367-384. doi: 復(fù)制

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  1. 1. MOH, UNAIDS, WHO. Progress of condition, prevention and therapy of AIDS in China, 2005. 2006.1.24.
  2. 2. CDC. Birth outcomes following zidovudine therapy in pregnant women. MMWR Morb Mortal Wkly Rep. 1994, 43(22):409, 415-416.
  3. 3. UNAIDS.2006 report on the global AIDS epidemic. Joint United Nations Programme on HIV/AIDS (UNAIDS) 2006.
  4. 4. 中華人民共和國衛(wèi)生部, 聯(lián)合國艾滋病規(guī)劃署, 世界衛(wèi)生組織. 2005年中國艾滋病疫情與防治工作進(jìn)展. 2006年1月24日.
  5. 5. Sperling R, Shapiro D, Coombs R, et al. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunode_ciency virus type 1 from mother to infant. N Engl J Med, 1996, 335: 1621-1629.
  6. 6. Alderson P, Green S, Higgins JPT, editors. Cochrane Reviewers’ Handbook 4.2.2 [updated March 2004]. http://www.cochrane.org/resources/handbook/hbook.htm (accessed 31st January 2004).
  7. 7. CRD Report 4: Undertaking systematic reviews of research on effectiveness (2nd edition), 2001, available from http://www.york.ac.uk/inst/crd/report4.htm.
  8. 8. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
  9. 9. Connor E, Sperling R, Gelber R, et al. Reduction of maternal-infant transmission of human immunode_ciency virus type 1 with zidovudine treatment. N Engl J Med, 1994, 331: 1173-1180.
  10. 10. CDC. Zidovudine for the Prevention of HIV Transmission from Mother to Infant. Morbidity and Mortality Weekly Report (MMWR). 1994, 43(16): 285-287.
  11. 11. Connor E, Mofenson L. Zidovudine for the reduction of perinatal human immunode_ciency virus transmission: Pediatric AIDS Clinical Trials Group Protocol 076 - results and treatment recommendations. Pediatri Infect Dis J, 1995, 14: 536-541.
  12. 12. Sperling R, Shapiro D, McSherry G, et al. Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 study. AIDS, 1998, 12: 1805-1813.
  13. 13. Dabis F, Msellati P, Meda N, et al. 6-month ef_cacy, tolerance and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Cote d’Ivoire and Burkina Faso: a double-blind placebocontrolled multicentre trial. Lancet, 1999, 353: 786-792.
  14. 14. DITRAME ANRS 049 Study Group. 15-month efficacy of maternal oral zidovudine to decrease vertical transmission of HIV-1 in breastfed African children. Lancet, 1999, 354: 2050-2051.
  15. 15. Dabis F, Elenga N, Meda N, et al. 18-Month mortality and perinatal exposure to zidovudine in West Africa. AIDS, 2001, 15: 771-779.
  16. 16. Msellati P, Ramon R, Viho I, et al. Prevention of mother-to-child transmission ofHIVin Africa: uptake of pregnant women in a clinical trial in Abidjan, Cote d’Ivoire. AIDS, 1998, 12: 1257-1258.
  17. 17. Manigart O, Crépin M, Leroy V, et al. Effect of Perinatal Zidovudine Prophylaxis on the Evolution of Cell-Free HIV-1 RNA in Breast Milk and on Postnatal Transmission. The Journal of Infectious Diseases, 2004, 190: 1422-1428.
  18. 18. Dabis F, Meda N, Msellati P, et al. Infant mortality and perinatal exposure to zidovudine in Africa. XI International Conference on AIDS, Canada 1996; Abstract Tu.C.444.
  19. 19. Dabis F, Welffens-Ekra C, Meda N, et al. Six month efficacy, tolerance and acceptability of a short course regimen of oral zidovudine (ZDV) in reducing vertical transmission of HIV in breast-fed African children: ANRS 049a. 6th Conf Retrovir Oppor Infect Conf, United States1999; abstract no. 268.
  20. 20. Dabis F, Msellati P, Meda N, et al. Infant mortality and perinatal exposure to zidovudine in Africa. XIII International AIDS Conference, Durban, South Africa 2000; Abstract MoPpB1024.
  21. 21. Leroy V, Montcho C, Meda N, et al. Maternal viral load and risk of mother-to-child transmission in DITRAME ANRS 049a trial. XIII International AIDS Conference, Durban, South Africa 2000; abstract no. WePpB1302.
  22. 22. Wiktor S, Ekpini E, Karon J, et al. Short-course oral zidovudine for prevention of mother-to-child transmission of HIV-1 in Abidjan, Cote d’Ivoire: a randomised trial. Lancet, 1999, 353: 781-785.
  23. 23. Ekpini RA, Nkengasong JN, Sibailly T, et al. Changes in plasma HIV-1-RNA viral load and CD4 cell counts, and lack of zidovudine resistance among pregnant women receiving short-course zidovudine. AIDS, 2002, 16: 625-630.
  24. 24. Diaby L, Sibailly T, Ekpini S, et al. Effectiveness of a short-course oral zidovudine regimen in preventing mother-to-child transmission of HIV-1 in Abidjan, Coà te d’Ivoire: long-term follow-up in a breast-feeding population. XIth International Conference on AIDS and STDs in Africa. Lusaka, Zambia 1999; Abstract 15PT38-90.
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  27. 27. Shaffer N, Chuachoowong R, Mock P, et al. Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Lancet, 1999, 353: 773-780.
  28. 28. Bhadrakom C, Simonds R, Mei J, et al. Oral zidovudine during labour to prevent perinatal HIV transmission, Bangkok: tolerance and zidovudine concentration in cord blood. AIDS, 2000, 14: 509-516.
  29. 29. Chotpitaysaunondh T, Vanprapar N, Simonds R, et al. Safety of late in utero exposure to zidovudine in infants born to human immunodeficiency virus-infected mothers: Bangkok. Pediatrics, 2001, 107: E5.
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