齊多夫定與拉米夫定聯用預防艾滋病病毒母嬰傳播效果的系統評價_《中國循證醫學雜志》

作者：

王莉 ¹ , 毛秀 ² , 孟月 ² , 彭麗華 ² , 孫鑫 ¹ , 敬媛媛 ² , 劉關鍵 ¹ ,  李幼平 ¹

1. 四川大學華西醫院中國循證醫學中心（成都 610041） 2. 四川大學華西臨床醫學院;

關鍵詞：

艾滋病病毒母嬰傳播齊多夫定拉米夫定奈韋拉平系統評價

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目的　系統評價齊多夫定（zidovudine，ZDV）與拉米夫定（lamivudine，3TC）聯用阻斷HIV母嬰傳播的有效性和安全性。
方法　計算機檢索Cochrane圖書館（2007第2期）、PubMed、EMbase、CINAHL、AIDSearch、AIDSLINE、AIDSTRIALS、AIDSDRUGS、AIDSinfo、CRD（center of review anddissemination）、CBMdisc，VIP 和CNKI 等數據庫，以及全球或地區性AIDS 相關的會議論文集、政府或非政府組織的相關文件等，全面收集ZDV+3TC聯用預防HIV母嬰傳播的隨機對照試驗。檢索日期從1980年1月1日到2007 年5 月31 日。由兩名評價員獨立篩查文獻、評價質量和提取資料，然后交叉核對，若遇分歧則征求第三方意見討論解決。Meta分析采用RevMan軟件。
結果　共納入4 篇全文和7篇摘要，涉及3個RCT。1個大樣本RCT（PETRA，1797例）比較了母乳喂養人群ZDV+3TC長療程（從孕36周到產后1周）、短療程（產時到產后1周）和超短療程（僅產時）與安慰劑預防HIV母嬰傳播的效果，結果顯示：在15個月內，長程和短程ZDV+3TC預防效果均優于安慰劑，能降低HIV母嬰傳播風險的35%～65%；但超短療程與安慰劑比較，差異無統計學意義。在6周到3月內，長程和短程ZDV+3TC均優于超短程，能降低HIV母嬰傳播風險的41%～63%。各組死產、嬰兒6周和18個月內死亡、出生缺陷和不良反應發生率均相似（P gt;0.05）。1個大樣本RCT（SAINT，1317例）比較了短程ZDV+3TC（產時到產后1周）與奈韋拉平（NVP，母嬰均單劑）預防HIV母嬰傳播的效果，結果顯示：兩組嬰兒8周時HIV感染率和死產率、母嬰死亡率、母嬰不良反應發生率差異均無統計學意義（P gt;0.05）。1個小樣本RCT（Moodley，20例）顯示：3TC單用和ZDV+3TC聯用（均從孕38周開始治療至產后1周），在產后1～2周兩組嬰兒均無HIV感染，12個月時僅1例感染，且兩組藥物耐受性均較好。
結論　與安慰劑比較，在母乳喂養人群中長程（孕36周至產后1周）和短程（產時至產后1周）ZDV+3TC預防HIV母嬰傳播更有效，而且安全性相似。短程ZDV+3TC預防效果和安全性與母嬰單劑NVP相似。長程ZDV+3TC預防效果與3TC相似。

引用本文： 王莉,毛秀,孟月,彭麗華,孫鑫,敬媛媛,劉關鍵,李幼平. 齊多夫定與拉米夫定聯用預防艾滋病病毒母嬰傳播效果的系統評價. 中國循證醫學雜志, 2007, 07(7): 487-495. doi: 復制

1.	Wang L, MengY, Mao X, et al. Effectiveness and Safety of Zidovudine for Preventing the Risk of Mother-to-Child Transmission of HIV: A Systematic Review. Chinese Journal of Evidence-based Medicine, 2007, 7(5): 367-384.
2.	Li TS, et al. the AIDS guideline group of Chinese Medical Associate. Guideline of AIDS diagnosis and therapy. http://www.moh.gov.cn/newshtml/9266.htm.
3.	Nation group of Handbook for the free antiretroviral therapy of HIV. Nation Free medical Information Handbook for the antiretroviral therapy of HIV. 2004. 12.
4.	Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. New Engl J Med, 1994, 331: 1173-1180.
5.	Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet, 1999, 354(9181): 795-802.
6.	Brocklehurst P, Volmink J. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. Cochrane Database of Systematic Reviews 2002, Issue 2. Art. No.: CD003510. DOI: 10. 1002/14651858.CD003510.
7.	Brocklehurst, P. and Volmink, J. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. The Cochrane Library. 2006 Issue 1. CD003510.
8.	王莉, 孟月, 毛秀, 等. 齊多夫定單用預防HIV母嬰傳播有效性和安全性的系統評價. 中國循證醫學雜志, 2007, 7(5): 367-384.
9.	Culnane M, Fowler MG, Lee S, et al. Lack of long-term effects of in utero exposure to zidovudine among uninfected childen born to HIV-infected women. JAMA, 1991, 281: 151-157.
10.	Allen UD, Conway B, Lapointe N, et al. Zidovudine resistance and associated factors among HIV-infected Canadian children. Int Conf AIDS, 996, 11: 311 (abstract no. Th.B.4353).
11.	Delvaux, Therese. Nevirapine sustains reduction of mother-to-child HIV transmission at 18 months. Evidence-Based Healthcare, 2004, 8(2): 87-88.
12.	Arrive E, Newell ML, Ekouevi DK, et al. Prevalence of resistance to nevirapine in mothers and children after single-dose exposure to prevent vertical transmission of HIV-1: a meta-analysis. Int J Epidemiol: dym104v1-13. 2007 May 28.
13.	The PETRA Study Team. Efficacy of three shortcourse regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (PETRA study): a randomized, double-blind, placebo-controlled trial. Lancet, 2002, 359: 1178-1186.
14.	Moodley D, McIntyre J. Evaluation of safety and efficacy of two simple regimens for the prevention of mother to child transmission(MTCT) of HIV-infection: nevirapine vs. lamivudine and zidovudine used in a randomized clinical trial (the SAINT study). XIII International AIDS Conference; July 9-14, 2000; Durban, South Africa. Abstract TuOrB356.
15.	Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission. JAMA, 2002, 288(2): 189-198.
16.	World Health Organization. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants.Guidelines on care, treatment and support for women living with HIV/AIDS and their children in resource-constrained settings. Geneva, 2004 (http://www.who.int/hiv/pub/mtct/guidelines/en/, accessed 19 June 2006).
17.	李太生, 等（中華醫學會艾滋病指南撰寫組）. 艾滋病診療指南. 中國衛生部網站http://www.moh.gov.cn/newshtml/9266.htm.
18.	國家免費艾滋病抗病毒藥物治療手冊編寫組. 國家免費艾滋病抗病毒藥物治療手冊. 2004. 12.
19.	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.
20.	Giuliano M, Palmisano L, Galluzzo CM, et al. Selection of resistance mutations in pregnant women receiving zidovudine and lamivudine to prevent HIV perinatal transmission. AIDS, 2003, 17(10): 1570-1572.
21.	Saba J. Interim analysis of early efficacy of three short ZDV/3TC combination regimens to prevent mother-to-child transmission of HIV-1: the PETRA trial. 6th Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4; 212: abstract no. S7.
22.	Saba J. The results of the PETRA intervention trial to prevent perinatal transmission in sub-Saharan Africa. Chicago: Foundation for Retrovirology and Human Health,, 1999. (See http://www.retroconference.org/99/lect_symposia/sym_session8.htm.) (See NAPS document no. 05531 for 19 pages, c/o Microfiche Publications, 248 Hempstead Tpke, West Hempstead, NY 11552.).
23.	Mcintyre JA, Gray GE. The Effect of Mode of Delivery and Other Variables on the Early Efficacy of Three Short ZDV/3TC Combination Regimens to Prevent Mother-to-Child Transmission of HIV-1: the PETRA Trial. Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 1999 Sep 26-29; 39: 478; abstract no. 585.
24.	Gray G. The PETRA study: early and late efficacy of three short ZDV/3TC combination regimens to prevent mother-to-child transmission of HIV-1. Int Conf AIDS 2000 Jul 9-14; 13:17; abstract no. LbOr5.
25.	Giuliano M, Galluzzo T, Amici R, et al. Selection of Resistance Mutations in Pregnant Women Receiving Short-Course Antiretroviral Regimens with ZDV and 3TC to Prevent Perinatal Transmission (PETRA Study). 9th Conference on Retroviruses and Opportunistic Infections. 2002 Feb 24-28, 9: abstract no. 802-W.
26.	Moodley D, Moodley J, Coovadia H, et al. A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early postpartum mother-to-child transmission of human immunodeficiency virus type 1. Journal of Infectious Diseases, 2003, 187(5): 725-735.
27.	McIntyre J. Evaluation of safety of two simple regimens for prevention of mother to child transmission (MTCT) of HIV infection ’Nevirapine (NVP) vs lamivudine (3TC)+zidovudine (ZDV)’ used in a randomized clinical trial (The SAINT Study).International Conference on AIDS, South Africa 2000 Jul 9-14; 13: abstract no. TuOrB356.
28.	Moodley D, McIntyre J. Evaluation of safety and efficacy of two simple regimens for the prevention of mother to child transmission (MTCT) of HIV infection: nevirapine vs lamivudine and zidovudine used in a randomised clinical trial (SAINT). XIII International AIDS Conference, Durban. 2000; Vol. Abstract TuOrB356.
29.	Moodley J, Moodley D, Pillay K, et al. Pharmacokinetics and antiretroviral activity of lamivudine alone or when coadministeredwith zidovudine in human immunodeficiency virus type 1-infected pregnant women and their offspring. Journal of Infectious Diseases, 1998, 178(5): 1327-1333.
30.	Elliot Marseille, James G. Kahn, Joseph Saba. Cost-effectiveness of antiviral drug therapy to reduce mother-to-child HIV transmission in sub-Saharan Africa. AIDS, 1998, 12: 939-948.

1. Wang L, MengY, Mao X, et al. Effectiveness and Safety of Zidovudine for Preventing the Risk of Mother-to-Child Transmission of HIV: A Systematic Review. Chinese Journal of Evidence-based Medicine, 2007, 7(5): 367-384.
2. Li TS, et al. the AIDS guideline group of Chinese Medical Associate. Guideline of AIDS diagnosis and therapy. http://www.moh.gov.cn/newshtml/9266.htm.
3. Nation group of Handbook for the free antiretroviral therapy of HIV. Nation Free medical Information Handbook for the antiretroviral therapy of HIV. 2004. 12.
4. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. New Engl J Med, 1994, 331: 1173-1180.
5. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet, 1999, 354(9181): 795-802.
6. Brocklehurst P, Volmink J. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. Cochrane Database of Systematic Reviews 2002, Issue 2. Art. No.: CD003510. DOI: 10. 1002/14651858.CD003510.
7. Brocklehurst, P. and Volmink, J. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. The Cochrane Library. 2006 Issue 1. CD003510.
8. 王莉, 孟月, 毛秀, 等. 齊多夫定單用預防HIV母嬰傳播有效性和安全性的系統評價. 中國循證醫學雜志, 2007, 7(5): 367-384.
9. Culnane M, Fowler MG, Lee S, et al. Lack of long-term effects of in utero exposure to zidovudine among uninfected childen born to HIV-infected women. JAMA, 1991, 281: 151-157.
10. Allen UD, Conway B, Lapointe N, et al. Zidovudine resistance and associated factors among HIV-infected Canadian children. Int Conf AIDS, 996, 11: 311 (abstract no. Th.B.4353).
11. Delvaux, Therese. Nevirapine sustains reduction of mother-to-child HIV transmission at 18 months. Evidence-Based Healthcare, 2004, 8(2): 87-88.
12. Arrive E, Newell ML, Ekouevi DK, et al. Prevalence of resistance to nevirapine in mothers and children after single-dose exposure to prevent vertical transmission of HIV-1: a meta-analysis. Int J Epidemiol: dym104v1-13. 2007 May 28.
13. The PETRA Study Team. Efficacy of three shortcourse regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (PETRA study): a randomized, double-blind, placebo-controlled trial. Lancet, 2002, 359: 1178-1186.
14. Moodley D, McIntyre J. Evaluation of safety and efficacy of two simple regimens for the prevention of mother to child transmission(MTCT) of HIV-infection: nevirapine vs. lamivudine and zidovudine used in a randomized clinical trial (the SAINT study). XIII International AIDS Conference; July 9-14, 2000; Durban, South Africa. Abstract TuOrB356.
15. Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission. JAMA, 2002, 288(2): 189-198.
16. World Health Organization. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants.Guidelines on care, treatment and support for women living with HIV/AIDS and their children in resource-constrained settings. Geneva, 2004 (http://www.who.int/hiv/pub/mtct/guidelines/en/, accessed 19 June 2006).
17. 李太生, 等（中華醫學會艾滋病指南撰寫組）. 艾滋病診療指南. 中國衛生部網站http://www.moh.gov.cn/newshtml/9266.htm.
18. 國家免費艾滋病抗病毒藥物治療手冊編寫組. 國家免費艾滋病抗病毒藥物治療手冊. 2004. 12.
19. 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.
20. Giuliano M, Palmisano L, Galluzzo CM, et al. Selection of resistance mutations in pregnant women receiving zidovudine and lamivudine to prevent HIV perinatal transmission. AIDS, 2003, 17(10): 1570-1572.
21. Saba J. Interim analysis of early efficacy of three short ZDV/3TC combination regimens to prevent mother-to-child transmission of HIV-1: the PETRA trial. 6th Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4; 212: abstract no. S7.
22. Saba J. The results of the PETRA intervention trial to prevent perinatal transmission in sub-Saharan Africa. Chicago: Foundation for Retrovirology and Human Health,, 1999. (See http://www.retroconference.org/99/lect_symposia/sym_session8.htm.) (See NAPS document no. 05531 for 19 pages, c/o Microfiche Publications, 248 Hempstead Tpke, West Hempstead, NY 11552.).
23. Mcintyre JA, Gray GE. The Effect of Mode of Delivery and Other Variables on the Early Efficacy of Three Short ZDV/3TC Combination Regimens to Prevent Mother-to-Child Transmission of HIV-1: the PETRA Trial. Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 1999 Sep 26-29; 39: 478; abstract no. 585.
24. Gray G. The PETRA study: early and late efficacy of three short ZDV/3TC combination regimens to prevent mother-to-child transmission of HIV-1. Int Conf AIDS 2000 Jul 9-14; 13:17; abstract no. LbOr5.
25. Giuliano M, Galluzzo T, Amici R, et al. Selection of Resistance Mutations in Pregnant Women Receiving Short-Course Antiretroviral Regimens with ZDV and 3TC to Prevent Perinatal Transmission (PETRA Study). 9th Conference on Retroviruses and Opportunistic Infections. 2002 Feb 24-28, 9: abstract no. 802-W.
26. Moodley D, Moodley J, Coovadia H, et al. A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early postpartum mother-to-child transmission of human immunodeficiency virus type 1. Journal of Infectious Diseases, 2003, 187(5): 725-735.
27. McIntyre J. Evaluation of safety of two simple regimens for prevention of mother to child transmission (MTCT) of HIV infection ’Nevirapine (NVP) vs lamivudine (3TC)+zidovudine (ZDV)’ used in a randomized clinical trial (The SAINT Study).International Conference on AIDS, South Africa 2000 Jul 9-14; 13: abstract no. TuOrB356.
28. Moodley D, McIntyre J. Evaluation of safety and efficacy of two simple regimens for the prevention of mother to child transmission (MTCT) of HIV infection: nevirapine vs lamivudine and zidovudine used in a randomised clinical trial (SAINT). XIII International AIDS Conference, Durban. 2000; Vol. Abstract TuOrB356.
29. Moodley J, Moodley D, Pillay K, et al. Pharmacokinetics and antiretroviral activity of lamivudine alone or when coadministeredwith zidovudine in human immunodeficiency virus type 1-infected pregnant women and their offspring. Journal of Infectious Diseases, 1998, 178(5): 1327-1333.
30. Elliot Marseille, James G. Kahn, Joseph Saba. Cost-effectiveness of antiviral drug therapy to reduce mother-to-child HIV transmission in sub-Saharan Africa. AIDS, 1998, 12: 939-948.

《中國循證醫學雜志》

齊多夫定與拉米夫定聯用預防艾滋病病毒母嬰傳播效果的系統評價

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《中國循證醫學雜志》

齊多夫定與拉米夫定聯用預防艾滋病病毒母嬰傳播效果的系統評價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

Format

Content

摘要全文圖表視頻參考文獻施引文獻補充材料