齐多夫定与拉米夫定联用预防艾滋病病毒母婴传播效果的系统评价  

Effectiveness and Safety of Combination Therapy of Zidovudine and Lamivudine for Preventing the Risk of Mother-to-Child Transmission of HIV:A Systematic Review

作　　者：王莉[1] 毛秀 孟月 彭丽华 孙鑫[1] 敬媛媛 刘关键[1] 李幼平[1] 

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041 [2]四川大学华西临床医学院

出　　处：《中国循证医学杂志》2007年第7期487-495,共9页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金面上项目（青年科学基金项目）资助（项目编号：70503021）

摘　　要：目的系统评价齐多夫定(zidovudine,ZDV)与拉米夫定(lamivudine,3TC)联用阻断HIV母婴传播的有效性和安全性。方法计算机检索Cochrane图书馆(2007第2期)、PubMed、EMbase、CINAHL、AIDSearch、AIDSLINE、AIDSTRIALS、AIDSDRUGS、AIDSinfo、CRD(center of review and dissemination)、CBMdisc,VIP和CNKI等数据库,以及全球或地区性AIDS相关的会议论文集、政府或非政府组织的相关文件等,全面收集ZDV+3TC联用预防HIV母婴传播的随机对照试验。检索日期从1980年1月1日到2007年5月31日。由两名评价员独立筛查文献、评价质量和提取资料,然后交叉核对,若遇分歧则征求第三方意见讨论解决。Meta分析采用RevMan软件。结果共纳入4篇全文和7篇摘要,涉及3个RCT。1个大样本RCT(PETRA,1797例)比较了母乳喂养人群ZDV+3TC长疗程(从孕36周到产后1周)、短疗程(产时到产后1周)和超短疗程(仅产时)与安慰剂预防HIV母婴传播的效果,结果显示:在15个月内,长程和短程ZDV+3TC预防效果均优于安慰剂,能降低HIV母婴传播风险的35%～65%;但超短疗程与安慰剂比较,差异无统计学意义。在6周到3月内,长程和短程ZDV+3TC均优于超短程,能降低HIV母婴传播风险的41%～63%。各组死产、婴儿6周和18个月内死亡、出生缺陷和不良反应发生率均相似(P>0.05)。1个大样本RCT(SAINT,1317例)比较了短程ZDV+3TC(产时到产后1周)与奈韦拉平(NVP,母婴均单剂)预防HIV母婴传播的效果,结果显示:两组婴儿8周时HIV感染率和死产率、母婴死亡率、母婴不良反应发生率差异均无统计学意义(P>0.05)。1个小样本RCT(Moodley,20例)显示:3TC单用和ZDV+3TC联用(均从孕38周开始治疗至产后1周),在产后1～2周两组婴儿均无HIV感染,12个月时仅1例感染,且两组药物耐受性均较好。结论与安慰剂比较,在母乳喂养人群中长程(孕36周至产后1周)和短程(产时至产后1周)ZDV+3TC预防HIV母婴传播更有效,而且安全性相似。�Objective To assess the effectiveness and safety of combination therapy of zidovudine and lamivudine （ZDV＋3TC） for preventing mother-to-child transmission （MTCT） of HIV. Methods A systematicreview of randomized controlled trials （RCTs） was conducted using the methodology of The Cochrane Collaboration. PUBMED,EMBASE, CINAHL, AIDSearch, AIDSLINE, AIDSTRIALS, The Cochrane Library （Issue 2, 2007）, AIDSDRUGS, AIDSinfo, CRD （Center of Review and Dissemination） databases and three Chinese Databases （CBM, CNKI, VIP） were searched from their establishment to 31 May 2007. We also searched documents of governmental and non-governmental organizations （NGOs）, and the proceedings of relevant conferences, including the International AIDS Conferences,and the annual Conference on Retroviruses and OpportunisticInfections. RCTs assessing the effects of ZDV＋3TC for preventing MTCT were included. Trial selection, quality assessment and data extraction were done by two reviewers independently. Different opinions were resolved by discussion with a third party. Meta-analyses were conducted using The Cochrane Collaboration＇s RevMan 4.2.9 software. Results Three studies in breastfeeding populations were included. One trial （PETRA, 1797 participants） foundthat ZDV＋3TC decreased the within 15 months compared risk of transmission by 35%-65% with placebo. However,there was no evidence that ultra-short course ZDV＋3TC （during labor） decreased the risk of transmission, compared with placebo. The safety of different courses of ZDV＋3TC and placebo were similar （P〉0.05）. Another trial （SAINT, 1317 participants） found that short course ZDV＋3TC （from 36 weeks gestation to labor） did not significantly reduce HIV infection among children at 8 weeks after delivery, when compared with single dose nevirapine given to the mother and the infant （P〉0.05）. No significant difference was found in the maternal and infants mortality and side effects of two groups. One small trial （Moodley1998

关 键 词：艾滋病病毒 母婴传播 齐多夫定 拉米夫定 奈韦拉平 系统评价 

分 类 号：R512.91[医药卫生—内科学]