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 systematic review 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 Opportunistic Infections. 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) found that ZDV+3TC decreased the risk of transmission by 35%-65% within 15 months compared 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 (Pgt;0.05). Another trial (SAINT, 1317 participants) found that short course ZDV+3TC (from 36weeks 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 (Pgt;0.05). No significant difference was found in the maternal and infants mortality and side effects of two groups. One small trial (Moodley1998, 20 participants) found no infant infection in both ZDV+3TC and 3TC alone within 2 weeks after birth. Conclusions Long course (from 36 weeks gestation to 1 week after delivery) and short course (from 36 weeks gestation to labor) ZDV+3TC were more effective than placebo in preventing MTCT of HIV in breastfeeding women with a similar safety profile. Short course ZDV + 3TC had similar effects to single dose nevirapine, and long course ZDV + 3TC had similar effects to lamivudine alone.
目的 系统评价单独应用齐多夫定（zidovudine，ZDV）阻断HIV母婴传播的有效性和安全性。方法 采用Cochrane系统评价方法，计算机检索Cochrane图书馆（2007第1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，检索日期截至2007年4月30日，全面收集全球抗艾滋病病毒药物预防HIV母婴传播的随机对照试验。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。使用RevMan软件进行Meta分析。结果 共纳入8个RCT，包括24篇全文和13篇摘要，其方法学质量的Jadad评分≥3分。Meta分析显示：① ZDV与安慰剂比较共纳入4个RCTs（2385例），无论长短疗程、母乳或非母乳喂养人群，ZDV预防HIV母婴传播的效果均优于安慰剂组，降低HIV母婴传播风险43%～50%，且两组死产率、婴儿死亡率、母亲死亡率、早产、低体重儿、出生缺陷、母婴不良反应发生率和母亲产前、产时和产后并发症发生率差异均无统计学意义（Pgt;0.05）。② 1个大样本RCT（1437例）比较了ZDV不同疗程的效果，结果显示ZDV“长–长疗程”（从孕28周开始到产后6周）比“短–短疗程”（从孕35周开始到分娩后3天）降低HIV母婴传播风险61%［RR=0.39，95%CI（0.19，0.82）］。长–长疗程与长–短疗程（从孕28周开始到产后3天）及短-长疗程（从孕35周开始到产后6周）比较，其预防HIV母婴传播的效果差异均无统计学意义（P gt;0.05）。各组死产、新生儿死亡、1年内婴儿死亡、母亲死亡、早产、低体重儿、出生缺陷、母婴不良反应发生率相似（Pgt;0.05）。③ 1个大样本RCT（1 200例）显示：人工喂养+短程ZDV预防HIV母婴传播的效果优于母乳喂养+长程ZDV，可降低婴儿HIV感染风险的35%～39%，但提高了婴儿7个月时的死亡率（9.3% vs 4.9%；P=0.003）；两组婴儿早产率、低体重儿出生率、出生缺陷率、不良反应发生率相似（Pgt;0.05）。④ 2个直接比较短程或超短程ZDV与单剂量奈韦拉平（Nevirapine，NVP）预防HIV母婴传播效果的RCT（702例）显示，NVP可降低HIV母婴传播风险的44%～48%，两组死产、6月内婴儿死亡、母亲死亡、低体重儿、母婴不良反应发生率相似（Pgt;0.05）。结论 无论长短疗程、母乳或非母乳喂养人群，ZDV预防HIV母婴传播的效果均优于安慰剂，且其妊娠结局和不良反应发生情况相似。ZDV“长–长疗程”比“短–短疗程”预防HIV母婴传播效果更好，但长–长疗程与长–短疗程、短–长疗程预防HIV母婴传播的效果相似；各组安全性相似。人工喂养+短程ZDV预防HIV母婴传播的效果优于母乳喂养+长程ZDV，但提高了婴儿7个月时的死亡率。单剂量NVP预防HIV母婴传播效果优于短程和超短程ZDV，且安全性相似。