Shaffer N, Chuachoowong R, Mock P A, Bhadrakom C, Siriwasin W, Young N L, Chotpitayasunondh T, Chearskul S, Roongpisuthipong A, Chinayon P, Karon J, Mastro T D, Simonds R J
99277089 Collaborative, Nonthaburi, Thailand.
Lancet. 1999 Mar 6;353(9155):773-80. doi: 10.1016/s0140-6736(98)10411-7.
Many developing countries have not implemented the AIDS Clinical Trials Group 076 zidovudine regimen for prevention of perinatal HIV-1 transmission because of its complexity and cost. We investigated the safety and efficacy of short-course oral zidovudine administered during late pregnancy and labour.
In a randomised, double-blind, placebo-controlled trial, HIV-1-infected pregnant women at two Bangkok hospitals were randomly assigned placebo or one zidovudine 300 mg tablet twice daily from 36 weeks' gestation and every 3 h from onset of labour until delivery. Mothers were given infant formula and asked not to breastfeed. The main endpoint was babies' HIV-1-infection status, tested with HIV-1-DNA PCR at birth, 2 months, and 6 months. We measured maternal plasma viral concentrations by RNA PCR.
Between May, 1996, and December, 1997, 397 women were randomised; 393 gave birth to 395 live-born babies. Median duration of antenatal treatment was 25 days, and median number of doses during labour was three. 99% of women took at least 90% of scheduled antenatal doses. Adverse events were similar in the study groups. Of 392 babies with at least one PCR test, 55 tested positive: 18 in the zidovudine group and 37 in the placebo group. The estimated transmission risks were 9.4% (95% CI 5.2-13.5) on zidovudine and 18.9% (13.2-24.2) on placebo (p=0.006; efficacy 50.1% [15.4-70.6]). Between enrolment and delivery, women in the zidovudine group had a mean decrease in viral load of 0.56 log. About 80% of the treatment effect was explained by lowered maternal viral concentrations at delivery.
A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child HIV-1 transmission by half. This regimen could prevent many HIV-1 infections during late pregnancy and labour in less-developed countries unable to implement the full 076 regimen.
许多发展中国家尚未采用艾滋病临床试验组076号齐多夫定方案来预防围产期HIV-1传播，因为该方案复杂且成本高昂。我们调查了妊娠晚期和分娩期间口服短疗程齐多夫定的安全性和有效性。
在一项随机、双盲、安慰剂对照试验中，两家曼谷医院的HIV-1感染孕妇被随机分配接受安慰剂或从妊娠36周起每天两次服用一片300毫克齐多夫定，从临产开始每3小时服用一次直至分娩。给母亲们提供婴儿配方奶粉，并要求她们不要母乳喂养。主要终点是婴儿的HIV-1感染状况，在出生时、2个月和6个月时用HIV-1-DNA PCR检测。我们通过RNA PCR测量母亲血浆病毒浓度。
在1996年5月至1997年12月期间，397名妇女被随机分组；393名妇女产下395名活产婴儿。产前治疗的中位持续时间为25天，分娩期间的中位剂量数为3剂。99%的妇女服用了至少90%的预定产前剂量。研究组的不良事件相似。在392名至少接受过一次PCR检测的婴儿中，55名检测呈阳性：齐多夫定组18名，安慰剂组37名。齐多夫定的估计传播风险为9.4%（95%CI 5.2-13.5），安慰剂为18.9%（13.2-24.2）（p=0.006；疗效50.1%[15.4-70.6]）。从入组到分娩，齐多夫定组妇女的病毒载量平均下降了0.56对数。约80%的治疗效果可归因于分娩时母亲病毒浓度的降低。
短疗程每日两次口服齐多夫定是安全且耐受性良好的，在不进行母乳喂养的情况下，可将母婴HIV-1传播风险降低一半。该方案可在无法实施完整076方案的欠发达国家预防妊娠晚期和分娩期间的许多HIV-1感染。
