Rouzioux C
Hôpital Necker-Enfants Malades, Paris, France.
Drugs. 1995;49 Suppl 1:17-24; discussion 38-40. doi: 10.2165/00003495-199500491-00006.
The recently published Protocol 076 study (ACTG 076/ANRS 024) showed that zidovudine significantly decreased the relative risk of maternal HIV transmission by 71.5% compared with placebo. Oral zidovudine 100 mg five times daily until the onset of labour, followed by intravenous zidovudine 2 mg/kg over 1 hour then 1 mg/kg.h until delivery, or an identical placebo regimen were administered to HIV-infected pregnant women (14 to 34 weeks' gestation) with CD4+ counts > 200 cells/microliters. 400 babies born to these women received zidovudine syrup 2 mg/kg or placebo administered 6-hourly for 6 weeks. The zidovudine regimens were well tolerated by both mothers and infants. Further studies should aim to determine the mechanism by which zidovudine reduces the risk of maternal HIV transmission, the timing of HIV transmission, the efficacy of zidovudine in women not meeting the entry criteria for Protocol 076 and the long term effects of zidovudine during pregnancy on both mother and infant, and should examine the possibility of developing a simplified zidovudine regimen. Following recent guidelines from the US and French public health services, the full Protocol 076 regimen should be given to all women fulfilling that study's entry criteria. This regimen should also be considered in women with more severe disease or in later stages of gestation. Clinical efficacy of zidovudine should be monitored closely in women and infants, who should also be followed up for long term adverse effects. Unblinded screening for HIV in pregnant women in the USA is facing extreme opposition; nevertheless, guidelines on HIV counselling and HIV testing of pregnant women are currently being developed there in light of the Protocol 076 findings.
最近发表的076号方案研究(艾滋病临床试验组076/法国国家艾滋病研究机构024)表明,与安慰剂相比,齐多夫定可使母亲传播艾滋病毒的相对风险显著降低71.5%。对妊娠14至34周、CD4+细胞计数>200个/微升的感染艾滋病毒的孕妇,给予每日5次口服100毫克齐多夫定直至分娩开始,随后1小时内静脉注射2毫克/千克齐多夫定,然后以1毫克/千克·小时的剂量持续至分娩,或给予相同的安慰剂方案。这些妇女所生的400名婴儿接受了2毫克/千克的齐多夫定糖浆或安慰剂,每6小时给药一次,持续6周。母亲和婴儿对齐多夫定方案的耐受性良好。进一步的研究应旨在确定齐多夫定降低母亲传播艾滋病毒风险的机制、艾滋病毒传播的时间、齐多夫定在不符合076号方案纳入标准的妇女中的疗效以及孕期齐多夫定对母亲和婴儿的长期影响,并应研究制定简化的齐多夫定方案的可能性。根据美国和法国公共卫生服务机构最近的指南,应向所有符合该研究纳入标准的妇女提供完整的076号方案治疗方案。对于病情更严重或妊娠晚期的妇女也应考虑采用该方案。应密切监测妇女和婴儿体内齐多夫定的临床疗效,并应对其进行长期不良反应随访。在美国,对孕妇进行非盲法艾滋病毒筛查面临极大反对;尽管如此,目前正在根据076号方案的研究结果制定关于孕妇艾滋病毒咨询和检测的指南。