A randomized trial of the intrauterine contraceptive device vs hormonal contraception in women who are infected with the human immunodeficiency virus
A randomized trial of the intrauterine contraceptive device vs hormonal contraception in women who are infected with the human immunodeficiency virus
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DOI：
10.1016/j.ajog.2007.03.031
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发表时间：
2007-08-01
影响因子：
9.8
通讯作者：
Stringer, Jeffrey A.
中科院分区：
文献类型：
--
作者：
Stringer, Elizabeth M.;Kaseba, Christine;Stringer, Jeffrey A.
目的：本研究的目的是确定宫内避孕器（IUD）是否是有效和安全的妇女感染人类免疫缺陷病毒（HIV）。研究设计：我们随机分配599产后，艾滋病毒感染的妇女在赞比亚接受铜IUD或激素避孕，并随访至少2年。随机分配接受激素避孕的妇女比随机分配接受宫内节育器的妇女更容易怀孕（发生率，4.6/ 100 vs 2.0/ 100妇女-年;风险比，2.4; 95%CI，1.3- 4.7）。一名被分配使用IUD的女性出现了盆腔炎性疾病（粗发生率，0.16/100女性年; 95%CI，0.004- 868）;被分配使用激素避孕的女性中没有盆腔炎性疾病。临床疾病进展（死亡或CD 4+淋巴细胞计数降至200个细胞/μ L以下）在分配使用激素避孕的女性中更常见（13.2/ 100妇女年）比分配到宫内节育器的妇女（8.6/ 100妇女年;危险比，1.5; 95%CI，1.04- 2.1）。结论：IUD对HIV感染妇女是安全有效的。激素避孕与更快的艾滋病毒疾病进展有关的意外观察结果需要紧急进一步研究。
OBJECTIVE: The purpose of this study was to determine whether the intrauterine contraceptive device (IUD) is effective and safe among women who are infected with the human immunodeficiency virus (HIV).STUDY DESIGN: We randomly assigned 599 postpartum, HIV-infected women in Zambia to receive either a copper IUD or hormonal contraception and followed them for at least 2 years.RESULTS: Women who were assigned randomly to hormonal contraception were more likely to become pregnant than those who were assigned randomly to receive an IUD ( rate, 4.6/ 100 vs 2.0/ 100 woman-years; hazards ratio, 2.4; 95% Cl, 1.3- 4.7). One woman who was assigned to the IUD experienced pelvic inflammatory disease (crude rate, 0.16/100 woman- years; 95% Cl, 0.004- 868); there was no pelvic in- flammatory disease among those women who were assigned to hormonal contraception. Clinical disease progression (death or CD4+ lymphocyte count dropping below 200 cells/ mu L) was more common in women who were allocated to hormonal contraception (13.2/ 100 woman-years) than in women who were allocated to the IUD (8.6/ 100 woman-years; hazard ratio, 1.5; 95% Cl, 1.04- 2.1).CONCLUSION: The IUD is effective and safe in HIV- infected women. The unexpected observation that hormonal contraception was associated with more rapid HIV disease progression requires urgent further study.