Tuomala Ruth E, Shapiro David E, Mofenson Lynne M, Bryson Yvonne, Culnane Mary, Hughes Michael D, O'Sullivan M J, Scott Gwendolyn, Stek Alice M, Wara Diane, Bulterys Marc
Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston 02115, USA.
N Engl J Med. 2002 Jun 13;346(24):1863-70. doi: 10.1056/NEJMoa991159.
Some studies suggest that combination antiretroviral therapy in pregnant women with human immunodeficiency virus type 1 (HIV-1) infection increases the risk of premature birth and other adverse outcomes of pregnancy.
We studied pregnant women with HIV-1 infection who were enrolled in seven clinical studies and delivered their infants from 1990 through 1998. The cohort comprised 2123 women who received antiretroviral therapy during pregnancy (monotherapy in 1590, combination therapy without protease inhibitors in 396, and combination therapy with protease inhibitors in 137) and 1143 women who did not receive antiretroviral therapy.
After standardization for the CD4+ cell count and use or nonuse of tobacco, alcohol, and illicit drugs, the rate of premature delivery (<37 weeks of gestation) was similar among the women who received antiretroviral therapy and those who did not (16 percent and 17 percent, respectively); the rate of low birth weight (<2500 g) was 16 percent among the infants born to both groups; and the rate of very low birth weight (<1500 g) was 2 percent for the group that received antiretroviral therapy and 1 percent for the group that did not. The rates of low Apgar scores (<7) and stillbirth were also similar or the same in the two groups. After adjustment for multiple risk factors, combination antiretroviral therapy was not associated with an increased risk of premature delivery as compared with monotherapy (odds ratio, 1.08; 95 percent confidence interval, 0.71 to 1.62) or delivery of an infant with low birth weight (odds ratio, 1.03; 95 percent confidence interval, 0.64 to 1.63). Seven of the women who received combination therapy with protease inhibitors (5 percent) had infants with very low birth weight, as compared with nine women who received combination therapy without protease inhibitors (2 percent) (adjusted odds ratio, 3.56; 95 percent confidence interval, 1.04 to 12.19).
As compared with no antiretroviral therapy or monotherapy, combination therapy for HIV-1 infection in pregnant women is not associated with increased rates of premature delivery or with low birth weight, low Apgar scores, or stillbirth in their infants. The association between combination therapy with protease inhibitors and an increased risk of very low birth weight requires confirmation.
一些研究表明，感染1型人类免疫缺陷病毒（HIV-1）的孕妇接受联合抗逆转录病毒治疗会增加早产及其他不良妊娠结局的风险。
我们研究了参与7项临床研究的感染HIV-1的孕妇，这些孕妇于1990年至1998年分娩。该队列包括2123名在孕期接受抗逆转录病毒治疗的女性（1590名单一疗法、396名不含蛋白酶抑制剂的联合疗法、137名含蛋白酶抑制剂的联合疗法）以及1143名未接受抗逆转录病毒治疗的女性。
在对CD4+细胞计数以及是否使用烟草、酒精和非法药物进行标准化后，接受抗逆转录病毒治疗的女性和未接受治疗的女性早产（妊娠<37周）率相似（分别为16%和17%）；两组婴儿低出生体重（<2500g）率均为16%；接受抗逆转录病毒治疗组极低出生体重（<1500g）率为2%，未接受治疗组为1%。两组低阿氏评分（<7）和死产率也相似或相同。在对多种风险因素进行调整后，与单一疗法相比，联合抗逆转录病毒治疗与早产风险增加无关（优势比，1.08；95%置信区间，0.71至1.62），与低出生体重婴儿的分娩也无关（优势比，1.03；95%置信区间，0.64至1.63）。接受含蛋白酶抑制剂联合疗法的7名女性（5%）的婴儿为极低出生体重，而接受不含蛋白酶抑制剂联合疗法的9名女性（2%）的婴儿为极低出生体重（调整后优势比，3.56；95%置信区间，1.04至12.19）。
与不进行抗逆转录病毒治疗或单一疗法相比，孕妇HIV-1感染的联合疗法与早产率增加、婴儿低出生体重、低阿氏评分或死产无关。含蛋白酶抑制剂联合疗法与极低出生体重风险增加之间的关联需要进一步证实。
