妊娠期轻度慢性高血压的治疗。
Treatment for Mild Chronic Hypertension during Pregnancy.
机构信息
From the Department of Obstetrics and Gynecology (A.T.T., W.W.A.), the Center for Women's Reproductive Health (A.T.T., J.M.S., N.A., S.O., G.R.C., W.W.A.), the Department of Biostatistics (J.M.S., G.R.C.), the Division of Neonatology, Department of Pediatrics (N.A.), and the Division of Cardiovascular Disease, Department of Medicine (S.O.), University of Alabama, Birmingham; the Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill (K.B.), and the Department of Obstetrics and Gynecology, Duke University, Durham (B.L.H.) - both in North Carolina; the Department of Obstetrics and Gynecology, University of Pennsylvania (L.D.), and the Department of Obstetrics and Gynecology, Drexel University College of Medicine (L.P.), Philadelphia, St. Luke's University Health Network, Fountain Hill (J.B.), and the Department of Obstetrics and Gynecology, Magee Women's Hospital, University of Pittsburgh, Pittsburgh (H.N.S.) - all in Pennsylvania; the Department of Obstetrics and Gynecology, University of Texas (B.S.), and the Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston (K.A.), the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas (B.C.), the Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston (G.R.S.), and the Department of Women's Health, University of Texas, Austin (L.H.); the Department of Obstetrics and Gynecology, Columbia University (K.L.), Weill Cornell University (P.A.), and the Department of Obstetrics and Gynecology, New York Presbyterian Queens Hospital (D.S.), New York, and the Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola (W.K.) - all in New York; the Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences, Oklahoma City (R.K.E.); MetroHealth System, Cleveland (K.G.); the Department of Obstetrics and Gynecology, Indiana University, Indianapolis (D.M.H.); the Department of Obstetrics and Gynecology, University of Utah (T.M.), and Intermountain Healthcare (S.E.), Salt Lake City; Ochsner Baptist Medical Center, New Orleans (S.L.); Christiana Care Health Services, Newark, DE (M.H.); the Department of Obstetrics and Gynecology, UnityPoint Health-Meriter Hospital/Marshfield Clinic, Madison (K.K.H.), and the Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee (A.P.); St. Peters University Hospital (J.F.) and the Department of Obstetrics and Gynecology, Robert Wood Johnson Medical School, Rutgers University (T.R.), New Brunswick, NJ; the Department of Obstetrics and Gynecology, Washington University, St. Louis (M.T.); the Department of Obstetrics and Gynecology, University of Mississippi Medical Center, Jackson (M.Y.O.); the Department of Obstetrics and Gynecology, Ohio State University, Columbus (H.F.); the Department of Obstetrics and Gynecology, University of South Alabama, Mobile (S.B.); the Department of Obstetrics and Gynecology, Yale University, New Haven, CT (U.M.R.); the Department of Obstetrics and Gynecology, University of Colorado, Boulder (E.S.), and the Department of Obstetrics and Gynecology, Denver Health, Denver (N.N.); the Department of Obstetrics and Gynecology, Emory University, Atlanta (I.K.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital (M.E.N.), San Francisco, the Department of Obstetrics and Gynecology, Stanford University, Stanford (Y.Y.E.-S.), and the Department of Obstetrics and Gynecology, Arrowhead Regional Medical Center, Colton (D.O.); Beaumont Hospital, Southfield, MI (D.O.); and the Division of Cardiovascular Sciences (Z.S.G.) and the Office of Biostatistics Research (N.L.G.), National Heart, Lung, and Blood Institute, Bethesda, MD.
出版信息
N Engl J Med. 2022 May 12;386(19):1781-1792. doi: 10.1056/NEJMoa2201295. Epub 2022 Apr 2.
BACKGROUND
The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth.
METHODS
In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth.
RESULTS
A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99).
CONCLUSIONS
In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).
背景
治疗轻度慢性高血压（血压<160/100mmHg）的益处和安全性尚不确定。需要数据来证明将血压目标定在<140/90mmHg 是否可以降低不良妊娠结局的发生率，而不会影响胎儿生长。
方法
在这项开放标签、多中心、随机试验中，我们将患有轻度慢性高血压和胎龄<23 周的单胎孕妇随机分为接受推荐用于妊娠的降压药物治疗（积极治疗组）或除非出现严重高血压（收缩压≥160mmHg；或舒张压≥105mmHg）才接受治疗（对照组）。主要结局是子痫前期伴有严重特征、<35 周早产、胎盘早剥、胎儿或新生儿死亡的复合结局。安全性结局是出生体重低于胎龄第 10 百分位的小于胎龄儿。次要结局包括严重新生儿或产妇并发症、子痫前期和早产的复合结局。
结果
共有 2408 名妇女参加了试验。与对照组相比，积极治疗组的主要结局事件发生率较低（30.2% vs. 37.0%），调整后的风险比为 0.82（95%置信区间[CI]，0.74 至 0.92；P<0.001）。出生体重低于胎龄第 10 百分位的比例在积极治疗组为 11.2%，在对照组为 10.4%（调整后的风险比，1.04；95%CI，0.82 至 1.31；P=0.76）。严重产妇并发症的发生率分别为 2.1%和 2.8%（风险比，0.75；95%CI，0.45 至 1.26），严重新生儿并发症的发生率分别为 2.0%和 2.6%（风险比，0.77；95%CI，0.45 至 1.30）。两组子痫前期的发生率分别为 24.4%和 31.1%（风险比，0.79；95%CI，0.69 至 0.89），早产的发生率分别为 27.5%和 31.4%（风险比，0.87；95%CI，0.77 至 0.99）。
结论
在患有轻度慢性高血压的孕妇中，将血压目标定在<140/90mmHg 比仅在出现严重高血压时才进行治疗的策略更能改善妊娠结局，且不会增加小于胎龄儿的风险。（由美国国立心肺血液研究所资助；CHAP 临床试验.gov 编号，NCT02299414。）
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