美国阿拉巴马大学伯明翰分校Alan T. Tita团队研究了妊娠期轻度慢性高血压的治疗对妊娠结局的影响。该项研究成果发表在2022年4月2日出版的《新英格兰医学杂志》上。

妊娠期治疗轻度慢性高血压（血压<160/100 mm Hg）的益处和安全性尚不确定。需要数据来确定血压低于140/90 mm Hg的策略是否能在不影响胎儿生长的情况下降低不良妊娠结局的发生率。

在这项开放标签、多中心、随机试验中，研究组招募轻度慢性高血压、单胎、孕周小于23周的孕妇，将其随机分组，分别接受推荐用于妊娠的抗高血压药物（积极治疗组），或不接受此类治疗，除非有严重高血压（收缩压≥160 mm Hg；或舒张压≥105 mm Hg）（对照组）。

主要结局是具有严重特征的先兆子痫、医学指征妊娠不足35周的早产、胎盘早剥或胎儿或新生儿死亡。安全结局为小于胎龄儿出生体重低于胎龄第10百分位。次要结局包括严重的新生儿或母亲并发症、先兆子痫和早产。

共有2408名女性参与了该试验。积极治疗组的主要结局事件发生率为30.2%，显著低于对照组（37.0%），校正后的风险比为0.82。积极治疗组中出生体重小于第10百分位的小于胎龄儿百分比为11.2%，对照组中为10.4%，组间差异不显著。

积极治疗组和对照组中母亲严重并发症的发生率分别为2.1%和2.8%，风险比为0.75；新生儿严重并发症的发生率分别为2.0%和2.6%，风险比为0.77。积极治疗组和对照组中先兆子痫的发生率分别为24.4%和31.1%，风险比为0.79；早产的发生率分别为27.5%和31.4%，风险比为0.87。

研究结果表明，对于患有轻度慢性高血压的孕妇，将血压控制在140/90 mm Hg以下的策略比仅重度高血压保留治疗的策略具有更好的妊娠结局，且不会增加出生体重小于胎龄的风险。

附：英文原文

Title: Treatment for Mild Chronic Hypertension during Pregnancy | NEJM

Author: Alan T. Tita, M.D., Ph.D.,, Jeff M. Szychowski, Ph.D.,, Kim Boggess, M.D.,, Lorraine Dugoff, M.D.,, Baha Sibai, M.D.,, Kirsten Lawrence, M.D.,, Brenna L. Hughes, M.D.,, Joseph Bell, M.D.,, Kjersti Aagaard, M.D., Ph.D.,, Rodney K. Edwards, M.D.,, Kelly Gibson, M.D.,, David M. Haas, M.D.,, Lauren Plante, M.D.,, Torri Metz, M.D.,, Brian Casey, M.D.,, Sean Esplin, M.D.,, Sherri Longo, M.D.,, Matthew Hoffman, M.D.,, George R. Saade, M.D.,, Kara K. Hoppe, D.O.,, Janelle Foroutan, M.D.,, Methodius Tuuli, M.D.,, Michelle Y. Owens, M.D.,, Hyagriv N. Simhan, M.D.,, Heather Frey, M.D.,, Todd Rosen, M.D.,, Anna Palatnik, M.D.,, Susan Baker, M.D.,, Phyllis August, M.D., M.P.H.,, Uma M. Reddy, M.D.,, Wendy Kinzler, M.D.,, Emily Su, M.D.,, Iris Krishna, M.D.,, Nicki Nguyen, M.D.,, Mary E. Norton, M.D.,, Daniel Skupski, M.D.,, Yasser Y. El-Sayed, M.D.,, Dotum Ogunyemi, M.D.,, Zorina S. Galis, Ph.D.,, Lorie Harper, M.D.,, Namasivayam Ambalavanan, M.D.,, Nancy L. Geller, Ph.D.,, Suzanne Oparil, M.D.,, Gary R. Cutter, Ph.D.,, and William W. Andrews, M.D., Ph.D.

Issue&Volume: 2022-04-02

Abstract:

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; 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.

DOI: 10.1056/NEJMoa2201295

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2201295