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肼屈嗪与硝苯地平用于妊娠急性高血压急症的比较:一项随机对照试验。

Hydralazine vs nifedipine for acute hypertensive emergency in pregnancy: a randomized controlled trial.

作者信息

Sharma Chanderdeep, Soni Anjali, Gupta Amit, Verma Ashok, Verma Suresh

机构信息

Dr Rajendra Prasad Government Medical College, Tanda (HP), India.

Dr Rajendra Prasad Government Medical College, Tanda (HP), India.

出版信息

Am J Obstet Gynecol. 2017 Dec;217(6):687.e1-687.e6. doi: 10.1016/j.ajog.2017.08.018. Epub 2017 Sep 1.

Abstract

BACKGROUND

There is a paucity of good quality evidence regarding the best therapeutic option for acute control of blood pressure during acute hypertensive emergency of pregnancy.

OBJECTIVE

We sought to compare the efficacy of intravenously administered hydralazine and oral nifedipine for acute blood pressure control in acute hypertensive emergency of pregnancy.

STUDY DESIGN

In this double-blind, randomized, controlled trial, pregnant women (≥24 weeks period of gestation) with sustained increase in systolic blood pressure of ≥160 mm Hg or diastolic blood pressure of ≥110 mm Hg were randomized to receive intravenous hydralazine injection in doses of 5, 10, 10, and 10 mg and a placebo tablet or oral nifedipine (10 mg tablet up to 4 doses) and intravenous saline injection every 20 minutes until the target blood pressure of 150 mm Hg systolic and ≤100 mm Hg diastolic was achieved. Crossover treatment was administered if the initial treatment failed. The primary outcome of the study was time necessary to achieve target blood pressure. The secondary outcomes were the number of dosages required, adverse maternal and neonatal effects, and perinatal outcome.

RESULTS

From December 2014 through September 2015, we enrolled 60 patients. The median time to achieve target blood pressure was 40 minutes in both groups (intravenous hydralazine and oral nifedipine) (interquartile interval 5 and 40 minutes, respectively, P = .809). The median dose requirement in both groups was 2 (intravenous hydralazine and oral nifedipine) (interquartile range 1 and 2 doses, respectively, P = .625). Intravenous hydralazine was associated with statistically significantly higher occurrence of vomiting (9/30 vs 2/30, respectively, P = .042). No serious adverse maternal or perinatal side effects were witnessed in either group.

CONCLUSION

Both intravenous hydralazine and oral nifedipine are equally effective in lowering of blood pressure in acute hypertensive emergency of pregnancy.

摘要

背景

关于妊娠期急性高血压急症时急性控制血压的最佳治疗方案,高质量证据匮乏。

目的

我们旨在比较静脉注射肼屈嗪和口服硝苯地平在妊娠期急性高血压急症中急性控制血压的疗效。

研究设计

在这项双盲、随机、对照试验中,收缩压持续升高≥160 mmHg或舒张压持续升高≥110 mmHg的孕妇(妊娠≥24周)被随机分组,分别接受5、10、10和10 mg剂量的静脉注射肼屈嗪及一片安慰剂,或口服硝苯地平(10 mg片剂,最多4剂),每20分钟静脉注射生理盐水,直至达到收缩压150 mmHg且舒张压≤100 mmHg的目标血压。如果初始治疗失败,则给予交叉治疗。该研究的主要结局是达到目标血压所需的时间。次要结局包括所需剂量数、孕产妇和新生儿不良影响以及围产期结局。

结果

从2014年12月至2015年9月,我们招募了60名患者。两组(静脉注射肼屈嗪组和口服硝苯地平组)达到目标血压的中位时间均为40分钟(四分位间距分别为5分钟和40分钟,P = 0.809)。两组的中位剂量需求均为2(静脉注射肼屈嗪组和口服硝苯地平组)(四分位间距分别为1剂和2剂,P = 0.625)。静脉注射肼屈嗪组呕吐发生率在统计学上显著更高(分别为9/30和2/30,P = 0.042)。两组均未观察到严重的孕产妇或围产期副作用。

结论

静脉注射肼屈嗪和口服硝苯地平在妊娠期急性高血压急症中降低血压方面同样有效。

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