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拉贝洛尔与硝苯地平治疗妊娠慢性高血压的随机对照试验。

Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial.

机构信息

From the Women's Health Academic Centre, King's College London, United Kingdom (L.M.W., C.N.-P., P.T.S., L.C.C.); Directorate of Women's Health, Guy's and St Thomas' Foundation Trust, London, United Kingdom (L.M.W., C.N.-P., K.H., L.C.C.); Maternaland Fetal Health ResearchCenter, Division of Developmental Biology and Medicine, School of Medical Sciences, University of Manchester, Manchester Academic Health ScienceCenter, UnitedKingdom(J.E.M.); St Mary's Hospital, Central Manchester Foundation Trust, United Kingdom (J.E.M.); Cardiovascular Division, Department of Clinical Pharmacology, St Thomas' Hospital, King's College London British Heart Foundation Centre, United Kingdom (J.K.C.); Fetal Maternal Medicine Unit, St George's University of London,UnitedKingdom (I.W.-C., A.K.); andDepartment of Obstetrics and Gynaecology, Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust, United Kingdom (C.W.).

出版信息

Hypertension. 2017 Nov;70(5):915-922. doi: 10.1161/HYPERTENSIONAHA.117.09972. Epub 2017 Sep 11.

DOI:10.1161/HYPERTENSIONAHA.117.09972
PMID:28893900
Abstract

UNLABELLED

Data from randomized controlled trials to guide antihypertensive agent choice for chronic hypertension in pregnancy are limited; this study aimed to compare labetalol and nifedipine, additionally assessing the impact of ethnicity on treatment efficacy. Pregnant women with chronic hypertension (12-27 weeks' gestation) were enrolled at 4 UK centers (August 2014 to October 2015). Open-label first-line antihypertensive treatment was randomly assigned: labetalol- (200-1800 mg/d) or nifedipine-modified release (20-80 mg/d). Analysis included 112 women (98%) who completed the study (labetalol n=55, nifedipine n=57). Maximum blood pressure after randomization was 161/101 mm Hg with labetalol versus 163/105 mm Hg with nifedipine (mean difference systolic: 1.2 mm Hg [-4.9 to 7.2 mm Hg], diastolic: 3.3 mm Hg [-0.6 to 7.3 mm Hg]). Mean blood pressure was 134/84 mm Hg with labetalol and 134/85 mm Hg with nifedipine (mean difference systolic: 0.3 mm Hg [-2.8 to 3.4 mm Hg], and diastolic: -1.9 mm Hg [-4.1 to 0.3 mm Hg]). Nifedipine use was associated with a 7.4-mm Hg reduction (-14.4 to -0.4 mm Hg) in central aortic pressure, measured by pulse wave analysis. No difference in treatment effect was observed in black women (n=63), but a mean 4 mm Hg reduction (-6.6 to -0.8 mm Hg; =0.015) in brachial diastolic blood pressure was observed with labetalol compared with nifedipine in non-black women (n=49). Labetalol and nifedipine control mean blood pressure to target in pregnant women with chronic hypertension. This study provides support for a larger definitive trial scrutinizing the benefits and side effects of first-line antihypertensive treatment.

CLINICAL TRIAL REGISTRATION

URL: https://www.isrctn.com. Unique identifier: ISRCTN40973936.

摘要

未标注

指导妊娠慢性高血压降压药物选择的随机对照试验数据有限;本研究旨在比较拉贝洛尔和硝苯地平,并评估种族对治疗效果的影响。2014 年 8 月至 2015 年 10 月,4 家英国中心招募了妊娠慢性高血压(12-27 孕周)的孕妇。一线开放标签降压治疗随机分配:拉贝洛尔(200-1800mg/d)或硝苯地平控释片(20-80mg/d)。分析纳入 112 名完成研究的女性(98%)(拉贝洛尔组 55 例,硝苯地平组 57 例)。随机分组后最大血压为 161/101mmHg(拉贝洛尔)与 163/105mmHg(硝苯地平)(收缩压平均差值:1.2mmHg[-4.9 至 7.2mmHg],舒张压:3.3mmHg[-0.6 至 7.3mmHg])。拉贝洛尔组平均血压为 134/84mmHg,硝苯地平组为 134/85mmHg(收缩压平均差值:0.3mmHg[-2.8 至 3.4mmHg],舒张压:-1.9mmHg[-4.1 至 0.3mmHg])。脉搏波分析显示,硝苯地平组的中心主动脉压降低 7.4mmHg(-14.4 至-0.4mmHg)。黑人女性(n=63)的治疗效果无差异,但与硝苯地平相比,拉贝洛尔组非黑人女性(n=49)的肱动脉舒张压平均降低 4mmHg(-6.6 至-0.8mmHg;=0.015)。拉贝洛尔和硝苯地平均可控制妊娠慢性高血压患者的平均血压。本研究为进一步研究一线降压治疗的益处和副作用提供了支持。

临床试验注册

网址:https://www.isrctn.com。唯一标识符:ISRCTN40973936。

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