Magee Laura A, Cham Chris, Waterman Elizabeth J, Ohlsson Arne, von Dadelszen Peter
University of British Columbia, BC Women's Hospital and Health Centre, 4500 Oak Street, Vancouver, BC, Canada V6H 3N1.
BMJ. 2003 Oct 25;327(7421):955-60. doi: 10.1136/bmj.327.7421.955.
To review outcomes in randomised controlled trials comparing hydralazine against other antihypertensives for severe hypertension in pregnancy.
Meta-analysis of randomised controlled trials (published between 1966 and September 2002) of short acting antihypertensives for severe hypertension in pregnancy. Independent data abstraction by two reviewers. Data were entered into RevMan software for analysis (fixed effects model, relative risk and 95% confidence interval); in a secondary analysis, risk difference was also calculated.
Of 21 trials (893 women), eight compared hydralazine with nifedipine and five with labetalol. Hydralazine was associated with a trend towards less persistent severe hypertension than labetalol (relative risk 0.29 (95% confidence interval 0.08 to 1.04); two trials), but more severe hypertension than nifedipine or isradipine (1.41 (0.95 to 2.09); four trials); there was significant heterogeneity in outcome between trials and differences in methodological quality. Hydralazine was associated with more maternal hypotension (3.29 (1.50 to 7.23); 13 trials); more caesarean sections (1.30 (1.08 to 1.59); 14 trials); more placental abruption (4.17 (1.19 to 14.28); five trials); more maternal oliguria (4.00 (1.22 to 12.50); three trials); more adverse effects on fetal heart rate (2.04 (1.32 to 3.16); 12 trials); and more low Apgar scores at one minute (2.70 (1.27 to 5.88); three trials). For all but Apgar scores, analysis by risk difference showed heterogeneity between trials. Hydralazine was associated with more maternal side effects (1.50 (1.16 to 1.94); 12 trials) and with less neonatal bradycardia than labetalol (risk difference -0.24 (-0.42 to -0.06); three trials).
The results are not robust enough to guide clinical practice, but they do not support use of hydralazine as first line for treatment of severe hypertension in pregnancy. Adequately powered clinical trials are needed, with a comparison of labetalol and nifedipine showing the most promise.
回顾比较肼屈嗪与其他抗高血压药物治疗妊娠期重度高血压的随机对照试验结果。
对1966年至2002年9月间发表的关于短效抗高血压药物治疗妊娠期重度高血压的随机对照试验进行荟萃分析。由两名审阅者独立提取数据。数据录入RevMan软件进行分析(固定效应模型、相对风险和95%置信区间);在二次分析中,还计算了风险差异。
在21项试验(893名女性)中,8项试验比较了肼屈嗪与硝苯地平,5项试验比较了肼屈嗪与拉贝洛尔。与拉贝洛尔相比,肼屈嗪有使持续性重度高血压减少的趋势(相对风险0.29(95%置信区间0.08至1.04);两项试验),但与硝苯地平或伊拉地平相比,重度高血压更多(1.41(0.95至2.09);四项试验);各试验间结果存在显著异质性,方法学质量也有差异。肼屈嗪与更多的母体低血压相关(3.29(1.50至7.23);13项试验);更多的剖宫产(1.30(1.08至1.59);14项试验);更多的胎盘早剥(4.17(1.19至14.28);五项试验);更多的母体少尿(4.00(1.22至12.50);三项试验);对胎儿心率的更多不良影响(2.04(1.32至3.16);12项试验);以及出生后1分钟时更低的阿氏评分(2.70(1.27至5.88);三项试验)。除阿氏评分外,所有结果经风险差异分析显示各试验间存在异质性。肼屈嗪与更多的母体副作用相关(1.50(1.16至1.94);12项试验),与拉贝洛尔相比,新生儿心动过缓更少(风险差异-0.24(-0.42至-0.06);三项试验)。
这些结果不够有力,不足以指导临床实践,但不支持将肼屈嗪作为治疗妊娠期重度高血压的一线用药。需要进行足够样本量的临床试验,比较拉贝洛尔和硝苯地平显示出最有前景。