拉贝洛尔和甲基多巴对妊娠结局的影响是否不同？来自妊娠高血压控制研究（CHIPS）试验的数据分析。

Do labetalol and methyldopa have different effects on pregnancy outcome? Analysis of data from the Control of Hypertension In Pregnancy Study (CHIPS) trial.

机构信息

Medicine, University of British Columbia, Vancouver, BC, Canada.

Obstetrics and Gynaecology, University of British Columbia, Vancouver, BC, Canada.

出版信息

BJOG. 2016 Jun;123(7):1143-51. doi: 10.1111/1471-0528.13569. Epub 2015 Aug 11.

OBJECTIVE

To compare pregnancy outcomes, accounting for allocated group, between methyldopa-treated and labetalol-treated women in the CHIPS Trial (ISRCTN 71416914) of 'less tight' versus 'tight' control of pregnancy hypertension.

DESIGN

Secondary analysis of CHIPS Trial cohort.

SETTING

International randomised controlled trial (94 sites, 15 countries).

POPULATION OR SAMPLE

Of 987 CHIPS recruits, 481/566 (85.0%) women treated with antihypertensive therapy at randomisation. Of 981 (99.4%) women followed to delivery, 656/745 (88.1%) treated postrandomisation.

METHODS

Logistic regression to compare outcomes among women who took methyldopa or labetalol, adjusted for the influence of baseline factors.

MAIN OUTCOME MEASURES

CHIPS primary (perinatal loss or high level neonatal care for >48 hours) and secondary (serious maternal complications) outcomes, birthweight <10th centile, severe maternal hypertension, pre-eclampsia and delivery at <34 or <37 weeks.

RESULTS

Methyldopa and labetalol were used commonly at randomisation (243/987, 24.6% and 238/987, 24.6%, respectively) and post-randomisation (224/981, 22.8% and 433/981, 44.1%, respectively). Following adjusted analyses, methyldopa (versus labetalol) at randomisation was associated with fewer babies with birthweight <10th centile [adjusted odds ratio (aOR) 0.48; 95% CI 0.20-0.87]. Methyldopa (versus labetalol) postrandomisation was associated with fewer CHIPS primary outcomes (aOR 0.64; 95% CI 0.40-1.00), birthweight <10th centile (aOR 0.54; 95% CI 0.32-0.92), severe hypertension (aOR 0.51; 95% CI 0.31-0.83), pre-eclampsia (aOR 0.55; 95% CI 0.36-0.85), and delivery at <34 weeks (aOR 0.53; 95% CI 0.29-0.96) or <37 weeks (aOR 0.55; 95% CI 0.35-0.85).

CONCLUSION

These nonrandomised comparisons are subject to residual confounding, but women treated with methyldopa (versus labetalol), particularly those with pre-existing hypertension, may have had better outcomes.

TWEETABLE ABSTRACT

There was no evidence that women treated with methyldopa versus labetalol had worse outcomes.

目的

比较 CHIPS 试验（ISRCTN 71416914）中分配组之间接受美托洛尔和拉贝洛尔治疗的女性的妊娠结局，该试验研究了妊娠高血压的“较宽松”与“严格”控制之间的差异。

设计

CHIPS 试验队列的二次分析。

设置

国际随机对照试验（94 个地点，15 个国家）。

人群或样本

在 987 名 CHIPS 招募者中，481/566（85.0%）名女性在随机分组时接受了降压治疗。在 981 名（99.4%）随访至分娩的女性中，656/745（88.1%）名女性在随机分组后接受了治疗。

方法

采用逻辑回归比较接受美托洛尔或拉贝洛尔治疗的女性的结局，同时调整了基线因素的影响。

主要观察指标

CHIPS 的主要（围产期损失或新生儿入住高水平护理超过 48 小时）和次要（严重产妇并发症）结局，出生体重<第 10 百分位数，严重产妇高血压，子痫前期和<34 周或<37 周分娩。

结果

美托洛尔和拉贝洛尔在随机分组时（分别为 243/987，24.6%和 238/987，24.6%）和随机分组后（分别为 224/981，22.8%和 433/981，44.1%）均广泛使用。经过调整后的分析，随机分组时使用美托洛尔（而非拉贝洛尔）与出生体重<第 10 百分位数的婴儿比例较低相关（调整后的优势比[aOR]0.48；95%置信区间[CI]0.20-0.87）。随机分组后使用美托洛尔（而非拉贝洛尔）与 CHIPS 的主要结局（aOR 0.64；95%CI 0.40-1.00）、出生体重<第 10 百分位数（aOR 0.54；95%CI 0.32-0.92）、严重高血压（aOR 0.51；95%CI 0.31-0.83）、子痫前期（aOR 0.55；95%CI 0.36-0.85）和<34 周（aOR 0.53；95%CI 0.29-0.96）或<37 周（aOR 0.55；95%CI 0.35-0.85）分娩的风险较低相关。

结论

这些非随机比较存在残余混杂的可能性，但接受美托洛尔（而非拉贝洛尔）治疗的女性，特别是那些患有高血压的女性，可能有更好的结局。

推文摘要

没有证据表明接受美托洛尔治疗的女性与接受拉贝洛尔治疗的女性相比，结局更差。