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补钙预防子痫前期的试验。

Trial of calcium to prevent preeclampsia.

作者信息

Levine R J, Hauth J C, Curet L B, Sibai B M, Catalano P M, Morris C D, DerSimonian R, Esterlitz J R, Raymond E G, Bild D E, Clemens J D, Cutler J A

机构信息

Division of Epidemiology, Statistics, and Prevention Research, National Institute of Child Health and Human Development, Bethesda, Md 20892-7510, USA.

出版信息

N Engl J Med. 1997 Jul 10;337(2):69-76. doi: 10.1056/NEJM199707103370201.

Abstract

BACKGROUND

Previous trials have suggested that calcium supplementation during pregnancy may reduce the risk of preeclampsia. However, differences in study design and a low dietary calcium intake in the populations studied limit acceptance of the data.

METHODS

We randomly assigned 4589 healthy nulliparous women who were 13 to 21 weeks pregnant to receive daily treatment with either 2 g of elemental calcium or placebo for the remainder of their pregnancies. Surveillance for preeclampsia was conducted by personnel unaware of treatment-group assignments, using standardized measurements of blood pressure and urinary protein excretion at uniformly scheduled prenatal visits, protocols for monitoring these measurements during the hospitalization for delivery, and reviews of medical records of unscheduled outpatient visits and all hospitalizations.

RESULTS

Calcium supplementation did not significantly reduce the incidence or severity of preeclampsia or delay its onset. Preeclampsia occurred in 158 of the 2295 women in the calcium group (6.9 percent) and 168 of the 2294 women in the placebo group (7.3 percent) (relative risk, 0.94; 95 percent confidence interval, 0.76 to 1.16). There were no significant differences between the two groups in the prevalence of pregnancy-associated hypertension without preeclampsia (15.3 percent vs. 17.3 percent) or of all hypertensive disorders (22.2 percent vs. 24.6 percent). The mean systolic and diastolic blood pressures during pregnancy were similar in both groups. Calcium did not reduce the numbers of preterm deliveries, small-for-gestational-age births, or fetal and neonatal deaths; nor did it increase urolithiasis during pregnancy.

CONCLUSIONS

Calcium supplementation during pregnancy did not prevent preeclampsia, pregnancy-associated hypertension, or adverse perinatal outcomes in healthy nulliparous women.

摘要

背景

既往试验表明,孕期补钙可能降低先兆子痫的风险。然而,研究设计的差异以及所研究人群中膳食钙摄入量较低限制了对这些数据的接受程度。

方法

我们将4589名怀孕13至21周的健康未生育妇女随机分为两组,一组在孕期剩余时间每天接受2克元素钙治疗,另一组接受安慰剂治疗。由不知道治疗组分配情况的人员对先兆子痫进行监测,并在统一安排的产前检查时使用标准化的血压和尿蛋白排泄测量方法,在分娩住院期间监测这些测量值的方案,以及对非计划门诊就诊和所有住院的病历进行审查。

结果

补钙并未显著降低先兆子痫的发生率或严重程度,也未延迟其发病。补钙组2295名妇女中有158名发生先兆子痫(6.9%),安慰剂组2294名妇女中有168名发生先兆子痫(7.3%)(相对风险为0.94;95%置信区间为0.76至1.16)。两组在无先兆子痫的妊娠相关高血压患病率(15.3%对17.3%)或所有高血压疾病患病率(22.2%对24.6%)方面无显著差异。两组孕期的平均收缩压和舒张压相似。补钙并未减少早产、小于胎龄儿出生或胎儿及新生儿死亡的数量;也未增加孕期尿路结石的发生。

结论

孕期补钙不能预防健康未生育妇女发生先兆子痫、妊娠相关高血压或不良围产期结局。

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