本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2307212

摘要内容如下：

背景

世界卫生组织建议膳食钙摄入量低的人群中的孕妇每日补充1500至2000毫克的钙，分为三个剂量，以降低先兆子痫的风险。然而，给药方案的复杂性导致了实施障碍。

方法

我们在印度和坦桑尼亚进行了两项关于钙补充剂的独立随机试验，以评估每日500毫克钙补充剂与每日1500毫克钙补充剂的非劣效性。在每个试验中，两个主要结局是先兆子痫和早产，相对风险的非劣效性界值分别为1.54和1.16。

结果

每项试验共纳入11，000名未产妇。在印度试验中，500毫克组先兆子痫的累积发生率为3.0%，1500毫克组为3.6%（相对危险度为0.84；95%可信区间[CI]，0.68至1.03），在坦桑尼亚试验中分别为3.0%和2.7%（相对风险，1.10；95%CI，0.88至1.36）-结果与两项试验中较低剂量的非劣效性一致。在印度试验中，500毫克组的早产活产儿百分比为11.4%，1500毫克组为12.8%（相对风险为0.89；95%CI，0.80-0.98），在1.16的非劣效性界值内；在坦桑尼亚试验中，百分比分别为10.4%和9.7%（相对危险度，1.07；95%CI，0.95至1.21），超过了非劣效性界值。

结论

在这两项试验中，就先兆子痫的风险而言，低剂量补钙并不劣于高剂量补钙。在印度的试验中，就早产活产风险而言，它是非劣效的，但在坦桑尼亚的试验中则不是。（由比尔及梅林达·盖茨基金会和其他机构资助）；ClinicalTrials.gov编号，NCT03350516；印度临床试验注册编号，CTRI/2018/02/012119；坦桑尼亚药品和医疗器械管理局试验登记号，TFDA0018/CTR/0010/5）。

英文原文如下：

Abstracts

BACKGROUND  The World Health Organization recommends 1500 to 2000 mg of calcium daily as supplementation, divided into three doses, for pregnant persons in populations with low dietary calcium intake in order to reduce the risk of preeclampsia. The complexity of the dosing scheme, however, has led to implementation barriers.

METHODS  We conducted two independent randomized trials of calcium supplementation, in India and Tanzania, to assess the noninferiority of a 500-mg daily dose to a 1500-mg daily dose of calcium supplementation. In each trial, the two primary outcomes were preeclampsia and preterm birth, and the noninferiority margins for the relative risks were 1.54 and 1.16, respectively.

RESULTS  A total of 11,000 nulliparous pregnant women were included in each trial. The cumulative incidence of preeclampsia was 3.0% in the 500-mg group and 3.6% in the 1500-mg group in the India trial (relative risk, 0.84; 95% confidence interval [CI], 0.68 to 1.03) and 3.0% and 2.7%, respectively, in the Tanzania trial (relative risk, 1.10; 95% CI, 0.88 to 1.36) - findings consistent with the noninferiority of the lower dose in both trials. The percentage of live births that were preterm was 11.4% in the 500-mg group and 12.8% in the 1500-mg group in the India trial (relative risk, 0.89; 95% CI, 0.80 to 0.98), which was within the noninferiority margin of 1.16; in the Tanzania trial, the respective percentages were 10.4% and 9.7% (relative risk, 1.07; 95% CI, 0.95 to 1.21), which exceeded the noninferiority margin.

CONCLUSIONS  In these two trials, low-dose calcium supplementation was noninferior to high-dose calcium supplementation with respect to the risk of preeclampsia. It was noninferior with respect to the risk of preterm live birth in the trial in India but not in the trial in Tanzania. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT03350516; Clinical Trials Registry-India number, CTRI/2018/02/012119; and Tanzania Medicines and Medical Devices Authority Trials Registry number, TFDA0018/CTR/0010/5).

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