世界卫生组织Olufemi T. Oladapo团队研究了在医疗资源匮乏国家中产前使用地塞米松治疗早产的效果。2020年10月23日，该研究发表在《新英格兰医学杂志》上。

在医疗资源匮乏国家有早产风险的女性中，产前使用糖皮质激素的安全性和有效性尚不确定。

研究组进行了一项多国随机试验，在孟加拉国、印度、肯尼亚、尼日利亚和巴基斯坦的29家二级和三级医院招募了2852名妊娠26周0天至33周6天有早产风险的孕妇（3070名胎儿），将其随机分组，分别接受肌内注射地塞米松或安慰剂治疗。主要结局为仅新生儿死亡，死产或新生儿死亡，以及可能的产妇细菌感染。

地塞米松组1417例婴儿中有278例（19.6%）发生新生儿死亡，安慰剂组1406例中有331例（23.5％），组间差异显著。地塞米松组中1532例胎儿和婴儿中有393例死产或新生儿死亡（25.7％），安慰剂组中1519例胎儿和婴儿中有444例（29.2％），组间差异显著；两组孕产妇细菌感染发生率分别为4.8％和6.3％。组间不良事件的发生率没有显著差异。

总之，对于医疗资源匮乏国家中有早产风险的女性，使用地塞米松治疗，与安慰剂相比，可显著降低死产率或新生儿死亡率，且不会增加孕产妇细菌感染的发生率。

附：英文原文

Title: Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries

Author: The WHO ACTION Trials Collaborators

Issue&Volume: 2020-10-23

Abstract:

BACKGROUND

The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.

METHODS

We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.

RESULTS

A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P=0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P=0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events.

CONCLUSIONS

Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection.

DOI: 10.1056/NEJMoa2022398

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2022398