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印度尼西亚孕产妇补充多种微量营养素对胎儿死亡和婴儿死亡的影响:一项双盲整群随机试验。

Effect of maternal multiple micronutrient supplementation on fetal loss and infant death in Indonesia: a double-blind cluster-randomised trial.

作者信息

Shankar A H, Jahari A B, Sebayang S K, Apriatni M, Harefa B, Muadz H, Soesbandoro S D A, Tjiong R, Fachry A, Shankar A V, Prihatini S, Sofia G

机构信息

Helen Keller International, Jakarta, Indonesia; Johns Hopkins University, Baltimore, MD, USA.

出版信息

Lancet. 2008 Jan 19;371(9608):215-27. doi: 10.1016/S0140-6736(08)60133-6.

DOI:10.1016/S0140-6736(08)60133-6
PMID:18207017
Abstract

BACKGROUND

Maternal nutrient supplementation in developing countries is generally restricted to provision of iron and folic acid (IFA). Change in practice toward supplementation with multiple micronutrients (MMN) has been hindered by little evidence of the effects of MMN on fetal loss and infant death. We assessed the effect of maternal supplementation with MMN, compared with IFA, on fetal loss and infant death in the setting of routine prenatal care services.

METHODS

In a double-blind cluster-randomised trial in Lombok, Indonesia, we randomly assigned 262 midwives to distribute IFA (n=15 ,86) or MMN (n=15,804) supplements to 31 290 pregnant women through government prenatal care services that were strengthened by training and community-based advocacy. Women obtained supplements, to be taken daily, every month from enrolment to 90 days post partum. The primary outcome was early infant mortality (deaths until 90 days post partum). Secondary outcomes were neonatal mortality, fetal loss (abortions and stillbirths), and low birthweight. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN34151616.

FINDINGS

Infants of women consuming MMN supplements had an 18% reduction in early infant mortality compared with those of women given IFA (35.5 deaths per 1000 livebirths vs 43 per 1000; relative risk [RR] 0.82, 95% CI 0.70-0.95, p=0.010). Infants whose mothers were undernourished (mid upper arm circumference <23.5 cm) or anaemic (haemoglobin <110 g/L) at enrolment had a reduction in early infant mortality of 25% (RR 0.75, 0.62-0.90, p=0.0021) and 38% (RR 0.62, 0.49-0.78, p<0.0001), respectively. Combined fetal loss and neonatal deaths were reduced by 11% (RR 0.89, 0.81-1.00, p=0.045), with significant effects in undernourished (RR 0.85, 0.73-0.98, p=0.022) or anaemic (RR 0.71, 0.58-0.87, p=0.0010) women. A cohort of 11 101 infants weighed within 1 h of birth showed a 14% (RR 0.86, 0.73-1.01, p=0.060) decreased risk of low birthweight for those in the MMN group, with a 33% (RR 0.67, 0.51-0.89, p=0.0062) decrease for infants of women anaemic at enrolment.

INTERPRETATION

Maternal MMN supplementation, as compared with IFA, can reduce early infant mortality, especially in undernourished and anaemic women. Maternal MMN supplementation might therefore be an important part of overall strengthening of prenatal-care programmes.

摘要

背景

在发展中国家,孕产妇营养补充通常仅限于提供铁和叶酸(IFA)。由于缺乏关于多种微量营养素(MMN)对胎儿死亡和婴儿死亡影响的证据,向MMN补充剂的实践转变受到了阻碍。我们评估了在常规产前护理服务中,与IFA相比,孕产妇补充MMN对胎儿死亡和婴儿死亡的影响。

方法

在印度尼西亚龙目岛进行的一项双盲整群随机试验中,我们将262名助产士随机分配,通过经过培训和社区宣传强化的政府产前护理服务,向31290名孕妇分发IFA(n = 1586)或MMN(n = 15804)补充剂。妇女从登记到产后90天每月领取补充剂并每日服用。主要结局是早期婴儿死亡率(产后90天内的死亡)。次要结局是新生儿死亡率、胎儿死亡(流产和死产)和低出生体重。分析采用意向性分析。该研究已注册为国际标准随机对照试验,编号为ISRCTN34151616。

结果

与接受IFA的妇女所生婴儿相比,服用MMN补充剂的妇女所生婴儿的早期婴儿死亡率降低了18%(每1000例活产中有35.5例死亡,而每1000例中有43例;相对风险[RR]0.82,95%CI 0.70 - 0.95,p = 0.010)。在登记时营养不良(上臂中段周长<23.5 cm)或贫血(血红蛋白<110 g/L)的妇女所生婴儿中,早期婴儿死亡率分别降低了25%(RR 0.75,0.62 - 0.90,p = 0.0021)和38%(RR 0.62,0.49 - 0.78,p<0.0001)。胎儿死亡和新生儿死亡合计减少了11%(RR 0.89,0.81 - 1.00,p = 0.045),在营养不良(RR 0.85,0.73 - 0.98,p = 0.022)或贫血(RR 0.71,0.58 - 0.87,p = 0.0010)的妇女中效果显著。一组11101名婴儿在出生后1小时内称重,结果显示MMN组低出生体重风险降低了14%(RR 0.86,0.73 - 1.01,p = 0.060),登记时贫血妇女所生婴儿的低出生体重风险降低了33%(RR 0.67,0.51 - 0.89,p = 0.0062)。

解读

与IFA相比,孕产妇补充MMN可降低早期婴儿死亡率,尤其是在营养不良和贫血的妇女中。因此,孕产妇补充MMN可能是全面加强产前护理计划的重要组成部分。

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