不同叶酸增补剂预防出生缺陷的效果评价--一项江苏地区横断面研究

Evaluation of effect of different folic acid supplementation preparations on preventing birth defects:A cross-sectional study in Jiangsu province

目的 比较江苏地区的不同叶酸(FA)增补剂对出生缺陷的预防效果.方法 选取2017年1月至2018年12月期间在江苏省分娩的胎龄≥28周的孕妇资料10662例.将服用FA增补剂者分为FA组,未增补FA者分为无FA组;根据孕期FA补充的剂量与成份分为三组:单纯0.4mg FA(0.4FA)组、含0.4mg FA的复合维生素(MV+0.4FA)组及含0.8mg FA的复合维生素(MV+0.8FA)组;同时根据补充FA增补剂的时间分为早孕期(妊娠3个月内)补充组和全孕期补充组.根据问卷调查表,由培训专员收集孕妇的一般情况、FA增补情况、生育史、职业和环境因素、新生儿出生缺陷情况等信息,并进行详细记录.用Logistic回归及卡方检验等方法对FA增补剂量、成份及时间与出生缺陷发生的关系进行统计分析.结果 在10662例江苏省女性分娩的新生儿中,总出生缺陷发生率为1.37%(146/10662).与FA组比较,无FA组中总出生缺陷发生率显著增加(OR=2.23,95%C I:1.05~4.73,P=0.03);进一步分析排名前八的具体出生缺陷类型为多指畸形、先天性心脏病、耳畸形、尿道下裂、脑积水、唇裂、腭裂及马蹄内翻,组间差异均无统计学意义(均P>0.05).不同FA增补剂量的三组总出生缺陷发生率比较差异无统计学意义(P>0.05);不同FA增补时间的两组总出生缺陷发生率比较差异无统计学意义(P>0.05).结论 孕期FA增补剂可显著降低总出生缺陷发生率,不同增补剂量及剂型的效果类似,且孕妇仅在早孕期补充FA可预防出生缺陷.

Objective To compare preventive effect of different preparations of folic acid(FA)supplementation on birth defects in Jiangsu province.Methods A institution-based cross-sectional study was conducted.The clinical data of 10662 pregnant women with gestational age≥28 weeks who delivered in Jiangsu province from January 2017 to December 2018 were collected.According to whether the pregnant women having had taken FA supplementation,the pregnant women were divided into FA group and Non-FA group.And according to the FA content in the preparation,the pregnant women again divided into three subgroups:FA0.4 group(pure 0.4 mg of FA),MV+FA0.4 group(multivitamins with 0.4 mg of FA)and MV+FA0.8 group(multivitamins with 0.8 mg of FA).According to the duration of FA supplementation,the pregnant women were divided into two groups:FA supplementation in the first trimester group and FA supplementation in the whole pregnancy group.General information of the pregnant women,FA intake during the gestational period,childbearing history,occupation and environmental factors and birth defects were collected and recorded in detail through face-to-face interview and chart-review by the trained doctors or midwives.Logistic regression and chi-square test were conducted and relationships of dose,content and duration of FA supplementation with occurrence of birth defect was statistically analyzed.Variables with P value<0.05 were considered statistically significant at 95%confidence interval(CI).Results The incidence of total birth defects in Jiangsu province was 1.37%(146/10662)and that in the non-FA group was significantly higher than that in the FA supplementation group(OR=2.23,95%CI:1.05~4.73,P=0.03).And no significant difference was found in the incidence among the top eight specific birth defects subgroups,including polydactyly,congenital heart disease,ear malformation,hypospadia,hydrocephalus,cleft lip,cleft palate and equinovarus(all P>0.05).However,no significant difference in total birth defects or specific birth defects among three FA dose groups was found(P>0.05),so did between the two FA supplementation duration groups(P>0.05).Conclusion FA supplementation in gestational period can reduce incidence rate of total birth defects greatly.The preventive effects of different dose and dosage forms of FA supplementation are similar.Even FA supplementation in early pregnancy can prevent occurrence of birth defects.