Mosha Dominic, Mazuguni Festo, Mrema Sigilbert, Abdulla Salim, Genton Blaise
Ifakara Health Institute, Rufiji, HDSS, P,O Box 40, Rufiji, Tanzania.
BMC Pregnancy Childbirth. 2014 Sep 15;14:322. doi: 10.1186/1471-2393-14-322.
There is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy.
Pregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome.
1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08-0.3).
Almost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines.
大多数孕期使用的药物的安全性信息有限。对于治疗热带疾病的药物而言尤其如此，因为这些地区的药物警戒系统不太完善。本研究的目的是证明利用健康与人口监测系统（HDSS）作为监测孕期药物安全性的平台的可行性。
从生殖与儿童健康（RCH）诊所或为HDSS进行的每月家访中招募孕周小于20周的孕妇。使用结构化问卷对孕妇进行访谈。每月对参与者进行随访，记录任何新使用的药物以及妊娠结局。
招募了1089名孕妇；994名（91.3%）完成随访直至分娩。98%的女性报告在孕期至少服用过一种药物，主要是用于产前项目的药物。其他最常报告的药物是镇痛药（24%）、抗生素（17%）和抗疟药（15%），不包括间歇性预防治疗（IPTp）。与其他抗疟药物组相比，蒿甲醚-本芴醇（AL）是治疗疾病时最常用的抗疟药，近四分之三的患者使用该药。总体而言，孕期抗疟药和抗生素暴露与不良妊娠结局无显著关联。补充铁和叶酸与流产/死产风险降低相关（比值比0.1；0.08 - 0.3）。
几乎所有女性在孕期都接触过药物。铁和叶酸暴露对妊娠结局有有益影响。HDSS被证明是在资源有限国家建立可靠药物警戒系统的有用平台。拓宽药物安全性信息对于促进孕期治疗基于证据的风险效益决策至关重要，这是新上市药物面临的一项重大挑战。
