Maiga Abderrahmane Sidèye, Diakite Mahamadou, Diawara Adama, Sango Hamadoun Aly, Coulibaly Cheick Oumar
Medecin, Professeur de Parasitologie-Mycologie, Institut national de recherche en sante publique, BP, Bamako, Mali.
Mali Med. 2010;25(3):41-8.
This study aimed to evaluate the impact of intermittent preventive treatment (IPT) and the associated adverse effects in pregnant women living in hyperendemic area of Sélingué in Mali on pregnancy outcome. Pharmacovigilance aims, monitoring the risk of adverse effects resulting from the use of drugs and products for human use licensees of marketing. IPT with sulfadoxine-pyrimethamine (SP) is based on the administration of 2 doses of SP treatment in pregnant women at defined intervals after about 18-20 weeks of pregnancy. The survey on attitudes and behavioural practices (KAP) has allowed us to interview 210 pregnant women attending antenatal clinics at the health district of Sélingué. Almost all women (99%) affirm to know malaria and 84.8% to know clinical signs of malaria. Self medication was practiced by 40% of the expectant mothers. A small proportion of women affirm to have mosquito nets (8.6%) while 14.3% affirm to use impregnated insecticide mosquito nets. The rate of severe anaemia was 30.5% (Hb < 7 g/dl) after the first dose and 13.3% after the second dose of S-P. In parallel, the rate of moderate anaemia (Hb 7-9g /dl) decreased by 54.8% after the first dose to 26.2% after the second dose. Anaemia was higher within multigestes (32.1%) compared with the primigestes (21.7%). We did not observe any case of therapeutic failure with S-P nor infection in our study. The rate of prematurity was 3% while the rate low birth weight was 17.6%. Observed adverse reactions were primarily nauseas and stomach upset (1.9% after first S-P dose and 1% after the 2nd dose of S-P). No case of severe side effects or malformations was observed within new-born babies. In conclusion, IPT with S-P was well tolerated by pregnant women living in Sélingué and presents very few minor secondary reactions. The S-P is currently the only antimalarial drug with a single-dose which has a prolonged action and which also has ideal properties (low cost, several data on its tolerance and its facility of use) for a better use during the pregnancy in Africa.
本研究旨在评估间歇性预防治疗（IPT）及其相关不良反应对马里塞林盖高流行地区孕妇妊娠结局的影响。药物警戒旨在监测药品和人类使用许可上市产品使用所产生的不良反应风险。使用磺胺多辛-乙胺嘧啶（SP）进行IPT是基于在妊娠约18-20周后的特定间隔为孕妇给予2剂SP治疗。态度和行为习惯（KAP）调查使我们能够采访在塞林盖健康区产前诊所就诊的210名孕妇。几乎所有女性（99%）声称了解疟疾，84.8%声称了解疟疾的临床症状。40%的准妈妈有自行用药的行为。一小部分女性声称有蚊帐（8.6%），而14.3%声称使用浸有杀虫剂的蚊帐。首剂S-P后严重贫血率为30.5%（血红蛋白<7g/dl），第二剂后为13.3%。同时，中度贫血率（血红蛋白7-9g/dl）首剂后下降54.8%，第二剂后降至26.2%。经产妇的贫血率（32.1%）高于初产妇（21.7%）。在我们的研究中，未观察到S-P治疗失败或感染的病例。早产率为3%，低出生体重率为17.6%。观察到的不良反应主要是恶心和胃部不适（首剂S-P后为1.9%，第二剂S-P后为1%）。在新生儿中未观察到严重副作用或畸形的病例。总之，居住在塞林盖的孕妇对S-P进行的IPT耐受性良好，且几乎没有轻微的继发反应。S-P目前是唯一一种单剂量且作用持久，并具有理想特性（低成本、关于其耐受性和使用便利性的多项数据）以便在非洲孕期更好使用的抗疟药物。
