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坦桑尼亚基戈马孕妇疟疾化学预防替代策略的随机试验:I. 原理与设计

Randomised trial of alternative malaria chemoprophylaxis strategies among pregnant women in Kigoma, Tanzania: I. Rationale and design.

作者信息

Mnyika K S, Kabalimu T K, Rukinisha K, Mpanju-Shumbusho W

机构信息

Department of Epidemiology and Biostatistics, Muhimbili University College of Health Sciences, Dar es Salaam, Tanzania.

出版信息

East Afr Med J. 2000 Feb;77(2):98-104. doi: 10.4314/eamj.v77i2.46409.

DOI:10.4314/eamj.v77i2.46409
PMID:10774083
Abstract

OBJECTIVE

The objective of the study was to assess the effectiveness of alternative strategies of malaria chemoprophylaxis on the reduction of malaria episodes and prevalence of parasitaemia among pregnant women in Kigoma urban district in western Tanzania.

DESIGN

Randomised antimalarial prophylactic trial.

SETTING

The study was conducted in an urban maternal and child health (MCH) clinic in Kigoma town.

SUBJECTS

All pregnant women attending antenatal care services at Kigoma urban MCH clinic were eligible. Informed consent was sought from each pregnant woman for participation in the study. INTERVENTION MEASURES: The intervention measures were intermittent and continuous malaria chemoprophylaxis using chloroquine and proguanil.

MAIN OUTCOME MEASURES

Reduction of malaria episodes and parasitaemia and haemoglobin levels among participating pregnant women in Kigoma urban district.

RESULTS

Baseline data indicates that the overall mean haemoglobin concentrations among the primigravidae and multigravidae women were similar within the intervention and comparison groups (F-test (df = 5, N = 701) = 1.27, P = 0.27). Similarly, no significant difference was observed in the prevalence of malaria parasitaemia within the primigravidae intervention and comparison groups (chi 2 test (df = 5, N = 701) = 5.4, P = 0.4). Hence, the process of randomisation produced comparable intervention and comparison groups with balanced characteristics. Specific results of the baseline studies are presented in the companion paper.

CONCLUSION

We conclude that the process of randomisation resulted in comparable intervention and comparison groups. As malaria is a common cause of considerable morbidity and mortality among pregnant women in Tanzania, the present study provided useful data for improving reproductive health in Kigoma region, western Tanzania.

摘要

目的

本研究的目的是评估疟疾化学预防替代策略对坦桑尼亚西部基戈马市区孕妇疟疾发作次数减少和疟原虫血症患病率的效果。

设计

随机抗疟预防试验。

地点

研究在基戈马镇的一家城市母婴健康(MCH)诊所进行。

研究对象

所有在基戈马市区母婴健康诊所接受产前护理服务的孕妇均符合条件。向每位孕妇寻求参与研究的知情同意。干预措施:干预措施为使用氯喹和氯胍进行间歇性和连续性疟疾化学预防。

主要观察指标

基戈马市区参与研究的孕妇中疟疾发作次数、疟原虫血症和血红蛋白水平的降低情况。

结果

基线数据表明,初产妇和经产妇女性的总体平均血红蛋白浓度在干预组和对照组中相似(F检验(自由度=5,N=701)=1.27,P=0.27)。同样,在初产妇干预组和对照组中,疟疾寄生虫血症患病率未观察到显著差异(卡方检验(自由度=5,N=701)=5.4,P=0.4)。因此,随机分组过程产生了具有平衡特征的可比干预组和对照组。基线研究的具体结果在配套论文中呈现。

结论

我们得出结论,随机分组过程产生了可比的干预组和对照组。由于疟疾是坦桑尼亚孕妇发病和死亡的常见重要原因,本研究为改善坦桑尼亚西部基戈马地区的生殖健康提供了有用数据。

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Randomised trial of alternative malaria chemoprophylaxis strategies among pregnant women in Kigoma, Tanzania: I. Rationale and design.坦桑尼亚基戈马孕妇疟疾化学预防替代策略的随机试验:I. 原理与设计
East Afr Med J. 2000 Feb;77(2):98-104. doi: 10.4314/eamj.v77i2.46409.
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