一项关于间歇性筛查与治疗对比间歇性预防性治疗在孕期疟疾控制中效果的非劣效性、个体随机试验。
A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy.
作者信息
Tagbor Harry, Cairns Matthew, Bojang Kalifa, Coulibaly Sheick Oumar, Kayentao Kassoum, Williams John, Abubakar Ismaela, Akor Francis, Mohammed Khalifa, Bationo Richard, Dabira Edgar, Soulama Alamissa, Djimdé Moussa, Guirou Etienne, Awine Timothy, Quaye Stephen, Njie Fanta, Ordi Jaume, Doumbo Ogobara, Hodgson Abraham, Oduro Abraham, Meshnick Steven, Taylor Steve, Magnussen Pascal, ter Kuile Feiko, Woukeu Arouna, Milligan Paul, Chandramohan Daniel, Greenwood Brian
机构信息
London School of Hygiene & Tropical Medicine, London, United Kingdom; School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
London School of Hygiene & Tropical Medicine, London, United Kingdom.
出版信息
PLoS One. 2015 Aug 10;10(8):e0132247. doi: 10.1371/journal.pone.0132247. eCollection 2015.
BACKGROUND
The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach.
METHODS AND FINDINGS
An open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana). Women in the IPTp-SP group received SP on two or three occasions whilst women in the ISTp group were screened two or three times with a RDT and treated if positive for malaria with artemether-lumefantrine (AL). ISTp-AL was non-inferior to IPTp-SP in preventing low birth weight (LBW), anemia and placental malaria, the primary trial endpoints. The prevalence of LBW was 15.1% and 15.6% in the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI: 0.88, 1.22]). The mean hemoglobin concentration at the last clinic attendance before delivery was 10.97g/dL and 10.94g/dL in the IPTp-SP and ISTp-AL groups respectively (mean difference: -0.03 g/dL [95% CI: -0.13, +0.06]). Active malaria infection of the placenta was found in 24.5% and in 24.2% of women in the IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81, 1.12]). More women in the ISTp-AL than in the IPTp-SP group presented with malaria parasitemia between routine antenatal clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000 pregnancies [95% CI 30.5, 68.3], but the number of hospital admissions for malaria was similar in the two groups.
CONCLUSIONS
Despite low levels of resistance to SP in the study areas, ISTp-AL performed as well as IPTp-SP. In the absence of an effective alternative medication to SP for IPTp, ISTp-AL is a potential alternative to IPTp in areas where SP resistance is high. It may also have a role in areas where malaria transmission is low and for the prevention of malaria in HIV positive women receiving cotrimoxazole prophylaxis in whom SP is contraindicated.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01084213 Pan African Clinical trials Registry PACT201202000272122.
背景
在非洲部分地区，磺胺多辛 - 乙胺嘧啶（IPTp - SP）用于孕期疟疾间歇性预防治疗的效果因对SP耐药性的出现和传播而受到威胁。采用快速诊断检测（RDT）进行间歇性筛查并治疗检测呈阳性的女性（ISTp）是一种替代方法。
方法与结果
在四个对SP耐药率较低的西非国家（冈比亚、马里、布基纳法索和加纳）对5354名初产妇或经产妇进行了一项IPTp - SP与ISTp的开放性、个体随机、非劣效性试验。IPTp - SP组的女性接受两次或三次SP治疗，而ISTp组的女性接受两次或三次RDT筛查，若疟疾检测呈阳性则用蒿甲醚 - 本芴醇（AL）治疗。在预防低出生体重（LBW）、贫血和胎盘疟疾（主要试验终点）方面，ISTp - AL不劣于IPTp - SP。IPTp - SP组和ISTp - AL组的LBW患病率分别为15.1%和15.6%（比值比 = 1.03 [95%置信区间：0.88, 1.22]）。分娩前最后一次门诊就诊时的平均血红蛋白浓度在IPTp - SP组和ISTp - AL组分别为10.97g/dL和10.94g/dL（平均差值： - 0.03 g/dL [95%置信区间： - 0.13, +0.06]）。IPTp - SP组和ISTp - AL组分别有24.5%和24.2%的女性胎盘有活动性疟疾感染（比值比 = 0.95 [95%置信区间0.81, 1.12]）。ISTp - AL组出现疟疾寄生虫血症的女性比IPTp - SP组更多（分别为310例和182例发作，率差：每1000例妊娠49.4例 [95%置信区间30.5, 68.3]），但两组因疟疾住院的人数相似。
结论
尽管研究地区对SP的耐药水平较低，但ISTp - AL的效果与IPTp - SP相当。在缺乏用于IPTp的有效替代SP药物的情况下，在SP耐药性高的地区，ISTp - AL是IPTp的潜在替代方法。它在疟疾传播率低的地区以及预防接受复方新诺明预防治疗且禁忌使用SP的HIV阳性女性的疟疾方面可能也有作用。
试验注册
ClinicalTrials.gov NCT01084213 泛非临床试验注册中心PACT201202000272122 。
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