An open label, randomised trial of artesunate+amodiaquine, artesunate+chlorproguanil-dapsone and artemether-lumefantrine for the treatment of uncomplicated malaria.

An open label, randomised trial of artesunate+amodiaquine, artesunate+chlorproguanil-dapsone and artemether-lumefantrine for the treatment of uncomplicated malaria.
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DOI:
10.1371/journal.pone.0002530
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发表时间:
2008-06-25
期刊:
影响因子:
3.7
通讯作者:
Chandramohan D
Chandramohan D
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Owusu-Agyei S;Asante KP;Owusu R;Adjuik M;Amenga-Etego S;Dosoo DK;Gyapong J;Greenwood B;Chandramohan D

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青蒿琥酯+阿莫地喹(AS + AQ)和蒿甲醚-苯芴醇(AL)目前是非洲最常推荐的无并发症疟疾一线治疗药物。青蒿琥酯+氯丙胍-氨苯砜(AS + CD)是治疗无并发症疟疾的潜在替代方案。这三种药物组合的疗效和安全性的比较是必要的,以制定基于证据的药物治疗政策。534例葡萄糖-6-磷酸脱氢酶(G6PD)正常儿童被随机分为AS + AQ、AL或AS + CD组,每组15例。研究药物给药由项目工作人员监督,儿童在治疗后第1、2、3、7、14和28天在家中接受随访。比较了研究组之间的寄生虫学和临床失败以及不良事件。在符合方案分析中,AS + AQ组治疗后第28天的寄生虫学和临床失败率(PCF 28)低于AL或AS + CD组(校正后的再感染率:分别为6.6% vs 13.8%和13.8%,p = 0.08;未校正的:分别为14.6% vs 27.6%和28.1%,p = 0.005)。    在意向治疗分析中,所有三组的早期治疗失败率均较高(AS + AQ 13.3%; AL 15.2%; AS + CD 9.3%,p = 0.2),主要是由于呕吐。  然而,与AL或AS + CD组相比,AS + AQ组中校正再感染的PCF 28较低,但不显著(AS + AQ 18.3%; AL 24.2%; AS + CD 20.8%,p = 0.4)。两组之间不良事件的发生率相当。  AS + AQ是加纳和西非邻国无并发症疟疾的适当一线治疗方法。在西非,需要进一步研究人工流产在常规方案条件下的有效性。ClinicalTrials.gov
Artesunate+amodiaquine (AS+AQ) and artemether-lumefantrine (AL) are now the most frequently recommended first line treatments for uncomplicated malaria in Africa. Artesunate+chlorproguanil-dapsone (AS+CD) was a potential alternative for treatment of uncomplicated malaria. A comparison of the efficacy and safety of these three drug combinations was necessary to make evidence based drug treatment policies. Five hundred and thirty-four, glucose-6-phosphate dehydrogenase (G6PD) normal children were randomised in blocks of 15 to the AS+AQ, AL or AS+CD groups. Administration of study drugs was supervised by project staff and the children were followed up at r home on days 1,2,3,7,14 and 28 post treatment. Parasitological and clinical failures and adverse events were compared between the study groups. In a per-protocol analysis, the parasitological and clinical failure rate at day 28 post treatment (PCF28) was lower in the AS+AQ group compared to the AL or AS+CD groups (corrected for re-infections: 6.6% vs 13.8% and 13.8% respectively, p = 0.08; uncorrected: 14.6% vs 27.6% and 28.1% respectively, p = 0.005). In the intention to treat analysis, the rate of early treatment failure was high in all three groups (AS+AQ 13.3%; AL 15.2%; and AS+CD 9.3%, p = 0.2) primarily due to vomiting. However, the PCF28 corrected for re-infection was lower, though not significantly, in the AS+AQ group compared to the AL or the AS+CD groups (AS+AQ 18.3%; AL 24.2%; AS+CD 20.8%, p = 0.4) The incidence of adverse events was comparable between the groups. AS+AQ is an appropriate first line treatment for uncomplicated malaria in Ghana and possibly in the neighbouring countries in West Africa. The effectiveness of AL in routine programme conditions needs to be studied further in West Africa. ClinicalTrials.gov NCT00119145
DOI: 10.1016/s0140-6736(04)16350-2
发表时间: 2004-06-05
期刊: LANCET
影响因子: 168.9
作者:
Alloueche, A;Bailey, W;Winstanley, PA
通讯作者: Winstanley, PA
DOI: 10.1371/journal.pctr.0010007
发表时间: 2006-05-19
期刊: PLOS CLINICAL TRIALS
影响因子: --
作者:
Bukirwa, Hasifa;Yeka, Adoke;Staedke, Sarah G.
通讯作者: Staedke, Sarah G.
DOI: 10.1016/s0140-6736(05)66417-3
发表时间: 2005-04-23
期刊: LANCET
影响因子: 168.9
作者:
Mutabingwa, TK;Anthony, D;Whitty, CJM
通讯作者: Whitty, CJM
DOI: 10.1016/j.actatropica.2005.06.018
发表时间: 2005-09-01
期刊: ACTA TROPICA
影响因子: 2.7
作者:
Koram, KA;Abuaku, B;Quashie, N
通讯作者: Quashie, N
DOI: 10.4269/ajtmh.2006.75.143
发表时间: 2006-07-01
影响因子: 3.3
作者:
Guthmann, Jean-Paul;Cohuet, Sandra;Balkan, Suna
通讯作者: Balkan, Suna