Treatment outcomes in a safety observational study of dihydroartemisinin/piperaquine (Eurartesim®) in the treatment of uncomplicated malaria at public health facilities in four African countries
Treatment outcomes in a safety observational study of dihydroartemisinin/piperaquine (Eurartesim®) in the treatment of uncomplicated malaria at public health facilities in four African countries
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DOI：
10.1186/s12936-016-1099-7
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发表时间：
2016-01-27
期刊：
影响因子：
3
通讯作者：
Gyapong, Margaret
中科院分区：
文献类型：
--
作者：
Adjei, Alexander;Narh-Bana, Solomon;Gyapong, Margaret
背景资料：双氢青蒿素-哌喹（DHA-PQ）是世卫组织推荐的用于治疗无并发症疟疾的五种青蒿素联合疗法之一。然而，人们对其在撒哈拉以南非洲注册后的安全性和有效性知之甚少。DHA-PQ提供了一个长期的治疗后预防再感染的效果;然而，新的感染已报告在治疗的几周内，特别是在儿童中。本文报告了在布基纳法索、加纳、莫桑比克和坦桑尼亚的公共卫生设施中，在现实生活条件下使用DHQ-PQ治疗确诊的无并发症疟疾的临床结果。方法：一项观察性、非比较性、纵向研究对10名，在四个国家的七个卫生和人口监测系统站点内，有591名确诊的无并发症疟疾患者前往公共卫生设施就诊。非洲国家（加纳、坦桑尼亚、布基纳法索、莫桑比克），2013年9月至2014年4月。根据患者体重采用DHA-PQ治疗，并随访28天以评估临床结局。对1002例嵌套队列进行了密切随访。使用完成3天治疗后报告疟疾体征和症状的患者比例评估临床结局。结果：共筛选了11，097例患者，其中11，017例入组，94例失访，332例退出，10，591例（96.1%）年龄在6个月至85岁之间的患者符合分析方案要求。女性为52.8%，其中48.5%小于5岁。疟疾的诊断方法以显微镜和快速诊断试验为主，分别占69.8%和29.9%.在第28天，复发性症状性寄生虫血症的未校正风险为0.5%（51/10，591）。有症状的疟疾复发患者中，大多数（76%）为< 5岁的儿童.平均血红蛋白水平从第1天的10.6 g/dl降至第7天的10.2 g/dl。有没有显着的肾功能损害嵌套队列在第一个7天的后续最低限度的非临床显着的变化，注意到在肝enzymes.Conclusion：DHA-PQ是有效的，耐受性良好的治疗简单的疟疾，并提供了一个很好的替代一线ACT在撒哈拉以南非洲。
Background: Dihydroartemisinin-piperaquine (DHA-PQ) is one of five WHO recommended artemisinin combination therapy (ACT) for the treatment of uncomplicated malaria. However, little was known on its post-registration safety and effectiveness in sub-Saharan Africa. DHA-PQ provides a long post-treatment prophylactic effect against re-infection; however, new infections have been reported within a few weeks of treatment, especially in children. This paper reports the clinical outcomes following administration of DHQ-PQ in real-life conditions in public health facilities in Burkina Faso, Ghana, Mozambique, and Tanzania for the treatment of confirmed uncomplicated malaria.Methods: An observational, non-comparative, longitudinal study was conducted on 10,591 patients with confirmed uncomplicated malaria visiting public health facilities within seven health and demographic surveillance system sites in four African countries (Ghana, Tanzania, Burkina Faso, Mozambique) between September 2013 and April 2014. Patients were treated with DHA-PQ based on body weight and followed up for 28 days to assess the clinical outcome. A nested cohort of 1002 was intensely followed up. Clinical outcome was assessed using the proportion of patients who reported signs and symptoms of malaria after completing 3 days of treatment.Results: A total of 11,097 patients were screened with 11,017 enrolled, 94 were lost to follow-up, 332 withdrew and 10,591 (96.1 %) patients aged 6 months-85 years met protocol requirements for analysis. Females were 52.8 and 48.5 % were < 5 years of age. Malaria was diagnosed by microscopy and rapid diagnostic test in 69.8 % and 29.9 %, respectively. At day 28, the unadjusted risk of recurrent symptomatic parasitaemia was 0.5 % (51/10,591). Most of the recurrent symptomatic malaria patients (76 %) were children < 5 years. The mean haemoglobin level decreased from 10.6 g/dl on day 1 to 10.2 g/dl on day 7. There was no significant renal impairment in the nested cohort during the first 7 days of follow-up with minimal non-clinically significant changes noted in the liver enzymes.Conclusion: DHA-PQ was effective and well tolerated in the treatment of uncomplicated malaria and provides an excellent alternative first-line ACT in sub-Saharan Africa.