Wang Qi, Zhang Zhenyan, Yu Weisheng, Lu Chenguang, Li Guoming, Pan Ziyi, Zhang Hongying, Wu Wanting, Oubou Tinah Atcha, Yuan Yueming, Guo Jiawen, Liang Yuan, Huang Xinan, Guo Wenfeng, Li Changqing, Julie Nadia, Xu Qin, Sanwogou Logte, Song Jianping, Deng Changsheng
Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, China.
Tinah ATCHA OUBOU, National Malaria Control Program, Ministry of Health and Social Security, Lome, Togo.
Front Pharmacol. 2020 Jun 5;11:784. doi: 10.3389/fphar.2020.00784. eCollection 2020.
Malaria is a major public health concern in Togo. The Est-Mono district of Togo has a population of 150,000. Accordingly, the Guangzhou University of Chinese Medicine, China and the Ministry of Health and Social Security, Togo launched a nationwide Mass Drug Administration Project with artemisinin-piperaquine (AP) in Est-Mono. Before launching this project, the sensitivity test of AP was conducted in a general clinic in Elawagnon, Togo. With this background, we evaluated the efficacy and safety of AP for the treatment of uncomplicated falciparum malaria in children under the age of 5 years.
Children aged 6-59 months with uncomplicated falciparum malaria were enrolled in this study. The selected patients were treated with a combination regime of artemisinin-piperaquine. The patients were followed up for 28 days, during which signs of the following were observed for: the duration for fever clearance, parasitemia density, gametophyte generation, cure rate, hemoglobin level, and ( polymorphism. The primary end point was a 28-day cure rate and polymerase chain reaction (PCR)-corrected reinfection and recrudescence. This research followed the standardized World Health Organization (WHO) protocol for the assessment of the efficacy of antimalarial drugs.
A total of 91 children with uncomplicated falciparum malaria were enrolled in this study. Adequate clinical and parasitological responses (ACPRs) before and after PCR-correction were 66 (73%) and 90 (99%), respectively. The average hemoglobin level in the patient increased by 0.05 g/dl per day (p < 0.0001) after the treatment. The gametophyte generation did not decline at the beginning of the treatment; however, after 14 days, it declined (day 21: p < 0.05; day 28: p < 0.01). In the polymorphism study of 24 children treated for parasite infection, one case of with haplotype and haplotype was noted, indicating its recrudescence, with a frequency of 4%. The remaining 23 cases could have been of reinfection, with a frequency of 96%. No serious adverse reactions occurred, and AP was well-tolerated by all patients.
Artemisinin-piperaquine was found to be an effective combination for treating uncomplicated falciparum malaria in children aged <5 years in Togo, and the drugs were well-tolerated. In Togo, remains sensitive to artemisinin-piperaquine, necessitating its trial in this region.
Trial registration: ECGPHCM No. B2017-054-01; MHSST AVIS N° 0001/2016/CBRS du 07 janvier 2016. Registered 17 March 2014, http://www.chinadrugtrials.org.cn/eap/main.
疟疾是多哥的一个主要公共卫生问题。多哥的滨海莫诺区有15万人口。因此，中国广州中医药大学与多哥卫生和社会保障部在滨海莫诺开展了一项全国性的青蒿素哌喹大规模药物管理项目。在启动该项目之前，在多哥埃拉瓦尼翁的一家普通诊所进行了青蒿素哌喹的敏感性试验。在此背景下，我们评估了青蒿素哌喹治疗5岁以下儿童非复杂性恶性疟的疗效和安全性。
本研究纳入了6至59个月患有非复杂性恶性疟的儿童。所选患者接受青蒿素哌喹联合治疗方案。对患者进行28天的随访，在此期间观察以下指标：发热消退时间、寄生虫血症密度、配子体产生情况、治愈率、血红蛋白水平以及（多态性。主要终点是28天治愈率以及聚合酶链反应（PCR）校正后的再感染和复发情况。本研究遵循世界卫生组织（WHO）评估抗疟药物疗效的标准化方案。
本研究共纳入91例患有非复杂性恶性疟的儿童。PCR校正前后的充分临床和寄生虫学反应（ACPR）分别为66例（73%）和90例（99%）。治疗后患者的平均血红蛋白水平每天增加0.05 g/dl（p < 0.0001）。治疗开始时配子体产生情况未下降；然而，14天后下降（第21天：p < 0.05；第28天：p < 0.01）。在对24例接受寄生虫感染治疗的儿童进行的多态性研究中，发现1例具有单倍型和单倍型的复发病例，复发频率为4%。其余23例可能为再感染，频率为96%。未发生严重不良反应，所有患者对青蒿素哌喹耐受性良好。
发现青蒿素哌喹是治疗多哥5岁以下儿童非复杂性恶性疟的有效组合，且药物耐受性良好。在多哥，对青蒿素哌喹仍敏感，有必要在该地区进行试验。
试验注册：ECGPHCM编号B2017 - 054 - 01；MHSST AVIS N°0001/2016/CBRS，2016年1月7日。于2014年3月17日注册，http://www.chinadrugtrials.org.cn/eap/main。
