Ibrahima I, Laminou I Maman, Adehossi E, Maman D, Boureima S, Harouna H Kadri, Hamidou H Hassan, Mahamadou A, Yacouba I, Hadiza J, Tidjani I Amadou
Centre de recherche médicale et sanitaire, BP 10887, Niamey, Niger.
Faculté des sciences de la santé, université Abdou-Moumouni de Niamey-Niger, BP 10896, Niamey, Niger.
Bull Soc Pathol Exot. 2020;113(1):17-23. doi: 10.3166/bspe-2020-0120.
This study aims to evaluate the therapeutic efficacy and tolerance of two ACTs widely used for the treatment of uncomplicated malaria due to Plasmodium falciparum in Niger. The study was conducted from September to November 2017, at the Integrated Health Centers of Dogondoutchi and Birni N'Gaouré, in patients aged from 6 months to 15 years, with uncomplicated malaria due to Plasmodium falciparum. They were treated with either Artemether-Lumefantrine (AL) or Artesunate-Amodiaquine (ASAQ). The primary endpoint was the appropriate clinical and parasitological response (RCPA) to D28, after PCR correction. The secondary criteria were the clearing time of fever, parasites, and gametocytes and then the occurrence of adverse events. A total of 459 patients were examined, of whom 312 patients met the inclusion criteria for therapeutic efficacy evaluation. We have followed 299 patients up to J28 including 146 in the AL arm and 153 in the ASAQ arm. After PCR correction at J28, RCPA were 95.8% and 96% (P = 0.7185) for arms AL and ASAQ, respectively, compared to 93.1% and 94.1% respectively before PCR correction (P = 0.7892). The number of patients on AL and ASAQ treatment who developed an adverse reaction were 6 (7.6%) and 23 (28%) respectively. AL and ASAQ associations are effective and well tolerated. No serious adverse event was noted. However, their monitoring must continue to detect possible resistance.
本研究旨在评估在尼日尔广泛用于治疗由恶性疟原虫引起的非复杂性疟疾的两种青蒿素联合疗法（ACTs）的治疗效果和耐受性。该研究于2017年9月至11月在Dogondoutchi和Birni N'Gaouré的综合健康中心进行，研究对象为6个月至15岁、患有由恶性疟原虫引起的非复杂性疟疾的患者。他们分别接受蒿甲醚-本芴醇（AL）或青蒿琥酯-阿莫地喹（ASAQ）治疗。主要终点是经PCR校正后第28天的适当临床和寄生虫学反应（RCPA）。次要标准是发热、寄生虫和配子体的清除时间，以及随后不良事件的发生情况。共检查了459名患者，其中312名患者符合治疗效果评估的纳入标准。我们对299名患者进行了随访直至第28天，其中AL组146名，ASAQ组153名。在第28天进行PCR校正后，AL组和ASAQ组的RCPA分别为95.8%和96%（P = 0.7185），而在PCR校正前分别为93.1%和94.1%（P = 0.7892）。接受AL和ASAQ治疗出现不良反应的患者数量分别为6例（7.6%）和23例（28%）。AL和ASAQ联合疗法有效且耐受性良好。未观察到严重不良事件。然而，必须继续对其进行监测以检测可能出现的耐药性。
