以双氢青蒿素为基础的联合用药治疗抗药性恶性疟的研究

EFFICACY OF DIHYDROARTEMISININ-BASED COMBINATIONS FOR TREATMENT OF UNCOMPLICATED FALCIPARUM MALARIA IN HAINAN PROVINCE

为了解以双氢青蒿素为基础的2种药物对抗药性恶性疟的治疗效果,本研究在海南省抗药性恶性疟流行区,对无严重并发症的单纯恶性疟病例进行了实验观察。由入院顺序按随机方法分为A、B2个治疗组,按照WHO推荐的28天体内观察法进行治疗和随访。共收治病人105例,科泰复片剂组(A)55例,病人平均退热时间(22.35±13.26)h,平均原虫转阴时间(34.99±12.28)h;双氢青蒿素片剂与咯萘啶胶囊伍用组(B)50例,平均退热时间(22.23±13.31)h,平均原虫转阴时间(34.73±10.13)h;2组比较没有显著性差异,2组均末发现复燃病例。A、B组中分别有10例和3例出现不良反应,主要是头痛、恶心等一些常见的症状,但不需处理而自行消失,且末发现特殊不良反应。结果表明,科泰复和双氢青蒿素伍用咯萘啶治疗抗性恶性疟疗效好,控制症状快,治愈率高,是目前治疗抗药性恶性疟较为理想的药物组合。

To evaluate the therapeutic efficacy of Dihydroartemisinin-based combinations on the treatment of uncomplicated falciparum malaria, the study was implemented in areas of Hainan, China with high levels of Plasmodiumfalciparum resistance to chloroquine. Patients aged 1 to 60 with uncomplicated P. falciparum infection and parasite density 1 000 to 150 000 parasites/mL enrolled following informed consent by parents. Eligible patients were randomly assigned into group A （Dihydroartemisininpiperaquine 40-320 mg/tablet） or group B （Dihydroartemisinin 20 rag/tablet combined Pyronaridine 100 rag/capsule） over three days. Patients were followed up with clinical and laboratory assessments until day 28 using standard WHO in-vivo antimalarial drug test protocol. A total 105 eligible patients were enrolled and completed the study. Adequate clinical and parasitological response （ACPR） was 55 （100%） and 50 （100%） for group A and group B respectively. The mean time of fever clearance and the mean time of asexual parasite clearance in group A were （22.35 ±13.26） h and （34.99 ± 12.28） h and in group B were （22.23± 13.31 ） h and （34.73±10.13） h. We compared the mean time of fever clearance and asexual parasite clearance between A and B. But the difference between them was not significance （ P 〉 0.05 ）. None of participants had recrudescence and serious adverse event. The results showed that Dihydroartemisinin-piperaquine and Dihydroartemisinin combined Pyronaridine have high and comparable cure rates and tolerability among the patients with uncomplicated falciparum malaria in Hainan, China.