Research Center for Qinghao (Artemisia annual L.), Guangzhou University of Chinese Medicine, Guangzhou, China.
Malar J. 2011 Aug 10;10:231. doi: 10.1186/1475-2875-10-231.
Drug resistance of falciparum malaria is a global problem. Sulphadoxine/pyrimethamine-resistant and mefloquine-resistant strains of falciparum malaria have spread in Southeast Asia at lightning speed in 1980s-1990s, and the Cambodia-Thailand border is one of the malaria epidemic areas with the most severe forms of multi-drug resistant falciparum malaria.
Artemisinin-piperaquine (AP), dihydroartemisinin-piperaquine phosphate (DHP) and artemether-lumefantrine (AL) were used to treat 110, 55 and 55 uncomplicated malaria patients, respectively. The total dosage for adults is 1,750 mg (four tablets, twice over 24 hours) of AP, 2,880 mg (eight tablets, four times over two days) of DHP, and 3,360 mg (24 tablets, six times over three days) of AL. The 28-day cure rate, parasite clearance time, fever clearance time, and drug tolerance of patients to the three drugs were compared. All of the above methods were consistent with the current national guidelines.
The mean parasite clearance time was similar in all three groups (66.7 ± 21.9 hrs, 65.6 ± 27.3 hrs, 65.3 ± 22.5 hrs in AP, DHP and AL groups, respectively), and there was no remarkable difference between them; the fever clearance time was also similar (31.6 ± 17.7 hrs, 34.6 ± 21.8 hrs and 36.9 ± 15.4 hrs, respectively). After following up for 28-days, the cure rate was 95.1%(97/102), 98.2%(54/55) and 82.4%(42/51); and the recrudescence cases was 4.9%(5/102), 1.8%(1/55) and 17.6%(9/51), respectively. Therefore, the statistical data showed that 28-day cure rate in AP and DHP groups was superior to AL group obviously.The patients had good tolerance to all the three drugs, and some side effects (anoxia, nausea, vomiting, headache and dizziness) could be found in every group and they were self-limited; patients in control groups also had good tolerance to DHP and AL, there was no remarkable difference in the three groups.
AP, DHP and AL all remained efficacious treatments for the treatment of falciparum malaria in Cambodia-Thailand border area. However, in this particular setting, the AP regimen turned out to be favourable in terms of efficacy and effectiveness, simplicity of administration, cost and compliance.
The trial was registered at Chinese Clinical Trial Register under identifier 2005L01041.
恶性疟原虫的耐药性是一个全球性问题。在 20 世纪 80 年代至 90 年代，东南亚的恶性疟原虫对磺胺多辛/乙胺嘧啶耐药株和甲氟喹耐药株迅速蔓延，柬埔寨-泰国边境地区是恶性疟原虫多药耐药最严重的疟疾流行区之一。
采用青蒿琥酯-哌喹（AP）、双氢青蒿素-哌喹磷酸盐（DHP）和蒿甲醚-本芴醇（AL）分别治疗 110、55 和 55 例单纯性疟疾患者。成人总剂量为 1750mg（4 片，24 小时内 2 次）AP、2880mg（8 片，2 天内 4 次）DHP 和 3360mg（24 片，3 天内 6 次）AL。比较三组患者的 28 天治愈率、寄生虫清除时间、退热时间和药物耐受性。所有方法均符合现行国家指南。
三组平均寄生虫清除时间相似（AP、DHP 和 AL 组分别为 66.7±21.9、65.6±27.3 和 65.3±22.5 小时），无显著差异；退热时间也相似（31.6±17.7、34.6±21.8 和 36.9±15.4 小时）。随访 28 天后，治愈率分别为 95.1%（97/102）、98.2%（54/55）和 82.4%（42/51）；复发病例分别为 4.9%（5/102）、1.8%（1/55）和 17.6%（9/51）。因此，统计数据显示，AP 和 DHP 组 28 天治愈率明显优于 AL 组。患者对三种药物均有良好的耐受性，各药物组均出现一些不良反应（缺氧、恶心、呕吐、头痛和头晕），且均为自限性；对照组患者对 DHP 和 AL 也有良好的耐受性，三组之间无显著差异。
AP、DHP 和 AL 对柬埔寨-泰国边境地区的恶性疟原虫仍有疗效。然而，在这种特殊情况下，AP 方案在疗效、有效性、给药简便性、成本和依从性方面具有优势。
该试验在中国临床试验注册中心注册，注册号为 2005L01041。
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