Chattopadhyay Rana, Mahajan Babita, Kumar Sanjai
Sanaria, Inc., Rockville, Maryland 20852, USA.
Expert Opin Drug Saf. 2007 Sep;6(5):505-21. doi: 10.1517/14740338.6.5.505.
Antimalarial drugs remain the major intervention tool for the global malaria control efforts that save millions of lives. Nonetheless, emergence and spread of Plasmodium parasites resistant against chloroquine and other major antimalarial drugs has brought the urgency to develop a new generation of safe and effective drugs against malaria. In this article, the safety data for major antimalarial drugs is reviewed. Although an ample amount of clinical data regarding the safety and tolerability of several of these drugs in older children and adults is available, more critical safety and tolerability studies in pregnant women and young children is desirable. To offset the partial loss in efficacy due to drug resistance in malaria parasites acquired against specific drugs, treatment regimens often rely upon the combination of two or more drugs. However, combination therapy requires additional safety, toxicity and tolerability studies in all population groups where these drugs are administered. A uniform standard in assessing the safety and tolerability of antimalarial drugs will be useful in the formulation and implementation of malaria treatment policies that are based on the drug effectiveness, safety and tolerability.
抗疟药物仍然是全球疟疾防治工作中的主要干预工具，拯救了数百万人的生命。尽管如此，疟原虫对氯喹及其他主要抗疟药物产生耐药性并出现传播，这使得开发新一代安全有效的抗疟药物变得紧迫。本文对主要抗疟药物的安全性数据进行了综述。虽然已有大量关于其中几种药物在大龄儿童和成人中的安全性及耐受性的临床数据，但针对孕妇和幼儿开展更关键的安全性和耐受性研究仍很有必要。为了抵消疟原虫对特定药物产生耐药性导致的部分疗效损失，治疗方案通常依赖两种或更多药物的联合使用。然而，联合疗法需要在所有使用这些药物的人群中开展额外的安全性、毒性和耐受性研究。在评估抗疟药物的安全性和耐受性方面采用统一标准，将有助于制定和实施基于药物有效性、安全性和耐受性的疟疾治疗政策。
