Eijkman-Oxford Clinical Research Unit, Jakarta, Indonesia.
Trends Parasitol. 2011 Jan;27(1):11-6. doi: 10.1016/j.pt.2010.08.005. Epub 2010 Sep 16.
Millions of people receive primaquine against sexual plasmodia responsible for malaria transmission. These gametocytes cause no symptoms and do not threaten the host, but they infect mosquitoes and threaten the community. Primaquine causes hemolysis in the small minority of patients with glucose-6-phosphate dehydrogenase deficiency (G6PDd). Clinical studies in the 1950s demonstrated gametocytocidal primaquine to be safe without G6PDd screening. However, the evaluated G6PDd variant, African A-, represents mild sensitivity to primaquine. The view of primaquine as a safe gametocytocide thus rests largely upon observations from a G6PDd variant that is unlikely to challenge safety. The early clinical work does not seem to afford an adequate assessment of safety in G6PDd patients. Potential risk of harm without clinical benefit to the patient raises ethical questions that should be examined.
数以百万计的人接受了针对引起疟疾传播的性疟原虫的伯氨喹治疗。这些配子体没有症状,也不会威胁宿主,但它们会感染蚊子,威胁到社区。伯氨喹会导致极少数葡萄糖-6-磷酸脱氢酶缺乏症(G6PDd)患者发生溶血。20 世纪 50 年代的临床研究表明,在没有 G6PDd 筛查的情况下,配子体杀灭性伯氨喹是安全的。然而,评估的 G6PDd 变体,即非洲 A-,对伯氨喹的敏感性轻微。因此,伯氨喹被视为一种安全的配子体杀灭剂,主要基于一种不太可能对安全性构成挑战的 G6PDd 变体的观察结果。早期的临床工作似乎没有对 G6PDd 患者的安全性进行充分评估。在没有给患者带来临床获益的情况下,潜在的危害风险引发了应该审查的伦理问题。