Leary Kevin J, Riel Michael A, Roy Michael J, Cantilena Louis R, Bi Daoqin, Brater D Craig, van de Pol Corina, Pruett Khadeeja, Kerr Caron, Veazey James M, Beboso Ronnie, Ohrt Colin
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland 21702-5009, USA.
Am J Trop Med Hyg. 2009 Aug;81(2):356-62.
A randomized, double-blind, placebo-controlled study was conducted to assess the effect of tafenoquine, 200 mg weekly for 6 months on ophthalmic and renal safety. This trial was carried out after observations in previous clinical trials that tafenoquine may be associated with the development of corneal deposits and elevations in serum creatinine. In 120 healthy volunteers who received tafenoquine or placebo in a 2:1 randomization, there was no effect on night vision or other ophthalmic indices measured. Persons taking tafenoquine also showed no difference in mean change in glomerular filtration rate (GFR, mL/s/1.73 m(2)) after 6 months of dosing, with a treatment difference of -0.061 (95% confidence interval, -0.168, 0.045), and non-inferiority margin of -0.247 mL/s/1.73 m(2). Tafenoquine was well tolerated over the course of the study. The results of this study showed no clinically significant effects of tafenoquine on ophthalmic or renal function, and support its continued development as an antimalarial drug.
开展了一项随机、双盲、安慰剂对照研究，以评估tafenoquine（每周200mg，持续6个月）对眼部和肾脏安全性的影响。此前的临床试验观察到tafenoquine可能与角膜沉积物的形成及血清肌酐升高有关，在此之后进行了该试验。120名健康志愿者按2:1随机分组接受tafenoquine或安慰剂，结果显示对所测量的夜视或其他眼部指标没有影响。服用tafenoquine的人在给药6个月后肾小球滤过率（GFR，mL/s/1.73 m²）的平均变化也没有差异，治疗差异为-0.061（95%置信区间，-0.168, 0.045），非劣效界值为-0.247 mL/s/1.73 m²。在整个研究过程中，tafenoquine耐受性良好。该研究结果表明tafenoquine对眼部或肾功能没有临床显著影响，并支持其作为抗疟药物继续研发。
