Harrison S M, Harris R W, Bales J D
Department of Clinical Investigation, Fitzsimons Army Medical Center; Aurora, Colorado, USA.
Am J Trop Med Hyg. 1997 Jun;56(6):632-6. doi: 10.4269/ajtmh.1997.56.632.
This study enrolled 28 CNS-involved patients with Trypanosoma brucei rhodesiense at the Kenya Trypanosomiasis Research Institute (Alupe, Kenya) to examine treatment efficacy and toxicity of melarsoprol in relation to renal excretion/dose relationships. This study complied with World Health Organization treatment recommendations, initially treating with suramin followed by three courses of melarsoprol. Traced study patients had a relapse rate of 4.1%. The toxicity and crude death rate was 7.1%. Total urine arsenic output was measured between 24 and 48 hr after the last dose for each course. The range of means of total urine arsenic output between the three treatment courses was 356-511 micrograms. There was no correlation comparing melarsoprol dose, estimated creatine clearance, or urine arsenic output. Urinary pharmacokinetic parameters are not predictive of toxicity or therapeutic efficacy.
本研究在肯尼亚锥虫病研究所（肯尼亚阿鲁佩）招募了28例累及中枢神经系统的罗德西亚布氏锥虫病患者，以研究美拉胂醇的治疗效果和毒性与肾脏排泄/剂量关系。本研究符合世界卫生组织的治疗建议，最初用苏拉明治疗，随后进行三个疗程的美拉胂醇治疗。追踪研究的患者复发率为4.1%。毒性和粗死亡率为7.1%。在每个疗程的最后一剂后24至48小时内测量总尿砷排出量。三个治疗疗程的总尿砷排出量均值范围为356 - 511微克。比较美拉胂醇剂量、估计的肌酐清除率或尿砷排出量之间没有相关性。尿药代动力学参数不能预测毒性或治疗效果。
