Moskovitz B L
Clinical Research Division, Rhone-Poulenc Pharmaceuticals, Princeton, New Jersey 08543.
Antimicrob Agents Chemother. 1988 Sep;32(9):1300-3. doi: 10.1128/AAC.32.9.1300.
An open-label, multicenter clinical trial assessed the tolerance of HPA-23 (ammonium-21-tungsto-9-antimoniate) in patients with acquired immune deficiency syndrome. Sixty-nine patients were sequentially assigned to receive 0.25, 0.5, 1.0, or 2.0 mg of HPA-23 per kg intravenously 5 days per week for 8 weeks. HPA-23 was fairly well tolerated at doses of 1.0 mg/kg or less; nearly 60% of patients given 2.0 mg/kg discontinued treatment. Twenty-six patients discontinued treatment because of adverse events or concurrent illness. HPA-23 produced dose-related decreases in platelet count and increases in serum glutamine oxalacetic transaminase. There were no changes in immune system function, as determined by total lymphocyte count, T4-cell count, T8-cell count, and T4/T8 ratio. The effects of HPA-23 seemed to be more closely related to the total dose than to the daily dose. No improvement in the clinical status of the patients was observed during the 8 weeks of treatment.
一项开放标签、多中心的临床试验评估了艾滋病患者对HPA - 23（二十一钨九锑酸铵）的耐受性。69名患者被依次分配，每周5天，静脉注射每千克体重0.25、0.5、1.0或2.0毫克的HPA - 23，持续8周。剂量为1.0毫克/千克及以下时，HPA - 23的耐受性相当良好；近60%接受2.0毫克/千克剂量的患者停止了治疗。26名患者因不良事件或并发疾病而停止治疗。HPA - 23导致血小板计数呈剂量相关下降，血清谷草转氨酶升高。通过总淋巴细胞计数、T4细胞计数、T8细胞计数和T4/T8比值测定，免疫系统功能没有变化。HPA - 23的作用似乎与总剂量的关系比与每日剂量的关系更为密切。在治疗的8周内，未观察到患者临床状况的改善。
