Calabrese C, Berman S H, Babish J G, Ma X, Shinto L, Dorr M, Wells K, Wenner C A, Standish L J
Bastyr University Research Institute, Bastyr University, Washington 98028, USA.
Phytother Res. 2000 Aug;14(5):333-8. doi: 10.1002/1099-1573(200008)14:5<333::aid-ptr584>3.0.co;2-d.
A phase I dose-escalating clinical trial of andrographolide from Andrographis paniculata was conducted in 13 HIV positive patients and five HIV uninfected, healthy volunteers. The objectives were primarily to assess safety and tolerability and secondarily to assess effects on plasma virion HIV-1 RNA levels and CD4(+) lymphocyte levels. No subjects used antiretroviral medications during the trial. Those with liver or renal abnormalities were excluded. The planned regimen was 5 mg/kg bodyweight for 3 weeks, escalating to 10 mg/kg bodyweight for 3 weeks, and to 20 mg/kg bodyweight for a final 3 weeks. The trial was interrupted at 6 weeks due to adverse events including an anaphylactic reaction in one patient. All adverse events had resolved by the end of observation. A significant rise in the mean CD4(+) lymphocyte level of HIV subjects occurred after administration of 10 mg/kg andrographolide (from a baseline of 405 cells/mm(3) to 501 cells/mm(3); p = 0.002). There were no statistically significant changes in mean plasma HIV-1 RNA levels throughout the trial. Andrographolide may inhibit HIV-induced cell cycle dysregulation, leading to a rise in CD4(+) lymphocyte levels in HIV-1 infected individuals.
对13名HIV阳性患者和5名未感染HIV的健康志愿者进行了穿心莲内酯的I期剂量递增临床试验。主要目的是评估安全性和耐受性，次要目的是评估对血浆病毒体HIV-1 RNA水平和CD4(+)淋巴细胞水平的影响。试验期间没有受试者使用抗逆转录病毒药物。排除有肝脏或肾脏异常的受试者。计划方案为5mg/kg体重，持续3周，然后递增至10mg/kg体重，持续3周，最后递增至20mg/kg体重，持续3周。由于包括一名患者发生过敏反应在内的不良事件，试验在6周时中断。所有不良事件在观察结束时均已解决。给予10mg/kg穿心莲内酯后，HIV受试者的平均CD4(+)淋巴细胞水平显著升高（从基线的405个细胞/mm(3)升至501个细胞/mm(3)；p = 0.002）。在整个试验过程中，平均血浆HIV-1 RNA水平没有统计学上的显著变化。穿心莲内酯可能抑制HIV诱导的细胞周期失调，导致HIV-1感染个体的CD4(+)淋巴细胞水平升高。
