Keeney R E, Kirk L E, Bridgen D
Am J Med. 1982 Jul 20;73(1A):176-81. doi: 10.1016/0002-9343(82)90086-9.
Acyclovir tolerance has been explored in a broad range of human populations and dosage regimens with intravenous, topical, and oral formulations. Phase I pharmacokinetic/tolerance studies assured safety in special populations at unique risk of complicated herpes infections who were simultaneously at increased risk of toxicity to anti-DNA chemotherapeutic agents. Further safety evaluations accompanied placebo-controlled Phase II studies in infected patients who represent future users of acyclovir. These studies confirm acyclovir as the safest antiherpes agent to be explored in clinical studies to date.
已经在广泛的人群和采用静脉注射、局部用药及口服制剂的给药方案中研究了阿昔洛韦的耐受性。I期药代动力学/耐受性研究确保了特殊人群(即有发生复杂疱疹感染独特风险且同时对抗DNA化疗药物毒性风险增加的人群)的安全性。在代表阿昔洛韦未来使用者的感染患者中进行的安慰剂对照II期研究伴随有进一步的安全性评估。这些研究证实阿昔洛韦是迄今为止临床研究中所探索的最安全的抗疱疹药物。