Louisiana State University School of Medicine, New Orleans, LA, USA.
Curr Eye Res. 2012 Jul;37(7):654-60. doi: 10.3109/02713683.2012.692846. Epub 2012 May 18.
Until the availability of ganciclovir ophthalmic gel in 2009, the only option for treating herpes simplex (HSV) keratitis in the USA has been trifluridine (TFT), a compound with tolerability issues related to its nonselective inhibition of DNA replication in both normal cells and virus-infected cells. Ganciclovir has selective pharmacologic activity on viral thymidine kinase and a lower potential for toxicity to healthy human cells. Our objective was to evaluate safety and efficacy findings reported with the use of ganciclovir ophthalmic gel, both for HSV keratitis and other potential clinical indications.
Clinical and preclinical data with ganciclovir were identified through a comprehensive electronic search of PubMed and Medline, using the search terms ganciclovir, ganciclovir 0.15% ophthalmic gel, acyclovir, acyclovir ointment 3%, herpes simplex keratitis, treatment of herpes simplex keratitis, and adenoviral keratoconjunctivitis. The authors were also granted access to previously unpublished ganciclovir surveillance safety data from Bausch & Lomb, Inc.
No clinical data comparing ganciclovir ophthalmic gel to 1% trifluorothymidine (TFT) for HSV keratitis could be identified. Four international, randomized, multicenter clinical trials have demonstrated that ganciclovir gel is at least as effective as acyclovir ointment for the treatment of HSV keratitis. Ganciclovir gel was better tolerated, with lower rates of blurred vision, eye irritation, and punctate keratitis. Recent data also indicate it may hold promise as a treatment for adenoviral keratoconjunctivitis. Worldwide safety surveillance data collected over the past 10-15 years in over 30 countries suggests an extremely low rate of spontaneously reported adverse events with ganciclovir ophthalmic gel.
Current data suggest that ganciclovir ophthalmic gel has similar efficacy as acyclovir ointment for the treatment of HSV keratitis and is better tolerated. Clinical head-to-head studies comparing ganciclovir and TFT would be of great interest, especially for US physicians.
直到 2009 年更昔洛韦眼用凝胶问世之前，美国治疗单纯疱疹（HSV）角膜炎的唯一选择一直是三氟胸苷（TFT），这种药物的耐受性存在问题，因为它在正常细胞和病毒感染细胞中对 DNA 复制具有非选择性抑制作用。更昔洛韦对病毒胸苷激酶具有选择性药理活性，对健康人类细胞的毒性较低。我们的目的是评估使用更昔洛韦眼用凝胶治疗单纯疱疹性角膜炎和其他潜在临床适应证的安全性和疗效发现。
通过对 PubMed 和 Medline 进行全面电子搜索，使用搜索词更昔洛韦、更昔洛韦 0.15%眼用凝胶、阿昔洛韦、阿昔洛韦软膏 3%、单纯疱疹性角膜炎、单纯疱疹性角膜炎的治疗和腺病毒性角结膜炎，确定了更昔洛韦的临床前和临床数据。作者还被授权访问 Bausch & Lomb，Inc. 以前未公布的更昔洛韦监测安全性数据。
没有发现比较更昔洛韦眼用凝胶与 1%三氟胸苷（TFT）治疗单纯疱疹性角膜炎的临床数据。四项国际、随机、多中心临床试验表明，更昔洛韦凝胶治疗单纯疱疹性角膜炎的疗效至少与阿昔洛韦软膏相当。更昔洛韦凝胶的耐受性更好，视力模糊、眼部刺激和点状角膜炎的发生率较低。最近的数据还表明，它可能有望成为治疗腺病毒性角结膜炎的一种方法。过去 10-15 年在 30 多个国家收集的全球安全性监测数据表明，更昔洛韦眼用凝胶的不良反应自发报告率极低。
目前的数据表明，更昔洛韦眼用凝胶治疗单纯疱疹性角膜炎的疗效与阿昔洛韦软膏相似，且耐受性更好。比较更昔洛韦和 TFT 的临床头对头研究将非常有趣，特别是对美国医生而言。
