Department of Dermatology and Cosmetic Surgery, Fukuoka University Hospital, Fukuoka, Japan.
Department of Dermatology, Federation of National Public Service Personnel Mutual Aid Associations, Hamanomachi Hospital, Fukuoka, Japan.
J Dermatol. 2024 Oct;51(10):1279-1289. doi: 10.1111/1346-8138.17364. Epub 2024 Jul 24.
Amenamevir is an oral once-daily antiherpesvirus drug that can be administered without dose adjustment in patients with impaired renal function. There are currently no clinical data on immunocompromised patients with herpes zoster treated with amenamevir. Therefore, an exploratory study of the efficacy and safety of amenamevir against herpes zoster in patients with immunosuppression was conducted. Inclusion criteria included patients with acute herpes zoster receiving immunosuppressive drugs or those with malignant tumors or autoimmune diseases. Twenty-four patients were included and received amenamevir (400 mg once daily after meals) for up to 14 days. The primary end point of overall improvement in skin symptoms 7 days after treatment initiation (day 7) was 58.3% for "markedly improved" and 20.8% for "improved." The combined improvement rate was 79.2% (95% confidence interval, 57.8-92.9), and 20.8% of patients experienced "worsened" symptoms. The secondary end points of overall improvement in skin symptoms on day 14 and day 28 were 95.7% and 100%, respectively. The skin symptoms progressed during treatment, peaking on day 7, and then began to heal. By Kaplan-Meier estimation, the median periods to complete crusting and healing were both day 14. There were five adverse events with a possible causal relationship to amenamevir (bacterial skin infection, anemia, hyponatremia, headache, and abnormal liver function) in one of the 24 patients. Although the bacterial skin infection was severe, all events in this patient were reported to be either recovered or recovering. These findings indicate that amenamevir can be effective and safe in immunocompromised patients with herpes zoster. However, as worsening can happen around day 7, it is necessary to carefully monitor such patients and switch to other therapies such as intravenous acyclovir if necessary. Clinical trial identifier: Japan Registry of Clinical Trials jRCTs031190208.
氨苯砜是一种口服、每日一次的抗疱疹病毒药物，可在肾功能受损的患者中无需调整剂量使用。目前尚无氨苯砜治疗疱疹病毒感染免疫功能低下患者的临床数据。因此，进行了一项探索性研究，评估氨苯砜治疗免疫抑制患者带状疱疹的疗效和安全性。纳入标准包括接受免疫抑制药物治疗的急性带状疱疹患者或患有恶性肿瘤或自身免疫性疾病的患者。24 例患者接受氨苯砜（餐后每日 400mg 一次）治疗，最长 14 天。治疗开始后第 7 天（第 7 天）皮肤症状总体改善的主要终点为“显著改善”占 58.3%，“改善”占 20.8%。联合改善率为 79.2%（95%置信区间，57.8-92.9），20.8%的患者出现“恶化”症状。第 14 天和第 28 天皮肤症状总体改善的次要终点分别为 95.7%和 100%。治疗期间皮肤症状进展，第 7 天达到高峰，然后开始愈合。根据 Kaplan-Meier 估计，完全结痂和愈合的中位时间均为第 14 天。24 例患者中有 1 例发生 5 例与氨苯砜可能相关的不良事件（细菌性皮肤感染、贫血、低钠血症、头痛和肝功能异常）。虽然细菌性皮肤感染较为严重，但该患者的所有事件均报告为已恢复或正在恢复。这些发现表明，氨苯砜对疱疹病毒感染免疫功能低下的患者有效且安全。但是，由于第 7 天左右可能会恶化，有必要仔细监测这些患者，并在必要时改用其他疗法，如静脉用阿昔洛韦。临床试验注册号：日本临床试验注册中心 jRCTs031190208。
