Wood M J, McKendrick M W, McGill J I
Infection. 1987;15 Suppl 1:S9-13. doi: 10.1007/BF01650105.
Previous studies have shown that intravenous acyclovir does modify rash development, reduce viral shedding and alleviate acute pain in herpes zoster. To assess the clinical efficacy of an oral dosage regimen with 800 mg acyclovir five times daily, double-blind, placebo-controlled studies were carried out at three centres within the U.K., using a common protocol. According to inclusion criteria (immune competent patients over 60 years of age with a clinical diagnosis of herpes zoster with rash of no more than 72 h duration, no previous systemic antiviral treatment, no history of renal insufficiency) 205 patients were recruited after they had given their informed consent. Patients were randomly assigned to receive either two 400 mg tablets acyclovir (41 men, 59 women) or matching placebo (46 men, 59 women) five times daily for seven days. Treatment was predominantly domiciliary based. According to clinical assessment and pain score acyclovir recipients showed a significant benefit in terms of reduction in rash progression if treatment was started within 48 h of the onset of rash, and alleviation of pain during the acute phase of herpes zoster. Overall, the number of patients developing extradermal lesions was significantly lower in the acyclovir group than in the placebo group (p = 0.02). However, there were no significant differences in rash progression and pain response in patients with herpes zoster affecting the ophthalmic division of the trigeminal nerve in patients who received acyclovir (n = 21) compared to those who received placebo (n = 32). 12 acyclovir and 13 placebo recipients reported symptoms, predominantly gastrointestinal in nature, possibly or probably related to therapy.(ABSTRACT TRUNCATED AT 250 WORDS)
既往研究表明,静脉注射阿昔洛韦确实可改变皮疹发展、减少病毒排出并减轻带状疱疹的急性疼痛。为评估每日5次口服800毫克阿昔洛韦剂量方案的临床疗效,在英国的三个中心按照通用方案开展了双盲、安慰剂对照研究。根据纳入标准(60岁以上免疫功能正常、临床诊断为带状疱疹且皮疹持续时间不超过72小时、既往未接受过全身抗病毒治疗、无肾功能不全病史),205名患者在签署知情同意书后入组。患者被随机分配,分别每日5次服用两片400毫克阿昔洛韦(41名男性,59名女性)或匹配的安慰剂(46名男性,59名女性),持续7天。治疗主要在家庭环境中进行。根据临床评估和疼痛评分,若在皮疹出现后48小时内开始治疗,阿昔洛韦治疗组患者在皮疹进展减缓以及带状疱疹急性期疼痛缓解方面显示出显著益处。总体而言,阿昔洛韦组出现皮肤外病变的患者数量显著低于安慰剂组(p = 0.02)。然而,与接受安慰剂的患者(n = 32)相比,接受阿昔洛韦治疗的三叉神经眼支带状疱疹患者(n = 21)在皮疹进展和疼痛反应方面无显著差异。12名阿昔洛韦治疗患者和13名安慰剂治疗患者报告了症状,主要为胃肠道症状,可能或很可能与治疗有关。(摘要截短于250字)