Spruance Spotswood L, Nett Robert, Marbury Thomas, Wolff Ray, Johnson James, Spaulding Theodore
Division of Infectious Diseases, University of Utah, Salt Lake City, Utah 84132, USA.
Antimicrob Agents Chemother. 2002 Jul;46(7):2238-43. doi: 10.1128/AAC.46.7.2238-2243.2002.
Acyclovir cream has been available for the treatment of herpes labialis in numerous countries outside the United States for over a decade. Evidence for its efficacy comes from a few small clinical trials conducted in the 1980s. To examine more comprehensively the efficacy and safety of this formulation, we conducted two independent, identical, parallel, randomized, double-blind, vehicle-controlled, large-scale multicenter clinical trials. Healthy adults with a history of frequent herpes labialis were recruited from the general population, screened for eligibility, randomized equally to 5% acyclovir cream or vehicle control, given study medication, and told to self-initiate treatment five times daily for 4 days beginning within 1 h of the onset of a recurrent episode. The number of patients who treated a lesion was 686 in study 1 and 699 in study 2. In study 1, the mean duration of episodes was 4.3 days for patients treated with acyclovir cream and 4.8 days for those treated with the vehicle control (hazards ratio [HR] = 1.23; 95% confidence interval [CI], 1.06 to 1.44; P = 0.007). In study 2, the mean duration of episodes was 4.6 days for patients treated with acyclovir cream and 5.2 days for those treated with the vehicle control (HR = 1.24; 95% CI, 1.06 to 1.44; P = 0.006). Efficacy was apparent whether therapy was initiated "early" (prodrome or erythema lesion stage) or "late" (papule or vesicle stage). There was a statistically significant reduction in the duration of lesion pain in both studies. Acyclovir cream did not prevent the development of classical lesions (progression to vesicles, ulcers, and/or crusts). Adverse events were mild and infrequent.
阿昔洛韦乳膏在美国以外的许多国家已用于治疗唇疱疹十余年。其疗效证据来自于20世纪80年代进行的一些小型临床试验。为更全面地研究该制剂的疗效和安全性，我们进行了两项独立、相同、平行、随机、双盲、赋形剂对照的大规模多中心临床试验。从普通人群中招募有频繁唇疱疹病史的健康成年人，进行资格筛查，将其平均随机分为5%阿昔洛韦乳膏组或赋形剂对照组，给予研究药物，并告知他们在复发性发作开始后1小时内每天自行用药5次，共4天。研究1中治疗皮损的患者有686例，研究2中有699例。在研究1中，阿昔洛韦乳膏治疗的患者发作平均持续时间为4.3天，赋形剂对照组为4.8天（风险比[HR]=1.23；95%置信区间[CI]，1.06至1.44；P=0.007）。在研究2中，阿昔洛韦乳膏治疗的患者发作平均持续时间为4.6天，赋形剂对照组为5.2天（HR=1.24；95%CI，1.06至1.44；P=0.006）。无论治疗是在“早期”（前驱期或红斑皮损期）还是“晚期”（丘疹或水疱期）开始，疗效均明显。两项研究中皮损疼痛持续时间均有统计学显著缩短。阿昔洛韦乳膏不能预防典型皮损的出现（进展为水疱、溃疡和/或结痂）。不良事件轻微且不常见。
