Sacks S L, Thisted R A, Jones T M, Barbarash R A, Mikolich D J, Ruoff G E, Jorizzo J L, Gunnill L B, Katz D H, Khalil M H, Morrow P R, Yakatan G J, Pope L E, Berg J E
Viridae Clinical Sciences, Inc, and the University of British Columbia, Vancouver, Canada.
J Am Acad Dermatol. 2001 Aug;45(2):222-30. doi: 10.1067/mjd.2001.116215.
Recurrent herpes simplex labialis (HSL) occurs in 20% to 40% of the US population. Although the disease is self-limiting in persons with a healthy immune response, patients seek treatment because of the discomfort and visibility of a recurrent lesion.
Our purpose was to determine whether docosanol 10% cream (docosanol) is efficacious compared with placebo for the topical treatment of episodes of acute HSL.
Two identical double-blind, placebo-controlled studies were conducted at a total of 21 sites. Otherwise healthy adults, with documented histories of HSL, were randomized to receive either docosanol or polyethylene glycol placebo and initiated therapy in the prodrome or erythema stage of an episode. Treatment was administered 5 times daily until healing occurred (ie, the crust fell off spontaneously or there was no longer evidence of an active lesion) with twice-daily visits.
The median time to healing in the 370 docosanol-treated patients was 4.1 days, 18 hours shorter than observed in the 367 placebo-treated patients (P =.008; 95% confidence interval [CI]: 2, 22). The docosanol group also exhibited reduced times from treatment initiation to (1) cessation of pain and all other symptoms (itching, burning, and/or tingling; P =.002; 95% CI: 3, 16.5); (2) complete healing of classic lesions (P =.023; 95% CI: 1, 24.5); and (3) cessation of the ulcer or soft crust stage of classic lesions (P <.001; 95% CI: 8, 25). Aborted episodes were experienced by 40% of the docosanol recipients versus 34% of placebo recipients (P =.109; 95% CI for odds ratio: 0.95, 1.73). Adverse experiences with docosanol were mild and similar to those with placebo.
Docosanol applied 5 times daily is safe and effective in the treatment of recurrent HSL. Differences in healing time compared favorably with those reported for the only treatment of HSL that has been approved by the Food and Drug Administration.
复发性唇疱疹（HSL）在美国20%至40%的人群中发病。尽管在免疫反应正常的人群中该病具有自限性，但患者因复发性皮损带来的不适和外观问题而寻求治疗。
我们的目的是确定10%多廿烷醇乳膏（多廿烷醇）与安慰剂相比，在局部治疗急性HSL发作时是否有效。
在总共21个地点进行了两项相同的双盲、安慰剂对照研究。有HSL病史记录的健康成年人被随机分为接受多廿烷醇或聚乙二醇安慰剂治疗，并在发作的前驱期或红斑期开始治疗。每天给药5次，直至愈合（即痂皮自行脱落或不再有活动性皮损的迹象），每天随访两次。
370例接受多廿烷醇治疗的患者愈合的中位时间为4.1天，比367例接受安慰剂治疗的患者短18小时（P = 0.008；95%置信区间[CI]：2，22）。多廿烷醇组从开始治疗到（1）疼痛及所有其他症状（瘙痒、灼痛和/或刺痛）停止的时间也缩短（P = 0.002；95% CI：3，16.5）；（2）典型皮损完全愈合的时间缩短（P = 0.023；95% CI：1，24.5）；（3）典型皮损的溃疡或软痂期停止的时间缩短（P < 0.001；95% CI：8，25）。40%接受多廿烷醇治疗的患者发作中止，而接受安慰剂治疗的患者为34%（P = 0.109；优势比的95% CI：0.95，1.73）。多廿烷醇的不良事件轻微，与安慰剂相似。
每天应用5次多廿烷醇治疗复发性HSL安全有效。与美国食品药品监督管理局批准的唯一一种HSL治疗药物相比，愈合时间差异良好。
