重组干扰素α-2b涂剂与安慰剂随机对照治疗单纯疱疹多中心临床研究

Randomized Controlled Multicenter Clinical Trial on Recombinant Interferon a -2b Solution Versus Placebo in The Treatment of Herpes Simplex

目的:评价国产重组干扰素α-2b治疗单纯疱疹的疗效及安全性。方法:采用多中心、随机、双盲和空白基质对照临床试验方法。重组干扰素α-2b涂剂(每瓶10ml,药物浓度为每毫升10万单位)局部外用,每日3次,疗程7d。入选病例221例,临床疗效及安全性评价合格病例共217例,其中试验组110例,对照组107例。结果:α-2b干扰素涂剂与安慰剂对照组相比较,在治疗d3,5,7,10的治愈率、显效率、有效率试验组高于对照组,总疗效也高于对照组,有显著性差异(P<0.05)。本试验中未发现全身药物不良反应,仅出现局部轻微的皮肤干燥和痉挛、刺痛感,药物不良反应率试验组为1.81％(2/110),对照组为1.87％(2/107)。结论:α-2b干扰素涂剂治疗单纯疱疹安全有效。

OBJECTIVE: To evaluate the afficacy and safety of solution formulation of recombinant interferon- α-2b (rIFN- α2b) in the treatment of herpes simplex. METHODS: A double-blind, randomized, multicenter, placebo-controlled clinical trial was conducted. Totally 221 patients with herpes simples were enrolled in the present study. rIFN- α 2b solution(1× 106U·ml-1) or vehicle solution was topically applied 3 times daily for 7 days. Two hundreds seventeen patients completed whole process of clinical trial and were assessed for safety and efficacy, including 110 patients of rIFN- α 2b group and 107 patients of placebo-controlled group. RESULTS: The results showed that efficacy of rIFN- a 2b is superior to that of placebo in promoting scab formation , fastening decrustation of lesions (P>0.05). The overall response rate of rIFN- α 2b is higher than that of placebo at day 3,5,7, 10, respectively(P>0.05). Local skin irritation was found in 1.81% of patients in rlFN-α 2b solution group and 1.87% in placebo group. No systemic events were found in either groups. CONCLUSION: The present study suggests that rIFN- α 2b solution were safe and effective in the treatment of herpes simplex.