重组人干扰素α-2b凝胶治疗慢性宫颈炎疗效观察

Treatment with Yallaferon for patients with chronic cervicitis

目的探讨重组人干扰素α-2b凝胶(商品名:尤靖安)治疗慢性宫颈炎的临床疗效。方法采用多中心、随机双盲、平行安慰剂对照的临床试验方法,选择2004-09-20-2005-09-10由6个试验中心共录入250例慢性宫颈炎患者,随机分为两组。治疗组:125例,采用尤靖安治疗;对照组:125例,采用凝胶基质治疗。隔日用药1次,10次为1疗程。于治疗后连续3次月经干净后的第3～7天进行疗效评价。结果纳入疗效分析240例(治疗组120例,对照组120例);通过统计分析,治疗组和对照组各时间点宫颈糜烂(现已改称宫颈柱状上皮异位)面积的减小值绝对值、相对于基线的变化百分率(%)间统计学差异有显著性意义(P=0·001);人乳头瘤病毒(HPV)阳性患者各时间点糜烂面积相对于基线的变化的绝对值和好转百分率差异有显著性意义(P<0·05),尤靖安组总有效率为84·87%,明显高于对照组的62·07%(P<0·05)。结论重组人干扰素α-2b凝胶治疗慢性宫颈炎疗效肯定,耐受性好,安全性高。

Objective Evaluate the efficacy of Yallaferon （ Recombinet α-2b interferon gel） in patients with chronic cervicitis. Methods The study was carried out as double-blind, randomized, paralleled and placebo-controlled study. The patients with chronic cervicitis （250） were randomly and evenly assigned to receive either Yallaferon every other day in total of ten times or placebo. Clinical efficacy was assessed within 3-7 days after the third menstruation. Results Among the 240 evaluable patients （ 120 in treatment group and 120 in placebo group）, 235 of them completed the follow-up according to the study protocol and 15 of them dropped out of the study （6 in treatment group and 9 in placebo group respectively）. There was statistically significant difference （P = 0. 001 ） between the treatment group and placebo group in both absolute reduction of erosion area and percentage reduction of erosion area. Patients with HPV positive also showed statistically significant improvement （ P 〈 0.05 ） in both absolute reduction of erosion area and percentage reduction of erosion area with treatment. The overall effective rate of treatment group was 84. 87% , significantly higher than placebo group （62.07%）. Conclusion Treatment with Yallaferon for patients with chronic cervicitis is well tolerated with demonstated efficacy and safety profile.