重组人干扰素α-2b凝胶治疗宫颈高危型人乳头瘤病毒感染有效性和安全性研究

Efficacy and safety of recombinant human interferon α-2b gel in the treatment of cervical HR-HPV infection

目的探讨重组人干扰素α-2b凝胶(尤靖安®)治疗宫颈高危型人乳头瘤病毒(HPV)感染的有效性和安全性。方法收集2011年7月至2012年7月北京大学第一医院等14家医院323例高危型HPV(hr-HPV)阳性患者随机分配到尤靖安组和空白组,其中尤靖安组233例,尤靖安阴道用药,1次1支,隔日用药1次,连续用药3个疗程(连续使用10次为1疗程);空白组90例不使用药物,仅做观察。结果在第6个月复查宫颈hr-HPV DNA。主要疗效:全分析(FAS)集,2组之间转阴率和总有效率均无统计学意义(P>0.05);符合方案(PPS)集,尤靖安组转阴率71.92%(146/203)高于空白组转阴率59.76%(49/82),且差异有统计学意义(P=0.0459)。次要疗效:(1)单型感染(仅一种类型的病毒感染),FAS集,尤靖安组的转阴率69.18%(110/159)高于空白组转阴率52.63%(30/57),且差异有统计学意义(P=0.0251);PPS集,尤靖安组转阴率和总有效率均高于空白组,且差异有统计学意义(P=0.0053,P=0.0310)。(2)复合型感染(仅两种类型的病毒感染)和多型感染(3种类型或以上的病毒感染),FAS集与PPS集,2组间疗效的差异无统计学意义(P>0.05)。尤靖安组不良事件发生率为1.3%(3/227),对照组无不良事件发生,2组间差异无统计学意义(P>0.05)。结论尤靖安外用治疗宫颈hr-HPV感染,可能有效,目前观察未发现严重不良反应。

Objective To assess the efficacy and safety of recombinant human interferon ~x-2b gel （Yallaferon） in the treatment of cervical high-risk human papillomavirus （hr-HPV） infection. Methods Totaly 323 patients with cervical hr-HPV infection were randomized to treatment or control groups. The 233 subjects in treatment group received Yallaferon vaginas suppository every other day for 3 courses. The control group （90 cases） received no treatment and just for observation. Results Cervical hr-HPV DNA was detected at sixth month after treatment. I . Efficacy results： 1.Primary endpoint： At FAS, there were no statistical differences for negative rate and total efficacy between two groups （P〉0.05）; at PPS, negative rate in treatment group and control group were 71.92% （146/203） and 59.76% （49/82）, respectively, with statistical difference （P=0.0459）. 2. Secondary endpoint ：（ 1 ）Single type infection： at FAS, the negative rate in treatment group and control group were 69.18% （110/159） and 52.63% （30/57）, respectively, with statistical difference （P= 0.0251）; at PPS, both negative rate and total effective rate in treatment group were significantly higher than control group, and there were statistical differences （P=0.0053 and P=0.0310）. （2）Complex infection （infected by two types of virus） and many infections （infected by three kinds or more viruses）, at FAS and PPS, there were no significant differences （P〉0.05）. n. Safety results： the adverse events occurred in treatment group, with incidence rate of 1.3%, and there were no significant differences （P〉0.05）. Conclusions Yallaferon may be an effective drug in the local treatment of high-risk human papillomavirus infection with good efficacy and safety.