【摘要】 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。更多还原

【Abstract】 Objective To assess the efficacy and safety of recombinant human interferon α-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). Ⅱ. 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.更多还原