Monsonego J, Cessot G, Ince S E, Galazka A R, Abdul-Ahad A K
Institut Alfred Fournier, Paris, France.
Genitourin Med. 1996 Apr;72(2):111-4. doi: 10.1136/sti.72.2.111.
To evaluate the safety and efficacy of two intralesional doses of recombinant human interferon-beta (r-hIFN-beta: Rebif, Ares Serono), given 3 times a week for 3 weeks, in the treatment of condyloma acuminatum.
A randomised, double-blind, within-patient, placebo-controlled study.
25 patients (24 males, 1 female) with a history of condyloma acuminatum. Twenty had failed previous treatment for condyloma acuminatum. In each patient, 3 distinct lesions were selected for treatment. Each selected lesion was randomly assigned to receive intralesionally one of the following: r-hIFN-beta 33,000 IU/day, r-hIFN-beta 1 x 10(6) IU/day, or matching placebo.
Institut Alfred Fournier, Paris, France.
Response was evaluated colposcopically at the end of treatment (day 22) and 5 weeks later (month 2). Complete response (CR) was defined as disappearance of the treated lesion. Partial response (PR) was defined as at least a 50% reduction in size, but not disappearance of the treated lesion.
The higher dose of 1 x 10(6) IU achieved significantly more complete and partial remissions than placebo, both by the end of treatment, and 5 weeks later.
r-hIFN-beta appears to be safe and effective when administered intralesionally to patients with condyloma acuminatum. Most of the treated patients had failed previous treatments and were therefore a resistant population.
评估每周3次、连续3周给予两种瘤内注射剂量的重组人干扰素-β（r-hIFN-β：Rebif，阿瑞斯·雪兰诺公司）治疗尖锐湿疣的安全性和有效性。
一项随机、双盲、患者自身对照、安慰剂对照研究。
25例有尖锐湿疣病史的患者（24例男性，1例女性）。其中20例既往尖锐湿疣治疗失败。为每位患者选择3个不同的病损进行治疗。每个选定的病损随机分配接受以下瘤内注射之一：r-hIFN-β 33,000 IU/天、r-hIFN-β 1×10⁶ IU/天或匹配的安慰剂。
法国巴黎阿尔弗雷德·富尼埃研究所。
在治疗结束时（第22天）和5周后（第2个月）通过阴道镜评估反应。完全缓解（CR）定义为治疗病损消失。部分缓解（PR）定义为大小至少减少50%，但治疗病损未消失。
在治疗结束时和5周后，1×10⁶ IU的较高剂量比安慰剂显著实现了更多的完全缓解和部分缓解。
对尖锐湿疣患者进行瘤内注射时，r-hIFN-β似乎是安全有效的。大多数接受治疗的患者既往治疗失败，因此是一个耐药群体。
