干扰素α-2a联合消融疗法治疗肛门生殖器疣的联合治疗试验
Combined therapy trial with interferon alpha-2a and ablative therapy in the treatment of anogenital warts.
作者信息
Armstrong D K, Maw R D, Dinsmore W W, Blaakaer J, Correa M A, Falk L, Ferenczy A S, Fortier M, Frazer I, Law C, Moller B M, Oyakawa N
机构信息
Department of Genitourinary Medicine, Royal Victoria Hospital, Belfast.
出版信息
Genitourin Med. 1996 Apr;72(2):103-7. doi: 10.1136/sti.72.2.103.
OBJECTIVE
To determine whether the combination of systemically administered interferon alpha-2a and ablative surgery for the treatment of genital and/or perianal warts produces a 30% or greater improvement in lasting response rate compared with a control group receiving a combination of placebo and ablative therapy.
DESIGN
Randomised, triple-blind, placebo-controlled trial using 1 or 3 MIU of interferon alpha-2a or placebo administered subcutaneously three times weekly for 10 weeks in combination with ablative surgery.
SETTING
International, multicentre study in 10 genitourinary medicine clinics.
PATIENTS
Two hundred and fifty patients with anogenital warts.
MAIN OUTCOME MEASURES
Lasting response at week 38.
RESULTS
Standard efficacy analysis at week 38 showed a lasting response in 51% (35/68) of 3 MIU interferon-treated patients, 48% (30/63) of 1 MIU interferon-treated patients and 43% (29/67) of placebo-treated patients.
CONCLUSIONS
With the doses and regime described, treatment with interferon alpha-2a in combination with ablative therapy is not significantly superior in the treatment of anogenital warts than placebo and ablative therapy.
目的
确定与接受安慰剂和消融治疗联合的对照组相比，全身给予干扰素α-2a与消融手术联合治疗生殖器和/或肛周疣是否能使持久缓解率提高30%或更多。
设计
随机、三盲、安慰剂对照试验，使用1或3百万国际单位的干扰素α-2a或安慰剂，每周皮下注射3次，共10周，联合消融手术。
地点
在10个泌尿生殖医学诊所进行的国际多中心研究。
患者
250例患有肛门生殖器疣的患者。
主要观察指标
第38周时的持久缓解情况。
结果
第38周的标准疗效分析显示，接受3百万国际单位干扰素治疗的患者中有51%（35/68）、接受1百万国际单位干扰素治疗的患者中有48%（30/63）、接受安慰剂治疗的患者中有43%（29/67）出现持久缓解。
结论
按照所述剂量和方案，干扰素α-2a联合消融治疗在治疗肛门生殖器疣方面并不比安慰剂和消融治疗有显著优势。
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