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重组干扰素α-2a治疗复发性尖锐湿疣。一项多中心双盲安慰剂对照临床试验。尖锐湿疣国际协作研究组。

Recurrent condylomata acuminata treated with recombinant interferon alfa-2a. A multicenter double-blind placebo-controlled clinical trial. Condylomata International Collaborative Study Group.

出版信息

JAMA. 1991;265(20):2684-7.

PMID:2023348
Abstract

Systemic interferon has been advocated as an effective therapy for recurrent genital warts. A double-blind, placebo-controlled, multicenter international trial involving 172 patients with recurrent condylomata was conducted using systemic interferon alfa-2a in doses of 3 or 9 MIU three times per week for 4 weeks. The treatment period was followed by a treatment-free follow-up period of 2 months. Complete responders at month 3 were followed up to 9 months or until they had a recurrence, whichever occurred first. The combined rates of complete response (total disappearance of all lesions without appearance of new ones) and major incomplete response (at least a 75% reduction in total lesion area) at 3 months after the commencement of therapy were 34%, 25%, and 30%, respectively, in 166 patients receiving 3 and 9 MIU of interferon alfa-2a and placebo. The recurrence rates at the end of 9 months were 9% in the placebo and 3-MIU groups and 36% in the 9-MIU group. We conclude that systemic interferon alfa-2a administered three times weekly for 4 weeks at doses of 3 and 9 MIU is not effective as monotherapy for genital warts that have recurred after standard ablative therapy.

摘要

全身性干扰素已被提倡作为复发性生殖器疣的一种有效治疗方法。一项双盲、安慰剂对照、多中心国际试验纳入了172例复发性湿疣患者,使用全身性干扰素α-2a,剂量为3或9百万国际单位,每周3次,共4周。治疗期后为2个月的无治疗随访期。对第3个月时的完全缓解者随访至9个月或直至复发,以先发生者为准。在开始治疗3个月后,166例接受3百万国际单位和9百万国际单位干扰素α-2a及安慰剂治疗的患者中,完全缓解(所有病灶完全消失且无新病灶出现)和主要不完全缓解(总病灶面积至少减少75%)的综合发生率分别为34%、25%和30%。9个月结束时,安慰剂组和3百万国际单位组的复发率为9%,9百万国际单位组为36%。我们得出结论,对于标准消融治疗后复发的生殖器疣,每周3次、共4周给予3和9百万国际单位剂量的全身性干扰素α-2a作为单一疗法无效。

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