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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 alpha-2a. A multicenter double-blind placebo-controlled clinical trial. Condylomata International Collaborative Study Group.

出版信息

Acta Derm Venereol. 1993 Jun;73(3):223-6. doi: 10.2340/0001555573223226.

Abstract

A randomized, double-blind, placebo-controlled, international multicenter trial was conducted, using 1.5 MIU subcutaneous interferon alpha-2a 3 times a week for 4 weeks in 170 patients (interferon, n = 125 or placebo, n = 45) with condylomata acuminata who had failed to respond to standard therapies. There was no difference in efficacy between the interferon alpha-2a and placebo treatment groups at 3 months after commencement of therapy. Although the recurrence rate at the end of 9 months' follow-up appeared lower in the interferon alpha-2a group than in the placebo group (9% versus 22%), this difference was not statistically significant. Most of the adverse events reported were typical interferon-associated mild to moderate flu-like symptoms. It is concluded that subcutaneous interferon alpha-2a, administered according to the current dosage and treatment schedule, is not effective as monotherapy in the treatment of refractory condylomata acuminata.

摘要

开展了一项随机、双盲、安慰剂对照的国际多中心试验,对170例对标准治疗无反应的尖锐湿疣患者(干扰素组125例,安慰剂组45例)采用150万国际单位皮下注射α-2a干扰素,每周3次,共4周。治疗开始后3个月,α-2a干扰素治疗组与安慰剂治疗组的疗效无差异。尽管在9个月随访结束时,α-2a干扰素组的复发率似乎低于安慰剂组(9%对22%),但这种差异无统计学意义。报告的大多数不良事件是典型的与干扰素相关的轻至中度流感样症状。结论是,按照当前剂量和治疗方案给予皮下α-2a干扰素,作为单一疗法治疗难治性尖锐湿疣无效。

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