Safety, acceptability, and tolerability of 3 topical microbicides among heterosexual Kenyan men.

Safety, acceptability, and tolerability of 3 topical microbicides among heterosexual Kenyan men.
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异性恋肯尼亚男性中 3 种局部杀菌剂的安全性、可接受性和耐受性。

DOI:
10.1097/qai.0b013e31802f852b
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发表时间:
2007
期刊:
Journal of acquired immune deficiency syndromes (1999)
影响因子:
--
通讯作者:
Holmes,KingK
Holmes,KingK
中科院分区:
--
文献类型:
--
作者:
Bukusi,ElizabethA;Steele,Matthew;Cohen,CraigR;Nguti,Rosemary;Maingi,CharityW;Thomas,KatherineK;Holmes,KingK

文献摘要

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目的:为了比较的可接受性,耐受性和安全性的3个局部杀微生物剂配方(62%乙醇的润肤凝胶和0.1%和0.4%苯扎氯铵的卫生wipe. Design)用于男性生殖器。设计:这三重随机交叉研究男性参加性传播疾病(STD)诊所在内罗毕,肯尼亚分配的个人没有性病的临床证据适用于产品的阴茎在一个预先确定的随机顺序,每个2周的时间内,每个产品之间的1周洗脱期。男性记录的副作用,并进行了检查的不良事件。结果:39名参与者中,33(84%)完成了6个诊所访问加3个社区卫生工作者的家访。参与者报告使用62%乙醇凝胶和0.1%和0.4%苯扎溴铵的每日计划应用率为99%、99%和96%;性交前应用率为99%、98%和97%,性交后应用率为99%、94%和98%。所有参与者都表示他们会向朋友推荐所有3种产品; 72%的人喜欢62%的乙醇凝胶,17%的人喜欢0.1%的苯扎氯铵,11%的人喜欢0.4%的苯扎氯铵。一个人开发了客观的迹象,生殖器溃疡后14天的0.4%苯扎溴铵wipe use.Conclusions:两个3局部杀微生物剂有最小的不良反应,并没有观察到不良反应,在使用乙醇凝胶,这是首选的大多数男性。
Objectives:To compare the acceptability, tolerability, and safety of 3 topical microbicide formulations (62% ethyl alcohol in emollient gel and 0.1% and 0.4% benzalkonium chloride on a sanitary wipe) for use on male genitalia.Design:This triple-randomized crossover study among men attending a sexually transmitted disease (STD) clinic in Nairobi, Kenya assigned individuals without clinical evidence of an STD to apply products to the penis in a predetermined random order, each for a 2-week period with a 1-week washout period between each product. Men recorded side effects and were examined for adverse events.Results:Of 39 participants, 33 (84%) completed 6 clinic visits plus 3 home visits by community health workers. Participants reported use of 62% ethanol gel and 0.1% and 0.4% benzalkonium on 99%, 99%, and 96% of daily scheduled applications; 99%, 98%, and 97% of preintercourse applications, and 99%, 94%, and 98% of postintercourse applications. All participants said they would recommend all 3 products to a friend; 72% preferred the 62% ethanol gel, 17% the 0.1% benzalkonium, and 11% the 0.4% benzalkonium. One person developed objective signs of a genital ulcer after 14 days of 0.4% benzalkonium wipe use.Conclusions:Two of the 3 topical microbicides had minimal reported adverse effects, and no adverse effects were observed during use of the ethanol gel, which was preferred by most men.