Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product
Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product
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DOI：
10.1016/j.contraception.2005.12.006
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发表时间：
2006-05-01
期刊：
影响因子：
2.9
通讯作者：
Faundes, A
中科院分区：
文献类型：
--
作者：
Amaral, E;Perdigao, A;Faundes, A
背景资料：ACIDFORM是一种杀菌和避孕候选人具有很强的缓冲capacity.Methods：这是一个阶段I盲法，随机和交叉临床研究的两个产品，ACIDFORM和商业壬苯醇醚-9（N-9）产品（2%），评估其阴道安全性在20对夫妇年龄在19岁至45岁。这些妇女月经规律，曾接受过输卵管结扎术，没有哺乳，没有阴道体征和症状，并且是稳定的伴侣关系;双方以前都没有性传播感染。阴道镜检查，阴道微生物学，炎症标志物和受试者的投诉进行了研究性交后。妇女被随机分配接受ACIDFORM 0-30分钟（性交前0-30分钟），ACIDFORM 8-10 h（性交前8-10小时）或N-9控制周期后0-30分钟。在5次性交后阴道镜检查中观察到轻度/中度外阴刺激，在6个治疗周期中报告了烧灼感和瘙痒，在5个不同治疗周期中发现了非刺激相关症状。阴道pH值，Nugent评分，H2 O2产生的白细胞或白细胞介素6在宫颈阴道灌洗液中的治疗和对照cycles.Conclusions：ACIDFORM似乎是安全的，每天一次的临床使用。除N-9外，ACIDFORM作为阴道植物群辅助剂或产品载体具有潜在的杀精子-杀微生物作用。(c)2006年爱思唯尔公司All rights reserved.
Background: ACIDFORM is a microbicidal and contraceptive candidate with strong buffering capacity.Methods: This was a Phase I blinded, randomized and crossover clinical study on two products, ACIDFORM and a commercial nonoxynol-9 (N-9) product (2%), evaluating their vaginal safety in 20 couples aged between 19 and 45 years. The women had regular menses, underwent previous tubal ligation, were not breast-feeding, had no vaginal sign and symptom and were in a stable partnership; both partners had no previous STI. Colposcopy, vaginal microbiology, inflammation markers and subject complaints were studied after coitus. Women were randomly assigned sequentially to receive ACIDFORM 0-30 min (0-30 min before intercourse), ACIDFORM 8-10 h (8-10 h before intercourse) or N-9 0-30 min after a control cycle.Results: Mild/moderate vulvar irritation was observed in five postcoital test colposcopies, burning and pruritus were reported in six treated cycles and non-irritation-related symptoms were found in five cycles with different treatments. No difference in vaginal pH, Nugent scores, H2O2-producing lactobacillus or leukocytes and interleukin 6 in the cervicovaginal lavage was found between the treatment and control cycles.Conclusions: ACIDFORM appears to be safe for clinical use once a day. There is a potential spennicidal-microbicidal role for ACIDFORM as a vaginal flora helper or as a vehicle for products, except N-9. (c) 2006 Elsevier Inc. All rights reserved.