Safety and toxicity of Nonoxynol-9 gel as a rectal microbicide
Safety and toxicity of Nonoxynol-9 gel as a rectal microbicide
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DOI：
10.1097/00007435-199911000-00005
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发表时间：
1999-11-01
影响因子：
3.1
通讯作者：
Celum, CL
中科院分区：
文献类型：
--
作者：
Tabet, SR;Surawicz, C;Celum, CL
背景和目标：艾滋病毒和性传播疾病的预防方法可由接受性伙伴控制，是研究和发展的高度优先事项。壬苯醇醚-9（N-9）对阴道粘膜的安全性研究产生了相互矛盾的结果。没有第一阶段的研究已经评估了N-9的效果an the rectal mucosal.Goals：To assess the safety of 52.5 mg的N-9 in a 1.5-g gel when applied one to four applicators per day to the rectal and penicilla.Study Design：该研究包括25 HIV阴性和10 HIV阳性，一夫一妻制的男同性恋夫妇，其中每个合作伙伴是专门插入或接受，而使用N-9凝胶。与N-9凝胶使用期间相比，每名受试者在安慰剂凝胶使用期间作为自己的对照。接受性伴侣在使用安慰剂1周后和使用N-9凝胶2、5和6周后进行肛门镜检查，并在使用安慰剂1周后和使用N-9凝胶5和6周后进行直肠活检。插入性伴侣在1.结果：未检测到直肠溃疡;仅在2名HIV阴性受试者中观察到浅表直肠糜烂。使用N-9凝胶后，仅在31名（89%）接受者中检测到直肠活检组织学异常或轻微异常，而使用安慰剂凝胶1周后，仅在24名（69%）接受者中检测到直肠活检组织学异常。尿道溃疡，而不是由单纯疱疹病毒引起的，在一个HIV阴性participation.Conclusion：低剂量N-9凝胶是不相关的宏观直肠和阴茎上皮破裂或炎症，但组织学异常通常观察到N-9凝胶以及安慰剂凝胶使用期间。
Background and Objectives: Methods of HIV and STD prevention, which can be controlled by the receptive partner, are a high priority for research and development. Studies on the safety of Nonoxynol-9 (N-9) on the vaginal mucosa have yielded conflicting results. No Phase I study has evaluated the effect of N-9 an the rectal mucosa.Goals: To assess the safety of 52.5 mg of N-9 in a 1.5-g gel when applied one to four applicators per day to the rectum and penis.Study Design: The study included 25 HIV-negative and 10 HIV-positive, monogamous gay male couples in which each partner was exclusively insertive or receptive while using N-9 gel. Each participant served as his own control during placebo gel use compared to during N-9 gel use. Receptive partners underwent anoscopic examination after 1 week of placebo use and after 2, 5, and 6 weeks of N-9 gel use, with rectal biopsies obtained after I week of placebo use and after 5 and 6 weeks of N-9 gel use. Insertive partners had safety monitoring after 1. week of placebo use and after 2, 5, and 6 weeks of N-9.Results: No rectal ulcers were detected; superficial rectal erosions mere noted in two HIV-negative participants. Abnormal or slightly abnormal histologic abnormalities of rectal biopsies mere detected in 31 (89%) receptive participants after N-9 gel use compared to 24 (69%) participants after 1 week of placebo gel use. Meatal ulceration, not caused by herpes simplex virus, was detected in one HIV-negative participant.Conclusion: Low-dose N-9 gel was not associated with macroscopic rectal and penile epithelial disruption or inflammation, but histologic abnormalities were commonly observed during N-9 gel as well as during placebo gel use.