Safety study of nonoxynol-9 as a vaginal microbicide: Evidence of adverse effects
Safety study of nonoxynol-9 as a vaginal microbicide: Evidence of adverse effects
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DOI：
10.1097/00042560-199804010-00006
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发表时间：
1998-04-01
期刊：
影响因子：
--
通讯作者：
Kitchen, VS
中科院分区：
文献类型：
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作者：
Stafford, MK;Ward, H;Kitchen, VS
壬醇-9(N-9)在体外具有杀灭病毒的作用，因此是一种用于预防HIV性传播的候选杀菌剂。然而，N-9的活性是非特异性的，这表明杀灭病毒的水平可能会产生不良影响，包括上皮破裂、生殖器粘膜炎症，或两者兼而有之。一项在40名女性志愿者身上进行的随机安慰剂对照试验，每天服用100毫克N-9，为期一周。结果测量包括症状、阴道镜检查和生殖道组织学改变，以及对阴道菌群的影响。N-9中有10人报告了生殖器刺激，安慰剂组有5人报告了生殖器刺激。阴道镜检查显示N-9组中有9人出现红斑，安慰剂组中有2人出现红斑。组织学炎症在N-9组中有7例，在安慰剂组中有2例。炎性改变的特点是固有层以CD8(+)淋巴细胞和巨噬细胞为主的斑片状浸润，没有上皮破坏。在使用N-9的15名女性中有9名观察到乳酸菌数量的短暂减少，在使用安慰剂的18名女性中有6名观察到乳酸菌数量的一过性减少。在标准杀精剂量下使用N-9 7天会增加刺激性、镜检查和炎症的组织学证据，而且更常见的是与使用凝胶期间乳杆菌数量的减少有关。将易受艾滋病毒感染的细胞招募到生殖器粘膜的临床意义尚不清楚，但引起了人们对N-9作为杀微生物剂的适宜性的关注。
Nonoxynol-9 (N-9) is virucidal in vitro, and is therefore a candidate microbicide for preventing sexual transmission of HIV. However, the activity of N-9 is nonspecific, suggesting that virucidal levels may produce adverse effects including epithelial disruption, inflammation of the genital mucosa, or both, A randomized placebo controlled trial of daily use of 100 mg of N-9 took place for 1 week in 40 female volunteers. Outcome measures included symptoms, colposcopic and histologic changes in the genital tract, and impact on vaginal flora. Genital irritation was reported by 10 of the N-9 and 5 of the placebo group. Colposcopy showed erythema in 9 of the N-9 group and 2 of the placebo group. Histologic inflammation was found in 7 of the N-9 group and 2 of the placebo group. Inflammatory changes were characterized by patchy infiltration of the lamina propria predominantly with CD8(+) lymphocytes and macrophages, in the absence of epithelial disruption. A transient reduction in numbers of lactobacilli was observed in 9 of the 15 women using N-9, and 6 of 18 women using placebo. N-9 used for 7 days in a standard spermicidal dose was associated with increased irritation, colposcopic and histologic evidence of inflammation and was more frequently associated with reduction in numbers of lactobacilli during gel use. The clinical significance of the recruitment of cells susceptible to HIV infection to the genital mucosa is unknown but raises concerns about the suitability of N-9 as a microbicide when given in this dose.