Stafford M K, Ward H, Flanagan A, Rosenstein I J, Taylor-Robinson D, Smith J R, Weber J, Kitchen V S
Department of Genitourinary Medicine and Communicable Diseases, Chelsea and Westminster Hospital, England.
J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Apr 1;17(4):327-31. doi: 10.1097/00042560-199804010-00006.
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.
壬苯醇醚 -9（N -9）在体外具有杀病毒作用，因此是预防艾滋病毒性传播的候选杀微生物剂。然而，N -9的活性是非特异性的，这表明其杀病毒水平可能会产生不良反应，包括上皮破坏、生殖黏膜炎症或两者皆有。一项针对40名女性志愿者的随机安慰剂对照试验进行了1周，她们每日使用100毫克N -9。结果指标包括症状、生殖道的阴道镜和组织学变化以及对阴道菌群的影响。N -9组有10名志愿者报告有生殖器刺激症状，安慰剂组有5名。阴道镜检查显示，N -9组有9名出现红斑，安慰剂组有2名。组织学炎症在N -9组发现7例，安慰剂组发现2例。炎症变化的特征是固有层有片状浸润，主要为CD8 +淋巴细胞和巨噬细胞浸润，且无上皮破坏。在使用N -9的15名女性中有9名以及使用安慰剂的18名女性中有6名观察到乳酸杆菌数量短暂减少。以标准杀精剂量使用7天的N -9与刺激增加、炎症的阴道镜和组织学证据相关，并且在使用凝胶期间更频繁地与乳酸杆菌数量减少相关。向生殖黏膜募集易感染艾滋病毒的细胞的临床意义尚不清楚，但这引发了对以该剂量使用N -9作为杀微生物剂适用性的担忧。
