Hoffman Irving F, Taha Taha E, Padian Nancy S, Kelly Clifton W, Welch Julia D, Martinson Francis E, Kumwenda Newton I, Rosenberg Zeda F, Chilongozi David A, Brown Joelle M, Chirenje Michael, Richardson Barbra A
Division of Infectious Diseases, University of North Carolina, Chapel Hill, NC 27599, USA.
AIDS. 2004 Nov 5;18(16):2191-5. doi: 10.1097/00002030-200411050-00012.
To evaluate the safety of 100 mg nonoxynol-9 (N-9) gel, a vaginal microbicide, on the genital mucosa of women from Malawi and Zimbabwe in preparation for a phase III efficacy study.
HIV-uninfected women (180) were enrolled and randomized to either N-9 or placebo gel and instructed to insert gel into the vagina twice daily for 14 days. Follow up examinations were conducted at 7 and 14 days.
The number of adverse events in the N-9 gel group was higher than in the placebo group (40% versus 13%; P < 0.01). Reported number of any genital symptoms was significantly higher in the N-9 group (38% N-9, 13% placebo; P = 0.01). The number of total epithelial disruptions was higher in the N-9 group (20% versus 3%; P < 0.01); however, the number of genital ulcers and abrasions in the N-9 group was low (2% and 3%, respectively) and not different from that in the placebo group (1% and 2%, respectively).
N-9 gel 100 mg caused a significant increase in the rate of genital symptoms and epithelial disruptions compared with placebo. The clinical significance of these epithelial disruptions is unknown. Although these findings alone were not sufficient to cancel the planned phase III study, when considered together with the negative results from the COL-1492 effectiveness trial of 52.5 mg N-9 gel, the decision was made to cancel the planned phase III trial of 100 mg N-9 gel.
评估一种阴道杀微生物剂——100毫克壬苯醇醚-9（N-9）凝胶对马拉维和津巴布韦女性生殖器黏膜的安全性，为三期疗效研究做准备。
招募180名未感染艾滋病毒的女性，随机分为N-9凝胶组或安慰剂凝胶组，并指导她们每天两次将凝胶插入阴道，持续14天。在第7天和第14天进行随访检查。
N-9凝胶组不良事件的数量高于安慰剂组（40%对13%；P<0.01）。N-9组报告的任何生殖器症状数量显著更高（N-9组为38%，安慰剂组为13%；P=0.01）。N-9组总的上皮破坏数量更高（20%对3%；P<0.01）；然而，N-9组生殖器溃疡和擦伤的数量较低（分别为2%和3%），与安慰剂组（分别为1%和2%）没有差异。
与安慰剂相比，100毫克N-9凝胶导致生殖器症状发生率和上皮破坏显著增加。这些上皮破坏的临床意义尚不清楚。虽然这些发现本身不足以取消计划中的三期研究，但与52.5毫克N-9凝胶的COL-1492有效性试验的阴性结果一起考虑时，决定取消计划中的100毫克N-9凝胶三期试验。
