关键词: Americas Contraception Contraceptive Agents--side effects Contraceptive Methods--beneficial effects Developed Countries Diseases Family Planning Government Agencies Hiv Infections--prevention and control Infections Knowledge Nonoxynol-9--side effects North America Northern America Organizations Product Approval Reproductive Tract Infections Sexually Transmitted Diseases--prevention and control Spermicidal Contraceptive Agents--side effects United States Usfda Usphs Vaginal Abnormalities Vaginal Injury Vaginal Spermicides--beneficial effects Viral Diseases

Mesh : Americas Consumer Product Safety Contraception Contraceptive Agents Developed Countries Disease Family Planning Services Government Agencies HIV Infections Infections Knowledge Nonoxynol North America Organizations Sexually Transmitted Diseases Spermatocidal Agents United States United States Food and Drug Administration United States Public Health Service Vagina Virus Diseases

来  源:   DOI:

Abstract:
Concerns about the potential of nonoxynol-9 to irritate the vaginal mucosa have deterred the US Centers for Disease Control from endorsing use of this product for the prevention of sexually transmitted diseases (STDs), including HIV. To date, no manufacturers of over-the-counter spermicides have applied for product labeling changes. The US Food and Drug Administration recently held a joint committee meeting of four advisory panels aimed at encouraging spermicide manufacturers to submit clinical results pertaining to STD transmission. The committee concluded that, while manufacturers of over-the-counter spermicides may claim short-term protection against chlamydia and gonorrhea, the long-term safety of such products remains unclear. Needed are clinical trials that investigate the effects of spermicide-induced cervical and vaginal irritation on the risk of HIV transmission. The joint committee indicated that studies conducted in STD clinics and with commercial sex workers would be acceptable evidence. The National Institute of Allergy and Infectious Diseases soon will release the findings of a case-control study that used colposcopy to document the extent of epithelial erosion and other lesions associated with low doses of nonoxynol-9. Of continuing concern is the possibility that the labeling of spermicides as effective against STDs will reduce use of condoms, the most effective barrier to HIV transmission.
摘要:
对nonoxynol-9刺激阴道粘膜的可能性的担忧阻止了美国疾病控制中心支持使用该产品预防性传播疾病(STD),包括艾滋病毒。迄今为止,没有非处方杀精剂制造商申请产品标签变更。美国食品和药物管理局最近举行了由四个咨询小组组成的联合委员会会议,旨在鼓励杀精子剂制造商提交与性病传播有关的临床结果。委员会的结论是,虽然非处方杀精剂的制造商可能会声称对衣原体和淋病的短期保护,此类产品的长期安全性尚不清楚。需要进行临床试验,以研究杀精子剂引起的宫颈和阴道刺激对HIV传播风险的影响。联合委员会指出,在性病诊所和商业性工作者进行的研究将是可以接受的证据。国家过敏和传染病研究所很快将发布一项病例对照研究的结果,该研究使用阴道镜检查来记录与低剂量nonoxynol-9相关的上皮侵蚀和其他病变的程度。持续关注的是,将杀精剂标记为有效预防性传播疾病的可能性会减少避孕套的使用,艾滋病毒传播最有效的屏障。
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