Elias C J, Coggins C, Alvarez F, Brache V, Fraser I S, Lacarra M, Lähteenmäki P, Massai R, Mishell D R, Phillips D M, Salvatierra A M
Population Council, New York, New York 10017, USA.
Contraception. 1997 Dec;56(6):387-9. doi: 10.1016/s0010-7824(97)00176-5.
There is an urgent need to develop safe, effective, and acceptable vaginal products for the prevention of sexually transmitted infections. Preliminary in vitro results suggest that vaginal formulations of sulfated polysaccharides, including iota-carrageenan, have the potential to block mucosal transmission of human immunodeficiency virus (HIV). Twenty-five women in five sites participated in Phase I trials to evaluate the safety of a formulation containing iota-carrageenan (PC 213). The results of this study indicate that a 5 mL 2% gel formulation of iota-carrageenan is not associated with significant irritation of the female reproductive tract when administered once daily in the absence of sexual intercourse. Given the small number of participants in this initial study, careful observation for potential irritation must also be included in larger studies of this and other vaginal formulations.
迫切需要开发安全、有效且可接受的阴道产品以预防性传播感染。初步体外研究结果表明，包括ι-卡拉胶在内的硫酸化多糖阴道制剂有潜力阻断人类免疫缺陷病毒（HIV）的黏膜传播。五个地点的25名女性参与了I期试验，以评估含ι-卡拉胶制剂（PC 213）的安全性。该研究结果表明，在无性交情况下每日给药一次时，5毫升2%的ι-卡拉胶凝胶制剂不会对女性生殖道造成明显刺激。鉴于这项初步研究的参与者数量较少，在对此及其他阴道制剂进行更大规模研究时，也必须仔细观察是否有潜在刺激。
