Center for Biomedical Research, Population Council, New York, NY, USA.
Center for Biomedical Research, Population Council, New York, NY, USA.
Adv Drug Deliv Rev. 2015 Sep 15;92:27-38. doi: 10.1016/j.addr.2014.12.005. Epub 2014 Dec 24.
Sexually transmitted infections like HIV, HPV, and HSV-2, as well as unplanned pregnancy, take a huge toll on women worldwide. Woman-initiated multipurpose prevention technologies that contain antiviral/antibacterial drugs (microbicides) and a contraceptive to simultaneously target sexually transmitted infections and unplanned pregnancy are being developed to reduce these burdens. This review will consider products that are applied topically to the vagina. Rectally administered topical microbicides in development for receptive anal intercourse are outside the scope of this review. Microbicide and microbicide/contraceptive candidates must be rigorously evaluated in preclinical models of safety and efficacy to ensure that only candidates with favorable risk benefit ratios are advanced into human clinical trials. This review describes the comprehensive set of in vitro, ex vivo, and in vivo models used to evaluate the preclinical safety and antiviral efficacy of microbicide and microbicide/contraceptive candidates.
性传播感染，如 HIV、HPV 和 HSV-2，以及意外怀孕，给全球女性带来了巨大的负担。正在开发的由女性主导的多用途预防技术包含抗病毒/抗菌药物（杀微生物剂）和避孕药，以同时针对性传播感染和意外怀孕，以减轻这些负担。本综述将考虑局部应用于阴道的产品。正在开发用于接受肛交的直肠内局部杀微生物剂不在本综述范围内。杀微生物剂和杀微生物剂/避孕药候选物必须在临床前安全和疗效模型中进行严格评估，以确保只有具有良好风险效益比的候选物才能进入人体临床试验。本综述描述了用于评估杀微生物剂和杀微生物剂/避孕药候选物的临床前安全性和抗病毒疗效的全面体外、离体和体内模型。
