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杀微生物剂可接受性研究:产品开发各阶段的最新发现与进展

Microbicide acceptability research: recent findings and evolution across phases of product development.

作者信息

Coly Astou, Gorbach Pamina M

机构信息

Department of Epidemiology, University of California Los Angeles, Los Angeles, California 90095-7353, USA.

出版信息

Curr Opin HIV AIDS. 2008 Sep;3(5):581-6. doi: 10.1097/COH.0b013e32830aba00.

Abstract

PURPOSE OF REVIEW

Research on the acceptability of microbicides has the potential to inform the microbicide development process by shedding light on desirable product characteristics, issues around product use and potential barriers. The purpose of this review is both to synthesize recent findings that are related to microbicide acceptability, highlight areas of deficiencies, and to point to the new directions in which research is needed.

RECENT FINDINGS

Recent studies have assessed acceptability using candidate microbicides in clinical trials, surrogate products, and descriptions of hypothetical products. While most studies have focused on physical characteristics of products, some small studies have investigated participants' short-term experiences with products during sexual intercourse. Overall, as currently measured and in their present formulations, vaginal microbicides have been found to be acceptable to adolescent girls, women, heterosexual men, whereas rectal microbicides were acceptable to men who have sex with men. Few studies have examined acceptability among high-risk HIV-uninfected women. The relationship between acceptability and adherence in trials, and ultimately in real-world settings, remains unknown.

SUMMARY

Data are needed on acceptability of microbicides from larger populations, high-risk HIV-uninfected women, as well as long-term acceptability and contextual factors surrounding acceptability. The association between acceptability and long-term adherence in clinical trials or ultimately in the open market has yet to be demonstrated.

摘要

综述目的

对杀微生物剂可接受性的研究,有望通过揭示理想产品特性、产品使用相关问题及潜在障碍,为杀微生物剂研发过程提供信息。本综述的目的是综合近期与杀微生物剂可接受性相关的研究结果,突出不足之处,并指出需要开展研究的新方向。

近期研究结果

近期研究已在临床试验中使用候选杀微生物剂、替代产品以及对假设产品的描述来评估可接受性。虽然大多数研究聚焦于产品的物理特性,但一些小型研究调查了参与者在性交期间使用产品的短期体验。总体而言,就目前的测量方式及其现有配方而言,已发现阴道杀微生物剂为青春期女孩、女性、异性恋男性所接受,而直肠杀微生物剂为男男性行为者所接受。很少有研究考察高危未感染艾滋病毒女性的可接受性。可接受性与试验中以及最终在现实环境中的依从性之间的关系尚不清楚。

总结

需要获取来自更多人群、高危未感染艾滋病毒女性的杀微生物剂可接受性数据,以及长期可接受性和围绕可接受性的背景因素数据。可接受性与临床试验中或最终在公开市场上的长期依从性之间的关联尚未得到证实。

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