The Procter & Gamble Company, Feminine Care Product Development, Cincinnati, Ohio, USA.
J Biomed Mater Res B Appl Biomater. 2010 Feb;92(2):535-41. doi: 10.1002/jbm.b.31550.
Vaginal tampons are Class II medical devices used by women to manage menstruation. The purpose of this study was to investigate intravaginal temperature changes with simulated and actual menstrual tampon use. Tampons (with varying absorbent compositions) embedded with a thermocouple sensor were used to study temperature effects in vitro in a model of the vagina (condom placed in a hollow glass tube, jacketed in a 37 degrees C water bath, and dosed with human menses to fluid saturation) and clinically during menstrual tampon wear under controlled conditions (up to 8 h in a stationary, supine position). Elevations in the temperature of the tampon core occurred upon menses fluid acquisition both in vitro and clinically. Temperature profile characteristics varied from a transient spike with commercial cotton-rayon blend tampons of two different absorbencies to a small but sustained rise (> or =6 h) with a carboxymethyl cellulose (CMC)-containing prototype. On the basis of the results from this study, fluid absorption by tampons generates an exothermic event whose characteristics vary with tampon design and composition. We speculate the small, sustained increased in tampon temperature noted during this study may enhance the production of a bacterial exotoxin associated with tampons composed of CMC.
阴道棉条是女性用于管理经期的 II 类医疗器械。本研究旨在调查模拟和实际使用月经棉条时阴道内温度的变化。使用嵌入热电偶传感器的棉条(具有不同的吸收成分)在阴道模型(避孕套放置在空心玻璃管中,外套在 37 摄氏度水浴中,并注入人月经血以达到流体饱和)中进行体外研究,以及在受控条件下(在静止、仰卧位长达 8 小时)进行临床研究。在体外和临床中,棉条芯的温度在获得月经血时都会升高。温度曲线特征从两种不同吸收能力的商业棉-粘胶混合棉条的短暂尖峰变化到含有羧甲基纤维素(CMC)的原型的小但持续升高(>或=6 小时)。根据这项研究的结果,棉条的液体吸收会产生放热事件,其特征随棉条设计和组成而变化。我们推测,在这项研究中注意到的棉条温度的微小、持续升高可能会增强与 CMC 组成的棉条相关的细菌外毒素的产生。