Vaginal distribution of two volumes of the novel microbicide gel cellulose sulfate (2.5 and 3.5 mL)

Vaginal distribution of two volumes of the novel microbicide gel cellulose sulfate (2.5 and 3.5 mL)
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DOI:
10.1016/j.contraception.2005.02.006
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发表时间:
2005-07-01
期刊:
影响因子:
2.9
通讯作者:
Mauck, C
Mauck, C
中科院分区:
医学3区
文献类型:
--
作者:
Barnhart, KT;Pretorius, ES;Mauck, C

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这是一项盲法交叉研究,旨在确定2.5 mL和3.5 mL 6%硫酸纤维素凝胶在体内的分布。这种潜在的阴道杀微生物剂与稀释的螯合钆混合并插入阴道。在基线时进行磁共振成像,并在5、20、35和50分钟后重复进行,受试者在数据采集之间休息或走动。在不走动的情况下使用2.5 mL,在50分钟内获得低线性扩散(阴道长度的53.1%)和表面接触(61.7%)。使用3.5 mL带移动的凝胶,在相同的时间间隔内提高了凝胶的线性扩散(84.5%)和表面接触(85.9%),没有明显的泄漏。大多数线性扩张发生在插入后的前5分钟,尽管横向扩张随着时间的推移继续增加,特别是在移动发生时。渗漏和凝胶在任何体积下都不是明显的问题。(C) 2005爱思唯尔公司版权所有。
This was a blinded crossover study to determine the in vivo distribution of 2.5 and 3.5 mL of 6% cellulose sulfate gel. This potential vaginal microbicide was mixed with dilute gadolinium chelate and inserted into the vagina. Magnetic resonance imaging was performed at baseline and repeated after 5, 20, 35 and 50 min with subjects either resting or ambulating between data acquisitions. Use of 2.5 mL with no ambulation gave low linear spread (53.1% of vaginal length) and surface contact (61.7%) at 50 min. Using 3.5 mL of gel with ambulation improved linear spread (84.5%) and surface contact (85.9%) of the gel in the same time interval without significant leakage. Most linear spreading took place in the first 5 min after insertion, although lateral spreading continued to increase with time especially when ambulation took place. Leakage and gel was not a significant problem at either volume. (C) 2005 Elsevier Inc. All rights reserved.