Cellulose sulfate: tolerance and acceptability of penile application
Cellulose sulfate: tolerance and acceptability of penile application
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DOI：
10.1016/s0010-7824(01)00270-0
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发表时间：
2001-12-01
期刊：
影响因子：
2.9
通讯作者：
Callahan, M
中科院分区：
文献类型：
--
作者：
Mauck, C;Frezieres, R;Callahan, M
纤维素硫酸钠 (CS) 正在开发作为阴道杀微生物剂和杀精子剂。这是一项针对男性的 I 期、随机、双盲研究，旨在评估连续七次每日剂量的 CS 与含有 nonoxynol-9 (Conceptrol) 的活性对照相比的可接受性、安全性和阴茎刺激程度。数据表明，CS 凝胶对男性生殖器的刺激并不比 Conceptrol 更大。这一点，加上在连续 6 天阴道给药后对女性进行的 I 期安全性研究中观察到的最小刺激，表明 CS 可以用于未来的研究，在夫妻进行阴道性交时不会产生过度风险。应告知未来研究中的男性志愿者，本研究中 CS 组的 24 名参与者中，有 1 名在接触后短暂经历了刺痛和轻微刺痛，而 Conceptrol 组中 12 名参与者中有 3 名报告了类似症状。 (C) 2002 Elsevier Science Inc. 保留所有权利。
Sodium cellulose sulfate (CS) is under development as a vaginal microbicide and spermicide. This was a Phase I, randomized, double-blind study of men to assess acceptability, safety, and degree of penile irritation of seven consecutive daily doses of CS compared to an active control containing nonoxynol-9 (Conceptrol). The data suggest that CS gel is not more irritating to the male genitalia than Conceptrol. This, along with the minimal irritation seen in a Phase I safety study in women following 6 consecutive days of vaginal administration, suggests that CS could be used in future studies, without undue risk, where couples engage in vaginal intercourse. Male volunteers in future studies should be informed that 1 out of 24 participants in the CS group in this study experienced tingling and slight stinging for a brief time after exposure compared with 3 out of 12 in the Conceptrol group who reported similar symptoms. (C) 2002 Elsevier Science Inc. All rights reserved.