Safety of single daily use for one week of C31G HEC gel in women
Safety of single daily use for one week of C31G HEC gel in women
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DOI：
10.1016/s0010-7824(02)00433-x
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发表时间：
2002-11-01
期刊：
影响因子：
2.9
通讯作者：
Archer, DF
中科院分区：
文献类型：
--
作者：
Ballagh, SA;Baker, JM;Archer, DF
比较7次夜间睡前暴露于1.2%C31G羟乙基纤维素(HEC)、2%壬醇-9(N-9)(Gynol II)或单独使用HEC后的生殖器刺激性和使用者的可接受性。60名18岁以上、月经正常、性传播疾病风险较低的健康女性被随机分配到三组之一。进入和离开盆腔检查记录了阴道酸碱度和革兰氏染色。通过患者日记、第一次使用后24至48天的电话、最后一次使用产品后第二天进行阴道镜检查以及退出时的可接受性问卷来评估生殖器刺激。80%的使用C31G HEC的女性经历了阴道灼热或发热的症状，相比之下，使用N-9的女性和使用车辆的女性的这一比例分别为25%和5%。对于C31G HEC和N-9的积极治疗，镜检查结果相似：分别有50%和60%出现新的病变，25%和20%的病变破坏了上皮完整性，50%和45%的病变较小。对HEC车辆的发现频率只有HEC的一半。12%的女性有上皮破裂，镜医生评估为与涂抹器有关。革兰氏染色显示，使用N-9后细菌性阴道病的可能性是使用N-9后的一半(6--gt；3)，使用车辆或C31G HEC后的可能性是四分之一(4-->；1)。当被问及如果该产品是有效的避孕措施，他们是否会使用该产品时，55%的车辆使用者、35%的N-9使用者和25%的C31G HEC使用者表示同意。C31G HEC的产品可接受性受到热感或烧灼感的限制。在这项对比试验中，C31G HEC产品的安全性与N-9相似。(C)2002 Elsevier Science Inc.保留所有权利。
Genital irritation and user acceptability was compared after seven nightly bedtime exposures to 1.2% C31G hydroxyethyl cellulose (HEC), 2% nonoxynol-9 (N-9) (Gynol II) or HEC vehicle alone. Sixty healthy women over 18 years old at low risk for sexually transmitted disease with normal menses were randomly assigned to one of three groups. Entrance and exit pelvic exams documented vaginal pH and Gram stain. Genital irritation was assessed by patient diaries, a telephone call 24 to 48 It after first use, colposcopy done the day after last product use, and an acceptability questionnaire at exit. Eighty percent of the women using C31G HEC experienced symptoms of vaginal burning or heat compared to 25% of the N-9 users and 5% of the vehicle users. Colposcopic findings were similar for the active treatments of C31G HEC and N-9: 50% vs. 60% developed new lesions, 25% vs. 20% had lesions that disrupted epithelial integrity, and 50% vs. 45% had minor lesions, respectively. Findings with the HEC vehicle were half as frequent. Twelve percent of women had epithelial disruption that was assessed by the colposcopist as applicator-related. Gram stains were half as likely to show bacterial vaginosis after N-9 use (6 --> 3) and one fourth as likely after vehicle or C31G HEC use (4 --> 1). When asked if they would use the product if it were an effective contraceptive, 55% of the vehicle users, 35% of the N-9 users, and 25% of the C31G HEC users agreed. Product acceptability of C31G HEC was limited by the sensation of heat or burning. The C31G HEC product had a similar safety profile to N-9 in this comparative trial. (C) 2002 Elsevier Science Inc. All rights reserved.