Mauck C K, Baker J M, Barr S P, Johanson W M, Archer D F
Contraceptive Research and Development (CONRAD) Program, Eastern Virginia Medical School, Arlington, USA.
Contraception. 1997 Aug;56(2):97-102. doi: 10.1016/s0010-7824(97)00099-1.
The objectives of this study were 1) to assess the ability of a new contraceptive vaginal film containing two doses of nonoxynol-9 (N-9) to prevent the penetration of sperm into midcycle cervical mucus, and 2) to determine the effect of the film on the vaginal epithelium. The novel formulation was compared with VCF (a currently marketed film also containing N-9). Ten women underwent two baseline cycles of postcoital testing in which no film was used, followed by three test cycles in which Allendale-N9 film, a new film containing either 100 or 130 mg N-9, or VCF containing 70mg N-9 was used. The sequence of testing cycles was randomized. In each cycle, condoms were used prior to midcycle, then a midcycle cervical mucus specimen was examined to ensure midcycle characteristics and the absence of sperm. Each woman then had intercourse using either no film (baseline cycles) or a test film (test cycles) and returned 2-3 h afterwards. Cervical mucus was again assessed for adequacy and the presence of sperm. Each woman also underwent colposcopy using a protocol developed by the World Health Organization. The average number of progressively motile sperm seen per high power field were as follows: average of the two baseline cycles, 19.3; test cycle with Allendale-N9 film containing 100 mg N-9, 0.6; test cycle with Allendale-N9 film containing 130 mg N-9, 0.9; and test cycle with VCF, 0.5. There was no significant difference between baseline cycles or between test cycles in the number of progressively motile sperm per high power field (HPF) seen (p = 0.31 and p > or = 0.50, respectively). The average number of motile sperm seen in each test cycle did, however, differ significantly from the number in either baseline cycle (p < 0.02). The majority of colposcopic examinations were normal. In one baseline cycle and eight test cycles, colposcopy showed superficial de-epithelialization without underlying inflammation. There was no apparent dose response and in all cases the volunteers were asymptomatic. A vaginal contraceptive containing either 100 or 130 mg N-9 in a new film base appears to be safe and comparable to VCF in preventing sperm from entering midcycle cervical mucus.
1）评估一种含有两剂壬苯醇醚-9（N-9）的新型避孕阴道膜阻止精子穿透月经周期中期宫颈黏液的能力；2）确定该阴道膜对阴道上皮的影响。将这种新型制剂与VCF（一种目前市场上销售的同样含有N-9的阴道膜）进行比较。10名女性进行了两个未使用阴道膜的性交后测试基线周期，随后进行三个测试周期，分别使用艾伦代尔-N9膜（一种含有100或130毫克N-9的新型阴道膜）或含有70毫克N-9的VCF。测试周期的顺序是随机的。在每个周期中，月经周期中期之前使用避孕套，然后检查一份月经周期中期的宫颈黏液样本，以确保其具有月经周期中期的特征且无精子。然后，每位女性在不使用阴道膜（基线周期）或使用测试阴道膜（测试周期）的情况下进行性交，并在2 - 3小时后返回。再次评估宫颈黏液是否合适以及是否存在精子。每位女性还按照世界卫生组织制定的方案接受了阴道镜检查。每个高倍视野中观察到的进行性活动精子的平均数量如下：两个基线周期的平均值为19.3；使用含有100毫克N-9的艾伦代尔-N9膜的测试周期为0.6；使用含有130毫克N-9的艾伦代尔-N9膜的测试周期为0.9；使用VCF的测试周期为0.5。在每个高倍视野中观察到的进行性活动精子数量，基线周期之间或测试周期之间均无显著差异（p分别为0.31和p≥0.50）。然而，每个测试周期中观察到的活动精子平均数量与任何一个基线周期中的数量均有显著差异（p<0.02）。大多数阴道镜检查结果正常。在一个基线周期和八个测试周期中，阴道镜检查显示有浅表性上皮脱失，但无潜在炎症。未观察到明显的剂量反应，所有情况下志愿者均无症状。一种以新型膜为基质、含有100或130毫克N-9的阴道避孕药在阻止精子进入月经周期中期宫颈黏液方面似乎是安全的，且与VCF相当。
