苯扎氯铵避孕凝胶剂避孕有效性的临床多中心研究  

Contraceptive efficacy of bioadhesive benzalkonium chloride gel in comparison with nonoxynol-9 gel

作　　者：徐晋勋[1] 黄紫蓉[2] 吴愉 王海云[4] 周晓波[1] 肖志琴 

机构地区：[1]上海市人口和计划生育委员会科学技术处,200003 [2]复旦大学附属妇产科医院计划生育科 [3]上海市计划生育技术指导所 [4]上海市第一妇婴保健院计划生育科

出　　处：《中华妇产科杂志》2006年第10期706-709,共4页Chinese Journal of Obstetrics and Gynecology

摘　　要：目的观察苯扎氯铵(BZK)避孕凝胶剂的避孕效果。方法将240例健康育龄期女性志愿者随机分为两组,其中120例使用BZK避孕凝胶剂(BZK组),120例使用壬苯醇醚(NP-9)避孕胶冻剂(NP-9组),随访6个月,以寿命表法、log-rank检验比较两组的妊娠率、因症停用率和非医学原因停用率。结果两组妇女6个月时的随访率,BZK组和NP-9组分别为100·0%(120/120)和99·2%(119/120);粗累积妊娠率分别为1·72/100妇女和0·91/100妇女;粗累积因症停用率为0和2·68/100妇女;粗累积非医学原因停用率为3·39/100妇女和6·05/100妇女;两组的3种粗累积率分别比较,差异均无统计学意义(P>0·05)。结论BZK避孕凝胶剂的避孕作用与NP-9避孕胶冻剂同样有效。Objective To compare the contraceptive efficacy of a new spermicide, bioadhesive benzalkonium chloride （BZK） gel, with the traditional nonoxynol （ NP-9 ） gel. Methods A total of 240 child-bearing age women volunteers were randomly divided into two groups： 120 using the BZK gel for contraception, and the other 120 using the NP-9 gel. Using life table method and log-rank test, we compared the pregnancy rates and discontinuation rates after follow-up for 6 months in two groups. Results No abnormal findings of cervical smears were detected before and after this clinical trial in all 240 women. The follow-up rates at 6 months were 100. 0% and 99.2% in the BZK group and the NP-9 group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 1.72 and 0. 91 per 100 women （P 〉 0.05 ） , respectively. If we excluded the 2 pregnant women （ 1 in each group）, who did not correctly or consistently use the spermicides for every intercourse, the cumulative pregnancy rates at 6 months in perfect use would be 0. 87 and 0 per 100 women （ P 〉 0. 05 ）. And the gross cumulative discontinuation rates due to allergy or other adverse reactions at 6 months in typical use were 0 and 2. 68 per 100 women （ P 〉 0. 05 ） , respectively. Conclusion The contraceptive efficacy of bioadhesive BZK gel is the same as that of the NP- 9 gel, and it is more acceptable in clinical use.

关 键 词：苯扎胺化合物 避孕药 女用 避孕 迟效制剂 

分 类 号：R169.42[医药卫生—公共卫生与预防医学]