苯扎氯铵避孕凝胶剂避孕有效性的临床多中心研究

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.

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

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.