生物黏附缓释避孕凝胶杀精剂的临床有效性试验

Contraceptive efficacy of bioadhesive nonoxynol-9 Gel:comparison with nonoxynol-9 suppository

目的 观察外用生物黏附缓释避孕凝胶杀精剂 (凝胶剂 )的临床避孕效果。方法 将2 4 0例育龄妇女志愿者随机分为两组 ,其中 12 0例使用凝胶剂 (凝胶剂组 ) ,12 0例使用避孕栓剂 (栓剂组 )。随访 6个月 ,以生命表法统计、Logrank检验比较两组的妊娠率、因症停用率和非医学原因停用率等。结果 两组使用药剂前后 ,宫颈刮片细胞学检查均无异常。 6个月的随访率 ,凝胶剂组和栓剂组分别为 10 0 0 %和 97 5 % ;粗累积妊娠率分别为 6 39/ 10 0妇女和 2 95 / 10 0妇女 ;因症停用率为3 4 5 / 10 0妇女和 4 5 7/ 10 0妇女 ;非医学原因停用率为 6 89/ 10 0妇女和 14 17/ 10 0妇女。两组比较 ,差异均无显著性 (P >0 0 5 )。结论 凝胶剂的临床效果与避孕栓剂一样 ,是安全、有效的。

Objective To compare the contraceptive efficacy of a new spermicide, bioadhesive nonoxynol (N-9) gel, with a traditional N-9 suppository. Methods A total of 240 child-bearing aged woman volunteers were randomly divided into two groups: 120 cases using the gel for contraception, and another 120 using the suppository. Using lifetable method and log rank test, we compared the pregnancy rates and other 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 97.5% in the gel group and the suppository group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 6.39 and 2.95 per 100 women (P>0.05), respectively. If we eliminated the 5 pregnancy women (3 in the gel group, and 2 in the suppository one), who did not consistently use the spermisides for every intercourse, the cumulative pregnancy rates at 6 month in perfect use would be 3.71 and 2.03 (P>0.05). And the discontinuation rates due to allergy or other side effects at 6 months in typical use were 3.45 and 4.57 (P>0.05), respectively. All of the results observed between two groups in this study were not statistically significant. Conclusion The contraceptive efficacy of bioadhesive N-9 gel is as same as that of the N-9 suppository, and its clinical use is quite safe.