左炔诺孕酮片诺爽用于紧急避孕的生物等效性研究

Relative Bioavailability of Levonorgestrel for Emergency Contraception

目的 验证左炔诺孕酮片 (诺爽 )用于紧急避孕的临床效果。方法 以北京紫竹药业有限公司生产的 0 .75m g左炔诺孕酮片 (毓婷 )为参比制剂 ,采用随机双盲对照试验 ,观察 0 .75 mg左炔诺孕酮片 (诺爽 ,由湖北中天爱百颗药业有限公司提供 )用于紧急避孕的临床效果及副反应。征集无保护性生活后 72 h内要求紧急避孕的健康妇女 142例 ,试验组和对照组各 71例 ,服药方法皆为口服 0 .75 m g左炔诺孕酮 1片 ,12 h后再服 0 .75 mg左炔诺孕酮 1片 ,总剂量为 1.5 mg。服药后按时随访并观察药物副反应及下次月经情况。结果 对照组 (毓婷 )有 1例妊娠 ,根据 Dixon方法计算 ,避孕有效率为 72 .66% ;试验组 (诺爽 )避孕效率为 10 0 % ,两组间差异无显著性 ( P>0 .0 5 )。两组副反应轻微、不需特别处理 ,对月经周期、月经量、经期的影响相似。结论 0 .75 m g诺爽用于紧急避孕的临床效果与毓婷相当 ,也是一种安全、有效。

Objective To investigate the clinical effectiveness of levonorgestrel (LNG) for emergency contraception. Methods By using randomized, double-blinded, controlled methods, comparison of the contraceptive efficacy and side effects between 0.75 mg Nuoshuang-produced LNG (Nuoshuang, Aibaike Pharm. Co. Ltd., Hubei) and 0.75 mg Yuting-made LNG (Yuting, Zizu Pharm. Co. Ltd., Beijing) was done. 142 women with unprotected intercourse within 72 h were allocated into two groups equally: experimental group and control group receiving two doses of 0.75 mg LNG taken 12 h apart. All patients were followed up to observe contraceptive efficacy, side effects and changes of next menstruation. Results In control group, one pregnancy occurred. According to the classic methods of Dixon, the effective rate of contraception was 72.66 % in control group and 100 % in experimental group respectively. However, there were no significant differences between two groups (P>0.05). The side effects were slight and there were no adverse reaction. Conclusion Nuoshuang-produced 0.75 mg LNG has the same effect as Yuting-made LNG for emergency contraception and was also a safe, effective and convenient method.