国产探亲避孕药的评估

目的:评估我国5种探亲避孕药的有效性、副反应、安全性及可接受性。方法:检索相关文献并对纳入评估系 统的探亲避孕药进行数据分析。结果:共检索到50篇相关文献,11篇文献被纳入本评估,其中4篇为无对照的临床 试验,7篇为一期临床试验。根据有限的资料分析,探亲避孕片1号及53号探亲抗孕片早期服用方案的避孕失败率 在3.5～16.4/100妇女年之间。一期临床试验显示服用53号探亲抗孕片后并不能完全抑制排卵。53号探亲抗孕片 还可能抑制乳汁分泌。未检索到探亲避孕片1号及53号探亲抗孕片现用方案及炔诺孕酮速效避孕片、左炔诺孕酮速 效避孕片和炔诺酮探亲丸临床资料。结论:建议在较短时间内逐渐停止使用探亲避孕药。如果需要保留部分探亲避 孕药,需要对其有效性、副反应、安全性重新进行研究。

"Visiting Pills" Used in China

Objective: To review and assess the efficacy, side effects, safety and acceptability of visiting pills currently provided by the National Population and Family Planning Commission in China. Method: Relevant published and unpublished literatures on visiting pills were searched and key data were extracted. Results: A total of 50 papers were identified and 11 of them were included in this review. Three studies were uncontrolled clinical trials and eight papers were phase I clinical studies. There were no randomized controlled clinical trials. Data on safety were also lack. The quality of the included early trials were poor. Based on the limited literatures, the failure rates of visiting pills ranged from 3.5 to 16.4 per 100 woman-years. The phase I clinical studies indicated that visiting pills could change the level of reproductive hormones and visiting pill 53 could not completely inhibit ovulation. Moreover, the current administration methods of visiting pill were different from that in earlier studies and there were no data on the efficacy, side effects, safety and acceptability of current used methods. Conclusions: No qualified evidence to prove the effectiveness and safety of visiting pill. It is suggested that the visiting pill should not be provided in national family planning programme.