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左炔诺孕酮硅橡胶植入剂(Norplant TM)的五年临床试验。

A five-year clinical trial of levonorgestrel silastic implants (Norplant TM).

作者信息

Diaz S, Pavez M, Miranda P, Robertson D N, Sivin I, Croxatto H B

出版信息

Contraception. 1982 May;25(5):447-56. doi: 10.1016/0010-7824(82)90033-6.

Abstract

Silastic implants containing the progestin, levonorgestrel, were tested as a long-term contraceptive system in 101 women. During five full years of use, no pregnancies occurred. The 5-year continuation rate was 54%. Menstrual irregularities were the most frequent reason for termination of use but only during the first year. More than half of the terminations for this reason were in the first year. Some of the subjects elected to continue use of the implants beyond 5 years, allowing release rate data to be obtained through 6 years. From the second through the sixth year of use, the implants delivered a constant 30 micrograms per day of levonorgestrel to the subjects, and even after six years 57% of the original steroid content remained in the capsules. Return of fertility following removal was essentially immediate and not related to time of use. Medical reasons for removal were infrequent and no pattern was discernible.

摘要

含有孕激素左炔诺孕酮的硅橡胶植入剂作为一种长效避孕系统在101名女性中进行了测试。在整整五年的使用期间,未发生妊娠。五年的续用率为54%。月经不规律是终止使用的最常见原因,但仅在第一年出现。因该原因终止使用的情况一半以上发生在第一年。一些受试者选择在5年后继续使用植入剂,从而获得了6年的释放率数据。从使用的第二年到第六年,植入剂每天向受试者释放恒定的30微克左炔诺孕酮,即使在六年之后,胶囊中仍保留了57%的原始类固醇含量。取出植入剂后生育能力基本立即恢复,且与使用时间无关。因医疗原因取出的情况很少见,且无明显规律。

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