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以Silastic~R作为赋形剂,载以甾体避孕药制成皮下埋植剂已应用于临床,有希望成为一种女性避孕方法。开始用载甾体的Silastic囊,以后发展具有不同释放率的新系统如实心棒和包囊棒。本文比较了皮下植入Norplant~R〔6枚,长34mm的囊,每囊内含左旋18甲(LNg)36mg〕和Norplant~R-2(2枚,长44mm的棒,每棒含LNg70mg)后血LNg水平、达峰时间,取出后半衰期以及SHBG和雌二醇(E_2)水平。研究包括283例健康妇女,随机分成两组,用Norp1ant~R(简称囊)92例,Norp1ant~R-2(简称棒)191例。两组年龄、身高、体重、产次无显著区别。囊植入后头18个月每天释放LNg60～80μg,以后为30μg/天;棒植入后释放LNg50μg/天。
Silastic ~ R as an excipient, containing steroidal contraceptives made of subcutaneous implants has been used in clinical, there is hope to become a female contraceptive method. Starting with steroid-loaded Silastic capsules, new systems such as solid rods and capsule rods with different release rates were later developed. In this study, we compared Norplant R (6 capsules 34 mm in length) with Norplant R-2 (2 rods 44 mm long and 70 mg LNg per rod) Blood LNg level, peak time, half-life after withdrawal, and SHBG and estradiol (E2) levels. The study included 283 healthy women who were randomly divided into two groups: 92 cases with Norpantant-R (abbreviated capsule) and 191 cases with Norpantant-R-2 (referred to as rod for short). There was no significant difference between the two groups in age, height, weight and delivery time. The first 18 months after balloon implantation release LNg 60 ~ 80μg daily, after 30μg / day; release of sticky LNg 50μg / day.