Laurikka-Routti M, Haukkamaa M
City Maternity Hospital, Helsinki, Finland.
Fertil Steril. 1992 Dec;58(6):1142-7.
To study ovarian function, bleeding patterns, and side effects during the 1-year use of a new modified contraceptive subdermal implant releasing the progestin ST-1435 with a lifetime of 2 years.
DESIGN, PATIENTS: The effect on ovarian function and bleeding patterns of one contraceptive implant releasing the progestin ST-1435 was studied in 26 healthy women who volunteered. Side effects were recorded.
The outpatient clinic of the City Maternity Hospital, Helsinki, Finland.
One ST-1435 contraceptive implant was inserted subcutaneously into the ventral aspect of left upper arm.
The women attended the clinic at half-year intervals. Records of bleeding were kept. Blood samples were collected from 5 women before insertion of an implant, from 12 women during the first 5 to 6 weeks of use, and from 10 women during the 6th and 12th month of use. Serum concentrations of ST-1435, progesterone, and estradiol were determined. Side effects were reported.
The study covered 302 woman-months. The implant gave serum concentrations of ST-1435 high enough to inhibit ovulation in all of the 37 analyzed cycles. No pregnancies occurred. Irregular bleeding or spotting was the main event observed, especially during the 1st year of use. One half of the users had irregular cycles. None of the women's implants was removed during 1 year of use because of irregular bleeding. The implant was well accepted and tolerated by the women; no hormonal side effects were reported.
One single 4-cm subdermal ST-1435 implant with a lifetime of 2 years showed good contraceptive efficacy and led to suppression of ovulation. No hormonal side effects were reported. Irregular bleeding patterns were common but well-tolerated, and the implant had a high continuation rate.
研究一种新型改良的释放孕激素ST - 1435且有效期为2年的皮下避孕埋植剂在使用1年期间的卵巢功能、出血模式及副作用。
设计、研究对象：对26名自愿参与的健康女性研究了一种释放孕激素ST - 1435的避孕埋植剂对卵巢功能和出血模式的影响，并记录副作用。
芬兰赫尔辛基市妇产医院门诊。
将一枚ST - 1435避孕埋植剂皮下植入左上臂腹侧。
女性每半年到门诊就诊一次，记录出血情况。在植入埋植剂前从5名女性中采集血样，在使用的前5至6周从12名女性中采集血样，在使用的第6个月和第12个月从10名女性中采集血样。测定血清中ST - 1435、孕酮和雌二醇的浓度，并报告副作用。
该研究涵盖302个妇女 - 月。在所有37个分析周期中，埋植剂使血清中ST - 1435的浓度高到足以抑制排卵。无妊娠发生。观察到的主要情况是不规则出血或点滴出血，尤其是在使用的第1年。一半使用者月经周期不规则。在1年的使用期间，没有女性因不规则出血而取出埋植剂。女性对埋植剂接受度和耐受性良好；未报告激素相关副作用。
一枚4厘米长、有效期为2年的皮下ST - 1435埋植剂显示出良好的避孕效果，可抑制排卵。未报告激素相关副作用。不规则出血模式常见但耐受性良好，且埋植剂的续用率高。
