皮下埋植剂Implanon和Norplant的临床对比性研究

A randomized study comparing the efficacy and bleeding pattern of Implanon and Norplant hormonal contraceptive implant

目的 比较皮下埋植剂Implanon(Implanon)和皮下埋植剂Norplant(Norplant)避孕的有效性、可接受性和阴道出血的情况。方法 采用随机对照的前瞻性研究方法 ,将 10 0例健康妇女 ,分为两组 ,使用Implanon 75例 (Implanon组 ) ,使用 2 5 5 5妇女年 ;使用Norplant 2 5例 (Norplant组 ) ,使用 94 4妇女年 ,共随访 4年 ,进行临床比较性研究。结果 两组均无妊娠发生。以 90d为 1个参照时限 ,Implanon组的阴道出血 (出血或滴血 )天数 ,由第 1个参照时限平均 33d ,减少至第 16个参照时限的 2 1d ;Norplant组由平均 31d减少至 2 0d。平均每个参照时限的出血次数 ,Implanon组为 2 2 5次 ,Norplant组为 2 99次 (P <0 0 5 )。有 1次或 1次以上出血和 (或 )滴血≥ 10d的发生率 ,Implanon组由第 1个参照时限的 6 6 %下降至第 16个参照时限的 2 7% ;Norplant组由 6 9%下降至 2 2 %。Implanon组有 7例 (9% )因出血过多或出血时间过长停止使用埋植剂。Norplant组有 1例 (4% )因使用埋植剂后闭经 2年而停止使用埋植剂。平均埋入埋植剂所用时间 ,Implanon组为 11s,Norplant组为 10 3s(P <0 0 0 1) ;平均取出埋植剂所用时间 ,Implanon组为 2 7s ,Norplant组为 10 2s(P <0 0 0 1)。结论 两种皮下埋植剂避孕有效性高、

Objective To compare the contraceptive efficacy, tolerability and bleeding patterns of Implanon and Norplant Methods One hundred healthy female volunteers received either Implanon (75 cases) or Norplant (25 cases) for 4 years, followed up with complain, bleeding patterns, hemoglobin, blood pressure, weight Record the time of insert and remove Results There were no pregnancies during the study Per 90 day reference period, the average number of bleeding spotting days with Implanon decreased from 33 day in the first period to 21 day in the last year, and Norplant decreased from 31 day to 20 day The average bleeding number of times was 2 25 of Implanon and 2 99 of Norplant per reference period( P <0 05) The mean insert time was 11 second of Implanon and 103 second of Norplant The mean remove time was 27 second of Implanon and 102 second of Norplant ( P <0 001) Conclusion Both contraceptive systems demonstrated excellent contraceptive efficacy and were well tolerated Because of its single rod design, Implanon was significantly quicker to insert and remove than the multiple capsule system