LEVONORGESTREL-RELEASING AND COPPER-RELEASING (NOVA T) IUDS DURING 5 YEARS OF USE - A RANDOMIZED COMPARATIVE TRIAL

LEVONORGESTREL-RELEASING AND COPPER-RELEASING (NOVA T) IUDS DURING 5 YEARS OF USE - A RANDOMIZED COMPARATIVE TRIAL
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DOI:
10.1016/0010-7824(94)90109-0
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发表时间:
1994-01-01
期刊:
影响因子:
2.9
通讯作者:
RYBO, G
RYBO, G
中科院分区:
医学3区
文献类型:
--
作者:
ANDERSSON, K;ODLIND, V;RYBO, G

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在一项开放随机多中心研究中,将 20 微克/24 小时释放左炔诺孕酮宫内避孕器 (LNG-IUD) 与铜释放器 Nova T 在 5 年的使用过程中进行了比较; 2821 名女性植入了 LNG-IUD,937 名女性植入了 Nova T。 Nova T 的 5 年累计总妊娠率为 5.9%,LNG-IUD 为 0.5%。左炔诺孕酮在子宫腔内的局部作用可减少经血量和少闭经,并且 LNG-IUD 使用者因月经量过多和/或经期延长而终止的比率显着降低 (P < 0.001)。然而,该组中因闭经而导致的总终止率为 6.0。使用 LNG-IUD 期间 Hb 升高,使用 Nova T 期间 Hb 降低,两种装置之间的差异具有统计学意义。无论年龄大小,LNG-IUD使用者的盆腔炎(PID)发病率都很低,而在Nova T组中,最年轻女性的PID发生率有所增加,这使得装置之间的差异显着(P < 0.01)。 LNG-IUD 组因荷尔蒙原因的总终止率为 12.2,而 Nova T 组为 2.0(P < 0.001)。 LNG-IUD是一种长效可逆避孕方法,有效期5年,妊娠率与女性绝育相当。即使在年轻女性中,PID 的发病率也很低。此外,减少经血量和增加血红蛋白浓度等积极的健康影响使 LNG-IUD 成为激素和宫内避孕的有利组合。
A 20 micrograms/24 hours levonorgestrel-releasing intrauterine contraceptive device (LNG-IUD) has, in an open randomized multicenter study, been compared to the copper-releasing device Nova T during 5 years of use; 2821 women had the LNG-IUD and 937 women had the Nova T inserted. The 5-year cumulative gross pregnancy rate was 5.9 % for Nova T and 0.5% for the LNG-IUD. The local effect of levonorgestrel in the uterine cavity causes reduction of menstrual blood loss and development of oligo-amenorrhea, and the termination rates because of heavy and/or prolonged menstrual flow were significantly (P < 0.001) lower among LNG-IUD users. However, the gross termination rate because of amenorrhea was 6.0 in this group. Hb increased during use of the LNG-IUD and decreased during Nova T use, and the difference between the devices was statistically significant. The incidence of pelvic inflammatory disease (PID) was low in LNG-IUD users regardless of age, whereas in the Nova T group, the PID rate was increased among the youngest women, which makes the difference between the devices significant (P < 0.01). The gross termination rate for reasons considered to be hormonal was 12.2 in the LNG-IUD group compared to 2.0 in the Nova T group (P < 0.001). The LNG-IUD is a long-acting reversible contraceptive method for 5 years with a pregnancy rate comparable to female sterilization. The incidence of PID is low even in young women. In addition, the positive health effects such as decreased menstrual blood loss and increased blood haemoglobin concentration make the LNG-IUD a favorable combination of hormonal and intrauterine contraception.