一项关于Gravigard、乳胶叶形、Dalkon Shield和Multiload Cu 250宫内节育器的前瞻性随机对照试验。

A prospective randomized comparative trial of the Gravigard, Latex Leaf, Dalkon Shield and Multiload Cu 250 IUDs.

作者信息

McCarthy T G, Chew S C, Lim S M, Cheng M C, Ratnam S S

出版信息

Aust N Z J Obstet Gynaecol. 1986 Aug;26(3):228-32. doi: 10.1111/j.1479-828x.1986.tb01573.x.

DOI:10.1111/j.1479-828x.1986.tb01573.x

Abstract

This prospective randomized trial in 843 patients compared the effectiveness and complications of 4 intrauterine devices. At 24 months the gross accidental pregnancy rate for the Dalkon Shield was higher than for the 7Cu200 (p less than 0.05) and the ML Cu250 (p less than 0.05). The 7Cu200 had a higher expulsion rate than the Dalkon Shield (p less than 0.01), Latex Leaf (p less than 0.001) and ML Cu250 (p less than 0.001). Use-related terminations were higher for the 7Cu200 than for the ML Cu250 (p less than 0.01). Removal for pelvic inflammatory disease was necessary in 8 women (2 for the Latex Leaf and 3 each for the 7Cu200 and Dalkon Shield). There was no significant difference in termination rates between the ML Cu250 and Latex Leaf but subsequently the Leaf has given problems with removal particularly in women who have defaulted follow-up for several years.

摘要

这项针对843名患者的前瞻性随机试验比较了4种宫内节育器的有效性和并发症。在24个月时，Dalkon Shield的意外妊娠总发生率高于7Cu200（p<0.05）和ML Cu250（p<0.05）。7Cu200的脱落率高于Dalkon Shield（p<0.01）、乳胶叶形节育器（p<0.001）和ML Cu250（p<0.001）。7Cu200因使用相关原因导致的取出率高于ML Cu250（p<0.01）。8名女性因盆腔炎需要取出节育器（乳胶叶形节育器2例，7Cu200和Dalkon Shield各3例）。ML Cu250和乳胶叶形节育器的取出率没有显著差异，但随后乳胶叶形节育器在取出时出现了问题，尤其是在那些多年未进行随访的女性中。