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铜T 300、达康盾节育器和贝壳环在经产妇中的随机对照研究。

Randomized comparative study of the copper T 300, Dalkon shield, and Shell Loop in parous women.

作者信息

Cooper D L, Israel R, Mishell D R

出版信息

Obstet Gynecol. 1975 May;45(5):569-73.

PMID:1124175
Abstract

A randomized comparative study of the Copper T 300, the standard Dalkon Shield and the Silicone Shell Loop D was conducted on 776 parous women. Net cumulative first event rates at 1 year and at 18 months, calculated by life-table analysis, were as follows: Copper T 300--pregnancy 1.2/1.9, expulsion 6.4/7.0, removal for pain or bleeding 7.4/10.8; Dalkon Shield--pregnancy 2.7/4.5, expulsion 5.8/5.8, removal for pain or bleeding 7.7/14.7; Shell Loop--pregnancy 3.8/4.9, expulsion 0.5/0.5, removal for pain or bleeding 9.1/13.1. None of the differences in event rates, except the lower expulsion rate of the Shell Loop, were significant. The continuation rates for the three devices at both 12 and 18 months were similar, indicating that there was little difference in their performance. As the results of this study showed a similarity of the incidence of events among very differently disigned IUD's, previously reported differences in performance of these and possibly other types of IUD's may very likely be more related to differences among clinics than to differences among the devices themselves.

摘要

对776名经产妇进行了铜T 300、标准的达康盾和硅胶壳环D的随机对照研究。通过寿命表分析计算得出的1年和18个月时的净累积首次事件发生率如下:铜T 300——妊娠发生率为1.2/1.9,脱落率为6.4/7.0,因疼痛或出血取出率为7.4/10.8;达康盾——妊娠发生率为2.7/4.5,脱落率为5.8/5.8,因疼痛或出血取出率为7.7/14.7;壳环——妊娠发生率为3.8/4.9,脱落率为0.5/0.5,因疼痛或出血取出率为9.1/13.1。除壳环的较低脱落率外,事件发生率的差异均无统计学意义。三种节育器在12个月和18个月时的持续使用率相似,表明它们的性能差异不大。由于本研究结果显示,设计差异很大的宫内节育器之间的事件发生率相似,因此先前报道的这些节育器以及其他可能类型的节育器在性能上的差异很可能更多地与不同诊所之间的差异有关,而非节育器本身的差异。

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