Comparison of the performances of TCu380A and TCu380S IUDs up to five years
Comparison of the performances of TCu380A and TCu380S IUDs up to five years
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DOI：
10.1023/a:1006780005535
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发表时间：
1999-01-01
期刊：
影响因子：
--
通讯作者：
Regina, CH
中科院分区：
文献类型：
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作者：
Bahamondes, L;Díaz, J;Regina, CH
许多年前，我们对 TCu380A IUD 进行了改进，创建了 TCu380S 型号。 TCu380S 采用与塑料齐平的铜套管，并设置在水平臂的两端。本研究的目的是比较 TCu380A 和 TCu380S IUD 的临床性能，特别是在随机插入这两种装置之一的女性群体中的避孕性能和排出情况。本文介绍了使用长达 5 年的结果。共有 1568 名女性参与其中：806 名女性接受了 TCu380A，762 名女性接受了 TCu380S 宫内节育器。通过生命表分析评估性能，并通过对数排序方法测试比率之间的显着性。在使用 5 年期间，两种型号 IUD 的使用者的累积妊娠率均较低，但 TCu380S 型号的使用者的累积妊娠率较低，但无统计学意义。在五年的使用过程中，TCu380S 型号用户的驱逐率明显更高。两种设备停止使用的其他原因相似，并且没有显示出统计显着性。 TCu380S 型号用户在使用第一年和第二年的继续使用率明显较低。两种设备的妊娠率都非常低，TCu380S 的妊娠率低于 TCu380A，但没有统计学意义。
A modification of the TCu380A IUD to create the model TCu380S was introduced many years ago. The TCu380S utilizes copper sleeves that are flush in the plastic and are set at both ends of the horizontal arm. The objective of this study is to compare the clinical performance of the TCu380A and the TCu380S IUDs, especially regarding contraceptive performance and expulsion, in a cohort of women who had one of these two devices inserted at random. This paper presents the results up to 5 years of use. A total of 1568 women were enrolled: 806 women received a TCu380A and 762 women received a TCu380S IUD. The performance was evaluated by life-table analysis and significance between rates was tested by the method of log-rank. The cumulative pregnancy rate was low in users of both models of IUD but lower in users of the TCu380S model through the 5 years of use, without statistical significance. Expulsion was significantly higher in users of the TCu380S model during the five years of use. The other reasons for discontinuation were similar for both devices and did not show statistical significance. The continuation rate was significantly lower in users of the TCu380S model in the first and second years of use. Both devices presented a very low pregnancy rate and TCu380S presented a lower pregnancy rate than the TCu380A, although without statistical significance.