BACKGROUND:The study was conducted to compare the antifertility effectiveness and side effects of the copper/low-density polyethylene nanocomposite IUD (experimental group) and the copper T220C IUD (control group). STUDY DESIGN:One hundred females were randomly divided into two groups (experimental group and control group, n = 50 in each group). Clinical observation and comparative study were performed on the two groups for 12 months. RESULTS:Follow-up rate was 100% at the 12th month. In the experimental group and control group, the cumulative continuation rates were both 92.0 per 100 women at the 12th month and there was no difference between them (p > .05). The pregnancy rate, removal rate and expulsion rate were low with the difference being not statistically significant (p>.05). The most common side effects were excessive menstrual bleeding, spotting and pain. The rates of side effects were lower in the experimental group than in control group, especially during the initial 3 months after insertion with the differences being statistically significant (p < .05). CONCLUSION:The new design of the copper/low-density polyethylene nanocomposite IUD showed low pregnancy rate, high contraceptive efficacy and satisfactory acceptability. The study suggested that the TCu220C IUD also had high contraceptive efficacy, but had relatively more side effects.

译文

背景:本研究旨在比较铜/低密度聚乙烯纳米复合材料宫内节育器(实验组)和铜T220C宫内节育器(对照组)的抗生育作用和副作用。
研究设计:将一百名女性随机分为两组(实验组和对照组,每组n = 50)。两组均进行了12个月的临床观察和比较研究。
结果:第12个月随访率为100%。在实验组和对照组中,第12个月的累积持续率均为每100名妇女92.0,并且两者之间没有差异(p> .05)。妊娠率,去除率和驱逐率均较低,差异无统计学意义(p> .05)。最常见的副作用是月经过多,出血和疼痛。实验组的副作用发生率低于对照组,尤其是在插入后的最初三个月内,差异具有统计学意义(p <.05)。
结论:新设计的铜/低密度聚乙烯纳米复合材料宫内节育器妊娠率低,避孕功效高,可接受性良好。研究表明,TCu220C宫内节育器也具有较高的避孕功效,但副作用相对较多。

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