TCu-380A和串铜-FlexiGard的临床3年对比研究

Clinical Study on the TCu-380A and the Frameless FlexiGard with Three-Year Data.

探讨宫内节育器串铜-FlexiGard 临床避孕效果、副反应和可接性。以目前公认最理想的TCu-380A 为对照,采用随机比较性研究。接纳对象各100例,3年随访率达99.5%,以生命表法统计结果。结果:3年时每百妇女串铜的意外妊娠率为2.0,对照组无一例发生(P>0.05);脱落率分别为9.2和1.0(P<0.01),且串铜55.6%的脱落发生于置器后的一个月内;因出血的停用率分别为5.0和2.1(P>0.05);因出血+疼痛的停用率分别为3.0和1.0(P>0.05);3年续用率分别为79%及93%(P<0.01);二组副反应发生率除放置后1～3个月串铜腹痛的发生率明显低于对照组(P<0.05)外,其余无显著性差异(P>0.05)。结论:串铜的脱落率明显高于 TCu-380A,放置技术可能为一主要原因;新型节育器串铜的特殊构型并未改善因出血和/或疼痛的停用率;串铜的临床有效性并不优于对照 TCu-380A。

Objectives:This study was to investigate the clini- cal effectiveness,adverse reactions and acceptance of frameless IUD-the FlexiGard.Methods:The TCu- 380A and FlexiGard IUDs were compared in a random- ized way and the former was used as control.In either group,100 cases were selected.99.5 % cases finished three-year followup.The efficacy of the IUDs was cal- culated with life table method.Results:At the end of 3 years,accumulated pregnant rate of FlexiGard was 2.0, whereas none was pregnant in control(P>0.05);accu- mulative expulsion rate was 9.2 in FlexiGard and 1.0 in control,55.6 % expulsions in FlexiGard occurred within one month after inserted IUD;accumulated rate of dis- continuation due to bleeding was 5.0 in FlexiGard and 2.1 in control(P>0.05),and those due to bleeding plus pain were 3.0 and 1.0 per 100 women respectively (P>0.05);accumulated rate of continuation was 79 % and 93% respectively(P<0.01).Rate of abdominal pain occurred in one to three months after inserted IUD was significantly lower in FlexiGard than in control(P <0.05).Otherwise there was no significant difference between the two groups.Conclusion:The expulsion rate of FlexiGard was markedly higher than TCu-380A, which may mostly he due to insertion skill.The special configuation of FlexiGard,as a new product may not im- prove continuation rate due to bleeding and /or pain. The clinical effectiveness of FlexiGard may not be supe- rior to TCu-380A.