GyneFix IN与r型、MLCu IUD的临床效果观察

Observation on clinical effects of GyneFix IN,r type and MLCu intrauterine devices

目的:观察新型GyneFix IN宫内节育器(IUD)的临床效果。方法:将450例健康经产妇女随机分成3组,A组:GyneFix IN组148例;B组:r型IUD组152例;C组:MLCu IUD组150例由经过培训的专人于月经间期放置GyneFix INIUD及r型IUD、MLCu IUD于放器后3,6,12和24个月随访以生命表法统计3种IUD的效果。结果:GyneFix IN组使用2年妊娠率、脱落率、因症取出率及续用率分别为1.35%﹑2.03%、2.03%、94.59%。GyneFix INIUD组脱落率(2.03%)明显低于MLCu IUD组的10.67%(P<0.01)也低于r型IUD的3.95%但差异无显著性(P>0.05)。3种IUD续用率分别为94.59%、89.47%和83.33%GyneFix INIUD续用率高于MLCu IUD(P<0.01)。结论:GyneFix INIUD无支架﹑铜表面积大并有固定系统,由经过培训的专人放置具有脱落率低、续用率高、不良反应小的优点值得临床推广。

Objective：To observe the clinical effects of the new intrauterine device（IUD）GyneFix IN.Methods：450 healthy multiparas were divided into 3 groups randomly.Group A：GyneFix IN group（148 cases）;group B：r-IUD group（152 cases）,group C：MLCu IUD group（150 cases）.IUD was inserted during the menstrual interval by the trained investigators.Follow-up were arranged at 3,6,12 and 24 months after insertion.The discontinuation rates were calculated by life table method.Results：At the end of the second year,the pregnant rate,expulsion rate,removal rate for medical reasons and continuously utilizing were respectively 1.35%,2.03%,2.03% and 94.59%.The rate of dropping of IUD in the GyneFix IN group（2.03%） was lower than that in the MLCu group（10.67%）（P〈0.01）and the r-IUD group（3.95%）（P〉0.05）.The rates of continuous employment of the devices were 94.59% in the GyneFixIN group,89.47% In r-IUD group and 83.33% in MLCu group,with GyneFixIN group being higher than MLCu group（P〈0.01）.Conclusion：GyneFix IN IUD is a excellent new IUD which is a frameless device with high copper surface and anchoring system.Due to lower expulsion rate and less side effect of pain,it could be recommended.