FR药铜300C与MLCu375 IUD多中心随机比较性临床研究

目的:比较FR药铜300C与MLCu375两种IUD的避孕有效性、安全性和副反应的发生情况。方法:采用多中心随机比较性临床研究方法,分别放置两种IUD各500例,并于放置后3,6,12月门诊随访。结果:放置满12个月时,FR药铜300C与MLCu375IUD的续用率分别为94.18/百妇女、92.58/百妇女(P>0.05);带器妊娠率分别为0.00/百妇女、0.21/百妇女(P>0.05);脱落率分别为2.04/百妇女、2.66/百妇女(P>0.05);因症取出率分别为2.24/百妇女、3.50/百妇女(P>0.05);3、6个月随访时经量增多分别为14.6%,12.3%和21.2%、17.5%,两者差异有极显著和显著性意义(P<0.01,P<0.05);3个月随访时经期延长分别为6.0%和9.6%,两者差异有显著性意义(P<0.05)。其他副反应两组间差异无显著性意义(P>0.05)。结论:FR药铜300C IUD结构合理,避孕效果与ML-Cu375 IUD相似,副反应少于MLCu375 IUD。是目前比较理想的IUD。

Multicentre Random Comparative Study on FRDCu300C and MLCu375 Intrauterine Device

Objective:To compare the clinical effect,safety and side-effects of the new type of FRDCu300C and MLCu375 Intrauterine Devices(IUDs).Methods:A multicentre random comparative clinical study was done.Each 500 users in five province were followed up after insertion of the third,sixth,twelfth month.Results:After insertion of twelve months,the continuous using rate of FRDCu300C and MLCu375 IUD were 94.18% and 92.58%,respectively(P>0.05).The pregnancy rate were 0.00% and 0.21%,respectively(P>0.05).The expulsion rate were 2.38% and 2.66%,respectively(P>0.05).The other causes of removal rate were 2.24% and 3.50%,respectively(P>0.05).Hypermenorrhea at the third and sixth month were 14.6%,12.3% and 21.2%,17.5%,respectively,of FRDCu300C and MLCu375 IUD,which showed significantly different between them(P<0.05).Menostaxis at the third month were 6.0% and 9.6%,respectively,of FRDCu300C and MLCu375 IUD,which showed significantly different between them(P<0.05).The other side-effects showed no significant difference.Conclusion:It is recommended that FRCu300C IUD should be used widely because of its well-reasoned construction and lower side-effects compared with MLCu375 IUD.