花式宫内节育器与MCu宫内节育器放置12个月临床比较

目的观察新型花式宫内节育器(HCu280 IUD)的临床效果、安全性、可接受性.方法采用随机对比临床研究方法,对放置HCu280 IUD及MCu IUD各208例,于置器后3个月、6个月、12个月进行随访.结果放置满12个月时HCu280 IUD和MCu IUD的带器妊娠率为0.96%,脱落率分别为1.47%和1.92%,经统计学处理无显著性差异;因症取出率分别为1.92%和5.77%;月经增多的发生率为6.7%和14.4%.两组比较有显著性差异(P＜0.05);腰腹痛发生率分别为2.4%和8.2%,继续使用率分别为92.79%和84.61%,两组比较有非常显著性差异(P＜0.01).结论HCu280 IUD是一种安全、有效、副作用少、续用率高的新型IUD,值得临床推广应用.

Comparative Study on the Clinical Effect of Hcu280 IUD and MCu IUD inserting for 12 Months

Objective To observe the clinical effect, safety and acceptability of the new intrauterine device (HCu IUD). Methods 416 patients were randomly divided into two groups, 208 patients were inserted with HCu IUD, the others were inserted with MCu IUD. All patients were followed up after 3 months, 6 months and 12 months. Results 12 months after inserting, the incidence of pregnancy with HCu IUD and MCu IUD was 0.96%, the expulsion rate was 1.47% and 1.92% respectively, there was no significant between two types IUD after statistics analysis. The removal rate for related complication was 1.92% and 5.77% respective, the incidence of menorrhagia was 6.7% and 14.4% respectively; there was significant difference between two types IUD (P <0.05). The incidence of flank abdominal pain was 2.4% and 8.2%, the continuous using rate was 92.7% and 84. 61% respectively; the difference of two types IUD was very significantly (P<0.01). Conclusion Hcu280 IUD is safe, effective, fewer side effects and higher continuous using rate as a new IUD, and it can be used widely in clinical work.