放置新型MCu Ⅱ IUD与TCu220 cIUD24个月的临床效果观察

Clinical observation on new-type MCu Ⅱ IUD and TCu220 cIUD Inserted for 24 Months

目的进一步观察新型MCu Ⅱ功能性宫内节育器(MCu Ⅱ IUD)的临床使用效果。方法随机放置MCu Ⅱ IUD和TCu220 cIUD各500例,放置后1、3、6、12、24个月进行随访观察。结果 24个月末的累积续用率依次为92.16%和89.89%;带器妊娠率为0.62%、0.84%;脱落率为0.41%、2.32%,差异有统计学意义(P<O.05);5次随访主诉(副反应)发生率MCu Ⅱ IUD低于TCu220 cIUD,主要为月经异常和腰腹疼痛及白带增多;因副反应取出率分别为3.51%、4.21%,差异无统计学意义(P>O.05);观察中无损伤、感染及贫血发生。结论 MCu Ⅱ IUD设计合理、妊娠率低、脱落率低,副反应发生率低,值得推广使用,放置时需按说明书正规操作。

Objective To further observe the clinical effect of new-type MCuⅡFunctional Intrauterine Device（MCuⅡIUD）.Methods Randomly inserting MCuⅡIUD and TCu220 cIUD each for 500 cases.Making follow-up visits and observation after 1,3,6,12,and 24 months.Results The accumulative continuous application rates at the end of 24 months were 92.16% and 89.89% in turn.The rates of pregnancy with IUD in situation were 0.62% and 0.84%.The expulsion rates were 0.41% and 2.32%,The difference had statistical significance（P0.05）.MCuⅡIUD＇s occurrence rates of chief compliant（side effects）,mainly abnormal menstruation,waist and abdomen pain,and leucorrhea increasing,was lower than that of TCu220 cIUD in 5 follow-up visits.The rates of removal due to side effects were 3.51% and 4.21% respectively,the difference had no statistical significance（P0.05）.There was no injury,infection and anemia observed.Conclusion With rational design,low rates of pregnancy,expulsion,and occurrence of side effects,MCuⅡIUD deserves promotion in application.Do standard operation according to the instruction for use while inserting.