3种含铜宫内节育器的临床效果及影响因素

目的:前瞻性研究3种含铜宫内节育器(IUD)临床效果及相关因素。方法:采用随机抽样方法将研究对象分为3组,分别放置TCu380A型IUD、MLCu375型IUD和元宫-365型IUD,置器后1、3、6、12个月分别进行随访。以3种IUD的妊娠率、脱落率、因症取出率和总停用率作为指标进行临床效果评估。结果:共纳入研究对象2283例,其中放置TCu380A型IUD773例、MLCu375型IUD738例和元宫-365型IUD772例。3种IUD的脱落率、因症取出率和总停用率差异有统计学意义(P=0.000)。3种IUD放置1年,累计非意愿妊娠率均<1%。怀孕1次组的非意愿妊娠、脱落、因症取出、总停用、医学原因终止等发生率大于怀孕2次以上组。以元宫-365型IUD为对照,MLCu375型与TCu380A型在上述情况中均有更大的发生风险。脱落率、医学原因终止率还与置器地区有关(P=0.000)。月经量多者比月经量少者停用风险更大(OR=2.513,95%CI1.037～6.092);IUD失败后再次使用组比首次使用组有更高的停用风险(OR=1.649,95%CI1.224～2.221);B超扫描IUD顶部与宫底距离越大,停用风险越大(OR=1.197,95%CI1.052～2.130)。结论:元宫-365型、TCu380A型与MLCu375型3种含铜IUD避孕效果确切,其中元宫-365型IUD在3种含铜IUD中不良停用率最低。IUD使用者的孕次、宫腔深度、B超扫描IUD顶部与宫底的距离、月经量、是否曾有IUD失败史、所放置的IUD种类以及不同置器地区等因素影响其临床效果。

Clinical efficacies and effect factors of three types of intrauterine device containing copper

Objective:To research the clinical efficacies and effect factors of three types of intrauterine device(IUD) containing copper.Methods:The study objects were divided into three groups by random sampling method,Tcu380A type IUD,MLCu375 type IUD and Yuan Gong-365 type IUD were placed in the three groups,respectively.The study subjects were followed up on the first,third,sixth and twelfth months after placement of IUD.The clinical efficacies in the three groups were assessed according to pregnancy rate,expulsion rate,removal rate due to disease and total discontinuation rate.Results:2 283 study objects were included in the study,773 cases in Tcu380A type IUD group,738 cases in MLCu375 type IUD group and 772 cases in Yuan Gong-365 type IUD group.There was significant difference in the expulsion rate,removal rate due to disease and total discontinuation rate among the three groups(P=0.000).At one year after placement of IUD,the cumulative rate of unwanted pregnancy was less than 1%.The rate of unwanted pregnancy,expulsion rate,removal rate due to disease,total discontinuation rate and terminate rate because of medical factors in one-time pregnancy group were significantly higher than those in two-time or more than two-time pregnancy group.Compared with Yuan Gong-365 type IUD group,the risks of MLCu375 type IUD group and Tcu380A type IUD group were larger under the above-mentioned conditions.The expulsion rate and terminate rate because of medical factors were related to the regions(P=0.000).The risk of expulsion in the cases with excessive menstrual amount was significantly higher than that in the cases with little menstrual amount(OR=2.513,95%CI:1.037~6.092);after failure of IUD placement,the risk of expulsion in secondary placement group was significantly higher than that in first placement group(OR=1.649,95%CI:1.224-2.221);type B ultrasound scanning showed that the cases with long distance between the top of IUD and the bottom of uterus had high risk of expulsion(OR=1.197,95%CI:1.052-2.130).Conclusion:The contraceptive effects of Tcu380A type IUD,MLCu375 type IUD and Yuan Gong-365 type IUD are good,the negative discontinuation rate of Yuan Gong-365 type IUD is the lowest among the three types of IUD.The factors including number of pregnancy,the depth of uterine cavity,the distance between the top of IUD and the bottom of uterus scanned by type B ultrasound,menstrual amount,having the failure history of IUD placement or not,the type of IUD placed and different regions affect the clinical efficacy.