摘要
目的比较人工流产术后即时放置含吲哚美辛固定式宫内节育器（IUD）和活性1型IUD的临床效果以及月经出血模式。方法采用多中心临床对照试验的方法，于2012年3月至2013年1月间在5家医院接收840例自愿要求放置IUD的流产妇女，于人工流产术后即时随机放置固定式IUD（固定式组）或活性1型IUD（活性1组），分别为414、426例；选择同期人工流产术后未放置IUD、也未使用甾体激素避孕方法进行避孕的464例流产妇女作为对照组。随访临床效果12个月。分析所有观察对象人工流产术后3个月内的出血情况。结果随访至人工流产术后12个月时，脱落均是两种IUD最主要的终止原因，固定式组和活性叮组的脱落相关终止率分别为2．48／100妇女年和3．12／100妇女年，两组比较，差异无统计学意义（P〉0．05），且两种IUD的脱落终止均以下移为主。随访12个月时固定式组和活性1组的与IUD使用相关的终止率分别为3．91／100妇女年和4．35／100妇女年，两组间比较，差异无统计学意义（P〉0．05）。人工流产术后1个参考时限内（90d），固定式组和活性1组的总出血天数（包括出血天数和滴血天数）分别比对照组增加了3,9和2．6d，3组间比较，差异有统计学意义（P〈0．05）；主要表现为滴血天数的增加，固定式组和活性Y组的滴血天数分别为（9．2±5．9）和（8．5±4．6）d，明显多于对照组的（5．2±4．0）d，组间比较，差异有统计学意义（P〈0．05），但两种IUD组间比较，差异无统计学意义（P〉0．05）。结论人工流产术后即时放置含吲哚美辛固定式IUD和活性叮型IUD均安全、可行、避孕效果可靠，不良反应轻微。
Objective To compare the effectiveness of medicated γintrauterine device (IUD) and medicated genefix IUD inserted immediately after abortion. Methods A multicenter clinical trail was performed for the study from Mar. 2012 to Jan. 2013. Totally 840 women who volunteered to participate were randomly allocated to γ-group (medicated γ IUD) or genefix-group (medicated genefix IUD) immediately after abortion. While 464 abortion women who had not used IUD or steroids contraceptive methods were chosen as control group. The effectiveness of the IUD were followed up for 1 year. All women were required to record the number of vaginal bleeding days and blood volume of vaginal bleeding within 3 months after abortion. Results At the 12th month, the expulsion was the most common reason for termination. The expulsion rates of genefix-group and γ-group were 2.48/100 women years and 3.12/100 women years, respectively (P>0.05). For the expulsion reasons, IUD moving down could account for more than seventy percent. The removal rate for IUD usage of two IUD groups were almost equal (3.91/100 women years verus 4.35/100 women years), the differences were not statistically significant (P>0.05). At the 90th day after abortion, comparing with control group, the bleeding and (or) spotting days of genefix-group and γ-group extended by 3.9 and 2.6 days respectively, the differences had statistical significance between the three groups (P<0.05). Among the bleeding and (or) spotting days, spotting days prolonged significantly. At the 12th month, spotting days of genefix-group andγ-group were (9.2±5.9) days and (8.5±4.6) days respectively, more than (5.2 ± 4.0) days of control group. The differences had statistical significance between IUD with control group (P<0.05), and had not between the two kinds of IUD (P>0.05). Conclusion The insertion of medicated genefix IUD and medicated γ IUD immediately after abortion is safe, feasible, has slight side effects and could be effective contraception.
出处
《中华妇产科杂志》
CAS
CSCD
北大核心
2016年第3期198-203,共6页
Chinese Journal of Obstetrics and Gynecology
