25岁以下未育女性负压吸宫术后即时放置两种宫内节育器的随机对照观察

Randomized controlled trial of two types intrauterine devices inserted randomly and immediately after vaccum aspiration of nulliparas with less 25 years old

目的:观察25岁以下未育女性负压吸宫术后即时分别放置吉妮致美或含药含铜宫型宫内节育器(IUD)的可行性和效果。方法:将自愿要求人工流产的≤25岁未育早孕女性作为观察对象,随机表法分组,分别放置吉妮致美IUD组(195例)和含药含铜宫型IUD组(简称宫药铜组)(196例)。于负压吸宫术后即时放置IUD,随访6个月,观察IUD的使用效果。结果:两组IUD的顺利放置率≥99%。采用生命表法对IUD的终止情况进行分析。两组均无妊娠发生,宫药铜组无脱落相关终止,吉妮致美组脱落相关终止率为2.09/100妇女年,高于宫药铜组(P<0.05)。吉妮致美组因症取出率为0.53/100妇女年,宫药铜组为1.60/100妇女年,但差异无统计学意义(P>0.05)。吉妮致美组和宫药铜组与IUD使用相关的终止率分别为1.60/100妇女年和2.60/100妇女年,两组间差异无统计学意义(P>0.05)。放置IUD后1、3、6个月随访时,吉妮致美组和宫药铜组IUD副作用的主诉率分别为17.3%、13.4%、6.7%和28.7%、29.5%、21.5%,吉妮致美组低于宫药铜组,差异有统计学意义(P<0.01、P<0.001、P<0.001)。结论:年轻未育女性负压吸宫术后即时放置吉妮致美或宫药铜IUD均安全、可行、避孕效果可靠,与宫药铜IUD相比吉妮致美IUD使用后不适主诉更少,需关注放置技术以减少脱落。

Objective:To observe the feasibility and the efficacy of the two types intrauterine device(IUD)inserted randomly and immediately after vaccum aspiration of nulliparas with≤25years old.Methods:The nulliparas request IUD insertion immediately after the vaccum aspiration during their first trimester of pregnancy were selected as the observative subjects and were randomly allocated into group A(195 cases with the medicated genefixed IUD inserted)and group B(196 cases with the medicated uterine shaped IUD inserted).The nulliparas in the two groups were given IUD inserted immediately after the vaccum aspiration and were followed up for 6months after the IUD inserted to observe the effect of the IUD.Results:More than 99% IUDs were inserted for the nulliparas in the two groups successfully.Life table analysis was used to analyze the IUD termination situation.There was no any nullipara with pregnancy in the two groups.There was no any nullipara with the IUD termination related the IUD expulsion in group B,but the rate of the termination related the IUD expulsion of the nulliparas in group A was 2.09/100 woman years,and which was significantly higher than that of the nulliparas in group B(P<0.05).The rates of IUD removal due to medical reasons of the nulliparas in group A and in group B were 0.53/100 women years and 1.60/100 women years,but which of the nulliparas had no significant difference between the two groups(P>0.05).The rates of the total IUD related discontinuation removal of the nulliparas in group A and in group B were 1.60/100 woman-years and 2.60/100 woman-years,but which of the nulliparas had no significant difference between the two groups(P>0.05).During 1,3,and 6 months of the follow-up of the nulliparas after IUD inserted,the rates of the side effects of the IUD used of the nulliparas in group A were 17.3%,13.4% and 6.7%,respectively,and which were significantly lower than those(28.7%,29.5% and 21.5%)of the nulliparas in group B(P<0.01,0.001 and 0.001).Conclusion:The insertions of the medicated genefixed IUD and the medicated uterine shaped IUD of the young nulliparas immediately after vaccum aspiration are safe,feasible and effective.Compared with those of the nulliparas with the medicated uterine shaped IUD inserted,the nulliparas with the genefixed IUD inserted have fewer complaints,and the more attention should be paid to the medicated genefixed IUD inserted skill of the nulliparas,so as to reduce the genefixed IUD expulsion.