4种新型宫内节育器使用5年临床效果评价

为较好掌握新型 IUD 的优点和特征,便于医务人员根据不同育龄妇女身体状况选择适当的 IUD 类型,本课题对2400例育龄妇女随机放置 TCu380A、三球头 TCu220C、MLCu375SL 和含药宫铜4种新型 IUD 使用5年间的终止原因进行临床多中心研究分析。结果表明:第二代活性 IUD具有安全、高效、长效的优点,其中尤以 TCu380A 具有较高续用率(78.1/100妇女),其妊娠率(带器妊娠及意外妊娠)为4.9/100妇女,脱落率也最低,为6.9/100妇女(P<0.05);MLCu375SL 城市组使用效果明显优于农村组,其5年续用率分别为80.54/100妇女和66.89/100妇女(P<0.05);农村组脱落率最高,为14.6/100妇女(P<0.05);含药宫铜 IUD 置器后月经量增加的症状明显减少,因症取出率最低,5年末为3.7/100妇女(P<0.01);;三球头 TCu220C 具有低因症取出率和低脱落率的优点,但带器妊娠率最高,为8.4/100妇女(P<0.01)。结果提示:T 铜 IUD 的脱落率相对较低;三球头 TCu220C 的球头和含药宫铜 IUD 所含的消炎痛在减少副反应方面有一定的作用;ML-Cu375SL 适合城市妇女使用。

A Multi-center Randomized Comparative Clinical Study on 4 Type IUDs (5 years follow up)

Objective:in an effort to judge the newly pro- duced/improred IUDs so that we could provide instruc- tions to family planning staffs about how to chose def- ferent IUD according to defferent client,we carried out a program focused on the rates of continuation,preg- nancy,expulsion and Needing/pain of 4 type IUDs. Method:TCu380A,TCu220 with Three Spherical Ends(newly produced in Jiangsu province),ML- Cu375SL and Uterine Shape Medicated IUD with Copper were studied in randomized comparison for 5 years in a cohort of 1 200 subjects in urban area and the same amount in rural area covering 9 centers.Re- sult:the result shows that 4 type IUDs provided long- term,safe and high effective contraception.TCu380A had the highest cumulative continuation rate(78.1 per 100 women),lowest expulsion rate(6.9 per 100 wom- en)and pregnancy rate(4.9 per 100 women)among 4 type IUDs at the end of the 5th year.The cumulative contin uation rates for MLCu375SL in urban and rural areas were 80.54 and 66.89 per 100 women respec- tively(P<0.01).The expulsion rate for MLCu375SL in rural area reached 14.6 per 100 women,which was the highest among 4 type IUDs(P<0.01).Uterine shape medicated IUD with copper reduced the IUD in- duced bleeding so that it had the lowest removal rate for bleeding/pain(3.7 per 100 women).TCu220 with Three Spherical Ends has lower expulsion and removal rate,but its pregnancy rate reached 13.0 per 100 women,which was the highest among 4 type IUDs. Conclusion:pregnancy rate has a certain relation to the copper surface of IUDs.Expulsion rate of TCu type Ⅰ- UDs is much lower.Both the spherical ends and the medication play an important role in reducing the ad- verse reactions caused by IUD insertion.MLCu375SL is more likely to give a better contraception in urban area,since its expulsion rate of rural area is much high- er than that of urban area.