活性γCu380IUD与TCu380AIUD临床比较性研究

A Comparative Study of γCu 380 IUD and TCu 380A IUD

本研究通过增加原γCu 2 0 0 IUD的铜表面积至 3 80 mm2 ,其目的为了进一步降低带器妊娠率 (包括异位妊娠 ) ,以期达到 TCu3 80 A IUD相似的避孕效果 ,而其副反应发生率明显低于 TCu3 80 A IUD。方法 :1 995年 8月～ 1 996年 6月由三个中心参加的随机比较性研究 ,共随访 2 4个月。每个中心分别放置γCu 3 80与 TCu 3 80 A IUD各 1 0 0例 ,共 6 0 0例。结果 :2 4个月末 γCu3 80与 TCu3 80 A IUD脱落率每百妇女分别为 0 .997和 2 .4 70 (P>0 .0 5)。带器妊娠率每百妇女分别为 0 .3 3 2和 2 .4 59(P<0 .0 5)。异位妊娠率每百妇女分别为 0 .1 6 1和 0 .3 3 0 (P>0 .0 5)。因症取出率每百妇女分别为 1 .6 6 1和 5.4 95(P<0 .0 5)。结论 :γCu 3 80 IUD临床避孕效果明显优于 TCu 3 80 A IUD;两种 IUD的异位妊娠率相似 ;γCu3 80 IUD的副反应发生率明显低于 TCu3 80 A IUD。本研究结果证实高铜面积 γCu3 80 IUD是一种优质的 IUD。

The study expanded the copper surface of the original γCu 220 IUD to 380 mm 2 to decrease the pregnancy rate with IUD in situ (including ectopic pregnancy) and achieve the contraceptive effects similar to TCu 380A IUD with lower sideeffects. Methods: From August 1995 to June 1996, a randomized comparative clinical study was conducted in three locations, each with inserting 100 γCu 380 IUDs and 100 TCu 380A IUDs (total 600 cases), and following up for 24 months. Results: 24 months after insertion, the expulsion rates of γCu 380 IUDs and TCu 380A IUDs were 0.997/100 women and 2.470/100 women respectively (P>0.05) . The pregnancy rates with IUDs in situ were 0.332/100 women and 2.459/100 women respectively (P<0.05). The occurrence rates of ectopic pregnancy were 0.161/100 women and 0.330/100 women respectively (P>0.05). The rates of removal due to medical reasons were 1.661/100 women and 5.495/100 women respectively (P<0.05). Conclusion: The clinical contraceptive effects of γCu 380 IUD are much better than that of TCu 380A IUD . The ectopic pregnancy rates of two IUDs were similar, and the women with γCu 380 IUD suffered less sideeffects. Therefore,γCu 380 IUD with higher copper surface areas is a kind of high quality IUD.