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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 purpose of this study was to further reduce the pregnancy rate of the device (including ectopic pregnancy) by increasing the copper surface area of the original γCu 2 O 0 IUD in order to achieve a similar contraceptive effect of TCu 380 AUD with side effects The rate was significantly lower than TCu3 80 A IUD. METHODS: A randomized, comparative study of three centers from August 1995 to June 1996 attended a total of 24 months. Each center were placed γCu 3 80 and TCu 3 80 A IUD each of 100 cases, a total of 600 cases. Results: The shedding rate of γCu3 80 and TCu3 80 A IUD was 0.997 and 2.70 (P> 0.05) per 100 women at the end of 24 months. The pregnancy rate per 100 women was 0.33 and 2 .59 (P <0.05), respectively. The rate of ectopic pregnancy was 0.116 1 and 0.33 (P> 0.05) per 100 women respectively. The rate of withdrawal was 1 661 and 5.4 95 per 100 women, respectively (P <0.05). CONCLUSION: The clinical contraception effect of γCu 3 80 IUD is better than that of TCu 3 80 A IUD. The incidence of ectopic pregnancy is similar between the two IUDs. The incidence of side effects of γCu3 80 IUD is significantly lower than that of TCu3 80 A IUDs. The results of this study confirm that high copper area γCu3 80 IUD is a good IUD.