活性γCu380 IUD与TCu380A IUD多中心比较性研究  

Multicenter Comparative Study between γCu380 IUD and TCu380A IUD

作　　者：杨秀兰[1] 庄留琪[1] 吴明辉[2] 陈焕荣 邱美英 钱敏芬 肖志琴[1] 

机构地区：[1]国际和平妇幼保健院,上海200030 [2]北京妇产医院,北京100006 [3]山东省计划生育科研所,济南250021 [4]上海嘉定区妇幼保健院,上海201800 [5]上海普陀区妇幼保健院,上海200060

出　　处：《生殖与避孕》2001年第2期92-95,共4页Reproduction and Contraception

摘　　要：本研究通过增加原γCu2 0 0 IUD的铜表面积至 380 mm2 ,以期在不增加副反应的基础上进一步降低带器妊娠率 (包括异位妊娠 ) ,而达到与 TCu380 A IUD相似的避孕效果 ,并保持原来的低副反应发生率。方法 :1 998年 1～ 5月由全国五个中心参加的随机比较性研究 ,共随访 1 2个月。每个中心分别放置γCu380与 TCu380 A IUD各 1 0 0例 ,共 1 0 0 0例。结果 :1 2个月末 γCu380与 TCu380 A IUD脱落率每百妇女分别为 0 .80和 1 .99(P>0 .0 5)。带器妊娠率每百妇女均为 0 .2 0。异位妊娠率每百妇女分别为 0 .2 0和 0 .0 0 (P>0 .0 5)。因症取出率每百妇女分别为 1 .0 0和 2 .6 0 (P>0 .0 5)。结论 :γCu380 IUD临床效果与 TCu380 A IUD相似 ,而 γCu380 IUD副反应发生率明显低于 TCu380 A IUD。本研究结果证实载高铜面积 γCu380 IUD是一种优质的 IUD。Objective:The study expanded the copper surface of the original γ Cu200 IUD to 380 mm 2 to decrease the pregnancy rate with IUD in situ(including ectopic pregnancy) and achieve the contraceptive effects similar to TCu380A IUD with fewer side effects. Methods: From January 1998 to May, a randomized comparative clinical study was conducted in five centers in China, each with inserting 100 γCu380 IUDs and 100 TCu380A IUDs (total 1 000 cases), and following up for 12 months. Results: 12 months after insertion, the expulsion rates of γCu380 IUDs and TCu380A IUDs were 0.8/100 women and 1.99/100 women respectively ( P >0.05). The pregnancy rates with IUDs in situ were 0.20/100 women respectively (P>0.05). The currence rates of ectopic pregnancy were 0.2/100 women and 0.0/100 women respectively (P>0.05). The rates of removal due to medical reasons were 1.00% and 2.60% respectively (P<0.05). Conclusion: The contraceptive effects of γCu380 IUDs and TCu380A IUDs were similar. The ectopic pregnancy rate of two IUDs were similar, and women with γCu380 IUD suffered less side effects. Therefore,γCu380 IUD with bigger copper surface areas is an IUD of higher quality.

关 键 词：γCu380IUD TCU380AIUD 宫内避孕器 脱落率 副反应发生率 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]