Contraception. 1997 Dec;56(6):341-52.
Few data on the long-term efficacy of intrauterine devices (IUD) are available, and this article reports on the final 12-year experience with the TCu220C and TCu380A devices from two randomized, multicenter trials conducted in 24 centers. A total of 3,277 and 1,396 women, respectively, were recruited for use of each device between 1981 and 1986 and followed at 3, 6, and 12 months after insertion and yearly thereafter. At the end of 12 years, a total of 17,098 women-years of experience had been accumulated for the TCu220C and 7,159 women-years for the TCu380A. The cumulative 12-year intrauterine pregnancy rates were 7.0 (standard error [SE] 0.6) per 100 women for the TCu220C and 1.9 (SE 0.5) for the TCu380A (p < 0.001). Pregnancy rates were highest in the first years after insertion; the TCu220C had a consistently higher annual pregnancy rate than did the TCu380A at all intervals since insertion. No pregnancies were reported with the TCu380A after 8 years of use. Total medical removals were approximately 6% in the first year and dropped to approximately 4% per year for each device for up to 12 years of use (cumulative 12 year rates were 37.3 [SE 1.3] and 40.2 [SE 2.1] per 100 women for the TCu220C and TCu380A devices, respectively). The overall continuation rate at all intervals since insertion was higher with the TCu220C device, mainly due to higher removal rates for nonmedical reasons with the TCu380A. The cumulative ectopic pregnancy rates were 0.7 and 0.4 for the TCu220C and TCu380A, respectively. Pregnancy rates were higher in the Chinese compared with the non-Chinese centers for both devices, though the greater efficacy of the TCu380A was apparent in both groups of centers. The total medical and nonmedical removal rates were lower in the Chinese compared with the non-Chinese centers, and did not show any substantial differences between the devices. We conclude that both devices are safe and effective for at least 12 years of use and the low pregnancy rate with the TCu380A is comparable with that reported in the United States among women who had undergone tubal sterilization. The very high efficacy of the TCu380A makes it the IUD of choice, and it can be considered as a potentially reversible, non-surgical alternative to sterilization for women requiring very long-term pregnancy protection.
关于宫内节育器（IUD）长期疗效的数据较少，本文报告了在24个中心进行的两项随机、多中心试验中使用TCu220C和TCu380A装置的最终12年经验。1981年至1986年期间，分别招募了3277名和1396名女性使用每种装置，并在插入后3个月、6个月和12个月以及此后每年进行随访。在12年结束时，TCu220C累计积累了17098妇女年的经验，TCu380A累计积累了7159妇女年的经验。TCu220C每100名妇女的12年累计宫内妊娠率为7.0（标准误[SE]0.6），TCu380A为1.9（SE 0.5）（p<0.001）。妊娠率在插入后的头几年最高；自插入以来，在所有时间段内，TCu220C的年妊娠率始终高于TCu380A。使用TCu380A 8年后未报告妊娠。两种装置在第一年的总医疗取出率约为6%，在长达12年的使用期内每年降至约4%（TCu220C和TCu380A装置每100名妇女的12年累计取出率分别为37.3[SE 1.3]和40.2[SE 2.1]）。自插入以来，所有时间段内TCu220C装置的总体持续使用率更高，主要是因为TCu380A因非医疗原因的取出率更高。TCu220C和TCu380A的累计宫外孕率分别为0.7和0.4。两种装置在中国中心的妊娠率均高于非中国中心，尽管TCu380A在两组中心的疗效均更显著。中国中心的总医疗和非医疗取出率低于非中国中心，且两种装置之间未显示出任何实质性差异。我们得出结论，两种装置在至少12年的使用期内都是安全有效的，TCu380A的低妊娠率与美国输卵管绝育妇女中报告的妊娠率相当。TCu380A的极高疗效使其成为首选的宫内节育器，对于需要长期妊娠保护的女性，它可被视为一种潜在的可逆、非手术绝育替代方法。
