Sivin I, Stern J, Coutinho E, Mattos C E, el Mahgoub S, Diaz S, Pavez M, Alvarez F, Brache V, Thevenin F
Center for Biomedical Research, Population Council, New York, NY 10021.
Contraception. 1991 Nov;44(5):473-80. doi: 10.1016/0010-7824(91)90149-a.
A levonorgestrel-releasing IUD and the Copper T 380Ag IUD were in randomized comparison for seven years in five clinics. In two other clinics the randomized study was truncated at five years, but use of the Copper T continued. No pregnancies occurred to users of either device in years 6 and 7. Cumulative pregnancy rates were 1.1 per 100 at seven years for the steroid-releasing and 1.4 per 100 for the copper-releasing IUDs. Cumulative rates of PID did not differ between devices. Infection rates appeared to be lowest during the sixth and seventh years of the study. Termination attributable to amenorrhea was the principal contributor to differences in cumulative continuation rates between devices. At the five clinics that carried the comparative study to seven years, cumulative continuation rates were 24.9 per 100 for LNg20 IUD users and 29.4 per 100 for TCu 380Ag users. Women who used either method for periods of five to seven years experienced, on average, marked to mild increases in hemoglobin as compared with levels at admission. The Copper T380 family and the LNg20 IUDs represent the most effective reversible contraceptive methods yet studied in long-term randomized trials.
在五家诊所对左炔诺孕酮宫内节育器(LNG-20 IUD)和铜T 380A宫内节育器(TCu 380Ag IUD)进行了为期七年的随机对照研究。在另外两家诊所,随机研究在五年时中断,但铜T宫内节育器仍继续使用。在第6年和第7年,两种宫内节育器的使用者均未发生妊娠。七年时,释放类固醇的宫内节育器累积妊娠率为每100人中有1.1例,释放铜的宫内节育器为每100人中有1.4例。两种宫内节育器的盆腔炎累积发生率无差异。在研究的第6年和第7年,感染率似乎最低。因闭经导致的终止使用是两种宫内节育器累积续用率差异的主要原因。在将比较研究进行到七年的五家诊所中,LNG-20 IUD使用者的累积续用率为每100人中有24.9例,TCu 380Ag使用者为每100人中有29.4例。与入院时的水平相比,使用这两种方法五至七年的女性血红蛋白平均有明显至轻度的升高。铜T 380系列和LNG-20宫内节育器是长期随机试验中研究过的最有效的可逆避孕方法。