CAJ | 학술논문

Objective To study the effectiveness and side effects of the modified newindomethacin VCu IUDMaterial & methods It is a randomized multi-center clinical trial. Indomethacin VCuand TCu 380A were inserted in 2 000 healthy women in 6 clinical units including urbanand rural area from May 1997to Feb 1998, with 1 000 cases in each group. Follow uptime were 6, 12, and 24 month after insertion.Results The clinical characteristics of subjects in two groups were similar. Follow upwas completed in 98. 25% of cases. The net cumulative continuous rate at 6 month was95. 5% in TCu380A group and 97. 5% in Indomethacin VCu group (P＜0. 05); at 12month it was 93. 79% and 94. 78% respectively; at 24 month it was 88. 23% and89. 77% respectively. The expulsion rate was higher in T group than in V group dur-ing 24 months. Termination due to pregnancy and bleeding or pain was similar in twogroups. The occurrence of menorrahgia, prolonged bleeding and abdominal pain wasalso higher in T group than that in V group during 24 months after insertion. Spottingwas more often in T group in 12 month. On the other hand, more subjects complainedhypomenorrhea in V group. The total B/S period, average B/S period and the longestB/S period were all longer in T group during 4～ 6 month after IUD insertion (P＜0. 01). The amount of hemoglobin was similar in two groups before IUD insertion. Atthe end of study, the amount of hemoglobin in T group decreased compared with base-line (P＜ 0. 001), and was lower than V group at the same time (P＜ 0. 001), while nochange was observed in V group.Conclusion Compared with TCu380A, the second generation of indomethacin VCupossess the same contraceptive effect and cumulative continuous rate and lower sideeffects such as bleeding and abdominal pain. VCu is more beneficial to reproductivehealth of women, therefore, is worth of clinical application.