第二代吲哚美辛VCu与TCu380A临床比较性研究

目的 :了解第二代吲哚美辛 VCu IUD的临床疗效。方法 :自 1 997.5～ 1 998.2 ,在包括城市和农村的 6个临床单位 ,放置第二代吲哚美辛 VCu IUD1 0 0 0 (V组 )例 ;放置后 6月、1 2月和 2 4月随访 ,并与 1 0 0 0例放置 TCu3 80 A IUD者 (T组 )比较。结果 :两组对象临床特征相仿。随访率 98.2 5 %。净累积续用率随访 6月时 T组 95 .5 % ,V组 97.5 % (P<0 .0 5 ) ;1 2月时分别为 93 .79%和94.78% ;2 4月时分别为 88.2 3 %和 89.77%。脱落率在各阶段均为 T组高于 V组。妊娠率和因出血、疼痛取出率两组基本相似。月经量多、经期延长和腹痛的发生率 T组始终高于 V组。点滴出血者在 1 2月内 T组多于 V组。 V组月经量减少者始终多于 T组。在置器 4～ 6月 ,T组总 B/S、平均B/S及最大 B/S段长均大于 V组 (P<0 .0 1 )。血红蛋白测定在放 IUD前两组相似 ,随访 2 4月时复查 ,T组较放置前有所下降 (P<0 .0 0 1 ) ,且低于 V组 (P<0 .0 0 1 ) ;V组与放置前相似。结论 :第二代吲哚美辛 VCu与 TCu3 80 A比较 ,具有相同的避孕效果及续用率 ,较低的出血、疼痛副反应 ,更有利于保护妇女的生殖健康 ,值得临床推广应用

The Multi-Center Comparative Clinical Trial of the Second Generation of Indomethacin VCu and TCu380A

Objective: It is a multi-center clinical trial with aim to study the effectiveness and side-effects of the modified new indomethacin VCu compared with TCu380A. Materials & methods: Two IUD were inserted in 2 000 healthy women in 6 clinical units including urban and rural area from May 1997 to Feb 1998, with 1 000 cases in each group. Follow up time were 6, 12, and 24 month after insertion. Results: The clinical characteristics of subjects in two groups were similar. Follow up was completed in 98.25% of cases finished . The net cumulative continuous rate at 6 month was 95.5% in TCu380A group and 97.5% in indomethacin VCu group (P< 0.05);at 12 month was 93.79% and 94.78% respectively;at 24 month was 88.23% and 89.77% respectively. The expulsion rate was higher in T group than in V group during 24 months. Termination due to pregnancy and bleeding or pain was similar in two groups. The occurrence of menorrahgia, prolonged bleeding and abdominal pain was also higher in T group than that in V group during at 24 months after insertion. Spotting was more often in T group in 12 month. On the other hand, more subjects complained hypomenorrhea in V group. The total B/S period, average B/S period and the longest B/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. At the end of study, the amount of hemoglobin in T group decreased significantly compared with baseline (P<0.001), and was lower than V group at the same time (P<0.001), while no change was observed in V group. Conclusion: Compared with Tcu380A, the second generation of indomethacin VCu possess the same contraceptive effect and cumulative continuous rate and lower side effects such as bleeding and abdominal pain. VCu is more beneficial to reproductive health of women, therefore, is worth of clinical application.