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目的 了解新型铜FlaxigardIUD(CuFixIUD)的避孕效果和副反应 ,以TCu380AIUD为对照组进行临床实验。方法 采用前瞻性、随机分配原则 ,共接收 2 0 0例受试者。结果 12个月内两组无一例发生妊娠 ,脱落率为每百妇女 10 2和 1 0 ,有明显统计学意义 (P <0 0 5 )。累积使用率为每百妇女 88 8和 97 0 ,两组无统计学意义 (P >0 0 5 )。 2 4个月时累积使用率两组分别为每百妇女 88 8和 93 0 ,36个月时随访率为 10 0 %。妊娠率两组分别为每百妇女 1 0和 3 0 ,因症取出率为每百妇女 2 0和 5 0。最常见的副反应为出血和疼痛。累积使用率分别为每百妇女 85 7和 89 0 ,两组无统计学意义 (P >0 0 5 )。结论 新型铜FlaxigardIUD为一种低妊娠率、高效和长效的IUD。TCu380A仍不失为一种高效、低副反应的IUD。
Objective To understand the contraceptive effects and side effects of the new copper Flaxigard IUD (CuFixIUD) and to conduct clinical trials with TCu380AIUD as a control group. Methods The prospective, random assignment principle was used to receive a total of 200 subjects. Results There was no pregnancy in both groups within 12 months. The rate of exfoliation was 102 and 100 per 100 women, with significant statistical significance (P <0.05). The cumulative utilization rate was 88 8 and 97 0 per 100 women, with no significant difference between the two groups (P> 0.05). The cumulative utilization rate at 24 months was 88 8 and 93 0 per 100 women respectively, with a follow-up rate of 10 0% at 36 months. The pregnancy rates were 10 and 30 per 100 women respectively, with a rate of 20 and 50 per 100 women. The most common side effects are bleeding and pain. The cumulative utilization rates were 85 7 and 89 0 per 100 women respectively, with no significant difference between the two groups (P> 0.05). Conclusion The new copper FlaxigardIUD is a low pregnancy rate, efficient and long-lasting IUD. TCu380A is still an efficient, low side reaction IUD.