In an open, single-group, phase III clinical trial of 5 years, the clinical performance of NOVA T 380 was investigated in three centers. The device having a higher copper surface of 380 mm(2) is a modification of NOVA T. A total of 400 voluntary women were enrolled in the study. The mean age was 31.4 years (SD 5.5) with the minimum of 18 and the maximum of 44 years. At the end of the study, 211 women had passed the 60-month visit. Cumulative discontinuation rates at the end of the first and the fifth year calculated by Kaplan-Meier estimates, were respectively as follows: pregnancy 0.5 and 1.9, expulsion 1.3 and 4.1, bleeding 4.4 and 14.0, pain 1.3 and 4.2, removal for other medical reason 1.4 and 6.4, planning pregnancy 0.8 and 13.5, and removal for other personal reason 2.4 and 11.9 per 100 users. Neither ectopic pregnancies nor episodes of pelvic inflammatory diseases (PIDs) occurred. One perforation was recorded; the calculated rate is 0.3 per 100 women (first year). The continuation rate was 88.3 and 52.5 at 1 and 5 years, respectively. In conclusion, the 5-year performance of NOVA T 380 was good compared to other "high-loaded" copper devices. Safety was acceptable over the entire study period.

译文

:在一项为期5年的开放性,单组,III期临床试验中,在三个中心对NOVA T 380的临床性能进行了研究。该设备具有380 mm(2)的较高铜表面,是NOVA T的改进形式。共有400名志愿妇女参加了这项研究。平均年龄为31.4岁(SD 5.5),最小18岁,最大44岁。研究结束时,有211名妇女通过了60个月的访问。由Kaplan-Meier估算得出的第一年和第五年末的累积停药率分别为:妊娠0.5和1.9,驱逐1.3和4.1,出血4.4和14.0,疼痛1.3和4.2,由于其他医疗原因而去除1.4和6.4,计划怀孕0.8和13.5,并出于其他个人原因删除每100个用户2.4和11.9。既未发生异位妊娠,也未发生盆腔炎。记录了一个穿孔;计算的比率是每100名妇女(第一年)0.3。 1年和5年的持续率分别为88.3和52.5。总之,与其他“高负载”铜制设备相比,NOVA T 380的5年性能很好。在整个研究期间,安全性是可以接受的。

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