论文部分内容阅读
目的观察新型ＧｙｎｅＦｉｘＩＮ宫内节育器（ＩＵＤ）的临床性能。方法采用随机对比性多中心临床研究方法，对６０７例健康经产妇女由经过培训的专人以随机方法于月经间期放置ＧｙｎｅＦｉｘＩＮＩＵＤ３２０例（ＧｙｎｅＦｉｘＩＮ组）及ＴＣｕ３８０ＡＩＵＤ３０５例（ＴＣｕ３８０Ａ组），于放器后１、３、６和１２个月随访，以生命表法统计两种ＩＵＤ的终止情况。结果ＧｙｎｅＦｉＸＩＮ组使用１年无妊娠发生，脱落和因症取出率分别为每百妇女２６７和１０２，与ＩＵＤ使用有关的终止率为每百妇女３６６，明显低于ＴＣｕ３８０Ａ组的每百妇女７８８（Ｐ＜００５）。ＧｙｎｅＦｉｘＩＮ组疼痛的主诉率也低于ＴＣｕ３８０Ａ组。结论此种无支架、铜表面积大并有固定系统的ＩＵＤ，由经过培训的人员放置，具有低脱落率和改善疼痛副反应的特点，有推广前景。
Objective To observe the clinical performance of a new GyneFixIN IUD. Methods A randomized controlled multicenter clinical trial was conducted in 607 healthy women who underwent GyneFixINIUD3 (GyneFixIN group) and TCu380AIUD305 group (TCu380A group) with randomized training in the menstrual cycle. , 3,6 and 12 months follow-up, the life table statistics of the two IUD termination. Results GyneFiXIN group used one year without pregnancy, shedding and removal rates were 2 67 and 1 02 per 100 women respectively. The termination rate associated with IUD use was 366 per 100 women, which was significantly lower than that of TCu380A group 7 88 per 100 women (P <0 05). The prevalence of pain in the GyneFixIN group was also lower than in the TCu380A group. Conclusion This stentless, large surface area copper IUD with a fixed system, placed by trained personnel, has the characteristics of low shedding and pain relief side effects and has promise of promotion.