GyneFix IN与TCu 380A宫内节育器的随机比较性临床研究

Randomized Comparative Study of GyneFix IN and TCu 380A Intrauterine Devices

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２６７和１０２，与ＩＵＤ使用有关的终止率为每百妇女３６６，明显低于ＴＣｕ３８０Ａ组的每百妇女７８８（Ｐ＜００５）。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 performances of the new intrauterine device (IUD) GyneFix IN. Methods The present study is a randomized comparative clinical trial. 607 healthy parous women were randomly allocated into GyneFix IN group ( n =302) or TCu 380A group ( n =305). IUD was inserted during the menstrual interval by the trained investigators. Follow up were arranged at 1,3,6 and 12 months after insertion. The discontinuation rates were calculated by life table method. Results At the end of the first year, there was no pregnancy occurred in GyneFix IN group. Its expulsion rate and removal rate for medical reasons were 2.67 and 1.02 per 100 women respectively. The use related discontinuation rates was 3.66, which was significantly lower than that in the TCu 380A group (7.88, P <0.05). The number of women with complaint of pain was also less in GyneFix IN group. Conclusion The excellent performance of the new IUD which is a frameless device with high copper surface and anchoring system was confirmed by this multicentre trial. Due to lower expulsion rate and less side effect of pain, it could be recommended.