含消炎痛铜宫形器临床效果初步观察

随机比较了含消炎痛铜宫腔形节育器（药铜器）和对照组含铜宫腔形节育器（宫铜器）各２０５例，观察一年的临床效果。结果显示，两组妊娠率、脱落率、因出血／疼痛取出率、续用率分别为：０．４９和１．５０、１．４９和１．９８、０．９９和２．００、９７．０４和９４．６１／１００妇女；两组比较差异均无显著意义（Ｐ均＞０．０５）。置器后３个月时，宫铜器组副反应发生多于药铜器组；月经血量减少药铜器组明显多于宫铜器组（Ｐ＜０．０１），而点滴出血药铜器组明显少于宫铜器组（Ｐ＜０．０５）。两组各测定１５例置器前后的月经血量，药铜器组置器后较置器前不增加或减少７％～１３％，而宫铜器组置器后增加２３％～２７％。提示药铜器能减少置器后早期出血副反应的发生。

Preliminary study on the clinical effect of uterine cavity shaped device Cu200 with indomethacin

Objectives: To observe the clinical effect of uterine cavity shaped device Cu200 (UCD Cu200) with indomethacin (medicated UCD Cu200).Design: A randomized clinical trial.Setting: Outpatients clinic and laboratory in Chongqing Family Planning Scientific Research Institute.Methods: 410 healthy women aged 20￣39 were randomized into two groups,205 cases inserting UCD Cu200 with medicated UCD Cu200 and 205 cases inserting UCD Cu200 (control group).Follow up visits were performed at the 3rd,6th and 12th months after insertion.The menstrual blood loss(MBL) of 15 cases from each group were measured with alkaline hematin photometric method before and at post insertion 1st,3rd,6th,12th month.Results were evaluated by life table method according to Tietze and etc.Results: The 12 months follow up resutts show that pregnancy rate,expulsion rate and removal rates for bleeding/pain and cumulative continuation per 100 women of the two groups were 0.49 and 1.50,1.49 and 1.98,0.99 and 2.00,97.04 and 94.61 respectively.The difference between the two groups didn't indicate any statistical significance (P>0.05). But at 3rd month after insertion the incidence of side effects for UCD Cu200 group was more than medicated UCD Cu200 group,the incidence of menstrual flow decrease in medicated UCD Cu200 group was significantly higher than in UCD Cu200 group(P<0.01),the medicated UCD Cu200 exhibited a significant lower incidence of spotting than UCD Cu200(P<0.05). MBL of medicated UCD Cu200 group didn't show increase at 1st cycle and showed decrease by 7%￣13% at 3rd,6th,12th after insertion,but UCD Cu200 group increased by 23%￣27%.Conculsion: Medicated UCD Cu200 can decrease bleeding at initial stage after insertion.