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本文系研究新型固定式宫内节育器（Ｆｉｘ—ＣｕＵ３００ＩＵＤ）的临床避孕效果、副反应和可接受性，选用目前公认较为理想的ＴＣｕ２２０Ｃ作对照，采用多中心随机比较性研究。自１９９３年２月至５月共接收合格对象２１０４例（各１０５２例），１年随访率为９９．９５％。使用１２个月结果表明：ＦＩＸ－Ｃｕ３００ＩＵＤ累积妊娠率为０．０９％，对照组为１．４３％（Ｐ＜０．０１）；脱落率分别为０．９５％和２．２８％（Ｐ＜０．０５）；因症取出率依次为１．０４％和２．０９％（Ｐ＞０．０５）；续用率分别为９７．３３％和９３．８２％（Ｐ＜０．０５）。９８％以上受试者对所使用的Ｆｉｘ－Ｃｕ３００ＩＵＤ的避孕效果满意，证实此种ＩＵＤ符合ＷＨＯ的可接受性ＩＵＤ标准。
In this paper, the clinical contraceptive effects, side effects and acceptability of the new fixed intrauterine device (Fix-CuU300IUD) were studied. TCu220C, which is generally accepted as the ideal control, was selected as a control and a multicenter randomized comparative study was conducted. A total of 2104 eligible patients (1052 cases each) were received from February to May 1993, with a 1-year follow-up rate of 99.95%. The results of 12 months showed that the cumulative pregnancy rate of FIX-Cu300IUD was 0.09% and that of the control group was 1.43% (P <0.01), and the rates of shedding were 0.95% and 2.28% (P < 0.05). The rates of removing the disease were 1.04% and 2.09%, respectively (P> 0.05). The follow-up rates were 97.33% and 93.82%, respectively (P <0.05). Over 98% of subjects were satisfied with the contraceptive efficacy of the Fix-Cu300IUD used, confirming that this IUD complies with WHO’s IUD standards of acceptability.