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国内5省市对3种新型国产宫内节育器(IUD)包括 TCu200c、宫形器及磁硅器与TCu220c进行随机临床多中心比较性研究。自1987年8月～1988年2月共接受合格对象4 003例。2年随访率99.9％。TCu220c、宫形器和磁硅器2年累积净妊娠率分别为1.6％、2.0％、6.2％和5.2％。两种 TCuIUD 妊娠率较宫形器、磁硅器显著低(P<0.001)脱落率分别为1.5％、1.6％、0.9％和1.9％均低于2％,与 IUD 有关的出血、疼痛、出血和疼痛取出率,分别为1.3％、1.1％、2.3％和2.9％,两种 TCu IUD显著低于宫形器和磁硅器(P<0.05和0.01)。2年修正后续用率分别为95.6％、95.3％和90.6％。以两种 TCu IUD 最高,与后两者相比有显著差异(P<0.001)。
Five domestic provinces and municipalities of the three new domestic IUDs including TCu200c, Miyazaki and magnetic silicon and TCu220c randomized clinical multicenter comparative study. From August 1987 to February 1988 a total of 4 003 eligible patients were accepted. 2-year follow-up rate of 99.9%. The cumulative 2-year pregnancy rates for TCu220c, pyramidal and magnetic silicon devices were 1.6%, 2.0%, 6.2% and 5.2%, respectively. Both TCuIUD pregnancy rates were significantly lower (1.5% vs 1.6%, 1.6%, 0.9%, 1.9%, respectively) than those of the wombi and magnetosilicone devices (P <0.001). Bleeding, pain and bleeding associated with IUD And pain removal rates were 1.3%, 1.1%, 2.3% and 2.9%, respectively. The TCu IUD of the two TCu IUDs were significantly lower than those of the pyramidal and magnetic silicon devices (P <0.05 and 0.01). The 2-year revised follow-up rates were 95.6%, 95.3% and 90.6% respectively. The two TCu IUDs were the highest with significant differences from the latter two (P <0.001).