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本器采用医用高分子硅橡胶为原料,外形仿日本优生型,中间空支架上附有硅橡胶薄膜。经临床前毒理试验和动物试用后,于1980年5月用于临床1136例,满12个月的随访结果(生命表统计法)为:12个月累积存放率为82.45%,带器妊娠率为4.5%;脱落率为8.49%;因症取出率为3.92%;个人原因取出率为0.64%。30例放器后月经量有所增加(放器前为51.96毫升,放器后1、2、3月经量分别为62.9、71.0、75.0毫升,p<0.001),但并不比其他节育器有更多的增高。此器的组织反应(子宫内膜病理及细胞学变化)亦并不比不锈钢节育器严重。
The device uses medical polymer silicone rubber as raw material, shape imitation Japanese eugenics, hollow stent with silicone rubber film attached. After the preclinical toxicology test and animal trial, 1136 cases were used clinically in May 1980, and the follow-up results (life table statistics method) of 12 months were as follows: the 12-month cumulative deposit rate was 82.45% The rate was 4.5%; the rate of exfoliation was 8.49%; the rate of removing the disease was 3.92%; the rate of removing the person was 0.64%. After 30 cases, the amount of menstrual flow increased (51.96 ml in front of the ampoule, 62.9, 71.0 and 75.0 ml respectively after the ampoule, respectively, p <0.001), but not more than other IUDs More increase. Tissue response (endometrial pathology and cytological changes) is also no worse than stainless steel IUD.