非阻塞性输精管滤过装置节育术远期有效性和安全性的临床研究

Clinical Study of Long-term Safety and Contraceptive Efficacy of Non-occlusive Intra-vas Device Sterilization.

本文报告125例输精管滤过装置(IVD)节育术远期(5～8年)有效性和安全性的临床研究。结果:随访率93.60％(117/125);节育有效率97.44％,精液中的精子消失率94.02％(110/117),术后5～8年仍有41.88％(49/117)的受术者精液中可测出中性α-糖苷酶活性(即有附睾液通过);受术者的血清抗精子抗体检出率为9.88％,与近期(术后一年的17.95％)比较有下降的趋势;组织学观察显示IVD与组织相容性好,电镜下可见IVD内尼龙线间隙中破损的精子;附睾膨大率和近睾端输精管代偿性增粗率分别为10.26％(12/117)和11.97％(14/117);所有被访者均未见远期并发症。结果表明IVD置入输精管内不仅远期节育效果可靠,IVD与输精管局部组织相容性良好,而且较好地避免或减轻附睾淤积及其所致并发症的发生。

This paper reported long-term(5-8years)safety and efficacy of intra-vas device(IVD)that implanted in 125 male volunteers. The clinical results demonstrated that the follow-up rate was93.60%(117/125),contraceptive efficacy was 97. 44% and sperm disappearance rate in ejaculates was94.02%(110/117).Neutral alpha glucosidase activities were detected from ejaculates in 43.33% of volunteers (epididymal fluid could pass through the IVD). The positive rate of serum anti-sperm anti-body of volunteer post-sterilization was 9.88% ,which was lower than that of short-term follow-up. Morphological observation revealed that there was good histo-compatibility between IVD and vas def-erence. Injured sperm between nylon thread within the IVD were found under electronic microscope. Epididymal enlarged rate and dilation of diameter of proximal vas deference end were 10. 26%(12/117)and 11. 97% (14/117) ,respectively. No long-term complications were found in these volunteers. We conclude that IVD implanted into vas deference not only had long-term contraceptive efficacy, good histo-compatibility.but also could avoid or better reduced epididymal stasis and complications post-sterilization.