博莱科成像的六氟化硫(SF6)超声造影剂获中国监管部门批准用于输卵管通畅性评估
SF6微泡超声造影剂新适应症在中国获批，可用于女性不孕症的超声造影无创评估。
业内前列的诊断成像技术公司博莱科成像(Bracco Imaging)今天宣布，其超声造影剂已成功获得中国国家药品监督管理局(NMPA)批准，用于子宫输卵管超声造影检查(HyCoSy)。
HyCoSy是一种超声造影(CEUS)检查手段，有助于识别与输卵管阻塞或子宫异常相关的女性不孕症的潜在原因，且诊断准确性较高(1,2)。输卵管疾病（如阻塞、瘢痕或其他损伤）是导致不孕的主要原因之一，在中国女性不孕症病例中约占25%至35% (3)。
此项监管批准标志着不孕症治疗领域的一个重要里程碑。与使用染料的腹腔镜下输卵管通畅性检查不同，HyCoSy是一种无创检查手段，此外，相较于传统的X射线子宫输卵管造影检查，HyCoSy还能避免育龄妇女的生殖道遭受辐射暴露(4-6)。
1) Qu E, Zhang M, Ju J, Chen Y, Lin X, Zhang X. Is Hysterosalpingo-Contrast Sonography (HyCoSy) Using Sulfur Hexafluoride Microbubbles (SonoVue) Sufficient for the Assessment of Fallopian Tube Patency? A Systematic Review and Meta-Analysis. J Ultrasound Med 2023; 42:7-15
2) Wang T, Dong T, Nie F. Clinical applications, advances, and future directions in hysterosalpingography. Front Med 2025; 12:1537506
3) Reproductive Health Branch of Chinese Preventive Medicine Association. Chinese Expert Consensus on Holistic Management of Tubal Factor Infertility (2023 edition) [J]. Chinese Journal of Practical Gynecology and Obstetrics 2023; 39:318-324
4) Roy KK, Gajapathy SR, Rai R, Zangmo R, Das A, Singhal S. Assessment of Tubal Patency with Selective Chromopertubation at Office Hysteroscopy versus Modified Minilaparoscopy in Infertile Women. Gynecol Minim Invasive Ther 2021; 10:159-165
5) Perisinakis K, Damilakis J, Grammatikakis J, Theocharopoulos N, Gourtsoyiannis N. Radiogenic risks from hysterosalpingography. Eur Radiol 2003; 13:1522-1528
6) Sulieman A, Theodorou K, Vlychou M, Topaltzikis T, Roundas C, Fezoulidis I, Kappas C. Radiation dose optimisation and risk estimation to patients and staff during hysterosalpingography. Radiat Prot Dosimetry 2008;128:217-226