输卵管四维超声造影效能的大样本临床评价

A Clinical Effectiveness Evaluation of four dimensional Hysterosalpingo-contrast Sonography with Large Sample

目的:探讨经阴道四维输卵管超声造影评估输卵管通畅性的临床价值。方法:对6096名不孕症患者行输卵管四维超声造影,与腹腔镜检查比较其诊断输卵管通畅性的准确度,记录造影剂静脉逆流情况,观察患者术中疼痛程度、副反应及术后并发症。结果:输卵管四维超声造影与腹腔镜检查相比,两者一致程度较高(Kappa=0.84,P<0.05),经阴道四维输卵管超声造影诊断输卵管通畅的敏感度95.1%,特异度88.4%,阳性预测值89.6%,阴性预测值94.4%,假阳性率11.6%,假阴性率4.9%,总符合率91.8%。6096例不孕症患者中共2665条输卵管判断为输卵管阻塞,阳性率21.9%;9456条判断为输卵管通畅,阴性率78.0%;造影剂静脉逆流率为5.0%。术中患者无疼痛或轻度疼痛76.1%,中等疼痛17.3%,重度疼痛6.6%。出现人流综合征者占2.4%。检查后阴道有血性分泌物者32.1%。感染率为0.016‰。结论:经阴道子宫输卵管四维超声造影安全、准确、对生殖时间窗影响小,是目前除腹腔镜检查外评估输卵管通畅性诊断效能较高的方法,大样本研究表明该方法有一定假阳性率,有进一步改善的空间。

Objective ： To investigate the synthetical clinical value of the four dimensional hysterosalpingocontrast sonography（4D-Hy Co Sy）. Methods ： 6096 patients with infertility underwent 4D-Hy Co Sy, the condition of contrast agent reflux were recorded and the pain degree and related side effects were assessed. 182 cases accepted laparoscopic hydrotubation and the results were compared with 4D-Hy Co Sy. Results ： In light of gold standard,the sensitivity of 4D-Hy Co Sy diagnosed tubal obstruction in 182 patients was 95.1%, specificity was 88.44%, positive predictive value was89.6%, negative predictive value was 94.4%, false positive rate was 11.6%, and false negative rate was 4.9%. It suggested high consistency between 4D-Hy Co Sy and larparoscopy with a Kappa value of 0.84（P〈0.05）. There were 2665 obstructive tubes and 9456 nonobstructive tubes in 6096 patients with infertility. 5.0%patients ocurred contrast agent reflux. 2.4% suffered mild induced abortion syndrome. There were 30.0% patients with bloody discharge. The infection rate was 0.016‰. Conclusion ： With high comfort degree, safety, accuracy and almost without influence on reproductive time window, a certain rate of contrast agent reflux, the 4D-Hy Co Sy is a safe, effective and convenient method to evaluate the tube patency and it needs to be improved as shown in the large sample with a certain false positive rate.