可溶性细胞间粘附分子-1检测试剂盒诊断胎膜早破的临床试验

Clinical trial of soluble intercellular adhesion molecule-1 detection kit in diagnosis of premature rupture of membrane

目的评价可溶性细胞间粘附分子-1(sICAM-1)检测试剂盒用于诊断胎膜早破的敏感度及特异性。方法选择妊娠15至42周到医院就诊的妊娠妇女,进行阴道液pH值测定、阴道后穹窿积液检查、阴道液涂片羊齿状结晶检查,其中两项阳性者诊断为胎膜早破,两项阴性者诊断为胎膜未破。所有妊娠妇女均进行sICAM-1试剂盒检测。运用kappa统计量评估检测结果的一致性和相关性。结果 1 047例妊娠妇女进入该临床试验研究。经阴道液pH值、阴道后穹窿积液和阴道液涂片羊齿状结晶三项检查,诊断胎膜早破423例,胎膜未破624例;sICAM-1检测试剂盒检测出胎膜早破446例,胎膜未破601例。sICAM-1检测试剂盒诊断胎膜早破的敏感度为99.53%,特异性为95.99%,假阳性率为4.01%,假阴性率为0.47%,阳性预测值为94.39%,阴性预测值为99.67%,准确度为97.42%。sICAM-1检测试剂盒诊断胎膜早破与阴道液pH值测定、阴道后穹窿积液检查具有极强一致性(kappa=0.919 3、0.919 2),与阴道液涂片羊齿状结晶检查具有中度一致性(kappa=0.493 1)。整个试验无不良事件发生。结论 sICAM-1检测试剂盒在诊断胎膜早破中具有较高的敏感度、特异性、准确度和安全性。

AIM To evaluate the sensitivity and specificity of soluble intercellular adhesion molecule- 1 （sICAM-1） detection kit in the diagnosis of premature rupture of membrane （PROM）. METHODS Pregnant women with gestational week from 15 to 42 weeks were detected by pH strip detection, vaginal posterior fornix effusion detection and fern-like crystals detection. If two of the three results were positive, the patient was enrolled in PROM group. If two of the three results were negative, the patient was enrolled in non-PROM group. All of the pregnant women were also detected by sICAM- 1 detection kit. Kappa statistics were used to evaluate the consistency and correlation of different results. RESULTS Totally 1 047 pregnant women were enrolled in this study, 423 with PROM and 624 with non-PROM detected by pH strip detection, vaginal posterior fornix effusion detection and fern-like crystals detection. There were 466 patients detected as PROM and 601 patients detected as non-PROM by slCAM- 1 detection kit. The sensitivity of sICAM- 1 detection kit in the diagnosis of PROM was 99.53%, specificity was 95.99%, false positive rate was 4.01%, false negative rate was 0.47%, positive predictive value was 94.39%, negative predictive value was 99.67%, and accuracy was 97.42%. There was very high consistency in diagnosis of PROM between pH strip detection, vaginal posterior fornix effusion detection and sICAM-1 detection kit （kappa = 0.919 3, 0.919 2）. There was medium consistency between fern- like crystals detection and sICAM-1 detection kit （kappa = 0.493 1）. There was no adverse event during the whole process. CONCLUSION sICAM-1 detection kit has high sensitivity, specificity, accuracy and safety in the diagnosis of PROM.