血清CA125,HE4及ROMA指数对卵巢癌诊断价值的临床研究

Diagnostic Value of Serum CA125,HE4 and ROMA Index in Patients with Ovarian Cancer

目的：探讨血清CA125，HE4及 ROMA指数对卵巢癌临床诊断价值，提高绝经前、后卵巢癌诊断的准确率。方法采用化学发光法对307例卵巢癌患者，271例卵巢囊肿患者和289例健康对照者进行血清 CA125和 HE4水平的检测，计算 ROMA指数，并进行统计学分析。结果①卵巢癌组血清 CA125，HE4水平和 ROMA指数均较健康对照组和卵巢囊肿组显著升高，差异具有统计学意义（P＜0.05）。②绝经前 ROMA指数（Pre-ROMA）对卵巢癌诊断效能敏感度最高（100％），与CA125，HE4相比，差异具有统计学意义（χ2＝10.69，P＜0.05）。HE4的特异度和阳性预测值均为100％，与CA125，Pre-ROMA相比，差异具有统计学意义（χ2＝19.74，11.05，P＜0.05）。Pre-ROMA指数的阴性预测值（100％）高于HE4，差异有统计学意义（χ2＝12.50，P＜0.05）。③在绝经后卵巢癌诊断效能的比较中，CA125的敏感度和阴性预测值（92.77％和93.62％）高于 HE4，差异均具有统计学意义（χ2＝7.48，6.28，P＜0.05）。HE4的特异度和阳性预测值（92.78％和90.41％）高于Post-ROMA，差异均具有统计学意义（χ2＝7.34，6.05，P＜0.05）。④以卵巢囊肿和正常对照组为参照，HE4和Pre-ROMA诊断绝经前卵巢癌的AUC分别为0.574和0.573，差异具有统计学意义（P＜0.05），而CA125差异无统计学意义（P＞0.05）。⑤以卵巢囊肿和正常对照组为参照，HE4，Post-ROMA和 CA125诊断绝经后卵巢癌的AUC由大到小分别为0.677，0.665及0.641，差异均具有统计学意义（P＜0.05）。结论①血清 CA125对绝经后卵巢癌患者诊断具有更高的敏感度；②血清 H E4对绝经前和绝经后卵巢癌患者均具有很好的临床诊断效能；H E4对卵巢癌的诊断特异度较CA125更高；③HE4和CA125联合检测，并计算 ROMA指数对绝经前和绝经后卵巢癌患者均具有很好的临床诊断效能，可显著提高单项检测对绝经前卵巢癌的诊断敏感度和阴性预测价值。

Objective To investigate the diagnostic value of serum CA125,HE4 and ROMA indexin patients with ovarian cancer in order to improve the accuracy of diagnosis of ovarian cancer.Methods HE4 and CA125 was detected by electro-chemical luminescence immunoassay （ECUA）in 307 ovarian cancer patients,271 ovarian cysts patients and 289 health con-trols.ROMA index were calculated for each selected women by the separated logistic regression algorithm based on the menopausal status.All data were analyzed statistically.Results ①Levels of CA125,HE4 and ROMA index were signifi-cently higher in ovarian cancer patients than those in ovarian cysts patients and health controls （P〈0.05）.②When these in-dexes were used to diagnize pre-ovarian cancer,the sensitivity （100%）and negative predicitive value （100%）of Pre-ROMA index was higher than CA125,HE4 （χ2=10.69,12.50,P〈0.05）while the spectivity （100%）and post predicitive value （100%）of HE4was higher than CA125,Pre-ROMA index （χ2=19.74,11.05,P〈0.05）.③When these indexes were used to diagnize post-ovarian cancer,the sensitivity （92.77%）and negative predicitive value （93.62%）of CA125 was higher than HE4 （χ2=7.48,6.28,P〈0.05）while the spectivity （92.78%）and post predicitive value （90.41%）of HE4 was higher than Post-ROMA index （χ2=7.34,6.05,P〈0.05）.④As the control of ovarian cysts patients and normal control group,the area under the receiver operating characteristic curve （ROC）of HE4 and Pre-ROMA index were 0.574 and 0.573 （P〈0.05）,but CA125 had no statistically significent （P〉0.05）.⑤As the control of ovarian cysts patients and normal con-trol group,the area under the receiver operating characteristic curve （ROC）of HE4,Post-ROMA and CA125 were 0.677, 0.665 and 0.641 （P〈0.05）.Conclusion ①The sensitivity of CA125 to the diagnosis of post-ovarian cancer was higher than that to the diagnosis of pre-ovarian cancer.②HE4 had good clinical diagnostic performance to pre-and post-ovarian cancer.Compared to CA125,the spectivity of HE4 was higher.③Detection of HE4 combined CA125 and ROMA had good clinical diagnostic performance to pre-and post-ovarian cancer,especially they could increase the sensitivity and negative predicitive value of HE4 or CA125 alone to pre-ovarian cancer.