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Abstract：
BACKGROUND: Most prior studies investigating the risk of ovarian malignancy algorithm (ROMA) with cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) have involved Caucasian population or other populations. To date, there have been no unique calculations of predicted probability (PP) risk specifically for Chinese populations to help physicians in primary care settings.
METHODS: A group of 534 women with ovarian tumor diagnoses were enrolled and serum HE4 and CA125 were measured in each individual. Modified cut-off values were obtained by maximizing area under the curve (AUC) values and adjusted by using logistic regression with corresponding sensitivity (SN), specificity (SP), Youden index (YI), positive predictive value (PPV), and negative predictive value (NPV).
RESULTS: By utilizing the ideal PPV, NPV, and AUC values, in premenopausal women modified HE4, CA125, ROMA, and PP cut-off values were 73.87 pmol/L, 61.60 U/mL, 18.47%, and 0.168, respectively. The same test values for postmenopausal women were 120.90 pmol/L, 76.21 U/mL, 26.48%, and 0.485, respectively. The SN for HE4 with the modified cut-off value was significantly lower than that for CA125 (P=0.040) in premenopausal women and lower than that for ROMA (P=0.001) and PP (P=0.044) in postmenopausal women. The AUC values for CA125, ROMA, and PP were all significantly higher than that for HE4 (P=0.006, 0.007, and 0.002, respectively) in postmenopausal women.
CONCLUSIONS: The modified cut-off values for HE4, CA125, ROMA, and PP with ideal SN, SP, YI, NPV, PPV were useful of ruling out ovarian malignancy among both pre- and post-menopausal women. In premenopausal women modified HE4, CA125, ROMA, and PP cut-off values were 73.87 pmol/L, 61.60 U/mL, 18.47%, and 0.168, respectively and in postmenopausal women were 120.90 pmol/L, 76.21 U/mL, 26.48%, and 0.485, respectively.
METHODS: A group of 534 women with ovarian tumor diagnoses were enrolled and serum HE4 and CA125 were measured in each individual. Modified cut-off values were obtained by maximizing area under the curve (AUC) values and adjusted by using logistic regression with corresponding sensitivity (SN), specificity (SP), Youden index (YI), positive predictive value (PPV), and negative predictive value (NPV).
RESULTS: By utilizing the ideal PPV, NPV, and AUC values, in premenopausal women modified HE4, CA125, ROMA, and PP cut-off values were 73.87 pmol/L, 61.60 U/mL, 18.47%, and 0.168, respectively. The same test values for postmenopausal women were 120.90 pmol/L, 76.21 U/mL, 26.48%, and 0.485, respectively. The SN for HE4 with the modified cut-off value was significantly lower than that for CA125 (P=0.040) in premenopausal women and lower than that for ROMA (P=0.001) and PP (P=0.044) in postmenopausal women. The AUC values for CA125, ROMA, and PP were all significantly higher than that for HE4 (P=0.006, 0.007, and 0.002, respectively) in postmenopausal women.
CONCLUSIONS: The modified cut-off values for HE4, CA125, ROMA, and PP with ideal SN, SP, YI, NPV, PPV were useful of ruling out ovarian malignancy among both pre- and post-menopausal women. In premenopausal women modified HE4, CA125, ROMA, and PP cut-off values were 73.87 pmol/L, 61.60 U/mL, 18.47%, and 0.168, respectively and in postmenopausal women were 120.90 pmol/L, 76.21 U/mL, 26.48%, and 0.485, respectively.
摘要：
背景：大多数先前的研究调查了使用癌症抗原125（CA125）和人附睾蛋白4（HE4）的卵巢恶性肿瘤算法（ROMA）的风险，涉及高加索人群或其他人群。迄今为止,没有专门针对中国人群的预测概率(PP)风险的独特计算方法来帮助初级保健机构的医生.
方法：一组534名诊断为卵巢肿瘤的妇女，并测量每个个体的血清HE4和CA125。通过最大化曲线下面积（AUC）值获得修正的临界值，并使用具有相应灵敏度（SN）的逻辑回归进行调整。特异性（SP），尤登指数(YI)，阳性预测值(PPV)，和阴性预测值(NPV)。
结果：利用理想的PPV，NPV,和AUC值，在绝经前妇女改良HE4，CA125，ROMA，PP的截止值为73.87pmol/L，61.60U/mL,18.47%,和0.168。绝经后妇女的相同测试值为120.90pmol/L，76.21U/mL,26.48%,和0.485。在绝经前妇女中，具有修正临界值的HE4的SN显着低于CA125（P=0.040），在绝经后妇女中低于ROMA（P=0.001）和PP（P=0.044）。CA125、ROMA、在绝经后妇女中，PP均显着高于HE4（P分别为0.006、0.007和0.002）。
结论：HE4，CA125，ROMA，和具有理想SN的PP，SP,YI,NPV,PPV有助于排除绝经前和绝经后妇女的卵巢恶性肿瘤。在绝经前妇女改良HE4，CA125，ROMA，PP的截止值为73.87pmol/L，61.60U/mL,18.47%,和0.168，分别在绝经后妇女为120.90pmol/L，76.21U/mL,26.48%,和0.485。
方法：一组534名诊断为卵巢肿瘤的妇女，并测量每个个体的血清HE4和CA125。通过最大化曲线下面积（AUC）值获得修正的临界值，并使用具有相应灵敏度（SN）的逻辑回归进行调整。特异性（SP），尤登指数(YI)，阳性预测值(PPV)，和阴性预测值(NPV)。
结果：利用理想的PPV，NPV,和AUC值，在绝经前妇女改良HE4，CA125，ROMA，PP的截止值为73.87pmol/L，61.60U/mL,18.47%,和0.168。绝经后妇女的相同测试值为120.90pmol/L，76.21U/mL,26.48%,和0.485。在绝经前妇女中，具有修正临界值的HE4的SN显着低于CA125（P=0.040），在绝经后妇女中低于ROMA（P=0.001）和PP（P=0.044）。CA125、ROMA、在绝经后妇女中，PP均显着高于HE4（P分别为0.006、0.007和0.002）。
结论：HE4，CA125，ROMA，和具有理想SN的PP，SP,YI,NPV,PPV有助于排除绝经前和绝经后妇女的卵巢恶性肿瘤。在绝经前妇女改良HE4，CA125，ROMA，PP的截止值为73.87pmol/L，61.60U/mL,18.47%,和0.168，分别在绝经后妇女为120.90pmol/L，76.21U/mL,26.48%,和0.485。
