血清CA125、HE4及基于二者的ROMA、CPH-I在卵巢肿瘤良恶性鉴别诊断中的应用价值

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摘要目的对比分析血清糖类抗原125（CA125）和人附睾上皮分泌蛋白4（HE4）及基于二者计算的卵巢恶性肿瘤风险模型（ROMA）、哥本哈根指数（CPH-I）在卵巢良恶性肿瘤鉴别诊断中的应用价值。方法回顾性分析2014年9月~2016年11月于南方医科大学南方医院妇产科就诊的719例卵巢肿瘤患者的临床资料。根据预后的差别将患者分为少见组织病理学类型卵巢恶性肿瘤（LCOHs）组（92例），非少见组织病理学类型卵巢恶性肿瘤（Non-LCOHs）组（96例），良性肿瘤（BOTs）组（531例）。采用ROC曲线计算CA125、HE4、ROMA、CPH-I的AUC、灵敏度、特异度，比较其鉴别LCOHs、Non-LCOHs和BOTs的效能大小。结果 LCOHs组早期比例较高（80.4%），Non-LCOHs组以晚期为主（77.1%）（P ＜ 0.01）；各组年龄、已绝经女性比例、CA125、HE4、ROMA、CPH-I大小排序为：Non-LCOHs组＞LCOHs组＞BOTs组（P ＜ 0.01）；在鉴别Non-LCOHs和BOTs时，ROMA、CPH-I、HE4（0.969、0.968、0.968）的AUC均大于CA125（0.935）；灵敏度排序：CPH-I＞ROMA＞CA125＞HE4（93.8%、92.7%、90.6%、88.5%）。在鉴别LCOHs和BOTs时，亦观察到相似的AUC趋势（0.735、0.739、0.736和0.642）；ROMA、CA125灵敏度大于CPH-I、HE4（44.6%、35.9%和32.6%，32.6%）。特异度排序：CPH-I＞HE4＞ROMA＞CA125（94.7%、93.6%、87.6%、83.6%）。结论 HE4、ROMA、CPH-I三者总体诊断效能相当，均优于CA125。在预测Non-LCOHs时，ROMA和CPH-I优于CA125，CPH-I稍占优势且更为简便实用，三者均优于HE4。在筛检出BOTs方面，CPH-I和HE4优于ROMA，三者有效弥补CA125特异性差的缺陷。CA125、HE4、ROMA、CPH-I用于发现LCOHs时漏诊率仍较高，还需进一步探索新的鉴别手段。

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	陈咏宁1 张雅迪1 陈莉2 李婵媛1 吴焕3 龚时鹏1

关键词 ：卵巢肿瘤, CA125, HE4, ROMA, CPH-I, 鉴别诊断

Abstract：Objective To compare diagnostic value of carbohydrate antigen 125 (CA125), human epididymis protein 4 (HE4) and on which risk of ovarian malignancy algorithm (ROMA), Copenhagen index (CPH-I) based in differentiating malignant from benign ovarian tumors. Methods Clinical data of 719 patients with ovarian tumors, who visited Department of Obstetrics and Gynecology of Nanfang Hospital, Southern Medical University, from September 2014 to November 2016 were analyzed retrospectively. According to different prognosis, patients were divided into 92 cases of less common ovarian histopathologies (LCOHs) group, 96 cases of non-less common ovarian histopathologies (Non-LCOHs) group, 531 cases of benign ovarian tumors (BOTs) group. ROC curve were used for calculating AUC, sensitivities and specificities, so as to compare diagnostic value of CA125, HE4, ROMA and CPH-I in differentiating malignant from benign ovarian tumors. Results Among ovarian cancer, 77.1% patients in non-LCOHs group were mainly staged advanced, while those in LCOHs group, 80.4% were mainly early stage, the differences were statistically significant (P < 0.01). The age, rate of postmenstrual cases and levels of serum CA125, HE4, ROMA, CPH-I in Non-LCOHs group were higher, followed by LCOHs group and BOTs group respectively, the differences were statistically significant (P < 0.01). In differentiating Non-LCOHs from BOTs patients, AUC of CPH-I, ROMA and HE4 were both higher than CA125 (0.969, 0.968, 0.968 and 0.935), and CPH-I made highest sensitivity, followed by ROMA, CA125 and HE4 (93.8%, 92.7%, 90.6% and 88.5%). Similar AUC trend was observed in differentiating LCOHs from BOTs patients (0.735, 0.739, 0.736 and 0.642), and sensitivity of ROMA was highest and followed by CPH-I, CA125 and HE4 (44.6%, 35.9%, 32.6% and 32.6%). The specificity of CPH-I, HE4, ROMA was higher than CA125 (94.7%, 93.6%, 87.6% and 83.6%). Conclusion HE4, ROMA, and CPH-I did the comparative performance in differentiating malignant from benign ovarian tumors and both are better than CA125. In terms of predicting Non-LCOHs patients, ROMA and CPH-I are superior to CA125, and CPH-I is slightly dominant and more convenient and practical than ROMA. Both of these models perform better than HE4. Furthermore, CPH-I and HE4 has better specificities for predicting benign ovarian diseases than ROMA and the former two index made up for shortcoming of weak specificity of CA125 effectively. However, the rate of missed diagnosis in LCOHs population is still staying at a high level and further researches for more effective differential diagnosis tools are needed.

Key words： Ovarian neoplasms CA125 HE4 ROMA CPH-I Differential diagnosis

基金资助:广东省科技计划项目（2016A020215115）；
广东省广州市花都区科技计划产学研协同创新重点专项（HD15CXY006）。

通讯作者: 龚时鹏（1972.7-），男，博士，副主任医师；研究方向：妇科良恶性肿瘤的诊治。

作者简介: 陈咏宁（1990.10-），男，硕士；研究方向：卵巢癌化疗耐药机制及药物干预。

引用本文:

陈咏宁1 张雅迪1 陈莉2 李婵媛1 吴焕3 龚时鹏1. 血清CA125、HE4及基于二者的ROMA、CPH-I在卵巢肿瘤良恶性鉴别诊断中的应用价值[J]. 中国医药导报, 2019, 16(17): 9-12,22.
CHEN Yongning1 ZHANG Yadi1 CHEN Li2 LI Chanyuan1 WU Huan3 GONG Shipeng1. Application value of serum CA125, HE4 and ROMA and CPH-I based on them in differential diagnosis of ovarian tumors. 中国医药导报, 2019, 16(17): 9-12,22.

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