ROMA在女性盆腔包块良恶性鉴别诊断的前瞻性研究

发布时间：2018-06-06 01:05

本文选题：盆腔包块 + 卵巢癌　；参考：《浙江大学》2014年硕士论文

【摘要】：目的卵巢癌仍然是迄今致死率最高的妇科恶性肿瘤。临床上极为重视检查发现的盆腔包块,因为以卵巢癌为主要病理类型的盆腔恶性肿瘤若不及时治疗,严重威胁患者生命,但若早期诊断,规范治疗5年存活率可高于70%,晚期患者则不到20%。不少包块在手术以前或更确切的说在获得病理诊断以前,常常难以确定其良恶性。盆腔包块的早期鉴别,有利于恶性肿瘤患者得到专科医生的规范治疗,从而显著提高疗效。因此,发现盆腔包块后进一步鉴别其良恶性已是妇科恶性肿瘤诊治研究的热点。CA125是最早用于卵巢癌检测的肿瘤标志物,几十年来已经在国内外得到了临床医生的认可,HE4是近年来最受关注的肿瘤标志物,两者在卵巢癌诊断上都有着良好的灵敏度和特异性,而ROMA(卵巢癌恶性肿瘤风险判定规则)是结合了两者的一个诊断指标,旨在提高肿瘤标志物在卵巢癌诊断上的诊断性能。本次前瞻性研究探讨ROMA针对中国女性群体在卵巢癌和良性卵巢疾病的鉴别诊断中是否存在优势。方法以2012年4月～2013年1月就诊于浙江大学附属妇产科医院的18岁的住院女性为研究对象,入选影像学检查(CT或者超声)证实有盆腔包块CA125的检测值=50U/mL(绝经前)或者=35U/mL(绝经后)的女性,排除有已知的活动性恶性肿瘤,两侧卵巢切除,怀孕等以及未进行手术获取病理结果的病例后,最终纳入病例318例。手术前静脉采血获取外周血标本,所有血清样本由同一个实验室技师进行检测,采用雅培Architect化学发光微粒子免疫分析(CMIA)及原装进口配套试剂检测血清CA125, HE4和FSH值,将雅培试剂和罗氏试剂的CA125检测结果进行对比分析。采用双盲法原则,所有的病理样本由同一个资深的病理医生进行病理检查,对每个样本进行病理组织分型和病理分期,将病理诊断结果作为诊断金标准。FSH可以反映卵巢的生理功能,根据检测得到的FSH值是否大于20mIU/mL重新判断女性的绝经状态,再根据绝经状态的不同计算ROMA值。分析各项指标的检测性能。用受试者工作特征(ROC)曲线评估CA125, HE4和ROMA的诊断性能。收集318例病例的影像学检查结果,由同一位经验丰富的超声科专家进行解读并判断每个样本的良恶性,分析超声结果与ROMA联合应用时对卵巢肿瘤的诊断价值。CA125, HE4和ROMA分析时2组及多组中位数与均值的比较分别采用秩和检验Mann-Whitney和Kruskall-Wallis。比较雅培试剂与罗氏试剂的CA125检测结果,采用一元直线回归分析,偏倚分析采用Bland-Altman法。采用ROC曲线评估CA125, HE4和ROMA的诊断性能。结果 1.患者年龄分布19～80岁,平均年龄36岁,绝经前277例,绝经后41例。病理诊断结果包括恶性卵巢肿瘤39(12%)例(上皮性29例,其他10例),良性卵巢疾病264(83%)例,交界性肿瘤15(5%)例。 2.卵巢癌和交界性肿瘤的患者CA125, HE4和ROMA值均高于子宫内膜异位症和其他良性肿瘤的患者。 3.卵巢癌III-IV期患者的HE4和ROMA值明显高于I-II期患者的值。 4.将良性肿瘤和恶性肿瘤作比较,根据受试者工作特性曲线(ROC), CA125的AUC0.785,临界值为171.45U/mL时,灵敏度和特异性分别为76.9%和81.4%,HE4的AUC0.907,临界值为59.2pmol/L时,灵敏度和特异性分别为76.9%和92.8%, ROMA值的AUC0.927,临界值为21.16时,灵敏度和特异性分别为82.1%和93.6%。HE4以120pmol/L为临界值时,特异性为100%。在良性妇科肿瘤和卵巢癌的鉴别诊断上,ROMA的灵敏度高达87.2%,HE4的特异性高达97.3%。 5.雅培试剂和罗氏试剂的CA125检测结果呈正相关,相关系数0.983。结论作为一种临床应用不久的肿瘤标志物,HE4具有高特异性的诊断性能,ROMA具有高灵敏度的优势,ROMA在盆腔包块的良恶性鉴别诊断上具有非常好的应用价值。
[Abstract]:objective
Ovarian cancer is still the most fatal gynecologic malignant tumor to date. It is highly valued to check the pelvic masses, because the pelvic malignant tumor which is the main pathological type of ovarian cancer is not treated in time, and it is a serious threat to the patient's life, but if early diagnosis, the 5 year survival rate can be higher than 70%, and the late patients are less than 20%.. The early identification of pelvic lumps is often difficult to determine before surgery or more specifically for pathological diagnosis. Early identification of pelvic masses is beneficial to patients with malignant tumors to receive standardized treatment by specialist and thus significantly improve the curative effect. Therefore, it is found that the pelvic lump is a step in the identification of malignant and malignant tumor diagnosis of gynecologic malignancies. .CA125 is the earliest tumor marker for ovarian cancer detection, which has been recognized by clinicians at home and abroad for several decades. HE4 is the most popular tumor marker in recent years. Both of them have good sensitivity and specificity in the diagnosis of ovarian cancer, and ROMA (the rule of the risk determination of ovarian cancer) is A diagnostic index was combined to improve the diagnostic performance of tumor markers in the diagnosis of ovarian cancer. This prospective study examines whether ROMA has advantages in the differential diagnosis of ovarian and benign ovarian diseases in Chinese women.
Method
The 18 year old hospitalized women who were hospitalized at the affiliated obstetrics and Gynecology Hospital of Zhejiang University from April 2012 to January 2013 were enrolled in the study. They were selected for imaging examination (CT or ultrasound) to confirm the detection value of pelvic masses of CA125 =50U/mL (premenopausal) or =35U/mL (postmenopausal) women, excluding the known active malignant tumors, bilateral ovariectomy, and arms. 318 cases were finally included in cases of pregnancy and other cases of pathological results without operation. Blood samples were collected from the blood samples before the operation. All the serum samples were tested by the same laboratory technician. The Architect chemiluminescent particle immunoassay (CMIA) and the original imported matching reagents were used to detect the serum CA125, HE4 and FSH. The results of CA125 detection of Abbott and Roche reagent were compared and analyzed. Using the principle of double blindness, all the pathological samples were examined by the same senior pathologist, and the pathological histological classification and pathological staging were carried out for each sample. The pathological diagnosis as the diagnostic gold standard.FSH could reflect the physiological function of the ovary. Ability to rejudge the menopause status of women based on whether the detected FSH values are greater than 20mIU/mL, and then calculate the ROMA values according to the different menopause status. Analyze the detection performance of each index. The diagnostic performance of CA125, HE4 and ROMA is evaluated with the working feature (ROC) curve of the subjects. The image examination results of 318 cases are collected from the same experience. The rich ultrasound specialists read and judged the benign and malignant of each sample, and analyzed the diagnostic value of the combined application of ultrasound and ROMA for ovarian tumors,.CA125, HE4 and ROMA analysis. The comparison of the 2 groups and the mean values of the multiple groups and the mean was used to compare the C of the rank sum test Mann-Whitney and Kruskall-Wallis. to the C of the Abbott reagent and the Roche reagent. A125 test results were analyzed by one-way linear regression analysis. Bland-Altman analysis was used for bias analysis. Diagnostic performance of CA125, HE4 and ROMA was evaluated by ROC curve.
Result
The age distribution of 1. patients was 19~80 years, with an average age of 36 years, 277 premenopausal and 41 postmenopausal. The pathological diagnosis included 39 (12%) malignant ovarian tumors (29 cases of epithelium, 10 in the other), 264 (83%) of benign ovarian disease, and 15 (5%) cases of borderline tumors.
2. the values of CA125, HE4 and ROMA in patients with ovarian cancer and borderline tumors were higher than those in patients with endometriosis and other benign tumors.
3. the HE4 and ROMA values of patients with stage III-IV ovarian cancer were significantly higher than those of patients with stage I-II.
4. compared the benign tumor with the malignant tumor, the sensitivity and specificity were 76.9% and 81.4% respectively, the sensitivity and specificity were 76.9% and 81.4%, respectively, when the critical value was 171.45U/mL, and the critical value was 59.2pmol/L, the sensitivity and specificity of the sensitivity and specificity were 76.9% and 92.8% respectively, and the ROMA value was AUC0.927 and the critical value was 21.16, spirit, when the critical value was 171.45U/mL. When the sensitivity and specificity were 82.1% and 93.6%.HE4 with 120pmol/L as the critical value, the specificity was 100%. in the differential diagnosis of benign gynecologic and ovarian cancer, the sensitivity of ROMA was up to 87.2%, and the specificity of HE4 was as high as 97.3%..
5. the CA125 test results of Abbott reagent and Roche reagent were positively correlated, and the correlation coefficient 0.983.
conclusion
As a tumor marker for clinical application, HE4 has a high specificity of diagnostic performance, and ROMA has a high sensitivity. ROMA is of great value in the differential diagnosis of pelvic masses.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R737.31

【共引文献】