本文選題：盆腔包塊 + 卵巢癌�。� 參考：《浙江大學(xué)》2014年碩士論文

【摘要】：目的 卵巢癌仍然是迄今致死率最高的婦科惡性腫瘤。臨床上極為重視檢查發(fā)現(xiàn)的盆腔包塊,因?yàn)橐月殉舶橹饕±眍愋偷呐枨粣盒阅[瘤若不及時(shí)治療,嚴(yán)重威脅患者生命,但若早期診斷,規(guī)范治療5年存活率可高于70%,晚期患者則不到20%。不少包塊在手術(shù)以前或更確切的說在獲得病理診斷以前,常常難以確定其良惡性。盆腔包塊的早期鑒別,有利于惡性腫瘤患者得到專科醫(yī)生的規(guī)范治療,從而顯著提高療效。因此,發(fā)現(xiàn)盆腔包塊后進(jìn)一步鑒別其良惡性已是婦科惡性腫瘤診治研究的熱點(diǎn)。CA125是最早用于卵巢癌檢測的腫瘤標(biāo)志物,幾十年來已經(jīng)在國內(nèi)外得到了臨床醫(yī)生的認(rèn)可,HE4是近年來最受關(guān)注的腫瘤標(biāo)志物,兩者在卵巢癌診斷上都有著良好的靈敏度和特異性,而ROMA(卵巢癌惡性腫瘤風(fēng)險(xiǎn)判定規(guī)則)是結(jié)合了兩者的一個(gè)診斷指標(biāo),旨在提高腫瘤標(biāo)志物在卵巢癌診斷上的診斷性能。本次前瞻性研究探討ROMA針對中國女性群體在卵巢癌和良性卵巢疾病的鑒別診斷中是否存在優(yōu)勢。 方法 以2012年4月～2013年1月就診于浙江大學(xué)附屬婦產(chǎn)科醫(yī)院的18歲的住院女性為研究對象,入選影像學(xué)檢查(CT或者超聲)證實(shí)有盆腔包塊CA125的檢測值=50U/mL(絕經(jīng)前)或者=35U/mL(絕經(jīng)后)的女性,排除有已知的活動(dòng)性惡性腫瘤,兩側(cè)卵巢切除,懷孕等以及未進(jìn)行手術(shù)獲取病理結(jié)果的病例后,最終納入病例318例。手術(shù)前靜脈采血獲取外周血標(biāo)本,所有血清樣本由同一個(gè)實(shí)驗(yàn)室技師進(jìn)行檢測,采用雅培Architect化學(xué)發(fā)光微粒子免疫分析(CMIA)及原裝進(jìn)口配套試劑檢測血清CA125, HE4和FSH值,將雅培試劑和羅氏試劑的CA125檢測結(jié)果進(jìn)行對比分析。采用雙盲法原則,所有的病理樣本由同一個(gè)資深的病理醫(yī)生進(jìn)行病理檢查,對每個(gè)樣本進(jìn)行病理組織分型和病理分期,將病理診斷結(jié)果作為診斷金標(biāo)準(zhǔn)。FSH可以反映卵巢的生理功能,根據(jù)檢測得到的FSH值是否大于20mIU/mL重新判斷女性的絕經(jīng)狀態(tài),再根據(jù)絕經(jīng)狀態(tài)的不同計(jì)算ROMA值。分析各項(xiàng)指標(biāo)的檢測性能。用受試者工作特征(ROC)曲線評估CA125, HE4和ROMA的診斷性能。收集318例病例的影像學(xué)檢查結(jié)果,由同一位經(jīng)驗(yàn)豐富的超聲科專家進(jìn)行解讀并判斷每個(gè)樣本的良惡性,分析超聲結(jié)果與ROMA聯(lián)合應(yīng)用時(shí)對卵巢腫瘤的診斷價(jià)值。CA125, HE4和ROMA分析時(shí)2組及多組中位數(shù)與均值的比較分別采用秩和檢驗(yàn)Mann-Whitney和Kruskall-Wallis。比較雅培試劑與羅氏試劑的CA125檢測結(jié)果,采用一元直線回歸分析,偏倚分析采用Bland-Altman法。采用ROC曲線評估CA125, HE4和ROMA的診斷性能。 結(jié)果 1.患者年齡分布19～80歲,平均年齡36歲,絕經(jīng)前277例,絕經(jīng)后41例。病理診斷結(jié)果包括惡性卵巢腫瘤39(12%)例(上皮性29例,其他10例),良性卵巢疾病264(83%)例,交界性腫瘤15(5%)例。 2.卵巢癌和交界性腫瘤的患者CA125, HE4和ROMA值均高于子宮內(nèi)膜異位癥和其他良性腫瘤的患者。 3.卵巢癌III-IV期患者的HE4和ROMA值明顯高于I-II期患者的值。 4.將良性腫瘤和惡性腫瘤作比較,根據(jù)受試者工作特性曲線(ROC), CA125的AUC0.785,臨界值為171.45U/mL時(shí),靈敏度和特異性分別為76.9%和81.4%,HE4的AUC0.907,臨界值為59.2pmol/L時(shí),靈敏度和特異性分別為76.9%和92.8%, ROMA值的AUC0.927,臨界值為21.16時(shí),靈敏度和特異性分別為82.1%和93.6%。HE4以120pmol/L為臨界值時(shí),特異性為100%。在良性婦科腫瘤和卵巢癌的鑒別診斷上,ROMA的靈敏度高達(dá)87.2%,HE4的特異性高達(dá)97.3%。 5.雅培試劑和羅氏試劑的CA125檢測結(jié)果呈正相關(guān),相關(guān)系數(shù)0.983。 結(jié)論 作為一種臨床應(yīng)用不久的腫瘤標(biāo)志物,HE4具有高特異性的診斷性能,ROMA具有高靈敏度的優(yōu)勢,ROMA在盆腔包塊的良惡性鑒別診斷上具有非常好的應(yīng)用價(jià)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.
【學(xué)位授予單位】：浙江大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R737.31

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