B超结合血清CA—125测定诊断卵巢恶性肿瘤

１２１例卵巢肿瘤患者手术后经病理学诊断，本文对他们的术前Ｂ超结果和ＣＡ－１２５浓度进行分析评价。Ｂ超对卵巢恶性肿瘤的检测灵敏度为８５％，特异性８９％。ＣＡ－１２５阳性界值为４５Ｕ／ｍｌ时，诊断恶性卵巢肿瘤的灵敏度为９７％，特异性８２％，两者联合使用的特异性９８％，联合阳性预测值（ＰＰＶ）为９５％；当ＣＡ－１２５的阳性界值定为６５Ｕ／ｍｌ时，特异性为９９％，ＰＰＶ９８％。因此，Ｂ超和ＣＡ－１２５联合     

肿瘤标志物CA－125免疫放射分析

从瑞典引进有关卵巢癌肿瘤抗原的单克隆抗体ＯＶ１９７作为捕捉抗体，以ＯＶ１８５作为标记抗体，建立了碘标固相双位点夹心模式的ＣＡ－１２５免疫放射分析（ＩＲＭＡ）。该方法的标准曲线斜率自０点至５００Ｕ／ｍｌ为９９．７倍，灵敏度在５Ｕ／ｍｌ以下，批内ＣＶ６．３６％，批间ＣＶ９．８％。初步临床应用检测血清ＣＡ－１２５水平的结果为：正常妇女（３３名）为５．８±３．７８Ｕ／ｍｌ，１９例术前或复发的卵巢癌患者为１７６．４±１７７．２Ｕ／ｍｌ，卵巢癌术后（７例）为８．１±６．３Ｕ／ｍｌ；以３５Ｕ／ｍｌ为阳性界值，卵巢癌诊断阳性率为７３．７％，３３名正常人中无假阳性。７例术后卵巢癌患者ＣＡ－１２５水平降至正常范围。说明此ＩＲＭＡ在卵巢癌的诊断和监测中有较大应用价值。该方法是我国第一个国产ＣＡ－１２５ＩＲＭＡ试剂盒，已开始在全国推广应用。     

肿瘤相关抗原CA 19－9免疫放射分析（IRMA）与免疫酶标分析（IEMA）

以抗ＣＡ１９－９单克隆抗体Ｃ２４１为捕捉抗体，以Ｃ１９２为标记抗体建立了ＣＡ１９－９免疫放射分析（ＩＲＭＡ）和ＣＡ１９－９免疫酶标分析（ＩＥＭＡ），ＣＡ１９－９ＩＲＭＡ的标准曲线斜率Ｂ３００ｕ／Ｂ０为３７．１倍，可测定下限在４Ｕ／ｍｌ以下，批内ＣＶ５．１％，批间ＣＶ９．４％，平均回收率９８．６％。ＣＡ１９－９ＩＥＭＡ的标准曲线斜率Ｂ１５０ｕ／Ｂ０为８８．２倍，批内ＣＶ为２．４７％，批间ＣＶ为５．４％，回收率９９．５％。以ＩＲＭＡ方法检测正常血清９９例，ＣＡ１９．９为１２．９±８．５Ｕ／ｍｌ；胰腺癌患者３０例，血清ＣＡ１９－９为１６５．３±１１７．２Ｕ／ｍｌ。以３０Ｕ／ｍｌ为正常上限，则对胰腺癌检测的灵敏度为８６．６％，特异性９６．９７％，说明该方法在胰腺癌诊断中有重要应用价值。本文中的ＣＡ１９－９ＩＲＭＡ已成为第一个国产ＣＡ１９－９试剂盒，开始在全国推广应用。     

血清CA125测定对卵巢恶性肿瘤的诊断及随访复发的价值

本文采用放射免疫法对９８例６１５份血清进行糖类抗原ＣＡ１２５值的测定，其中正常对照３０例，卵巢良性肿瘤２５例，交界性肿瘤１例，卵巢恶性肿瘤４２例。对恶性肿瘤患者中２４例同时进行了阴道超声检查的随访监测，发现卵巢恶性是血清ＣＡ１２５值明显高于良性肿瘤和正常对照组（Ｐ〈０．０１）；良性肿瘤ＣＡ１２５值与正常对照组无显著性差异（Ｐ〉０．０５）。术前卵巢恶性肿瘤阳性检出率８５．１９％，其中卵巢上皮性癌阳性     

卵巢癌标志物CA125酶联免疫吸附分析法的建立

目的：建立一种血清ＣＡ１２５的临床检测方法。方法：一株ＣＡ１２５单抗用于固相包被，另一株与辣根过氧化物酶偶联制备ＣＡ１２５的酶标记物，以四甲基联苯胺为底物，采用一步法，建立了ＣＡ１２５的酶联免疫吸附分析法。结果；灵敏度为２．００Ｕ／ｍｌ。批内ＣＶ值低于５．３２％，批间ＣＶ值低于７．３９％。     

CA—125免疫放射分析的动力学研究

以抗卵巢肿瘤抗原的单克隆抗体ＯＶ１９７作为捕捉抗体，ＯＶ１８５作为标记抗体，建立了特异性和灵敏度高的碘标固相双位点夹心式的ＣＡ－１２５免疫放射分析（ＩＲＭＡ）。本文报导了ＣＡ－１２５ ＩＲＭＡ的动力学研究。ＣＡ－１２５例抗原捕捉抗体ＯＶ１９７室温３￣４小时达到平衡；而固相ＯＶ１９７抗体结合的ＣＡ－１２５抗原与标记抗体ＯＶ１８５室温孵育２￣３小时达到平衡。反应时振荡与否、振汇频率大小以及捕捉抗体和标     

非放射性乙型肝炎病毒核酸探针的制备和应用

非放射性的生物素（Ｂｉｏｔｉｎ）和地高辛（Ｄｉｇｏｘｉｇｅｎｉｎ）标记的乙肝病原基因探针（Ｂｉｏ－ＨＢＶＤＮＡ和Ｄｉｇ－ＨＢＶＤＮＡ探针），特异性强，灵敏度高，最低检出值分别为１ｐｇ和０．５ｐｇ。３２０份血清检测了ＨＢＶＤＮＡ和ＨＢｅＡｇ，并与α－_（３２）Ｐ标记的探针检测结果相比较，它们的特异性分别为９６．５％、９８．１％和８８．９％；灵敏度分别为８１．７％、８６．７％和６１．７％；符合率则为９３．８％、９５．９％和８３．８％。应用Ｄｉｇ－ＨＢＶＤＮＡ探针，作斑点杂交试验，在乙肝患者血清、白细胞、尿、粪、唾液以及旅客列车的桌面、车箱门把手、厕所门把手和水笼头上，均可检得阳性结果。我所研制的非放射性乙型肝炎病原基因诊断试剂，为科学研究和临床检测提供了极为有用的工具。     

CA－125免疫放射分析的动力学研究

以抗卵巢癌肿瘤抗原的单克隆抗体ＯＶ１９７作为捕捉抗体，ＯＶ１８５作为标记抗体，建立了特异性和灵敏度高的碘标固相双位点夹心式的ＣＡ－１２５免疫放射分析（ＩＲＭＡ）。本文报导了ＣＡ－１２５ＩＲＭＡ的动力学研究。ＣＡ－１２５抗原与捕捉抗体ＯＶ１９７室温３～４小时达到平衡；而固相ＯＶ１９７抗体结合的的ＣＡ－１２５抗原与标记抗体ＯＶ１８５室温孵育２～３小时达到平衡。反应时振荡与否、振荡频率大小以及捕捉抗体和标记抗体的量等都对ＩＲＭＡ有一定影响。这就为ＩＲＭＡ的理论研究提供了基础，并对ＩＲＭＡ的实际操作起到了指导作用。     

抗Epstein－Bars病毒壳抗原gp125单克隆抗体的研制

用重组痘苗病毒在１４３细胞上表达的ｇＰ１２５粗提物免疫Ｂａｌｂ／Ｃ小鼠，用杂交瘤技术获得７株稳定分泌抗Ｅｐｓｔｅｉｎ－Ｂａｒｓ（ＥＢ）病毒ｇｐ１２５单克隆抗体的杂交瘤细胞株。对杂交瘤细胞及单克隆抗体进行一系列分析和鉴定，初步建立了用表达产物及特异性单克隆抗体检测ＥＢ病毒ＩｇＡ／ｇｐ１２５抗体的三步ＥＬＩＳＡ法。用此法检测ＩｇＡ／ＶＣＡ阳性的鼻咽癌病人血清及ＩｇＡ／ＶＣＡ阴性的正常人血清，结果完全吻合。     

CA242测定对恶性肿瘤的诊断价值

为研究肿瘤标志物ＣＡ２４２免疫放射分析的临床应用价值,应用＾１２５Ｉ标记糖类抗原Ｃ２４２的单克隆抗体ＣＡ２４２,因相珠用单克隆抗体Ｃ２４１包被,建立夹心的免疫分析（ＩＲＭＡ）。结果表明,１００名正常人和５３例良性疾病患者,其ＣＡ２４２分别为５．６７±５．８１Ｕ／ｍＬ和６．８０±４．１３Ｕ／ｍＬ。如果以２７Ｕ／ｍＬ为阳性界值测定１６７例恶性肿瘤患者,其阳性率为６８．３％;其中胰腺癌、结－直肠癌、胃癌     

The diagnostic usefulness of tumour markers CEA and CA-125 in pleural effusion

Pleural effusion is a common diagnostic problem. The analysis of serum and pleural fluid for tumour markers is widely used as a diagnostic aid in clinical practice. The aim of the present study was to determine the usefulness of simultaneous quantification of carcinoembryonic antigen (CEA) and carbohydrate antigen (CA-125) in distinction of malignant from benign effusion. Data from a total of 78 patients including 53 patients with benign and 25 patients with malignant effusion was evaluated. The cut-off values for differentiating benign from malignant effusions were determined using results obtained from patients with known benign effusions (mean + 2 SD, 95% confidence interval). The cut-off for CEA and CA-125 were 5.1 ng/ml and 1707 IU/ml respectively. CEA assay in pleural fluid had an acceptable sensitivity and good specificity of 64% and 98% respectively. CA-125 had a sensitivity of 36% and specificity of 94%. The combination of the two tumour markers gave a sensitivity of 72% and specificity of 92.4%. We suggest a good clinical strategy may be to begin with CEA measurement (assay specificity 98%); if CEA is below the cut-off value (negative), CA-125 could then be measured to improve the sensitivity of detection of malignant effusions. However, measurement of these tumour markers is not cost effective from the point of view that it does not give information on the type of malignancy present. The latter has to be determined either by histological or cytological study.     

Usefulness and limits of CA-125 in diagnosis of endometriosis without associated ovarian endometriomas

BACKGROUND: The aim of this study was to evaluate the diagnostic significance of CA-125 for endometriosis without ovarian endometriomas. METHODS: Preoperative serum CA-125 levels were measured in 775 consecutive women diagnosed by laparoscopy or laparotomy with endometriosis, adenomyosis, leiomyomas, or normal pelvis. RESULTS: Receiver operating characteristic curve analysis revealed that the area under the curve for endometriosis without endometriomas was 0.788, significantly smaller than that for endometriosis with endometriomas (0.935, P < 0.05). In diagnosis of endometriosis without endometriomas, both the maximal accuracy of 78.8% and the maximal diagnostic value of 61.2% were obtained at the cutoff value of 20 U/mL. Negative predictive value was 78.0% at the cutoff value of 20 U/mL, whereas positive predictive value was 92.9% at the cutoff value of 30 U/mL. This range is clearly superior to the empirical single cutoff of 35 U/mL. CONCLUSIONS: In the diagnosis of endometriosis without endometriomas, combined use of two cutoff values for CA-125, 20 and 30 U/mL, provides improved diagnostic performance. However, the accuracy of using only CA-125 testing for diagnosis is still limited. Serum CA-125 testing can be done during initial screenings of women with possible endometriosis.     

Diagnosis of ovarian tumor by measuring tumor markers]

Values of CA125, CA19-9, TPA, CA72-4, BFP and LDH in sera were detected in 148 malignant ovarian tumors, 41 borderline malignant ovarian tumors, 71 benign ovarian tumors and 64 benign uterine diseases. A new cut-off value was determined by ROC graph for distinguishing malignant and borderline ovarian tumors from benign ovarian tumors. CA125 (cut off: 30 U/ml) was a highly sensitive marker for malignant and borderline malignant ovarian tumors, the value being 88.1% (52/59) and 81.8% (9/11), respectively. On the other hand, in 37 benign ovarian tumors, the positive rate was 21.6% and in 21 benign uterine diseases it was 52.4%. CA19-9 (cut off: 150 U/ml) was inferior to CA125, but it was an effective marker for mucinous ovarian tumors. TPA (cut off: 40 U/ml) was also a sensitive (84.7%, 50/59) marker of malignant ovarian tumors. CA72-4 (cut off: 4 U/ml) was a highly specific (87.0%, 60/69) marker of malignant ovarian tumors. Combination assays of CA125/CA19-9, CA125/TPA and CA125/CA72-4 were not effective. Usefulness of BFP for early malignant ovarian tumors was suggested. Seven cases of dysgerminoma showed extremely elevated LDH levels (1,248 +/- 886 IU/1/37 degrees C). Malignancy and histological type of ovarian tumors could be decided by combination assay of these tumor markers, before surgical operation.     

Relationship between tumor markers and clinical symptoms in ovarian cancer]

To assess their usefulness in the prediction of tumor recurrence, we retrospectively examined the accuracy of preoperative diagnosis of ovarian cancer based on tumor markers on 279 patients with benign and malignant ovarian tumors treated at our department. Of the tumor markers examined, CA125 had the highest diagnostic accuracy, suggesting that it is the most useful marker in the diagnosis of ovarian cancer. TPA and IAP were found to be relatively useful, the tumor markers recently identified, CA72-4 had a high true positive rate. We examined the factors affecting the cut-off value for CA125 in healthy volunteers and determined the corrected cut-off value. Using this value, we assessed the usefulness of CA125 in distinguishing between benign and malignant tumors and in predicting tumor recurrence. Factors found to affect the serum CA125 level included pregnancy, menstrual cycle, dysmenorrhea, menopause, and blood type. Using our equation for women over 40 years of age, we obtained a specific cut-off level of 16 U/ml for postmenopausal women, which was found to more accurately distinguish between ovarian tumors in this age group than did the conventional cut-off level of 35 U/ml, which has been used for all age groups. Furthermore, the specific cut-off level predicted tumor recurrence about 2 months earlier than did the conventional cut-off value. In tumor recurrence, CA125 had risen gradually but was within the normal range. Tumor recurrence was observed in all patients who had shown continuous three-stage elevation of CA125 within the normal range.     

CA-125 in fine-needle aspirates of solid tumors: Comparison with cytologic diagnosis and carcinoembryonic antigen (CEA) assay

One hundred and twenty-two fine needle aspirates (FNA) from female patients were studied to determine whether CA-125 assay contributed to cytologic diagnosis and CEA assay. Cytologic examination was done on Papanicolaou-stained smears and cell blocks, CEA by EIA (Abbott Laboratory, > 5 ng/ml cutoff) and CA-125 by RIA (Abbott Laboratory, North Chicago, IL, > 66 μ/ml cutoff). Final diagnosis were correlated with histologic diagnosis when available, clinical, radiologic studies, and follow-up. Results: 29 benign, 93 malignant. Sensitivities and specificities: cytology, 91%, 100%; CEA: 59%, 86%; CA-125, 50%, 55%. CEA plus cytology sensitivity, 97%. CA-125 content was highest in endometrial/ovarian carcinoma (39,899 μ/ml) and < 5,000 μ/ml in other tumors and benign FNA in contrast to CEA which showed highest levels in carcinomas of colon, pancreas, and lung (> 280 ng/ml). While elevated CEA enhances the sensitivity of cytologic diagnosis of carcinomas of the colon, pancreas, and lung, low CEA and high CA-125 content supports an ovarian/endometrial primary. Diagn Cytopathol 1996;14:121–125. © 1996 Wiley-Liss, Inc.     

压迫式弹性成像与声脉冲辐射力成像技术在乳腺肿瘤良恶性鉴别中的价值比较

目的:探讨分析压迫式弹性成像（CE）与声脉冲辐射力成像（ARFI）技术在乳腺肿瘤良恶性鉴别中的价值。方法:选择门诊或住院行超声检查发现的有乳腺肿块患者71例共89个病灶,经病理组织学确认良性病灶57个,恶性病灶32个。对各病灶进行彩色多普勒超声检查,并采取CE及ARFI技术,分别计算病灶弹性应变率比值（SR）及声触诊组织定量（VTQ）值,采用ROC曲线分析SR、VTQ对良恶性肿瘤的诊断效能。结果:恶性组病灶VTQ值与SR值均显著高于良性组（P<0.05）。采用ROC曲线分析VTQ、SR对乳腺良恶性肿瘤诊断效能,VTQ诊断曲线下面积（AUC）为0.918,95% CI为0.871~0.980（P<0.05）,最佳截断值为3.97,在此最佳截断值下,VTQ诊断敏感性94.64%、诊断特异性90.63%;SR诊断AUC为0.899,95% CI为0.854~0.956（P<0.05）,最佳截断值为4.12,在此最佳截断值下,SR诊断敏感性92.86%、诊断特异性84.38%。VTQ和SR诊断敏感性、特异性比较差异无统计学意义（P>0.05）。结论:两种超声诊断技术对乳腺良恶性肿瘤均具有较高的诊断价值,其诊断效能相似,临床上可联合使用,以实现优势互补,提高对乳腺癌的早期检出率。     

Comparison between clinical examination, transvaginal sonography and magnetic resonance imaging for the diagnosis of deep endometriosis

BACKGROUND: Deeply infiltrating endometriosis affecting the retrocervical region and the rectosigmoid generally requires surgical treatment. Clinical examination, transvaginal ultrasonography (TVUS) and pelvic magnetic resonance imaging (MRI) are useful in the preoperative diagnosis of the involvement of these sites. The objective of this study was to evaluate the capacity of digital vaginal examination, TVUS and MRI to diagnose rectosigmoid and retrocervical involvement. METHODS: A total of 104 patients with clinically suspected endometriosis were submitted to clinical examination, pelvic MRI and TVUS until 3 months prior to videolaparoscopy and the findings of these methods were matched with histopathological confirmation of endometriosis. RESULTS: Endometriosis was histologically confirmed in 98 of 104 (94.2%) patients. With respect to the rectosigmoid and retrocervical sites, respectively, digital vaginal examination had a sensitivity of 72 and 68%, specificity of 54 and 46%, positive predictive value (PPV) of 63 and 45%, negative predictive value (NPV) of 64 and 69% and accuracy of 63 and 55%. For TVUS, sensitivity was 98 and 95%, specificity 100 and 98%, PPV 100 and 98%, NPV 98 and 97% and accuracy 99 and 97%. MRI had a sensitivity of 83 and 76%, specificity of 98 and 68%, PPV of 98 and 61%, NPV of 85 and 81% and accuracy of 90 and 71%. CONCULSIONS: TVUS had better sensitivity, specificity, PPV, NPV and accuracy in cases of deep retrocervical and rectosigmoid endometriosis when compared with MRI and digital vaginal examination, confirming that it is an important preoperative examination for the definition of surgical strategies.     

Serum interleukin-6 levels are elevated in women with minimal-mild endometriosis

BACKGROUND: There is a need for a reliable marker of endometriosis, especially in early stages of peritoneal disease during which imaging is not effective. The use of serum interleukin (IL)-6 as a marker is controversial. To readdress the matter, patients undergoing laparoscopy were prospectively evaluated for serum IL-6 levels. MATERIALS AND METHODS: A total of 119 women 31 years old who underwent laparoscopy were divided into groups: control patients (n = 38) with no pathologic findings; endometriosis sufferers (n = 47) with minimal-mild (MM, n = 11) or moderate-severe (MS, n = 36) endometriosis; uterine myomas (n = 13) and benign ovarian pathologies (n = 21). Blood was drawn on cycles days 5-12 and stored for subsequent analysis of IL-6 and carbohydrate antigen (CA)-125 levels. RESULTS: Serum IL-6 levels were significantly (P = 0.002) higher in women with MM endometriosis (29.4 9.0 pg/ml) than in controls (15.7 9.3 pg/ml). When all the non-endometriosis patients were grouped together (n = 72) and serum IL-6 (17.8 12.1 pg/ml) compared with MS (n = 36; 17.6 10.3 pg/ml) and MM (n = 11; 29.4 9.0 pg/ml) endometriosis significantly (P < 0.01) higher levels in MM endometriosis were observed as compared to the other two groups. Serum Ca-125 levels were significantly (P < 0.01) elevated in MS endometriosis. A serum IL-6 threshold of 25.75 pg/ml afforded a sensitivity of 75% and specificity of 83% in the diagnosis of MM endometriosis. Sensitivity and specificity for CA-125 in the diagnosis of MS endometriosis, using 35 IU/ml as the cut-off value, were 47% and 97%, respectively. CONCLUSIONS: IL-6 is a reliable non-invasive marker of MM endometriosis, whereas Ca-125 is of use as a marker of severe cases.     

The Value of CA 125 and CA72-4 in Management of Patients with Epithelial Ovarian Cancer

The role of the tumor markers CA125 and CA72-4 has been evaluated in the diagnosis and management of ovarian cancer. Both markers were measured in 30 patients with proven epithelial ovarian cancer, 30 patients with benign pelvic masses and 30 normal women. CA125 and CA72-4 were measured using the luminometric immunoassay and immuno-radiometric assay respectively. All patients with ovarian cancer were submitted to surgical staging and cytoreduction followed by adjuvant platinum based chemotherapy for 3–6 courses. Fixing the specificity at 95%, CA125 had a sensitivity of 76.7% at a cut-off 85u/ml while CA72-4 had a sensitivity of 70% at a cut-off 8.5 u/ml. The combination of CA72-4 with CA125 increased the sensitivity to 95% while fixing the specificity at 95%. Among seven cases with stage I and II ovarian cancer five cases had CA125 level below 85 U/ml, three patients out of them had CA72-4 above 8.5 U/ml. CA 72-4 could reflect the residual disease following cytoreduction and could improve the detection of relapse by CA125.Conclusion: CA72-4 could complement the standard tumor marker CA125 both in diagnosis and follow up of patients with epithelial ovarian cancer.     

CA-125 concentration in serum and peritoneal fluid in patients with endometriosis – preliminary results

Introduction

Cancer antigen 125 (CA-125), known as a biomarker for women genital tract malignancies, could be also useful in detecting and monitoring endometriosis. The aim of this study was to evaluate CA-125 in serum and peritoneal fluid (PF) as an indicator of endometriosis.

Material and methods

Fifty-six patients admitted to the First Department of Obstetrics and Gynaecology for diagnostic or therapeutic laparoscopy conducted for infertility, pelvic pain, suspected endometriosis or ovarian cysts entered the study. Those with laparoscopically confirmed endometriosis were assigned to group A, those without this condition to group B. Blood for CA-125 was taken prior to surgery, centrifuged and assayed in accordance with the manufacturer''s instructions (VIDAS CA-125 II). Peritoneal fluid and an endometrial biopsy were taken during laparoscopy. Statistical comparisons were performed using Statistica 7.1.

Results

Group A consisted of 44 women with laparoscopically confirmed diagnosis; 15 patients served as a control group. The mean value of CA-125 concentration in the endometriosis group was 33.98 U/ml, vs. 9.3 U/ml in the control group. The mean value of CA-125 in peritoneal fluid was 1241.88 U/ml in the non-endometriosis group versus 2640.23 U/ml in the study group; both results were statistically significant (p < 0.05). There was a significant correlation between the stage of endometriosis and CA-125 plasma concentration (R = 0.5993, p < 0.001). Cancer antigen 125 concentration in serum was a moderate predictor to distinguish between patients with and without endometriosis (AUC 0.794; 95% CI 0.668-0.921; p = 0.001).

Conclusions

Cancer antigen 125 is a well-known biomarker for endometriosis and helpful in daily clinical practice when endometriosis is suspected. The cut-off value in serum suggesting endometriosis with 68% sensitivity is 11 U/ml. This value is normal range for Ca-125 concentration.