血清MUC1粘蛋白IRMA及其初步临床应用

Establishment of immunoradiometric assay of serum MUC1 and its preliminary application

建立有效的ＭＵＣ１粘蛋白免疫放射分析法（ＩＲＭＡ），并初步用于乳腺肿瘤的诊断。利用纯化的ＭＵＣ１及其多抗，建立ＭＵＣ１双抗夹心ＩＲＭＡ法，对５５例健康女性、１１例乳腺良性肿瘤、２７例乳腺癌及２８例乳腺癌术后患者进行血清ＭＵＣ１的测定。结果：血清ＭＵＣ１ＩＲＭＡ的灵敏度为０７４ｋＵ／Ｌ；健康女性、乳腺良性肿瘤、乳腺癌及乳腺癌术后患者血清ＭＵＣ１的平均含量分别为７２３±３６７、１７８０±１０５６、３００４±２３８４和３１８４±２４７９ｋＵ／Ｌ；正常值上限为１３５４ｋＵ／Ｌ，假阳性率为１８２％；乳腺肿瘤患者血清ＭＵＣ１水平较健康女性明显提高；乳腺癌患者血清ＭＵＣ１水平高于乳腺良性肿瘤患者，但两者的阳性率（７７８７％和７２７０％）差异无显著性（χ２＝０１５４，Ｐ＞００５）；乳腺癌与乳腺癌术后患者血清ＭＵＣ１水平差异无显著性（ｔ＝－０２２，Ｐ＞００５）。ＭＵＣ１血清水平与肿瘤恶性程度成正相关，对于乳腺癌的诊断具有重要参考价值。

PURPOSE To establish an IRMA method of serum MUC1 and report its preliminary use in breast tumor diagnosis METHODS A sandwiches IRMA was established with purified MUC1 and anti MUC1 polyclonal antibodies and used to measure the sera MUC1 level in 55 healthy women, 11 benign breast tumor, 27 breast cancer and 28 post operative breast cancer patients RESULTS The sensitivity was 0 74kU/L The average sera MUC1 concentrations were 7 23±3 67, 17 80±10 56, 30 04±23 84 and 31 48±24 79kU/L for healthy women, benign breast tumor, breast cancer and post operative breast cancer patients respectively The cut off value was 13 54kU/L and false positive rate was 1 82% The serum level of breast tumor patient is significantly higher than that of healthy one (t=-4 943,P<0 01); and breast cancer patients had a higher sera MUC1 concentration than benign one (t=2 191,P<0 05), but their positive rate had no significant difference (χ 2=0 154,P>0 05); There was no significant difference between the MUC1 level of breast cancer patients before and after operation (t=-0 22,P>0 05) CONCLUSIONS Sera MUC1 level of breast tumor patients was positively correlated with the malignancy of the tumors and had an important reference value for breast cancer diagnosis