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目的:探讨妊娠早期妇女血清瘦素、人绒毛膜促性腺激素β(β-hCG)及融合素-α(ADAM12)的浓度变化及这些指标对自然流产发生的预测价值。方法:分别测定172例妊娠妇女(其中自然流产者20例)及非妊娠健康妇女48例,妊娠组在孕10～12周时分别测血清瘦素、β-hCG、ADAM12的浓度。瘦素、β-hCG采用ELISA法测定,ADAM12采用时间分辨荧光免疫分析方法测定,预测界限值根据ROC曲线确定。结果:①在妊娠早期自然流产患者血清β-hCG、瘦素、ADAM12水平低于正常妊娠者,差异显著(P<0.001);自然流产组、正常妊娠组β-hCG、瘦素水平均高于非妊娠组,差异显著(P<0.05)。②妊娠早期以血清瘦素≤11 ng/ml、血清β-hCG≤22 IU/ml及血清ADAM12≤335 ng/ml为预测界值,其预测自然流产发生的曲线下面积、灵敏度、特异度、阳性预测值(PPV)及阴性预测值(NPV)分别为:79.60%、90.00%、71.71%、29.51%和98.20%;91.00%、85.00%、87.50%、47.22%和97.79%;78.40%、80.00%、78.75%、48.48%和94.03%。③根据ROC曲线图确定临界值:以血瘦素≤11 ng/ml、血β-hCG≤22 IU/ml为预测界值,两者联合灵敏度75%,特异度96.05%,阳性预测值71.43%,阴性预测值96.69%,两者联合预测阳性率显著高于单项血清β-hCG及瘦素预测率(P<0.05)。④根据ROC曲线图确定临界值:以血β-hCG≤22 IU/ml、血ADAM12≤335 ng/ml为预测界值,两者联合灵敏度75%、特异度95%,阳性预测值78.95%,阴性预测值93.83%,两者联合预测阳性率显著高于单项血清β-hCG及ADAM12预测率(P<0.05)。结论:妊娠早期,检测孕妇血瘦素、β-hCG及ADAM12,可作为自然流产发生的有效预测指标;联合多项指标可进一步提高对自然流产发生的阳性预测率及准确率。
Objective: To investigate the changes of serum leptin, human chorionic gonadotropin β (β-hCG) and fusion protein-α (ADAM12) in early pregnancy and their predictive value for spontaneous abortion. Methods: 172 cases of pregnant women (including 20 cases of spontaneous abortion) and 48 cases of non-pregnant healthy women were measured. The levels of serum leptin, β-hCG and ADAM12 in pregnancy group were measured at 10-12 weeks of gestation. Leptin, β-hCG were measured by ELISA, ADAM12 was determined by time-resolved fluorescence immunoassay, and the prediction limit was determined by ROC curve. The levels of serum β-hCG, leptin and ADAM12 in patients with spontaneous abortion were lower than those in normal pregnancy (P <0.001). The levels of β-hCG and leptin in spontaneous abortion group and normal pregnancy group were significantly higher than those in normal pregnancy group Non-pregnant group, the difference was significant (P <0.05). ②In the first trimester of pregnancy, serum leptin ≤11 ng / ml, serum β-hCG≤22 IU / ml and serum ADAM12≤335 ng / ml were used as predictive cutoff, which predicted the area under the curve, sensitivity and specificity of spontaneous abortion, The positive predictive value (PPV) and negative predictive value (NPV) were 79.60%, 90.00%, 71.71%, 29.51% and 98.20%; 91.00%, 85.00%, 87.50%, 47.22% and 97.79%; 78.40%, 80.00 %, 78.75%, 48.48% and 94.03% respectively. ③ According to the ROC curve to determine the critical value: leptin ≤ 11 ng / ml, blood β-hCG ≤ 22 IU / ml as a cut-off value, the combined sensitivity of 75%, specificity of 96.05%, a positive predictive value of 71.43% , And the negative predictive value was 96.69%. The positive predictive value of the combined test was significantly higher than that of single serum β-hCG and leptin (P <0.05). ④ According to the ROC curve to determine the critical value: the blood β-hCG ≤ 22 IU / ml, blood ADAM12 ≤ 335 ng / ml as the cutoff value, the combined sensitivity of 75%, specificity of 95%, a positive predictive value of 78.95% The negative predictive value was 93.83%. The positive predictive value of the combined test was significantly higher than that of single serum β-hCG and ADAM12 (P <0.05). Conclusion: The detection of serum leptin, β-hCG and ADAM12 in pregnant women can be used as an effective predictor of spontaneous abortion in early pregnancy. Combined with multiple indicators can further improve the positive predictive rate and accuracy of spontaneous abortion.