精浆弹性硬蛋白酶检测的临床应用评价与使用策略

Clinical Evaluation and Use Strategy of Seminal Plasma Elastase Detection

目的 对精浆弹性硬蛋白酶筛查生殖道潜在感染/炎症进行临床应用评价,制定合理的使用策略.方法 回顾性分析2011年8月～11月男性不育门诊中随机选取的422例患者资料,分析精浆弹性硬蛋白酶浓度升高与精液参数、生殖道感染、炎症因素的相关性;以前列腺液白细胞升高作为男性生殖道潜在炎症指标,对精浆弹性硬蛋白酶检测限的灵敏度、特异度、准确度等指标做临床评价,绘制ROC曲线,指导临床应用.结果 精浆弹性硬蛋白酶与生殖道炎症指标（精液白细胞、前列腺白细胞）具有很好的相关性（P=0.000,0.000）;与感染指标（支原体、衣原体、细菌）无统计学相关性（P=0.256,0.498,0.658）;与精液常规检查各项指标无统计学相关性（P〉0.05）.以300 ng/ml作为界值,有较高灵敏度,但特异度不足（Se=88.4%,Sp=33.1%）,以1 000 ng/ml,2 000 ng/ml作界值有较好的灵敏度和特异度（Se=75.0%,Sp=65.1%;Se=54.5%,Sp=81.1%）.结论 精浆弹性硬蛋白酶可以作为男性不育门诊生殖道潜在炎症的筛查手段,但是使用要注意策略;精浆弹性硬蛋白酶筛查不能够代替微生物学检查;单纯精浆弹性蛋白酶的升高,不能作为治疗的依据,必须同时考虑精液常规参数和附属腺炎症情况.

Objective To evaluate seminal plasma elastase screening for potential genital tract infection/inflammation and de-velop a reasonable strategy in male infertility clinic. Methods 422 cases of data were analyzed retrospectively,which＇were selected randomly from the patients attending the outpatient infertility clinic from August to November 2011. Seminal plasma elastase concentration correlation with semen parameters, genital tract infections and inflammatory were analyzed. In the de-tection of genital tract potential inflammation as defined by prostatic fluid leukocytes increase （〉20 leukocytes/HP）, the elastase different cut-off value of sensitivity,specificity and accuracy for the diagnosis and prognosis of genital tract inflam- mation were evaluated and the receiver operating characteristic （ROC） curve was drawn. Results There was good correla-tion between the concentration of seminal plasma elastase and genital tract inflammatory markers （semen leucocytes, prostate leukocytes） （P=0. 000,0. 000）. However, neither the infection markers （mycoplasma, chlamydia, bacterial） nor the semen parameters could be found statistically significant correlation with the concentration of seminal plasma elastase （P=0. 256, 0. 498,0. 658）. Elastase at the cut-off value of 9300 ng/ml was shown to be efficient sensitivity （Se=88. 4%, Sp=33. 1%）,but the specificity inefficient. Defined 1 000 ng/ml or 2 000 ng/ml for cut-off value was shown to be efficient sensi-tivity and specificity （Se = 75.0 %, Sp = 65.1% ; Se = 54.5 %, Sp = 81.1% ）. Conclusion Seminal plasma elastase detection can be used as the means of male infertility outpatient screening potential inflammation of the genital tract. However,clinical application need the strategy. The seminal plasma elastase screening could not substitute for the microbiological examina-tion. Seminal plasma elastase rise alone could not be used as treatment indications, that the situation of semen parameters and asgociated glands inflammation should be considered at the same time.