Takahashi M, Kushida K, Hoshino H, Miura M, Ohishi T, Inoue T
Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Japan.
Clin Endocrinol (Oxf). 1997 Aug;47(2):177-83. doi: 10.1046/j.1365-2265.1997.2221055.x.
Recently, a bone alkaline phosphatase (AP) enzyme immunoassay (EIA) was developed for measurement of bone AP activity with a monoclonal antibody. We compared the clinical performance of bone AP (bAP) measured by EIA and total AP (tAP) to examine if bAP is preferable to tAP as a bone formation marker in the post-menopause and established osteoporosis.
Serum was obtained from 50 pre- and 93 post-menopausal healthy women, and 54 osteoporotic patients with vertebral fractures and 57 patients with hip fracture.
Total AP was measured spectrophotometrically with p-nitrophenyl phosphate as substrate. The intra- and inter-assay coefficients of variation were 0.7-1.8% and 0.6-1.1%, respectively. Bone AP activity (bAP) was measured by EIA kit, ALKPHASE-B (Metra Biosystems, Inc.) using a monoclonal antibody against human bone AP. The intra- and inter-assay CVs were 4.0-8.3% and 6.2-7.9%, respectively.
The percentage mean increase of bAP (54.9%) in post-menopausal subjects over premenopausal subjects was higher than that of tAP (40.1%). In age-matched comparison, % mean increases were 57.5% for bAP and 35.3% for tAP. Z-score for bAP in post-menopausal subjects was significantly higher than that for tAP. However, there was no significant difference in Z-scores between tAP and bAP in osteoporotic patients with vertebral fractures or with hip fracture. The correlation coefficient of bAP with age (r = 0.316) was similar to that of tAP with age (r = 0.319). In post-menopausal subjects, there was no difference in the concentrations of tAP nor bAP among the groups in whom times since the menopause was 0-9 years, 10-19 years and more than 20 years. Bone AP was highly correlated to tAP in the normal subjects, the patients and the total study group.
Preference can be given to bone AP by enzymatic immunoassay over total AP based on their clinical utility during the menopause; however, no preference can be given to bone AP over total AP in established osteoporosis.
最近，一种骨碱性磷酸酶（AP）酶免疫测定法（EIA）被开发出来，用于使用单克隆抗体测量骨AP活性。我们比较了通过EIA测量的骨AP（bAP）和总AP（tAP）的临床性能，以检查在绝经后和已确诊的骨质疏松症中，bAP作为骨形成标志物是否比tAP更具优势。
从50名绝经前和93名绝经后健康女性、54名患有椎体骨折的骨质疏松症患者以及57名髋部骨折患者中获取血清。
以对硝基苯磷酸酯为底物，通过分光光度法测量总AP。批内和批间变异系数分别为0.7 - 1.8%和0.6 - 1.1%。使用针对人骨AP的单克隆抗体的EIA试剂盒ALKPHASE - B（Metra Biosystems公司）测量骨AP活性（bAP）。批内和批间CV分别为4.0 - 8.3%和6.2 - 7.9%。
绝经后受试者的bAP平均增加百分比（54.9%）高于绝经前受试者的tAP平均增加百分比（40.1%）。在年龄匹配的比较中，bAP的平均增加百分比为57.5%，tAP为35.3%。绝经后受试者中bAP的Z评分显著高于tAP。然而，在患有椎体骨折或髋部骨折的骨质疏松症患者中，tAP和bAP的Z评分没有显著差异。bAP与年龄的相关系数（r = 0.316）与tAP与年龄的相关系数（r = 0.319）相似。在绝经后受试者中，绝经时间为0 - 9年、10 - 19年和超过20年的组之间，tAP和bAP的浓度没有差异。在正常受试者、患者和整个研究组中，骨AP与总AP高度相关。
基于它们在绝经期间的临床效用，酶免疫测定法检测的骨AP比总AP更具优势；然而，在已确诊的骨质疏松症中，骨AP并不比总AP更具优势。
