伊班膦酸钠对高龄老年性骨质疏松症患者血清骨源性碱性磷酸酶和抗酒石酸酸性磷酸酶表达的影响

The Influence of Ibandronate on Expressions of Serum Bone Alkaline Phosphatase and Tartrate-resistant Acid Phosphatase of Senile Osteoporosis Patients

目的评价伊班膦酸钠注射液对超高龄老年性骨质疏松症骨转换指标骨源性碱性磷酸酶和抗酒石酸酸性磷酸酶表达的影响。方法纳入88例高龄老年性骨质疏松症患者,随机分为2组。对照组给予钙尔奇D片口服,每日1片;试验组在对照组基础上每3个月静脉输注伊班膦酸钠2mg。两组均治疗12个月。分别收集两组受试者试验前、治疗3、6和12个月后的血清,采用酶联免疫法(ELISA)测定骨源性碱性磷酸酶(BALP)和抗酒石酸酸性磷酸酶-5b(TRAP-5b)的水平。安全性指标包括血尿常规、肝肾功、心电图及不良反应。结果 87例患者完成为期1年的研究。治疗3个月时,试验组BALP和TRAP-5b与治疗前比较,分别减低10.86%和29.14%,组内比较有统计学差异(P<0.05);对照组BALP和TRAP-5b则分别减低2.83%和3.74%,组内比较无明显统计学差异(P>0.05)。治疗6个月时,试验组BALP和TRAP-5b与治疗前比较,分别减低11.52%和29.70%,组内比较有统计学差异(P<0.05);对照组BALP和TRAP-5b则分别减低2.59%和4.30%,组内比较无明显统计学差异(P>0.05)。治疗12个月时,试验组BALP和TRAP-5b与治疗前比较,分别减低11.03%和29.32%,组内比较有统计学差异(P<0.05);对照组BALP和TRAP-5b则分别减低2.67%和3.55%,组内比较无明显统计学差异(P>0.05)。治疗3、6和12个月时,组间比较均有明显统计学差异(P<0.05);治疗3、6和12个月后的BALP或TRAP-5b两两配对比较均无明显差异(P>0.05)。整个实验中患者无明显的不良反应。结论伊班膦酸钠治疗3个月后破骨细胞活性明显受到抑制,同时成骨细胞活性也受到一定程度的抑制,成骨和破骨达到一个新的平衡;在伊班膦酸钠治疗的1年内成骨和破骨一直维持在低水平。

Objective To assess the influence of ibandronate on expressions of bone alkaline phosphatase（BALP） and tartrate-resistant acid phosphatase-Sb（TRAP-5b）of the oldest senile osteoporosis patients. Methods 88 cases of the oldest senile osteoporosis patients were chosed, which including 20 cases of women. These patients were randomly divid- ed into two groups. The patients in control group were administered orally Caltrate D 600mg qd. The patients in experi- mental group received ibandronate （2 rag） infusions in every three months except Caltrate D. And two groups were trea- ted for 12 months. The serum was collected from all subjects before the test, after treating 3 months, 6 months and 12 months. The levels of BALP and TRAP-Sb of patients were measured by ELISA. The adverse effects, electrocardio- gram, liver and kidney functions, blood and urine routine were checked to assess the tolerability. Results 87 patients completed the observation. After treating 3 months, the levels of BALP and TRAP-Sb in experimental group decreased by 10. 86% and 29. 14% respectively compared with those before treating. There was a significant difference within group comparison （P〈0. 05）. The levels of BALP and TRAP-Sb in control group decreased by 2.83% and 3.74% re- spectively. And there was no significant difference within group comparison （P〈0. 05）. After 6 months treatment, the levels of BALP and TRAP-Sb in experimental group decreased by 11.52 % and 29. 70 % respectively compared with those before treating. There was a significant difference within group comparison （P〈0. 05）. The levels of BALP and TRAP- 5b in control group decreased by 2.59% and 4. 30% respectively. And there was no significant difference within group comparison （P〉0. 05）. After treating12 months, the levels of BALP and TRAP-Sb in experimental group decreased by 11.03% and 29. 32% respectively compared with those before treating. There was a significant difference within groupcomparison （P〈0.05）. The levels of BALP and TRAP-Sb in control group decreased by 2. 67%and 3.55% respective- ly. And there was no signifieant difference within group comparison （P〉0. 05）o There was a significant difference be- tween the levels of BALP or TRAP-5b of two groups （P〈0. 05） after treating 3, 6, 12 months. There was no significant difference in the levels of BALP or TRAP-Sb when paired comparison after treating 3, 6, 12 months. There was no obvi- ous adverse reaction in patients during entire experiment. Conclusion After treating 3 months with ibandronate, the os- teoclast activity in the oldest senile osteoporosis patients was inhibited significantly, and osteoblast activity was also in- hibited. The osteoblast and osteoclast activities reached a new equilibrium. And they always remained at low level during lyear ibandronate treatment.