注射甲状旁腺素相关肽6个月后停药18个月骨密度随访

Bone mineral density in postmenopausal osteoporosis after PTHrP 1-34 injection for 6 months then followed up for 18 months

目的研究重组人甲状旁腺素相关肽注射6个月治疗绝经后骨质疏松,随后停药18个月时,对于骨密度是否仍存在作用。方法以采用甲状旁腺素相关肽注射6个月的32例绝经后骨质疏松患者作为研究对象,同时选取年龄匹配的绝经后骨质疏松患者26例作为对照组。比较治疗组和对照组在治疗6个月及停药18个月时的骨密度变化。结果 6个月后治疗组腰椎骨密度平均增加(1.115±3.711)%,全髋骨密度下降(0.498±2.871)%,股骨颈骨密度增加(0.127±4.912)%;对照组在腰椎下降(1.773±2.626)%,全髋下降(1.255±3.02)%,股骨颈增加(1.959±4.065)%;除腰椎外,两组比较差异均无统计学意义(P>0.05);停止治疗18个月时,治疗组腰椎骨密度增加(2.210±8.171)%,全髋下降(0.734±4.266)%,股骨颈下降(1.854±4.184)%;对照组腰椎下降(2.004±5.065)%,全髋下降(3.271±3.003)%,与治疗组比较差异有统计学意义(P<0.05),股骨颈下降(2.704±2.659)%,与治疗组比较差异无统计学意义(P>0.05)。两组人群均未出现严重的不良反应。结论对于绝经后骨质疏松妇女应用甲状旁腺相关肽6个月,随后停药18个月时,对腰椎和全髋骨密度仍有一定的保护作用。

Objective To investigate if there is continuous effect on bone mineral density(BMD) in postmenopausal osteoporosis in Chinese women who received an injection of parathyroid hormone related protein(PTHrP) 1-34 for 6 months and then stopped and followed up for 18 months(24 months from baseline). Methods Thirty-two Chinese postmenopausal osteoporosis women who met the inclusion criteria and without the exclusion conditions were investigated as treatment group, they were all treated with PTHrP 1-34 20μg, Alfacalcidol 0.5μg and 600 mg elementary calcium daily. Another twenty-six patients with matched age and gender served as controls, they received Alfacalcidol 0.5μg and elementary calcium 600 mg daily only. All drugs were given for 6 months and then discontinued for 18 months. BMD changes were compared between the treatment group and the control group at 6 months after treatment and 18 months after drug withdrawal. Results 6 months after receiving PTH treatment, the changes of BMD were(1.115±3.711)% at the lumbar spine,(-0.498±2.871)% at total hip and(0.127±4.912)% at neck of femur in the treatment group;in contrast in the control group the changes were(-1.773±2.626)% at lumbar spine,(-1.255±3.02)% at total hip and(1.959±4.065)% at neck of femur(P<0.05 for lumbar spine, and P>0.05 for hip and femoral neck comparing between the two group). At 18 months after PTH treatment completed, in the treatment group BMD increased by(2.210±8.171)% at lumbar spine, decreased by(0.734±4.266)% at total hip and decreased by(1.854±4.184)% at femur neck compared with baseline;in the control group, BMD decreased by(2.004±5.065)% at lumbar spine, by(3.271±3.003)% at total hip and by(2.704±2.659)% at femur neck(P<0.05 for lumbar spine and total hip, and P>0.05 for femoral neck comparing between the two groups). About 68.75%(22/32) vs 19.24%(5/26)(P<0.05) at lumbar spine, 56.25%(18/32) vs 15.38%(4/26)(P<0.05) at total hip and 37.5%(12/32) vs 19.24%(5/26)(P>0.05) at femur neck whose BMD was higher than baseline in treatment group compared with controls after completing rPTH 1-34 injection for 18 months. There were no serious adverse reactions during the study. Conclusion After injection of PTH for 6 months, the benefit on BMD of lumbar spine and total hip could last for 18 months, it shows that injection of rPTH1-34 for 6 months is an effective method in the treatment of osteoporosis in Chinese postmenopausal women.