特立帕肽与唑来膦酸治疗绝经后低转化型骨质疏松症的临床对比研究

Effects of Teriparatide (PTH 1-34) and Zoledronic Acid on Postmenopausal Osteoporotic Patients with Low Bone Turnover

摘要: 目的：比较特立帕肽与唑来膦酸对青岛地区绝经后低转化型骨质疏松症(postmenopausal osteoporosis, PMOP)的临床疗效。方法：120例绝经后低转化型骨质疏松症患者分成特立帕肽组和唑来膦酸组，观察所有患者用药前及用药后6个月及12个月腰椎1~4 (L1~4)、股骨颈、全髋骨密度(BMD)，血清I型前胶原氨基端前肽(PINP)，I型胶原羧基端β降解产物(β-CTX)，视觉模拟评分法评分(VAS评分)及药物不良反应。结果：治疗后6个月及12个月，两组患者各部位BMD较治疗前水平均提高(P < 0.05)，其中特立帕肽组患者腰椎1~4、股骨颈BMD升高水平优于唑来膦酸组(P < 0.05)；与基线相比，治疗后3个月、6个月及12个月，特立帕肽组PINP、β-CTX水平明显升高(P < 0.05)，唑来膦酸组PINP、β-CTX水平明显降低(P < 0.05)；特立帕肽组VAS评分低于唑来膦酸组(P < 0.05)；两组患者均未出现严重不良事件，安全性较好。结论：特立帕肽和唑来膦酸均可明显提高患者骨密度，减轻疼痛，且安全性好。其中在提高腰椎骨密度及降低VAS评分方面，特立帕肽治疗效果优于唑来膦酸。

Abstract: Objective: To compare the clinical efficacy of Teriparatide (PTH 1-34) (recombinant human parathyroid hormone 1-34) and Zoledronic acid for postmenopausal patients with low-bone turnover osteoporosis in Qingdao area. Methods: 120 patients with low turnover postmenopausal osteoporosis were divided into two groups: patients in one group were treated with Teriparatide, and the others were treated with Zoledronic acid. Bone mineral density (BMD) of the 1st~4th lumbar vertebra (L1~4), femoral neck and total hip, serum procollagen type 1 N-peptide (PINP), β-serum type I collagen carboxy-terminal peptide(β-CTX), serum alkaline phosphatase (ALP), general biochemical index (like blood calcium and blood phosphorus) and bone metabolism regulation hormone (like parathyroid hormone, 25-hydroxy vitamin D3), score of visual analogue scale (VAS) and adverse drug reactions were observed before and 6 and 12 months after medication. Results: After 6 months and 12 months, the BMD level in every bone part in both groups increased (P < 0.05), and in Teriparatide group, for the 1~4 Lumbar vertebra and femoral neck, the level of the BMD was increased more than that in Zoledronic acid group (P < 0.05); compared with the baseline, the levels of PINP and β-CTX in Teriparatide group significantly increased at 3, 6 and 12 months after treatment (P < 0.05), while those in Zoledronic acid group significantly decreased (P < 0.05). VAS score in Teriparatide group was lower than that in Zoledronic acid group (P < 0.05). No severe adverse events were observed in both groups, which shows high safety of drug use. Conclusion: Both Teriparatide and Zoledronic acid can significantly increase the BMD level, relieve pain, and have high safety of medication. Yet for improving the BMD level in lumbar vertebra and decreasing the score of VAS, Teriparatide is better than Zoledronic acid.