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| 重组人甲状旁腺素1-34治疗绝经后骨质疏松症的临床研究 |
| Clinical study of the efficacy of recombinant human parathyroid hormone 1-34 on postmenopausal osteoporosis |
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| DOI：10.3969/j.issn.1006.7108.2018.11.023 |
| 中文关键词: 绝经后骨质疏松症 重组人甲状旁腺素1-34 骨代谢指标 骨密度 |
| 英文关键词:postmenopausal osteoporosis recombinant human parathyroid hormone 1-34 bone metabolic index bone mineral density |
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| 中文摘要: |
| 目的 观察重组人甲状旁腺素1-34（recombinant human parathyroid hormone 1-34）应用于绝经后骨质疏松症（postmenopausal osteoporosis，PMOP）患者的临床疗效。方法 筛选出68例绝经后骨质疏松症患者，所有患者入组后均口服元素钙 500 mg/d和维生素D 200 U/d，连续服用26周后加用皮下注射重组人甲状旁腺素1-34（特立帕肽）20 μg /d，再连续治疗26周，于应用特立帕肽治疗前及治疗后的13和26周测定腰椎（L1-4）和股骨近端骨密度(BMD)，采静脉血测定血清骨钙素（OC）、碱性磷酸酶（AKP）水平，应用疼痛视觉模拟评分法（VAS 评分）评价患者的疼痛程度，并记录不良反应情况。结果 68位患者均完成全疗程治疗。应用特立帕肽治疗13周时，腰椎L1-4、股骨颈、大粗隆和股骨干骨密度改善不明显（P＞0.05），血清骨钙素和碱性磷酸酶较治疗前升高（P＜0.05），疼痛缓解明显（P＜0.05）； 治疗26周时，腰椎L1-4和股骨颈骨密度较治疗前明显增高（ P ＜0.05），而大粗隆和股骨干骨密度改善不明显（P＞0.05），血清骨钙素和碱性磷酸酶呈持续升高趋势（P＜0.05），疼痛明显减轻（P＜0.05）。治疗期间不良反应的情况均较轻微，没有给予特殊处理即自行缓解。结论 连续26周使用重组人甲状旁腺素1-34能有效地促进患者骨形成，缓解骨质疏松症患者疼痛症状，提高患者腰椎、股骨骨密度。 |
| 英文摘要: |
| Objective To observe the clinical efficacy of recombinant human parathyroid hormone 1-34 on the treatment of postmenopausal osteoporosis (PMOP). Methods Sixty-eight patients with PMOP were selected. All the patients received an oral medication of 500mg calcium and 200U Vitamin D per day. After 26 weeks, all the patient received a subcutaneous injection of 20μg teriparatide per day. The whole study lasted for 26 weeks. Bone mineral densities (BMD) of the lumbar vertebrae (L1-4) and proximal femoral was measured before and after 13- and 26-week treatment. At the same time the levels of osteocalcin (OC) and alkaline phosphatase (AKP) were determined. The pain degree of the patients was recorded with the visual analogue score. The adverse events were recorded. Results All the patients finished the whole treatment. After 13-week treatment, no significant improvement of BMD of L1-4, the femoral neck, the greater trochanter, and the shaft of femur was observed (P>0.05). The serum levels of OC and AKP improved compared with those before the treatment (P<0.05). The pain of the patients was relieved significantly (P<0.05). After 26-week treatment, BMD of L1-4 and the femoral neck improved significantly compared with that before the treatment (P<0.05), but no significant improvement of BMD of the greater trochanter and the shaft of femur was observed (P>0.05). The serum levels of OC and AKP increased continuously and the pain released (P<0.05). During the whole study, a few adverse events were observed, and the syndromes were tolerable and had spontaneous remission without any specific treatment. Conclusion Recombinant human parathyroid hormone 1-34 effectively promotes bone formation, improves BMD, and relieves the pain of PMOP patients after continuous use of 26 weeks. |
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