甲状旁腺激素(1-34)联合伊班膦酸钠治疗严重骨质疏松症的临床研究

目的甲状旁腺激素(parathyroid hormone,PTH)(1-34)联合伊班膦酸钠治疗严重骨质疏松症效果临床观察。方法98例严重绝经后骨质疏松症合并骨骼疼痛患者随机分为治疗组和对照组,治疗组使用PTH联合伊班膦酸钠治疗,对照组单纯予以伊班膦酸钠治疗,为期12个月。分别检测两组受试者腰椎及髋部骨密度、血清骨代谢指标治疗前后的改变。结果药物治疗6个月后两组患者腰椎L1~4及股骨粗隆、左侧股骨颈、Ward三角区的骨密度明显增加,且12个月后骨密度进一步增加,显著高于对照组(P0.05);药物治疗12个月后两组血清及碱性磷酸酶(ALP)、血清Ⅰ型胶原C末端肽(s-CTX)、血清抗酒石酸酸性磷酸酶-5b(TRACP-5b)、血清骨源性碱性磷酸酶(BAP)及血清骨钙素(OC)水平均显著改变,且治疗组对ALP及s-CTX、BAP、OC及TRACP-5b影响更明显(P0.05),而两组血钙(Ca)及血磷(P)治疗前后无明显差异(P0.05)。结论PTH联合伊班膦酸钠使用能有效提高严重骨质疏松症患者髋部及腰椎骨密度,改善骨代谢。

Clinical study of parathyroid hormone (1-34) combined with ibandronate in the treatment of serious postmenopausal osteoporosis

Objective To observe the effect of parathyroid hormone (1-34, PTH) combined with ibandronate sodium on serious postmenopausal osteoporosis. Methods 98 patients with serious postmenopausal osteoporosis and bone pain were randomly divided into treatment group and control group. The treatment group was treated with PTH combined with ibandronate, and the control group was treated with ibandronate sodium for 12 months. The changes of bone mineral density and serum bone metabolic index were measured before and after treatment. Results In both groups, bone density of lumbar vertebrae L1-4, proximal femur, left femoral neck and Ward triangle increased significantly after 6 months of intervention, and further increased after 12 months, with greater effects in the combined treatment group than in the control group (P<0.05). After 12 months of intervention, the levels of serum alkaline phosphatase (ALP), serum type I collagen C-terminal peptide (s - CTX), serum anti-tartrate acid phosphatase - 5b (TRACP -5b) and serum osteocalcin (OC) changed significantly, and the changes in ALP, s-CTX, BAP, OC and TRACP-5b were greater in the treatment group compared with that of the control group (P<0.05). There were no significant differences between the two groups in the concentrations of serum Ca and phosphorus (P) before and after treatment (P?0.05). Conclusion PTH combined with ibandronate can effectively protect hip and lumbar vertebrae bone mineral density and improve bone metabolism in serious postmenopausal osteoporosis.