重组人甲状旁腺激素治疗绝经后骨质疏松妇女234例临床研究

Clinical study of recombinant human parathyroid hormone in treatment of 234 postmenopausal women with osteoporosis

目的:研究重组人甲状旁腺激素〔rhPTH(1-34)〕治疗绝经后骨质疏松妇女的临床疗效和安全性。方法:选取医院收治的绝经后骨质疏松妇女234例随机分为观察组和对照组,观察组112例患者每天皮下注射rhPTH(1-34)20μg(200 u),对照组122例患者每周肌肉注射依降钙素20 u。于治疗前和治疗后3、6个月分别检测两组患者的腰椎1～4和股骨颈的骨密度以及骨吸收和骨形成的生化指标,随访观察两组患者治疗过程中出现的不良反应。结果:观察组患者的腰椎1～4骨BMD改善程度高于对照组(P<0.05),BSAP、尿NTX/Cr改善程度均高于对照组(P<0.05);两组患者不良反应发生率差异无统计学意义(P>0.05)。结论:与依降钙素相比,rhPTH(1-34)治疗绝经后骨质疏松妇女临床疗效安全、可靠,建议推广使用。

Objective： To research the clinical efficacy and safety of recombinant human parathyroid hormone [ rhPTH （ 1-34） ] in treatment of postmenopausal women with osteoporosis. Methods： A total of 234 postmenopausal women with osteoporosis who were treated in the hospital were selected and divided into observation group and control group randomly, 112 patients in observation group were treated with subcutaneous injection of rhPTH （1 N 34）, 20 μg （200 U） every day; while 122 patients in control group were treated with intramuscular injection of calcitonin, 20 U every week. The bone mineral densities of lumber 1 -4 and neck of femur, the biochemical indexes of bone resorption and bone formation in the two groups were detected before treatment, at three and six months after treatment, the adverse reactions during the course of treatment in the two groups were followed up and observed. Results： The degree of improvement of bone mineral density of lumber 1 - 4 in observation group was significantly higher than that in control group （ P 〈 0.05） ; the degrees of improvement of BSAP and urinary NTX/Cr in observation group were significantly higher than those in control group （ P 〈 0. 05 ） ; there was no significant difference in the incidence of adverse reactions between the two groups （ P 〉 0.05 ） . Conclusion： Compared with calcitonin, the clinical efficacy of rhPTH （ 1 - 34） is safe and reliable in treatment of postmenopausal women with osteoporosis, the method is worthy to be popularized in clin