目的:观察国产重组人甲状旁腺素(1-34)〔rhPTH(1-34)〕和口降钙素对绝经后骨质疏松症(PMOP)的疗效和安全性。方法:将57例PMOP患者随机分为试验组和对照组,试验组皮下注射rhPTH(1-34)20μg治疗,1次/日,对照组肌肉注射降钙素20 U治疗,1次/周。两组均给予凯思立D,1片/日(每片含元素钙500 mg和Vit D3200 U),试验时间6个月。观察患者治疗前后腰椎L2-4、股骨颈骨密度(BMD)、骨代谢物血钙、血磷及骨源性碱性磷酸酶(BALP)、血清Ⅰ型胶原交联C末端肽(CTX)等指标及有无不良反应,比较两组疗效和安全性。结果:试验组治疗后腰椎BMD较治疗前明显增加,且差异有统计学意义(P<0.01);对照组腰椎BMD治疗前后比较差异无统计学意义(P>0.05);两组腰椎BMD治疗前后差异没有统计学意义(P>0.05)。而两组股骨颈BMD的变化治疗前后比较差异均无统计学意义(P>0.05)。试验组CTX和BALP水平治疗后较治疗前均显著上升,差异有统计学意义(P<0.01)。而对照组CTX治疗后比治疗前明显下降,差异有统计学意义(P<0.05),BALP在治疗后较治疗前明显升高,差异有统计学意义(P<0.01)。两组均未见严重不良反应。结论:rhTH(1-34)能明显增加腰椎BMD,升高骨转换指标,治疗PMOP安全有效。 Objective: To observe the efficacy and safety of domestic recombinant human parathyroid hormone (1-34) [rhPTH (1-34)] and oral calcitonin in postmenopausal osteoporosis (PMOP). Methods: Fifty-seven PMOP patients were randomly divided into experimental group and control group. The experimental group was given subcutaneous rhPTH (1-34) 20μg once a day, while the control group received intramuscular calcitonin 20 U once a week. Two groups were given Caseris D, 1 tablet / day (each containing elemental calcium 500 mg and Vit D3200 U), the test time of 6 months. The lumbar spine L2-4, the bone mineral density (BMD) of the femur, the calcium, serum phosphate and bone alkaline phosphatase (BALP), the serum Cx-CTX Indicators and whether adverse reactions, the two groups were compared efficacy and safety. Results: The BMD of lumbar spine in experimental group was significantly higher than that before treatment (P <0.01), but there was no significant difference in BMD of lumbar spine before and after treatment in control group (P> 0.05) The difference was not statistically significant (P> 0.05). There was no significant difference in BMD of femoral neck between the two groups before and after treatment (P> 0.05). The levels of CTX and BALP in experimental group were significantly higher than those before treatment, the difference was statistically significant (P <0.01). However, the level of CTX in the control group was significantly lower than that before treatment (P <0.05). The level of BALP in the control group was significantly higher than that before treatment (P <0.01). No serious adverse reactions were seen in both groups. CONCLUSION: rhTH (1-34) can significantly increase BMD of lumbar spine and increase bone turnover index, which is safe and effective in treating PMOP.