重组人甲状旁腺激素(1-34)和依降钙素治疗原发性骨质疏松症的随机对照研究  

Effect of recombinant human parathyroid hormone( 1-34 ) and elcatonin in the treatment of primary osteoporosis: a randomized controlled trial

作　　者：杨艳[1] 李蓬秋[1] 朱显军[1] 张磊[1] 包明晶[1] 张学军[1] 鲜杨[1] 吴冀川[1] 刘丽梅[1] 杨毅[1] 

机构地区：[1]四川省人民医院内分泌科,成都610072

出　　处：《中国骨质疏松杂志》2014年第2期137-141,155,共6页Chinese Journal of Osteoporosis

摘　　要：目的评价重组人甲状旁腺激素(1-34)[rhPTH(1-34)]治疗原发性骨质疏松症(OP)的疗效和安全性,并与依降钙素进行对比。方法 60例原发性OP患者按3:1被随机分入rhPTH(1-34)组(PTH组)和依降钙素组(CT组)。PTH组予rhPTH(1-34)20μg每日1次皮下注射,连续用药18月。CT组予益钙宁20U每周1次肌肉注射,连续用药12月。受试前检测腰2-4椎体(L2-4)和股骨颈骨密度(BMD)、血钙、血磷、尿钙、血清骨特异性碱性磷酸酶(BSAP)、尿Ⅰ型胶原交基C端肽(CTX-I),治疗后6、12、18月复查上述指标。结果与基线时比较,PTH组L2-4BMD在治疗6、12、18月时显著升高,股骨颈BMD在18月时显著升高,BSAP在6、12月时均显著升高,CTX-I校正值在6、12、18月时均显著升高;CT组L2-4BMD在治疗12月前升高,股骨颈BMD在12、18月时升高,BSAP12、18月时均显著下降,CTX-I校正值治疗前后无统计学差异。两组比较,PTH组患者在6、12月和18月时L2-4的BMD增长值和增长率均高于CT组。但CT组在治疗12月时股骨颈BMD增长值高于PTH组,不良反应:两组差异无统计学意义;PTH组有一过性高钙血症。结论 rhPTH(1-34)治疗原发性OP安全有效,对改善椎体BMD起效时间、增长速度和增长幅度均优于依降钙素,但改善股骨颈BMD较依降钙素起效更慢,增长幅度更小。Objective To evaluate the clinical efficacy and safety of recombinant human parathyroid hormone （1-34） [ rhPTH （1-34） ] in the treatment of osteoporosis （ OP）, and to compare that with the efficacy of elcatonin. Methods A total of 60 patients with primary OP were randomly divided into 2 groups： rhPTH （1-34） group （PTH group） and elcatonin group （CT group）, with the ratio of 3：1. Patients in PTH group received a daily subcutaneous injection of 20μg rhPTH （1-34） for 18 months, while patients in CT group received a weekly intramuscular injection of 20U elcatonin for 12 months. The bone mineral density （BMD） of the lumbar vertebrae 2-4 （L2~） and the femoral neck, blood calcium and phosphorus, urinary calcium, serum bone specific alkaline phosphatase （BSAP）, and urinary c-terminal telopeptides of type I collagen （CTX-I） were detected before the treatment and at the 6^th month, the 12th month, and the 18^th month after the treatment. Results Compared with those at the baseline, BMD of L2-4 in PTH group increased significantly at the 6^th , the 12^th , and the 18th month after the treatment. BMD of the femoral neck increased significantly at the 18^th month after the treatment, while BSAP increased significantly at the 6^th month and the 12＇h month after the treatment, and the correction value of CTX-I increased significantly at the 6^th month, the 12^th month, and the 18th month. In CT group, BMD of the L224 increased significantly at the 12^th month. BMD of the femoral neck increased significantly at the 12^th month and the 18th month, while BSAP decreased significantly at the 12^th month and the 18^th month, and no significant difference of the correction value of CTX-I before and after the treatment was observed. The comparison between 2 groups showed that the improvement of BMD of the LE2-4 and growth rate at the 6th month, the 12^th month, and the 18^th month in PTHgroup were higher than that in CT group. However, the increase of BMD of the femoral neck and growth

关 键 词：重组人甲状旁腺激素 骨密度 骨质疏松症 原发性 降钙素 

分 类 号：R45[医药卫生—治疗学]