重组人甲状旁腺激素（1-34）与依降钙素治疗绝经后骨质疏松症妇女多中心、随机对照研究

A randomized, multicenter, active-controlled trial to compare the efficacy of recombinant human parathyroid hormone （1-34） with that of elcatonin in postmenopausal women with osteoporosis in China

目的 比较重组人甲状旁腺激素（rhPTH）（1-34）和依降钙素在治疗绝经后骨质疏松症（OP）妇女中的疗效和安全性.方法 205例绝经后OP妇女,被随机分为rhPTH（1-34）组和依降钙素组,其中前者接受rhPTH（1-34）20μg（200 U）每天皮下注射1次,后者接受依降钙素20 U每周肌肉注射1次.治疗前和治疗后3个月、6个月分别检测腰椎1～4（L1～4）和股骨颈的骨密度（BMD）以及骨形成和骨吸收生化指标,同时记录治疗过程中所出现的不良反应.结果 治疗结束时,rhPTH（1-34）组和依降钙素组L1～4的BMD均增加,股骨颈的BMD没有明显变化.治疗3个月和6个月时,rhPTH（1-34）组L1～4、股骨颈的BMD较基线分别增加2.2%（P〈0.05）、0.37%和5.51%（P〈0.01）、0.65%;依降钙素组分别增加0.41%、-0.10%和1.55%（P〈0.05）、0.11%;与依降钙素组相比,rhPTH（1-34）组在3个月和6个月时L1～4 BMD改善更明显.治疗3个月和6个月时,rhPTH（1-34）组和依降钙素组的血清骨碱性磷酸酶（BSAP）分别增加36.79%和0.31%及92.42%和-0.17%,尿I型胶原N末端肽与肌酐比值（NTX/Cr）分别增加48.91%和-5.32%及68.82%和-10.86%.在整个治疗过程中,两种药物均具有较好耐受性,两组在不良反应方面差异无统计学意义.结论 与依降钙素相比,rhPTH（1-34）治疗绝经后妇女OP,能更好地促进骨形成,提高BMD,并具有较好耐受性、副作用少,对肝、肾功能均无不良影响.

Objective To compare the clinical efficacy and safety between recombinant human parathyroid hormone （ rhPTH） （ 1 -34） and elcatonin in the treatment of postmenopausal women with osteoporosis in China.Methods This 6 month, multicenter, randomized and controlled study enrolled 205 postmenopausal women with osteoporosis.They were randomized to receive either rhPTH （1 -34） 20 μg （200 U） daily or elcatonin 20 U weekly.Lumbar spine （L1-4 ） and femoral neck bone mineral density （BMD） and biochemical markers of bone turnover were measured. In the meantime adverse events were recorded. Results The results showed that both rhPTH （ 1 -34） and elcatonin increased L1-4 BMD significantly at the endpoint of the study, but femoral neck BMD did not change significantly.From baseline to endpoint, BMD of L1-4 and femoral neck in the rhPTH（ 1-34） group increased by 5.51% （P 〈0.01） and 0.65% （P 〉0.05）, but BMD of L1-4 and femoral neck in elcatonin group increased by 1.55% （P 〈0.05） and 0.11% （P〉0.05）.Moreover, the rhPTH（1-34） group had better improvement in L1-4 BMD than the elcatonin group at 3, 6 months, but there was no difference of BMD in these two groups with regard to femoral neck.There were greater mean increases of the bone markers in the rhPTH（ 1-34） group than those in the elcatonin group at 3, 6 months [serum bone-specific alkaline phosphatase （ BSAP） 36.79% vs 0.31% ; 92.42% vs -0.17% ; the ratio of urine N-telopeptide of type I collagen and creatinine （NTX/Cr） 48.91% vs -5.32% ; 68.82% vs - 10.86%].Both kinds of treatment were well tolerated and there were no differences between the two groups in the rates of adverse events and serious adverse events.Conclusion It is concluded that rhPTH （1 -34） has more positive effects on bone formation than elcatonin as shown by the greater increments of L1-4 BMD and bone formation markers and the less occurrence of adverse events as well as no significant change in hepatic, renal or hemopoietic function.