CAJ | 학술논문

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.
목적 비교중조인갑상방선격소(rhPTH)(1-34)화의강개소재치료절경후골질소송증(OP)부녀중적료효화안전성.방법 205례절경후OP부녀,피수궤분위rhPTH(1-34)조화의강개소조,기중전자접수rhPTH(1-34)20μg(200 U)매천피하주사1차,후자접수의강개소20 U매주기육주사1차.치료전화치료후3개월、6개월분별검측요추1～4(L1～4)화고골경적골밀도(BMD)이급골형성화골흡수생화지표,동시기록치료과정중소출현적불량반응.결과 치료결속시,rhPTH(1-34)조화의강개소조L1～4적BMD균증가,고골경적BMD몰유명현변화.치료3개월화6개월시,rhPTH(1-34)조L1～4、고골경적BMD교기선분별증가2.2%(P<0.05)、0.37%화5.51%(P<0.01)、0.65%;의강개소조분별증가0.41%、-0.10%화1.55%(P<0.05)、0.11%;여의강개소조상비,rhPTH(1-34)조재3개월화6개월시L1～4 BMD개선경명현.치료3개월화6개월시,rhPTH(1-34)조화의강개소조적혈청골감성린산매(BSAP)분별증가36.79%화0.31%급92.42%화-0.17%,뇨I형효원N말단태여기항비치(NTX/Cr)분별증가48.91%화-5.32%급68.82%화-10.86%.재정개치료과정중,량충약물균구유교호내수성,량조재불량반응방면차이무통계학의의.결론 여의강개소상비,rhPTH(1-34)치료절경후부녀OP,능경호지촉진골형성,제고BMD,병구유교호내수성、부작용소,대간、신공능균무불량영향.
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.