中国骨质疏松杂志
中國骨質疏鬆雜誌
중국골질소송잡지
CHINESE JOURNAL OF OSTEOPOROSIS
2014年
2期
137-141,155
,共6页
杨艳%李蓬秋%朱显军%张磊%包明晶%张学军%鲜杨%吴冀川%刘丽梅%杨毅
楊豔%李蓬鞦%硃顯軍%張磊%包明晶%張學軍%鮮楊%吳冀川%劉麗梅%楊毅
양염%리봉추%주현군%장뢰%포명정%장학군%선양%오기천%류려매%양의
重组人甲状旁腺激素%骨密度%骨质疏松症,原发性%降钙素
重組人甲狀徬腺激素%骨密度%骨質疏鬆癥,原髮性%降鈣素
중조인갑상방선격소%골밀도%골질소송증,원발성%강개소
Recombinant human parathyroid hormone%Bone mineral density%Osteoporosis%Primary%Calcitonin
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L2-4 BMD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L2-4 BMD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。
目的：評價重組人甲狀徬腺激素（1-34）[rhPTH（1-34）]治療原髮性骨質疏鬆癥（OP）的療效和安全性，併與依降鈣素進行對比。方法60例原髮性OP患者按3：1被隨機分入rhPTH（1-34）組（PTH組）和依降鈣素組（CT組）。 PTH組予rhPTH （1-34）20μg每日1次皮下註射，連續用藥18月。 CT組予益鈣寧20U每週1次肌肉註射，連續用藥12月。受試前檢測腰2-4椎體（L2-4）和股骨頸骨密度（BMD）、血鈣、血燐、尿鈣、血清骨特異性堿性燐痠酶（BSAP）、尿Ⅰ型膠原交基C耑肽（CTX-I），治療後6、12、18月複查上述指標。結果與基線時比較，PTH組L2-4 BMD在治療6、12、18月時顯著升高，股骨頸BMD在18月時顯著升高，BSAP在6、12月時均顯著升高，CTX-I校正值在6、12、18月時均顯著升高；CT組L2-4 BMD在治療12月前升高，股骨頸BMD在12、18月時升高，BSAP12、18月時均顯著下降，CTX-I校正值治療前後無統計學差異。兩組比較， PTH組患者在6、12月和18月時L2-4的BMD增長值和增長率均高于CT組。但CT組在治療12月時股骨頸BMD增長值高于PTH組，不良反應：兩組差異無統計學意義；PTH組有一過性高鈣血癥。結論rhPTH（1-34）治療原髮性OP安全有效，對改善椎體BMD起效時間、增長速度和增長幅度均優于依降鈣素，但改善股骨頸BMD較依降鈣素起效更慢，增長幅度更小。
목적：평개중조인갑상방선격소（1-34）[rhPTH（1-34）]치료원발성골질소송증（OP）적료효화안전성，병여의강개소진행대비。방법60례원발성OP환자안3：1피수궤분입rhPTH（1-34）조（PTH조）화의강개소조（CT조）。 PTH조여rhPTH （1-34）20μg매일1차피하주사，련속용약18월。 CT조여익개저20U매주1차기육주사，련속용약12월。수시전검측요2-4추체（L2-4）화고골경골밀도（BMD）、혈개、혈린、뇨개、혈청골특이성감성린산매（BSAP）、뇨Ⅰ형효원교기C단태（CTX-I），치료후6、12、18월복사상술지표。결과여기선시비교，PTH조L2-4 BMD재치료6、12、18월시현저승고，고골경BMD재18월시현저승고，BSAP재6、12월시균현저승고，CTX-I교정치재6、12、18월시균현저승고；CT조L2-4 BMD재치료12월전승고，고골경BMD재12、18월시승고，BSAP12、18월시균현저하강，CTX-I교정치치료전후무통계학차이。량조비교， PTH조환자재6、12월화18월시L2-4적BMD증장치화증장솔균고우CT조。단CT조재치료12월시고골경BMD증장치고우PTH조，불량반응：량조차이무통계학의의；PTH조유일과성고개혈증。결론rhPTH（1-34）치료원발성OP안전유효，대개선추체BMD기효시간、증장속도화증장폭도균우우의강개소，단개선고골경BMD교의강개소기효경만，증장폭도경소。
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 (L2-4 ) 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 6th month, the 12th month, and the 18th month after the treatment.Results Compared with those at the baseline, BMD of L2-4 in PTH group increased significantly at the 6th , the 12th , and the 18th month after the treatment.BMD of the femoral neck increased significantly at the 18th month after the treatment, while BSAP increased significantly at the 6th month and the 12 th month after the treatment, and the correction value of CTX-I increased significantly at the 6th month, the 12th month, and the 18 th month.In CT group, BMD of the L2-4 increased significantly at the 12th month.BMD of the femoral neck increased significantly at the 12th month and the 18th month, while BSAP decreased significantly at the 12th month and the 18th 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 L2-4 and growth rate at the 6th month, the 12th month, and the 18th month in PTH group were higher than that in CT group.However, the increase of BMD of the femoral neck and growth rate at the 12th month and the 18th month in CT group were higher than that in PTH group.There was no significant difference of the rate of adverse events between 2 groups.Nevertheless, there was a transient hypercalcemia in PTH group.Conclusion The application of rhPTH (1-34) is safe and effective in the treatment of primary OP.It is superior to calcitonin on improving BMD of the vertebrae in onset time, growth rate, and growth range, but inferior to calcitonin on improving BMD of the femoral neck.
