国产重组人甲状旁腺素1-34联合钙尔奇D治疗原发性骨质疏松症的疗效与安全性观察

Observation on efficacy and safety of recombinant human parathyroid hormone 1-34 with Caltrate D in primary osteoporosis

目的评价国产重组人甲状旁腺素1-34(recombinant human parathyroid hormone 1-34,rhPTH1-34)治疗原发性骨质疏松症的临床疗效和安全性。方法入选原发性骨质疏松症患者39例,采用自身前后对照试验设计,皮下注射rhPTH1-34每日20μg,同时口服钙尔奇D 600 0.6 g/d,试验时间6个月,观察患者治疗前后骨密度变化、骨折发生情况,以及血尿常规、肝肾功能、电解质、心电图改变等。结果患者L1骨密度(T值,以下同)由-2.58±0.86增加至-1.99±1.06(P<0.01),L2骨密度由-3.21±0.73增加至-2.65±0.92(P<0.01),L3骨密度由-2.89±0.74增加至-2.47±0.89(P<0.01),L4骨密度由-2.58±0.94增加至-2.03±1.08(P<0.01),L平均骨密度由-2.84±0.69增加至-2.31±0.84(P<0.01),股骨颈骨密度由-1.66±1.05增加至-1.54±1.27(P>0.05),大粗隆骨密度由-1.58±0.76增加至-1.54±0.76(P>0.05),Wards区骨密度由-1.98±0.60降低至-1.99±0.83(P>0.05)。试验期间新发骨折2例,其中右肱骨骨折1例,腰椎压缩骨折1例;无其他严重不良事件发生。结论 rhPTH1-34联合钙尔奇D治疗原发性骨质疏松症有效,腰椎骨密度增加显著,不良反应较轻。

Objective To investigate the curative effect and safety of recombinant human parathyroid hormone 1-34（rhPTH1-34） in the treatment of primary osteoporosis.Methods Thirty-nine patients with primary osteoporosis received rhPTH 1-34 20ug/d by hypodermic injection and Caltrate D 600 0.6g/d p.o.for 6 months.Skeletal density change before and after treatment,incidence of bone fracture,and changes of blood,urine,liver and kidney function,electrolytes and electrocardiogram were observed.Results After treatment,bone density of L1 increased from（-2.58±0.86） to（-1.99±1.06）（P0.01）,of L2 from（-3.21±0.73） to（-2.65±0.92）（P0.01）,of L3 from（-2.89±0.74） to（-2.47±0.89）（P0.01） and of L4 from（-2.58±0.94） to（-2.03±1.08）（P0.01）.The average bone density of lumbar spine increased 18.5%（P0.01）,of femoral and neck 6.7%（P0.05）,of greater trochanter bone 2.0%（P0.05）;of Wards area decreased 0.4%（P0.05）.Two newly-occurred bone fractures,one fracture of right humerus,one vertebral compression fracture were discovered during the test,with no other serious adverse events.Conclusion rhPTH1-34 with Caltrate D is effective in the treatment of primary osteoporosis,especially for lumbar vertebra,with mild adverse reactions.