鲑鱼降钙素治疗维持性透析患者骨质疏松的临床研究
Effects of salmon calcitonin in treatment of osteoporosis in patients undergoing dialysis
摘要目的 调查维持性透析患者骨质疏松症的患病率情况,并探讨鲑鱼降钙素治疗维持性透析患者骨质疏松症的有效性和安全性.方法 256例在北京朝阳医院血液净化中心维持性透析患者经双能量X线骨密度仪检测腰椎和股骨颈骨密度,以了解维持性透析患者中骨质疏松的患病情况.按随机表将108例合并骨质疏松症的维持性透析患者随机分为实验组(54例)和对照组(54例),两组患者均在餐中嚼服碳酸钙1500 mg,每日 2~3次,活性维生素D30.25 μg/d.实验组患者应用鲑鱼降钙素50 U皮下注射,每周3次,血液透析患者于透析后给予.总疗程18个月.观察鲑鱼降钙素治疗后患者腰椎骨密度、股骨颈骨密度、全段甲状旁腺激素(iPTH)、骨钙素(BGP)、血钙、血磷、血清碱性磷酸酶(ALP)等骨代谢指标的变化及不良反应的发生情况.结果 (1)256例维持性透析患者中,骨质疏松的患病率为42.19%;(2)治疗前两组患者在年龄、性别比例、透析方式、腰椎骨密度、股骨颈骨密度及血清骨代谢指标等方面差异均无统计学意义;(3)治疗18个月后实验组腰椎及股骨颈骨密度较对照组明显上升[实验组比对照组:腰椎骨密度(g/cm2):0.99±0.04 vs 0.79±0.06,P<0.01;股骨颈骨密度(g/cm2):0.84±0.04 vs 0.77±0.07,P<0.01];(4)治疗后实验组血ALP、iPTH和BGP水平较对照组明显下降;对照组血钙水平较实验组明显升高;(5)治疗18个月时,实验组骨质疏松改善的总有效率为40.74%,明显高于对照组(P<0.01);(6)实验组所有患者在皮下注射鲑鱼降钙素治疗过程中生命体征平稳,无不良反应发生.结论 维持性透析患者骨质疏松的患病率较高;鲑鱼降钙素可有效改善维持性透析患者的骨质疏松症,且安全性好.
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abstractsObjective To investigate the prevalence of osteoporosis in patients undergoing maintenance dialysis and explore the safety and efficacy of salmon calcitonin in maintenance dialysis patients underwent with osteoporosis.Methods Double-energy X-ray bone density meter was used on 256 patients undergoing maintenance dialysis,126 males and 130 females,aged 60±14(22-79),to measure the bone mineral density (BMD)at the lumbar spine and femoral neck.108 of them with the T values<-2.5 s were diagnosed as with osteoporosis,and then were randomly divided into 2 equal groups matched in baseline age,sex,mode of dialysis,and levels of iPTH,ALP,and BMD:control group receiving oral administration of calcium carbonate 1500 mg tid and rccaltrol 0.25 μg qn for 18 months,and experimental group,received subcutaneous injection of salmon calcitonin(50 U)three times a week in addition.The BMD levels of lumbar spine and femoral neck,and serum intact parathyroid hormone(iPTH),calcium,phosphorus,and alkaline phosphatase(ALP)were assessed before treatment and 3,6,12,and 18 months after treatment.Resuits (1)The osteoporosis rate of the 256 maintenance dialysis patients was 42.19%.(2)The osteoporosis rate of the 201 patients undergoing maintenance hemodialysis(MHD)was 47.76%,significantly higher than that of the 55 patients undergoing maintenance peritoneal dialysis(21.82%,P<0.01).(3)At the end of the trial,there was a significant increase of BMD of lumbar spine and femoral neck in the experiment group compared with the control group.(4)Compared with the control group,the serum ALP,iPTH,and BGP levels 3,6,12,and 18 months after treatment were all significantly lower than the baseline level and those of the corresponding control groups(all P<0.01).The serum calcium of the control group at the end of experiment increased significantly in comparison with baseline level(P<0.05).(5)No adverse events were found after the treatment of salmon calcitonin.Conclusion Salmon calcitonin effectively increases the BMD of the maintenance dialysis patients and is well tolerated.
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