地舒单抗治疗维持性血液透析患者骨质疏松的临床效果  

Efficacy of denosumab in treatment of osteoporosis in patients receiving maintenance hemodialysis

作　　者：孙立娜[1] 王云飞[2] 孙福云[1] 徐海平[1] 马晓迎[1] 贾莉莉[1] 刘文敏 Sun Li-na;Wang Yun-fei;Sun Fu-yun;Xu Hai-ping;Ma Xiao-ying;Jia Li-li;Liu Wen-min(Department of Nephrology,Cangzhou Central Hospital,Cangzhou 061000,China;Department of Cardiovascular Medicine,Cangzhou Central Hospital,Cangzhou 061000,China)

机构地区：[1]沧州市中心医院肾内科,沧州061000 [2]沧州市中心医院心血管内科,沧州061000

出　　处：《中国药物应用与监测》2025年第1期30-33,共4页Chinese Journal of Drug Application and Monitoring

基　　金：河北省2020年度医学科学研究课题计划项目(20200318);沧州市2022年科技计划项目(222107002)。

摘　　要：目的探讨地舒单抗治疗维持性血液透析患者骨质疏松的临床效果。方法根据随机数字表法将2021年2月至2023年6月于沧州市中心医院透析中心行长期维持性血液透析治疗合并骨质疏松的96例患者分为地舒单抗组(n=48)与常规治疗组(n=48)。常规治疗组给予常规改善钙磷代谢治疗,地舒单抗组在常规治疗基础上给予地舒单抗。观察两组患者的临床疗效、不良反应以及治疗前后全段甲状旁腺激素(iPTH)、血钙(Ca)、血磷(P)、血碱性磷酸酶(ALP)、骨密度及骨痛程度的变化。结果地舒单抗组总有效率为93.75%(45/48),高于常规治疗组总有效率72.92%(35/48),差异有统计学意义(χ^(2)=7.500,P=0.006)。治疗后,地舒单抗组Ca、P、ALP水平[分别为(2.01±0.32)mmol·L^(-1),(1.51±0.17)mmol·L^(-1),(120.63±4.52)U·L^(-1)]均低于常规治疗组[分别为(2.16±0.36)mmol·L^(-1),(1.69±0.19)mmol·L^(-1),(126.55±5.17)U·L^(-1)],差异有统计学意义(t=-2.158、-4.891、-5.973,P=0.034、P<0.001、P<0.001);治疗后地舒单抗组iPTH水平为(369.85±81.39)pg·mL^(-1),与常规治疗组iPTH水平(367.96±81.88)pg·mL^(-1)比较,差异无统计学意义(t=0.113,P=0.910);治疗后,地舒单抗组骨密度值为(1.05±0.06)g·cm^(-2),高于常规治疗组骨密度值(0.85±0.06)g·cm^(-2),差异有统计学意义(t=16.330,P<0.001)。治疗后地舒单抗组视觉模拟量表(VAS)评分为(2.16±0.18)分,低于常规治疗组的(3.46±0.25)分,差异有统计学意义(t=-29.237,P<0.001)。地舒单抗组不良反应发生率为12.50%(6/48),与常规治疗组不良反应发生率8.33%(4/48)比较,差异无统计学意义(χ^(2)=0.447,P=0.504)。结论地舒单抗在维持性血液透析合并骨质疏松患者中具有较好的治疗效果,可减轻钙磷代谢的紊乱,增加骨密度,减轻骨痛症状,且无明显不良反应。Objective To explore the clinical effect of denosumab for osteoporosis in patients receiving maintenance hemodialysis.Methods According to the random number method,96 patients receiving long-term maintenance hemodialysis who had osteoporosis in Cangzhou Central Hospital from February 2021 to June 2023 were randomly divided into the denosumab group(n=48)and conventional treatment group(n=48).The patients in the conventional treatment group were given conventional treatment while those in the denosumab group were given denosumab and conventional treatment.Clinical efficacy,adverse reactions,parathyroid hormone(PTH),blood calcium(Ca),blood phosphorus(P),alkaline phosphatase(ALP),bone mineral density and degree of bone pain were observed and recorded in each group.Results The total effective rate of the denosumab group was 93.75%(45/48),which was higher than that of 72.92%(35/48)in the conventional treatment group,and the difference was statistically significant(χ^(2)=7.500,P=0.006).The levels of Ca,P and ALP in the denosumab group((2.01±0.32)mmol·L^(-1),(1.51±0.17)mmol·L^(-1),(120.63±4.52)U·L^(-1),respectively)after treatment were lower than those in the conventional treatment group((2.16±0.36)mmol·L^(-1),(1.69±0.19)mmol·L^(-1),(126.55±5.17)U·L^(-1)),the differences were statistically significant(t=-2.158,-4.891,-5.973,P=0.034,P<0.001,P<0.001).After treatment,the iPTH level of the denosumab group was(369.85±81.39)pg·mL^(-1),which had no significant change compared with that of the conventional treatment group((367.96±81.88)pg·mL^(-1))(t=0.113,P=0.910).Bone mineral density(BMD)of the denosumab group after treatment was(1.05±0.06)g·cm^(-2),which was higher than that of the conventional treatment group((0.85±0.06)g·cm^(-2)),and the difference was statistically significant(t=16.330,P<0.001).The VAS score of the denosumab group after treatment was(2.16±0.18)points,which was lower than that of(3.46±0.25)points in the conventional treatment group(t=-29.237,P<0.001).The incidence of adverse reactions

关 键 词：维持性血液透析 骨质疏松 地舒单抗 骨密度 骨代谢 疼痛 

分 类 号：R692.5[医药卫生—泌尿科学] R580[医药卫生—外科学]