唑来膦酸注射液联合骨肽注射液治疗绝经后骨质疏松症的临床疗效及安全性分析
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摘要
目的:研究唑来膦酸注射液联合骨肽注射液治疗绝经后骨质疏松症的临床效果以及安全性。方法:选择2014年1月～2018年1月我院收治的100例绝经后骨质疏松症患者,将其随机分为两组。对照组采用静脉滴注唑来膦酸注射液5 mg一次,观察组在对照组基础上静脉注射骨肽注射液,每次30 mg,每天1次。治疗6个月后,检测并比较两组治疗前后的骨代谢指标(血清骨特异性碱性磷酸酶(BAP)、甲状旁腺素(PTH)、血磷(P)、血钙(Ca)和碱性磷酸酶(ALP))以及骨转换指标(骨钙素(OC)和Ⅰ型胶原交联C-末端肽(CTX-1))的变化及不良反应的发生情况。结果:治疗后,观察组总有效率明显高于对照组(P<0.05);两组血清ALP、PTH以及BAP等骨代谢指标均较治疗前明显降低(P<0.05),且观察组以上指标明显低于对照组(P<0.05);两组的OC均较治疗前明显升高(P<0.05),CTX-1均较治疗前明显降低(P<0.05),且观察组的骨转换指标改善的程度较对照组更为明显(P<0.05)。观察组的不良反应发生率为8.00%(4/50),明显低于对照组[18.00%(9/50)](P<0.05)。结论:唑来膦酸注射液联合骨肽注射液治疗绝经后骨质疏松症的效果明显优于单独使用唑来膦酸注射液,其可以显著改善患者的骨代谢及骨转换状态,且安全性更高。
Objective: To investigate the clinical efficacy and safety of zoledronic acid injection combined with bone peptide injection in the treatment of postmenopausal osteoporosis. Methods: 100 cases of patients with postmenopausal osteoporosis admitted to our hospital from January 2014 to January 2018 were randomly divided into two groups. The control group was given zoledronic acid injection 5 mg once, while the observation group was given bone peptide injection 30 mg once a day on the basis of the control group. After 6 months of treatment, the changes of bone metabolism indexes(serum bone specific alkaline phosphatase (BAP), parathyroid hormone (PTH), blood phosphorus (P), blood calcium (Ca) and alkaline phosphatase (ALP), bone turnover indexes (OC) and collagen type I cross-linked C-terminal peptide (CTX-1) and adverse reactions were detected and compared between the two groups before and after treatment. Results: After treatment, the total effective rate of observation group was significantly higher than that of the control group(P<0.05); the serum ALP, PTH and BAP of both groups were significantly lower than those before treatment(P<0.05), and the above indexes of observation group were significantly lower than those of the control group(P<0.05); the OC of the two groups were significantly higher than before treatment(P<0.05), the CTX-1 was significantly lower than before treatment(P<0.05). The improvement of bone turnover index in the observation group was more significant than that in the control group(P<0.05). The incidence of adverse reactions in the observation group was 8%(4/50), which was significantly lower than that in the control group [18.00%(9/50)](P<0.05). Conclusion: Zoledronic acid injection combined with bone peptide injection is significantly effective than zoledronic acid injection alone in the treatment of postmenopausal osteoporosis, which can significantly improve bone metabolism and bone turnover with higher safety.
Objective: To investigate the clinical efficacy and safety of zoledronic acid injection combined with bone peptide injection in the treatment of postmenopausal osteoporosis. Methods: 100 cases of patients with postmenopausal osteoporosis admitted to our hospital from January 2014 to January 2018 were randomly divided into two groups. The control group was given zoledronic acid injection 5 mg once, while the observation group was given bone peptide injection 30 mg once a day on the basis of the control group. After 6 months of treatment, the changes of bone metabolism indexes(serum bone specific alkaline phosphatase (BAP), parathyroid hormone (PTH), blood phosphorus (P), blood calcium (Ca) and alkaline phosphatase (ALP), bone turnover indexes (OC) and collagen type I cross-linked C-terminal peptide (CTX-1) and adverse reactions were detected and compared between the two groups before and after treatment. Results: After treatment, the total effective rate of observation group was significantly higher than that of the control group(P<0.05); the serum ALP, PTH and BAP of both groups were significantly lower than those before treatment(P<0.05), and the above indexes of observation group were significantly lower than those of the control group(P<0.05); the OC of the two groups were significantly higher than before treatment(P<0.05), the CTX-1 was significantly lower than before treatment(P<0.05). The improvement of bone turnover index in the observation group was more significant than that in the control group(P<0.05). The incidence of adverse reactions in the observation group was 8%(4/50), which was significantly lower than that in the control group [18.00%(9/50)](P<0.05). Conclusion: Zoledronic acid injection combined with bone peptide injection is significantly effective than zoledronic acid injection alone in the treatment of postmenopausal osteoporosis, which can significantly improve bone metabolism and bone turnover with higher safety.
引文
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[20]Yang L,Liu T S,Da-Bin W U,et al.The clinical effect of ossotide injection and risedronate for the treatment of lumbar bone tissue repair after surgery for fracture[J].Journal of Clinical&Experimental Medicine,2017,16(7):675-677
[21]Zhou Y Q,Nephrology D O.Effect of ossotide injection combined with alendronate sodium on bone metabolism and bone mineral density in senile male patients with type 2 diabetic osteoporosis[J].Journal of Cervicodynia&Lumbodynia,2017,38(2):128-131
[22]Lao K,Wu Y Q.Clinical curative Ooservation of using self-made jiangu recipe in the treatment of postmenopausal osteoporotic vertebral compression fracture and its influence on OPG/RANKL/RANKof the patients[J].Journal of Sichuan of Traditional Chinese Medicine,2017,35(1):127-129
[23]Zeng H,Ming-Dao T U,Pharmacy D O.Clinical observation on chuanlong guci capsules combined with ossotide injection in treatment of hyperostosis[J].Drugs&Clinic,2017,32(7):1333-1336
[24]Tian-Xin H U,ZHOU-you,Xiong L,et al.Clinical study on glucosamine hydrochloride capsules combined with compound ossotide injection in treatment of knee osteoarthritis[J].Drugs&Clinic,2018,33(7):1793-1797
[25]J?rgensen N R,M?llehave L T,Ybl H,et al.Comparison of two automated assays of BTM(CTX and P1NP)and reference intervals in a Danish population[J].Osteoporosis international:a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,2017,28(7):2103
[26]Kharroubi A,Saba E,Smoom R,et al.Serum 25-hydroxyvitamin Dand bone turnover markers in palestinian postmenopausal osteoporosis and normal women[J].Archives of Osteoporosis,2017,12(1):13
[27]Jepsen D B,Ryg J,J?rgensen N R,et al.The combined effect of Parathyroid hormone(1-34)and whole-body Vibration exercise in the treatment of OSteoporosis(Pa VOS)-study protocol for a randomized controlled trial[J].Trials,2018,19(1):186
[28]Liu Z Y,Yang Y,Wen C Y,et al.Serum osteocalcin and testosterone concentrations in adult males with or without primary osteoporosis:a meta-analysis[J].Biomed Research International,2017,2017(5):9892048
[29]Levinger I,Brennan-Speranza T C,Zulli A,et al.Multifaceted interaction of bone,muscle,lifestyle interventions and metabolic and cardiovascular disease:role of osteocalcin[J].Osteoporosis International,2017,28(8):1-9
[30]Kim M H,Lee J E,Lee J S,et al.Improvement of osteoporosis by Lycium chinense administration in ovariectomized mice[J].Journal of the Chinese Medical Association,2017,80(4):222
[2]Langdahl B L,Libanati C,Crittenden D B,et al.Romosozumab(sclerostin monoclonal antibody)versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy:a randomised,open-label,phase 3 trial[J].Lancet,2017,390(10102):1585
[3]Qaseem A,Forciea M A,Mclean R M,et al.Treatment of low bone density or osteoporosis to prevent fractures in men and women:a clinical practice guideline update from the American college of physicians[J].Annals of Internal Medicine,2017,167(12):899
[4]Ross,Battista,Cabal,et al.Dynamics of bone cell signaling and PTHtreatments of osteoporosis[J].Discrete and Continuous Dynamical Systems-Series B(DCDS-B),2017,17(6):2185-2200
[5]Tarantino U,Iolascon G,Cianferotti L,et al.Clinical guidelines for the prevention and treatment of osteoporosis:summary statements and recommendations from the Italian Society for Orthopaedics and Traumatology[J].Journal of Orthopaedics&Traumatology,2017,18(Suppl 1):3-36
[6]Cosman F,Hattersley G,Hu M Y,et al.Effects of abaloparatide-sc on fractures and bone mineral density in subgroups of postmenopausal women with osteoporosis and varying baseline risk factors[J].Journal of Bone&Mineral Research,2017,32(1):17-23
[7]Ganguly P,Eljawhari J J,Giannoudis P V,et al.Age-related changes in bone marrow mesenchymal stromal cells:a potential impact on osteoporosis and osteoarthritis development[J].Cell Transplantation,2017,26(9):1520-1529
[8]Nakamura T,Fukunaga M,Nakano T,et al.Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis:two-year results from a randomized placebo-controlled double-blind study(ZOledroNate treatment in Efficacy to osteoporosis;ZONE study)[J].Osteoporosis International,2017,28(1):389-398
[9]Liao H,Zhang J J.The clinical efficacy of alendronate combined with ossotide injection on osteoporosis treatmen[J].Chin J Osteoporos,2017,23(6):784-786
[10]Bone H G,Wagman R B,Brandi M L,et al.10 years of denosumab treatment in postmenopausal women with osteoporosis:results from the phase 3 randomised FREEDOM trial and open-label extension[J].Lancet Diabetes&Endocrinology,2017,5(7):513
[11]Cummings S R,Cosman F,Lewiecki E M,et al.Goal-directed treatment for osteoporosis:a progress report from the ASBMR-NOFWorking Group on goal-directed treatment for osteoporosis[J].Journal of Bone&Mineral Research the Official Journal of the American Society for Bone&Mineral Research,2017,32(1):3
[12]Diez-Perez A,Naylor K E,Abrahamsen B,et al.International Osteoporosis Foundation and European Calcified Tissue Society Working Group.Recommendations for the screening of adherence to oral bisphosphonates[J].Osteoporos Int,2017,28(3):767-774
[13]Nakamura T,Fukunaga M,Nakano T,et al.Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis:two-year results from a randomized placebo-controlled double-blind study(ZOledroNate treatment in Efficacy to osteoporosis;ZONE study)[J].Osteoporosis International,2017,28(1):389-398
[14]Boschitsch E P,Durchschlag E,Dimai H P.Age-related prevalence of osteoporosis and fragility fractures:real-world data from an austrian menopause and osteoporosis clinic[J].Climacteric the Journal of the International Menopause Society,2017,20(2):157-163
[15]Cai Y,Gao T,Fu S,et al.Development of zoledronic acid functionalized hydroxyapatite loaded polymeric nanoparticles for the treatment of osteoporosis[J].Experimental&Therapeutic Medicine,2018,16(2):704-710
[16]Ding Y,Zeng J C,Yin F,et al.Multicenter study on observation of acute-phase responses after infusion of zoledronic acid 5 mg in Chinese women with postmenopausal osteoporosis[J].Orthop Surg,2017,9(3):284-289
[17]Darvishikhezri H,Kosaryan M,Akbarzadeh R,et al.Administration of intravenous zoledronic acid every 3 months vs.annually inβ-thalassemia patients with low bone mineral density:a retrospective comparison of efficacy[J].Medical Archives,2018,72(3):170-173
[18]Hayer P S,Deane A K,Agrawal A,et al.Effect of zoledronic acid on fracture healing in osteoporotic patients with intertrochanteric fractures[J].International Journal of Applied&Basic Medical Research,2017,7(1):48-52
[19]Fan Y,Xue S,Bin D U,et al.Observation on Efficacy of compound ossotide injections in treatment of femoral neck fracture after compression screw immobilization[J].Evaluation and Analysis of Drug-Use in Hospitals of China,2017,17(2):194-196
[20]Yang L,Liu T S,Da-Bin W U,et al.The clinical effect of ossotide injection and risedronate for the treatment of lumbar bone tissue repair after surgery for fracture[J].Journal of Clinical&Experimental Medicine,2017,16(7):675-677
[21]Zhou Y Q,Nephrology D O.Effect of ossotide injection combined with alendronate sodium on bone metabolism and bone mineral density in senile male patients with type 2 diabetic osteoporosis[J].Journal of Cervicodynia&Lumbodynia,2017,38(2):128-131
[22]Lao K,Wu Y Q.Clinical curative Ooservation of using self-made jiangu recipe in the treatment of postmenopausal osteoporotic vertebral compression fracture and its influence on OPG/RANKL/RANKof the patients[J].Journal of Sichuan of Traditional Chinese Medicine,2017,35(1):127-129
[23]Zeng H,Ming-Dao T U,Pharmacy D O.Clinical observation on chuanlong guci capsules combined with ossotide injection in treatment of hyperostosis[J].Drugs&Clinic,2017,32(7):1333-1336
[24]Tian-Xin H U,ZHOU-you,Xiong L,et al.Clinical study on glucosamine hydrochloride capsules combined with compound ossotide injection in treatment of knee osteoarthritis[J].Drugs&Clinic,2018,33(7):1793-1797
[25]J?rgensen N R,M?llehave L T,Ybl H,et al.Comparison of two automated assays of BTM(CTX and P1NP)and reference intervals in a Danish population[J].Osteoporosis international:a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,2017,28(7):2103
[26]Kharroubi A,Saba E,Smoom R,et al.Serum 25-hydroxyvitamin Dand bone turnover markers in palestinian postmenopausal osteoporosis and normal women[J].Archives of Osteoporosis,2017,12(1):13
[27]Jepsen D B,Ryg J,J?rgensen N R,et al.The combined effect of Parathyroid hormone(1-34)and whole-body Vibration exercise in the treatment of OSteoporosis(Pa VOS)-study protocol for a randomized controlled trial[J].Trials,2018,19(1):186
[28]Liu Z Y,Yang Y,Wen C Y,et al.Serum osteocalcin and testosterone concentrations in adult males with or without primary osteoporosis:a meta-analysis[J].Biomed Research International,2017,2017(5):9892048
[29]Levinger I,Brennan-Speranza T C,Zulli A,et al.Multifaceted interaction of bone,muscle,lifestyle interventions and metabolic and cardiovascular disease:role of osteocalcin[J].Osteoporosis International,2017,28(8):1-9
[30]Kim M H,Lee J E,Lee J S,et al.Improvement of osteoporosis by Lycium chinense administration in ovariectomized mice[J].Journal of the Chinese Medical Association,2017,80(4):222