重组人甲状旁腺激素联合钙剂对绝经后骨质疏松症患者骨密度及骨代谢的影响
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摘要
目的探讨重组人甲状旁腺激素联合钙剂对绝经后骨质疏松症患者骨密度及骨代谢的影响。方法选择2015年1月至2017年5月河北省廊坊市中医院及河北医科大学第一医院收治的122例绝经后骨质疏松症患者,采用随机数字表法分为对照组和研究组,每组61例。对照组采用钙剂治疗,研究组采用重组人甲状旁腺激素联合钙剂治疗,均连续治疗6个月。比较两组患者治疗前后的骨密度水平、骨代谢指标、生活质量评分及临床疗效、不良反应发生情况。结果研究组治疗总有效率为90.16%,明显高于对照组的75.41%,差异有显著性(P<0.05)。两组治疗后股骨颈、腰椎2-4、股骨大转子骨密度均较治疗前升高,且研究组高于对照组,差异有显著性(P<0.05)。两组治疗后骨源性碱性磷酸酶、Ⅰ型胶原交联C末端肽及血钙水平均较治疗前升高,且研究组高于对照组,差异有显著性(P<0.05)。两组治疗后生活质量均较治疗前改善,且研究组优于对照组,差异有显著性(P<0.05)。研究组的不良反应发生率(21.31%)与对照组(13.11%)比较差异无显著性(P>0.05)。结论重组人甲状旁腺激素联合钙剂对绝经后骨质疏松症的疗效显著,可提高骨密度并改善骨代谢,值得临床推广应用。
Objective To explore the influences of recombinant human parathyroid hormone combined with calcium agent on bone mineral density, bone metabolism and fracture occurrence in patients with postmenopausal osteoporosis. Method 122 cases of postmenopausal osteoporosis patients who treated from January 2015 to May 2017 in Langfang City Hospital of Traditional Chinese Medicine and the First Hospital of Hebei Medical University, those patients were divided into the control group and the research group according to the random number table method, 61 cases in each group. control group was treated with calcium agent, and the research group was treated with recombinant human parathyroid hormone based on calcium. then clinical effects, bone density, bone metabolism, quality of life score,fracture occurrence, and adverse reactions between two group was compared. Result Total effective rate in research group was higher than that of the control group, and the difference was statistically significant(P<0.05). After treatment, femoral neck, lumbar vertebrae L2-4 and femoral large rotor BMD in two group was increased, and the research group was higher than the control group, and the difference was statistically significant(P<0.05). After treatment, bone alkaline phosphatase(BALP), collagen type Ⅰ crosslinking C terminal peptide(CTX) and blood calcium in two group were rised, the research group was higher than the control group, the difference was statistically significant(P<0.05). quality of life scores in both groups was decreased, and the research group was lower than the control group(P<0.05).fracture rate in research group was lower than the control group, and the difference was statistically significant(P<0.05). The adverse reactions in two group was no difference(P>0.05). Conclusion Clinical efficacy of recombinant human parathyroid hormone combined with calcium agent in treatment postmenopausal osteoporosis is affirmation, can improve bone mineral density and bone metabolism and reduce the risk of fracture.
Objective To explore the influences of recombinant human parathyroid hormone combined with calcium agent on bone mineral density, bone metabolism and fracture occurrence in patients with postmenopausal osteoporosis. Method 122 cases of postmenopausal osteoporosis patients who treated from January 2015 to May 2017 in Langfang City Hospital of Traditional Chinese Medicine and the First Hospital of Hebei Medical University, those patients were divided into the control group and the research group according to the random number table method, 61 cases in each group. control group was treated with calcium agent, and the research group was treated with recombinant human parathyroid hormone based on calcium. then clinical effects, bone density, bone metabolism, quality of life score,fracture occurrence, and adverse reactions between two group was compared. Result Total effective rate in research group was higher than that of the control group, and the difference was statistically significant(P<0.05). After treatment, femoral neck, lumbar vertebrae L2-4 and femoral large rotor BMD in two group was increased, and the research group was higher than the control group, and the difference was statistically significant(P<0.05). After treatment, bone alkaline phosphatase(BALP), collagen type Ⅰ crosslinking C terminal peptide(CTX) and blood calcium in two group were rised, the research group was higher than the control group, the difference was statistically significant(P<0.05). quality of life scores in both groups was decreased, and the research group was lower than the control group(P<0.05).fracture rate in research group was lower than the control group, and the difference was statistically significant(P<0.05). The adverse reactions in two group was no difference(P>0.05). Conclusion Clinical efficacy of recombinant human parathyroid hormone combined with calcium agent in treatment postmenopausal osteoporosis is affirmation, can improve bone mineral density and bone metabolism and reduce the risk of fracture.
引文
[1]Naylor KE,Jacques RM,Paggiosi M,et al.Response of bone turnover markers to three oral bisphosphonate therapies in postmenopausal osteoporosis:the TRIO study[J].Osteoporos Int,2016,27(1):21-31.
[2]Hadji P,Papaioannou N,Gielen E,et al.Persistence,adherence,and medication-taking behavior in women with postmenopausal osteoporosis receiving denosumab in routine practice in Germany,Austria,Greece,and Belgium:12-month results from a European non-interventional study[J].Osteoporos Int,2015,26(10):2479-2489.
[3]Bone HG,Dempster DW,Eisman JA,et al.Odanacatib for the treatment of postmenopausal osteoporosis:development history and design and participant characteristics of LOFT,the Long-Term Odanacatib Fracture Trial[J].Osteoporos Int,2015,26(11):2721-2721.
[4]DarbàJ,Kaskens L,Sorio Vilela F,et al.Cost-utility of denosumab for the treatment of postmenopausal osteoporosis in Spain[J].Clinicoecon Outcomes Res,2015,7:105-117.
[5]Karlsson L,Lundkvist J,Psachoulia E,et al.Persistence with denosumab and persistence with oral bisphosphonates for the treatment of postmenopausal osteoporosis:a retrospective,observational study,and a meta-analysis[J].Osteoporos Int,2015,26(10):2401-2411.
[6]Gennari L,Rotatori S,Bianciardi S,et al.Treatment needs and current options for postmenopausal osteoporosis[J].Expert Opin Pharmacother,2016,17(8):1141-1152.
[7]Wolski H,Drews K,Bogacz A,et al.The RANKL/RANK/OPGsignal trail:significance of genetic polymorphisms in the etiology of postmenopausal osteoporosis[J].Ginekol Pol,2016,87(5):347-352.
[8]Olmos JM,Hernández JL,García-Velasco P,et al.Serum25-hydroxyvitamin D,parathyroid hormone,calcium intake,and bone mineral density in Spanish adults[J].Osteoporos Int,2016,27(1):105-113.
[9]Kurth AA,Pfeilschifter J.Diagnosis and treatment of postmenopausal osteoporosis and osteoporosis in men.German Guidelines Update 2006[J].Orthopade,2007,36(7):683-690.
[10]Zhou C,Li Q,Huang S,et al.Validation of the simplified Chinese version of the quality of life questionnaire of the European foundation for osteoporosis(QUALEFFO-31)[J].Eur Spine J,2016,25(1):318-324.
[11]Boyanov M,Shinkov A,Psachoulia E,et al.Base line characteristics and changes in bone mineral density T-scores of Bulgarian women with postmenopausal osteoporosis receiving denosumab in routine clinical practice[J].Drugs R D,2017,17(1):125-132.
[12]Shen Y,Gray DL,Martinez DS.Combined pharmacologic therapy in postmenopausal osteoporosis[J].Endocrinol Metab Clin North Am,2017,46(1):193-206.
[13]Ishtiaq S,Fogelman I,Hampson G.Treatment of post-menopausal osteoporosis:beyond bisphosphonates[J].J Endocrinol Invest,2015,38(1):13-29.
[14]Ohta H,Solanki J.Incorporating bazedoxifene into the treatment paradigm for postmenopausal osteoporosis in Japan[J].Osteoporos Int,2015,26(3):849-863.
[15]Yun BH,Chon SJ,Choi YS,et al.The effect of prolonged breastfeeding on the development of postmenopausal osteoporosis in population with insufficient calcium intake and vitamin D level[J].Osteoporos Int,2016,27(9):1-9.
[16]Billington EO,Bristow SM,Gamble GD,et al.Acute effects of calcium supplements on blood pressure:randomised,crossover trial in postmenopausal women[J].Osteoporos Int,2016,28(1):119-125.
[17]Lampropoulos CE,Kalamara P,Konsta M,et al.Osteoporosis and vascular calcification in postmenopausal women:a cross-sectional study[J].Climacteric,2016,19(3):1-5.
[18]Matsumoto T,Itamochi S,Hashimoto Y.Effect of concurrent use of whole-body vibration and parathyroid hormone on bone structure and material properties of ovariectomized mice[J].Calcif Tissue Int,2016,98(5):1-10.
[19]Cosman F,Hattersley G,Hu MY,et al.Effects of abaloparatideSC on fractures and bone mineral density in subgroups of postmenopausal women with osteoporosis and varying baseline risk factors[J].J Bone Miner Res,2017,32(1):17-23.
[20]Shin CJ,Kim S,Choi CS,et al.Effectiveness of osteoporosis drug in postmenopausal women with spinal compression fracture:combined consecutive therapy of teriparatide and raloxifene versus bisphosphonate single[J].Korean J Neurotrauma,2016,12(2):123-127.
[21]Miller PD,Hattersley G,Riis BJ,et al.Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis:a randomized clinical trial[J].JAMA,2016,316(7):722-733.
[22]Ra?ka I Jr,Ra?kováM,Zikán V,et al.High prevalence of hypovitaminosis D in postmenopausal women with type 2 diabetes mellitus[J].Prague Med Rep,2016,117(1):5-17.
[23]Tao ZS,Zhou WS,Bai BL,et al.The effects of combined human parathyroid hormone(1-34)and simvastatin treatment on the interface of hydroxyapatite-coated titanium rods implanted into osteopenic rats femurs[J].J Mater Sci Mater Mede,2016,27(3):43.
[24]Pavel OR,Popescu M,Novac L,et al.Postmenopausal osteoporosis-clinical,biological and histopathological aspects[J].Rom J Morphol Embryol,2016,57(1):121-130.
[25]Dionello CF,Sácaputo D,Pereira HVFS,et al.Effects of whole body vibration exercises on bone mineral density of women with postmenopausal osteoporosis without medications:novel findings and literature review[J].J Musculoskelet Neuronal Interact,2016,16(3):193-203.
[26]Kharroubi A,Saba E,Smoom R,et al.Serum 25-hydroxyvitamin Dand bone turnover markers in Palestinian postmenopausal osteoporosis and normal women.[J].Arch Osteoporos,2017,12(1):13.
[27]Lee CM,Terrizzi AR,Bozzini C,et al.Chronic lead poisoning magnifies bone detrimental effects in an ovariectomized rat model of postmenopausal osteoporosis[J].Exp Toxicol Pathol,2016,68(1):47-53.
[28]Engin-üstün Y,?alayan EK,G??men AY,et al.Postmenopausal osteoporosis is associated with serum chemerin and irisin but not with apolipoprotein M levels[J].J Menopausal Med,2016,22(2):76-79.
[29]Gokosmanoglu F,Varim C,Atmaca A,et al.The effects of zoledronic acid treatment on depression and quality of life in women with postmenopausal osteoporosis:A clinical trial study[J].J Res Med Sci,2016,21:112.
[30]Kharroubi A,Saba E,Smoom R,et al.Serum 25-hydroxyvitamin D and bone turnover markers in Palestinian postmenopausal osteoporosis and normal women[J].Arch Osteoporos,2017,12(1):13.
[2]Hadji P,Papaioannou N,Gielen E,et al.Persistence,adherence,and medication-taking behavior in women with postmenopausal osteoporosis receiving denosumab in routine practice in Germany,Austria,Greece,and Belgium:12-month results from a European non-interventional study[J].Osteoporos Int,2015,26(10):2479-2489.
[3]Bone HG,Dempster DW,Eisman JA,et al.Odanacatib for the treatment of postmenopausal osteoporosis:development history and design and participant characteristics of LOFT,the Long-Term Odanacatib Fracture Trial[J].Osteoporos Int,2015,26(11):2721-2721.
[4]DarbàJ,Kaskens L,Sorio Vilela F,et al.Cost-utility of denosumab for the treatment of postmenopausal osteoporosis in Spain[J].Clinicoecon Outcomes Res,2015,7:105-117.
[5]Karlsson L,Lundkvist J,Psachoulia E,et al.Persistence with denosumab and persistence with oral bisphosphonates for the treatment of postmenopausal osteoporosis:a retrospective,observational study,and a meta-analysis[J].Osteoporos Int,2015,26(10):2401-2411.
[6]Gennari L,Rotatori S,Bianciardi S,et al.Treatment needs and current options for postmenopausal osteoporosis[J].Expert Opin Pharmacother,2016,17(8):1141-1152.
[7]Wolski H,Drews K,Bogacz A,et al.The RANKL/RANK/OPGsignal trail:significance of genetic polymorphisms in the etiology of postmenopausal osteoporosis[J].Ginekol Pol,2016,87(5):347-352.
[8]Olmos JM,Hernández JL,García-Velasco P,et al.Serum25-hydroxyvitamin D,parathyroid hormone,calcium intake,and bone mineral density in Spanish adults[J].Osteoporos Int,2016,27(1):105-113.
[9]Kurth AA,Pfeilschifter J.Diagnosis and treatment of postmenopausal osteoporosis and osteoporosis in men.German Guidelines Update 2006[J].Orthopade,2007,36(7):683-690.
[10]Zhou C,Li Q,Huang S,et al.Validation of the simplified Chinese version of the quality of life questionnaire of the European foundation for osteoporosis(QUALEFFO-31)[J].Eur Spine J,2016,25(1):318-324.
[11]Boyanov M,Shinkov A,Psachoulia E,et al.Base line characteristics and changes in bone mineral density T-scores of Bulgarian women with postmenopausal osteoporosis receiving denosumab in routine clinical practice[J].Drugs R D,2017,17(1):125-132.
[12]Shen Y,Gray DL,Martinez DS.Combined pharmacologic therapy in postmenopausal osteoporosis[J].Endocrinol Metab Clin North Am,2017,46(1):193-206.
[13]Ishtiaq S,Fogelman I,Hampson G.Treatment of post-menopausal osteoporosis:beyond bisphosphonates[J].J Endocrinol Invest,2015,38(1):13-29.
[14]Ohta H,Solanki J.Incorporating bazedoxifene into the treatment paradigm for postmenopausal osteoporosis in Japan[J].Osteoporos Int,2015,26(3):849-863.
[15]Yun BH,Chon SJ,Choi YS,et al.The effect of prolonged breastfeeding on the development of postmenopausal osteoporosis in population with insufficient calcium intake and vitamin D level[J].Osteoporos Int,2016,27(9):1-9.
[16]Billington EO,Bristow SM,Gamble GD,et al.Acute effects of calcium supplements on blood pressure:randomised,crossover trial in postmenopausal women[J].Osteoporos Int,2016,28(1):119-125.
[17]Lampropoulos CE,Kalamara P,Konsta M,et al.Osteoporosis and vascular calcification in postmenopausal women:a cross-sectional study[J].Climacteric,2016,19(3):1-5.
[18]Matsumoto T,Itamochi S,Hashimoto Y.Effect of concurrent use of whole-body vibration and parathyroid hormone on bone structure and material properties of ovariectomized mice[J].Calcif Tissue Int,2016,98(5):1-10.
[19]Cosman F,Hattersley G,Hu MY,et al.Effects of abaloparatideSC on fractures and bone mineral density in subgroups of postmenopausal women with osteoporosis and varying baseline risk factors[J].J Bone Miner Res,2017,32(1):17-23.
[20]Shin CJ,Kim S,Choi CS,et al.Effectiveness of osteoporosis drug in postmenopausal women with spinal compression fracture:combined consecutive therapy of teriparatide and raloxifene versus bisphosphonate single[J].Korean J Neurotrauma,2016,12(2):123-127.
[21]Miller PD,Hattersley G,Riis BJ,et al.Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis:a randomized clinical trial[J].JAMA,2016,316(7):722-733.
[22]Ra?ka I Jr,Ra?kováM,Zikán V,et al.High prevalence of hypovitaminosis D in postmenopausal women with type 2 diabetes mellitus[J].Prague Med Rep,2016,117(1):5-17.
[23]Tao ZS,Zhou WS,Bai BL,et al.The effects of combined human parathyroid hormone(1-34)and simvastatin treatment on the interface of hydroxyapatite-coated titanium rods implanted into osteopenic rats femurs[J].J Mater Sci Mater Mede,2016,27(3):43.
[24]Pavel OR,Popescu M,Novac L,et al.Postmenopausal osteoporosis-clinical,biological and histopathological aspects[J].Rom J Morphol Embryol,2016,57(1):121-130.
[25]Dionello CF,Sácaputo D,Pereira HVFS,et al.Effects of whole body vibration exercises on bone mineral density of women with postmenopausal osteoporosis without medications:novel findings and literature review[J].J Musculoskelet Neuronal Interact,2016,16(3):193-203.
[26]Kharroubi A,Saba E,Smoom R,et al.Serum 25-hydroxyvitamin Dand bone turnover markers in Palestinian postmenopausal osteoporosis and normal women.[J].Arch Osteoporos,2017,12(1):13.
[27]Lee CM,Terrizzi AR,Bozzini C,et al.Chronic lead poisoning magnifies bone detrimental effects in an ovariectomized rat model of postmenopausal osteoporosis[J].Exp Toxicol Pathol,2016,68(1):47-53.
[28]Engin-üstün Y,?alayan EK,G??men AY,et al.Postmenopausal osteoporosis is associated with serum chemerin and irisin but not with apolipoprotein M levels[J].J Menopausal Med,2016,22(2):76-79.
[29]Gokosmanoglu F,Varim C,Atmaca A,et al.The effects of zoledronic acid treatment on depression and quality of life in women with postmenopausal osteoporosis:A clinical trial study[J].J Res Med Sci,2016,21:112.
[30]Kharroubi A,Saba E,Smoom R,et al.Serum 25-hydroxyvitamin D and bone turnover markers in Palestinian postmenopausal osteoporosis and normal women[J].Arch Osteoporos,2017,12(1):13.