骨肽注射剂治疗原发性骨质疏松症的Meta分析
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摘要
目的系统评价使用骨肽注射液治疗原发性骨质疏松症的有效性。方法依据Meta分析要求,在CBM、CNKI、PubMed、Springer、Embase databases、Cochrane Library、维普、万方、中国科技论文统计与分析网、专利数据库等网站上进行检索,纳入以骨肽注射剂作为主要干预措施治疗原发性骨质疏松症临床试验的研究文献,检索年限从建库至2018年8月,检索资料由两名研究人员独立进行提取,若有分歧,则由第三方协助并解决;采用Review Manager 5.3、Stata/IC 15.0、R语言对有效性、骨密度进行系统评价。结果最终纳入20篇文献,受试者共2 230人,有6篇文献报道了不良反应;有16篇文献报道了总有效率Chi~2=16.98,I~2=12%,P=0.32>0.1;OR=6.17,95%CI(4.74,8.04),P<0.01,差异有统计学意义。经漏斗图分析、Egger、Begg’s检验表明不存在明显发表偏倚;有10篇文献报道了用药后骨密度的变化情况,发现治疗后的腰椎骨密度异质性较大,采用亚组分析、Galbraith异质性检验分析以及Meta回归分析来寻找异质性来源;有6篇文献报道了治疗后髋部骨密度分析情况,SMD=0.18,95%CI(0.02,0.34),Z=2.20,P=0.03<0.05,其差异具有统计学意义。结论骨肽注射剂对治疗原发性骨质疏松症着实有效,安全性较高。
Objective To systematically evaluate the efficacy of ossotide injection in the treatment of primary osteoporosis. Methods According to meta-analysis requirements, data in CBM, CNKI, PubMed, Springer, Embase databases, Cochrane Library, Chinese technical paper statistics and analysis, and patent databases were searched. The clinical studies on the treatment of primary osteoporosis with ossotide injection as the main intervention measure were enrolled from database founded to August 2018. All the information was extracted independently by two researchers and assisted and resolved by a third party if there gets some disagreement. The effectiveness and bone mineral density(BMD) were evaluated systematically by using the software named Review Manager 5.3, Stata/IC 15.0 and R language. Results Twenty literatures were finally included, and a total of 2,230 subjects are enrolled. Adverse reactions were reported in6 studies. The total effective rate was reported in 16 literatures, Chi~2=16.98, I~2=12%, P=0.32>0.1, OR=6.17, 95% CI(4.74,8.04), P<0.01, and the difference was statistically significant. Funnel plot, Egger, and Begg's test showed no obvious publication bias. The changes of BMD after taking the medication were reported in 10 literatures, showing that the heterogeneity of BMD of lumbar vertebrae after treatment is greater. Subgroup analysis, Galbraith heterogeneity test analysis, and Meta regression analysis were used to find the sources of heterogeneity. There were 6 literatures that reported the BMD analysis of the hip, SMD=0.18, 95% CI(0.02,0.34), Z=2.20, P=0.03<0.05, and the difference was statistically significant. Conclusion Ossotide injection is effective and safe in the treatment of primary osteoporosis.
Objective To systematically evaluate the efficacy of ossotide injection in the treatment of primary osteoporosis. Methods According to meta-analysis requirements, data in CBM, CNKI, PubMed, Springer, Embase databases, Cochrane Library, Chinese technical paper statistics and analysis, and patent databases were searched. The clinical studies on the treatment of primary osteoporosis with ossotide injection as the main intervention measure were enrolled from database founded to August 2018. All the information was extracted independently by two researchers and assisted and resolved by a third party if there gets some disagreement. The effectiveness and bone mineral density(BMD) were evaluated systematically by using the software named Review Manager 5.3, Stata/IC 15.0 and R language. Results Twenty literatures were finally included, and a total of 2,230 subjects are enrolled. Adverse reactions were reported in6 studies. The total effective rate was reported in 16 literatures, Chi~2=16.98, I~2=12%, P=0.32>0.1, OR=6.17, 95% CI(4.74,8.04), P<0.01, and the difference was statistically significant. Funnel plot, Egger, and Begg's test showed no obvious publication bias. The changes of BMD after taking the medication were reported in 10 literatures, showing that the heterogeneity of BMD of lumbar vertebrae after treatment is greater. Subgroup analysis, Galbraith heterogeneity test analysis, and Meta regression analysis were used to find the sources of heterogeneity. There were 6 literatures that reported the BMD analysis of the hip, SMD=0.18, 95% CI(0.02,0.34), Z=2.20, P=0.03<0.05, and the difference was statistically significant. Conclusion Ossotide injection is effective and safe in the treatment of primary osteoporosis.
引文
[1] 赵辉,畅新燕.补肾活血汤联合钙尔奇治疗绝经后原发性骨质疏松症临床疗效观察[J].中国实用医药,2018,13(6):89-90.
[2] 刘冬冬.内分泌失调性骨质疏松症的临床治疗效果观察[J].世界最新医学信息文摘,2018,18(8):36-37.
[3] 薛鹏,李玉坤.2017年版《原发性骨质疏松症诊疗指南》解读[J].河北医科大学学报,2018,39(1):1-6.
[4] Almeida M,Laurent MR,Dubois V,et al.Estrogens and Androgens in Skeletal Physiology and Pathophysiology[J].Physiol Rev,2017,97(1):135-187.
[5] Imai Y.Epigenetic Regulation by Androgen Receptor and Possible Function in Bone Metabolism[J].Clin Calcium,2016,26(7):1017-1022.
[6] 张凯凯,刘晋闽.甲状腺功能减退致骨质疏松症的机制及治疗进展[J].中国骨质疏松杂志,2017,23(6):837-840.
[7] Qin S,Zhang Q,Zhang L.Effect of OPG gene mutation on protein expression and biological activity in osteoporosis[J].Exp Ther Med,2017,14(2):1475-1480.
[8] Yao Z,Lei W,Duan R,et al.RANKL cytokine enhances TNF-induced osteoclastogenesis independently of TNF receptor associated factor (TRAF) 6 by degrading TRAF3 in osteoclast precursors[J].J Biol Chem,2017,292(24):10169-10179.
[9] Elsori DH,Hammoud MS.Vitamin D deficiency in mothers,neonates and children[J].J Steroid Biochem Mol Biol,2018(175):195-199.
[10] Yoshiya S.The effects of exercise and sports activities on bone and joint morbidities[J].Clin Calcium,2017,27(1):39-43.
[11] Jang HD,Hong JY,Han K,et al.Relationship between bone mineral density and alcohol intake:A nationwide health survey analysis of postmenopausal women[J].PLoS One,2017,12(6):e180132.
[12] 崔曼曼,卢晓翠,王怡静,等.广州市某高校大学生骨质疏松知识认知调查[J].中国骨质疏松杂志,2018,24(5):651-655.
[13] 蔡沁,丁志军,章歆,等.经皮椎体成形术治疗老年骨质疏松椎体压缩性骨折的疗效观察[J].慢性病学杂志,2018(8):1-2.
[14] 夏凯,牛素玲,王楠.骨肽注射液在下肢骨折患者术后应用对骨折愈合的影响及其机制[J].创伤外科杂志,2018,20(7):540-543.
[15] 姜溪,陈芙蓉,任雷鸣,等.注射用复方骨肽的药效学及其作用机制研究[J].现代药物与临床,2017,32(6):961-966.
[16] 区志坚,刘学东,黄思聪,等.中医三联序贯疗法与注射用骨肽治疗膝骨性关节炎的临床对照研究[J].海南医学,2018,29(9):1214-1217.
[17] 中国人原发性骨质疏松症诊断标准[J].浙江中西医结合杂志,2007(4):220-227.
[18] 徐苓.2011版《原发性骨质疏松症临床诊疗指南》解读[C].中华医学会第六次全国骨质疏松和骨矿盐疾病学术会议暨中华医学会骨质疏松和骨矿盐疾病分会成立十周年,苏州,2011.
[19] 王玮琪,茹选良,刘春,等.阿托伐他汀联合阿仑膦酸钠治疗老年性骨质疏松的临床疗效及安全性评价[J].中国临床药理学杂志,2016(4):312-314.
[20] Lo CK,Mertz D,Loeb M.Newcastle-Ottawa Scale:comparing reviewers‘ to authors’ assessments[J].BMC Med Res Methodol,2014(14):45.
[21] Margulis AV,Pladevall M,Riera-Guardia N,et al.Quality assessment of observational studies in a drug-safety systematic review,comparison of two tools:the Newcastle-Ottawa Scale and the RTI item bank[J].Clin Epidemiol,2014(6):359-368.
[22] 郑辉烈,俞慧强,刘勇,等.Meta分析发表偏倚的联合诊断研究[J].现代预防医学,2016,43(7):1153-1155.
[23] 郑亮,兰琴,周晓慧,等.STATA软件network模块在两分类数据网络meta分析中的应用[J].同济大学学报(医学版),2018,39(3):119-122.
[24] 成志伟,哈丽恰·霍加西.骨肽注射液治疗骨质疏松症的效果评价[J].新疆医学,2011,41(6):76-77.
[25] 廖化波,张俊娟.阿仑膦酸钠联合骨肽治疗骨质疏松症患者的临床效果[J].中国骨质疏松杂志,2017,23(6):784-786.
[26] 祝雁冰.复方骨肽注射液治疗胸腰椎骨质疏松性骨折临床分析[J].实用药物与临床,2013,16(5):454-455.
[27] 许鹏,姚建锋,王效东,等.谷慷太林对骨质疏松症患者骨密度和血清酶学的影响[J].中国矫形外科杂志,2003(12):49-50.
[28] 孙燕,张建萍.骨化三醇联合骨肽注射液对老年男性骨质疏松症患者骨密度血清IGF-I及BAP表达的影响[J].临床心身疾病杂志,2018(4):9-11,19.
[29] 庞众,刘宁,于尚伟.骨肽在骨质疏松所致腰背痛中的临床应用分析[J].中国伤残医学,2014(16):74.
[30] 张衡才.骨肽注射液穴位注射治疗老年骨质疏松症30例临床观察[J].湖南中医杂志,2017,33(3):84-86.
[31] 陈晓芹.骨肽注射液治疗骨质疏松症50例临床分析[J].中外医学研究,2013,11(26):52-53.
[32] 田杰.骨肽注射液治疗骨质疏松症60例临床分析[J].当代医学,2012,18(11):151.
[33] 彭志军.骨肽注射液治疗骨质疏松症临床效果[J].医学信息,2014(32):315-316.
[34] 高平.骨肽注射液治疗老年骨质疏松症疗效分析[J].现代医学与健康研究电子杂志,2017,1(9):30-31.
[35] 钱学渊.骨肽注射液治疗原发性骨质疏松症64例疗效观察[J].内蒙古中医药,2011,30(10):89-90.
[36] 刘悦,吴刚,李磊.骨肽注射液治疗中老年骨质疏松症疗效观察[J].海南医学院学报,2004(6):404-405.
[37] 康靖东,陈娟,徐伟军,等.鲑降钙素与注射用骨肽联合超声药物透入治疗老年骨质疏松腰背痛的临床比较[J].颈腰痛杂志,2012,33(6):450-453.
[38] 杨大鹏.老年骨质疏松应用骨肽注射液治疗的临床分析[J].中国保健营养,2013(11):6773.
[39] 贾文.穴位注射骨肽注射液治疗原发性骨质疏松症的临床观察[D].武汉:湖北中医药大学,2015.
[40] 赵刚,张士坤.应用复方骨肽注射液治疗原发性骨质疏松症的临床观察[J].中国医院药学杂志,2009,29(6):478-479.
[41] 张辉.用骨肽注射液治疗原发性骨质疏松症的疗效研究[J].当代医药论丛,2014,12(16):221-222.
[42] 刘圳奋,陈军.注射用骨肽与依降钙素在老年性骨质疏松伴全身疼痛患者中的应用比较[J].中国社区医师(医学专业),2012,14(4):110-111.
[43] 黄洁玲,洪曼杰.注射用骨肽在骨质疏松症的防治作用[J].国际医药卫生导报,2009(17):57-59.
[44] Chaimani A,Caldwell DM,Li T,et al.Additional considerations are required when preparing a protocol for a systematic review with multiple interventions[J].Journal of Clinical Epidemiology,2017(83):65-74.
[45] 中华医学会骨质疏松和骨矿盐疾病分会.原发性骨质疏松症诊疗指南(2017)[J].中国实用内科杂志,2018,38(2):127-150.
[46] 屈永周,何绍烜,赵刚.原发性骨质疏松症的病因学研究进展[J].世界最新医学信息文摘,2018,18(35):36-37.
[47] 白璧辉,谢兴文,李鼎鹏,等.我国近5年来骨质疏松症流行病学研究现状[J].中国骨质疏松杂志,2018,24(2):253-258.
[48] 曾淋.足三里雷火灸联合耳穴贴压治疗原发性骨质疏松症的疗效观察[J].当代护士,2018,25(6):111-112.
[49] 赵志强,阎晓霞.中药补肾法改善原发性骨质疏松症临床症状的研究[J].中国骨质疏松杂志,2018,24(3):371-375.
[50] 冯建兵.原发性骨质疏松症30例患者诊疗体会[J].航空航天医学杂志,2018,29(5):579-580.
[51] 李琴.阿仑膦酸钠、唑来膦酸治疗原发性骨质疏松症临床比较[J].世界最新医学信息文摘,2018,18(44):99-101.
[52] 冯小兵,彭阳,吴天昊,等.藤黄健骨胶囊联合唑来膦酸治疗老年原发性骨质疏松的临床研究[J].现代药物与临床,2018,33(7):1788-1792.
[53] 马洁,宋燕青.骨肽注射液的临床应用及其药理作用[J].中国生化药物杂志,2016,36(2):16-18.
[54] 王维刚,王志刚,李大鹏.骨肽对成骨细胞成骨功能表达的影响[J].中国实验诊断学,2012,16(5):764-765.
[55] 王维刚,王志刚,李大鹏.骨肽对骨髓间充质干细胞TGF-1表达的影响[J].中国实验诊断学,2012,16(4):607-608.
[2] 刘冬冬.内分泌失调性骨质疏松症的临床治疗效果观察[J].世界最新医学信息文摘,2018,18(8):36-37.
[3] 薛鹏,李玉坤.2017年版《原发性骨质疏松症诊疗指南》解读[J].河北医科大学学报,2018,39(1):1-6.
[4] Almeida M,Laurent MR,Dubois V,et al.Estrogens and Androgens in Skeletal Physiology and Pathophysiology[J].Physiol Rev,2017,97(1):135-187.
[5] Imai Y.Epigenetic Regulation by Androgen Receptor and Possible Function in Bone Metabolism[J].Clin Calcium,2016,26(7):1017-1022.
[6] 张凯凯,刘晋闽.甲状腺功能减退致骨质疏松症的机制及治疗进展[J].中国骨质疏松杂志,2017,23(6):837-840.
[7] Qin S,Zhang Q,Zhang L.Effect of OPG gene mutation on protein expression and biological activity in osteoporosis[J].Exp Ther Med,2017,14(2):1475-1480.
[8] Yao Z,Lei W,Duan R,et al.RANKL cytokine enhances TNF-induced osteoclastogenesis independently of TNF receptor associated factor (TRAF) 6 by degrading TRAF3 in osteoclast precursors[J].J Biol Chem,2017,292(24):10169-10179.
[9] Elsori DH,Hammoud MS.Vitamin D deficiency in mothers,neonates and children[J].J Steroid Biochem Mol Biol,2018(175):195-199.
[10] Yoshiya S.The effects of exercise and sports activities on bone and joint morbidities[J].Clin Calcium,2017,27(1):39-43.
[11] Jang HD,Hong JY,Han K,et al.Relationship between bone mineral density and alcohol intake:A nationwide health survey analysis of postmenopausal women[J].PLoS One,2017,12(6):e180132.
[12] 崔曼曼,卢晓翠,王怡静,等.广州市某高校大学生骨质疏松知识认知调查[J].中国骨质疏松杂志,2018,24(5):651-655.
[13] 蔡沁,丁志军,章歆,等.经皮椎体成形术治疗老年骨质疏松椎体压缩性骨折的疗效观察[J].慢性病学杂志,2018(8):1-2.
[14] 夏凯,牛素玲,王楠.骨肽注射液在下肢骨折患者术后应用对骨折愈合的影响及其机制[J].创伤外科杂志,2018,20(7):540-543.
[15] 姜溪,陈芙蓉,任雷鸣,等.注射用复方骨肽的药效学及其作用机制研究[J].现代药物与临床,2017,32(6):961-966.
[16] 区志坚,刘学东,黄思聪,等.中医三联序贯疗法与注射用骨肽治疗膝骨性关节炎的临床对照研究[J].海南医学,2018,29(9):1214-1217.
[17] 中国人原发性骨质疏松症诊断标准[J].浙江中西医结合杂志,2007(4):220-227.
[18] 徐苓.2011版《原发性骨质疏松症临床诊疗指南》解读[C].中华医学会第六次全国骨质疏松和骨矿盐疾病学术会议暨中华医学会骨质疏松和骨矿盐疾病分会成立十周年,苏州,2011.
[19] 王玮琪,茹选良,刘春,等.阿托伐他汀联合阿仑膦酸钠治疗老年性骨质疏松的临床疗效及安全性评价[J].中国临床药理学杂志,2016(4):312-314.
[20] Lo CK,Mertz D,Loeb M.Newcastle-Ottawa Scale:comparing reviewers‘ to authors’ assessments[J].BMC Med Res Methodol,2014(14):45.
[21] Margulis AV,Pladevall M,Riera-Guardia N,et al.Quality assessment of observational studies in a drug-safety systematic review,comparison of two tools:the Newcastle-Ottawa Scale and the RTI item bank[J].Clin Epidemiol,2014(6):359-368.
[22] 郑辉烈,俞慧强,刘勇,等.Meta分析发表偏倚的联合诊断研究[J].现代预防医学,2016,43(7):1153-1155.
[23] 郑亮,兰琴,周晓慧,等.STATA软件network模块在两分类数据网络meta分析中的应用[J].同济大学学报(医学版),2018,39(3):119-122.
[24] 成志伟,哈丽恰·霍加西.骨肽注射液治疗骨质疏松症的效果评价[J].新疆医学,2011,41(6):76-77.
[25] 廖化波,张俊娟.阿仑膦酸钠联合骨肽治疗骨质疏松症患者的临床效果[J].中国骨质疏松杂志,2017,23(6):784-786.
[26] 祝雁冰.复方骨肽注射液治疗胸腰椎骨质疏松性骨折临床分析[J].实用药物与临床,2013,16(5):454-455.
[27] 许鹏,姚建锋,王效东,等.谷慷太林对骨质疏松症患者骨密度和血清酶学的影响[J].中国矫形外科杂志,2003(12):49-50.
[28] 孙燕,张建萍.骨化三醇联合骨肽注射液对老年男性骨质疏松症患者骨密度血清IGF-I及BAP表达的影响[J].临床心身疾病杂志,2018(4):9-11,19.
[29] 庞众,刘宁,于尚伟.骨肽在骨质疏松所致腰背痛中的临床应用分析[J].中国伤残医学,2014(16):74.
[30] 张衡才.骨肽注射液穴位注射治疗老年骨质疏松症30例临床观察[J].湖南中医杂志,2017,33(3):84-86.
[31] 陈晓芹.骨肽注射液治疗骨质疏松症50例临床分析[J].中外医学研究,2013,11(26):52-53.
[32] 田杰.骨肽注射液治疗骨质疏松症60例临床分析[J].当代医学,2012,18(11):151.
[33] 彭志军.骨肽注射液治疗骨质疏松症临床效果[J].医学信息,2014(32):315-316.
[34] 高平.骨肽注射液治疗老年骨质疏松症疗效分析[J].现代医学与健康研究电子杂志,2017,1(9):30-31.
[35] 钱学渊.骨肽注射液治疗原发性骨质疏松症64例疗效观察[J].内蒙古中医药,2011,30(10):89-90.
[36] 刘悦,吴刚,李磊.骨肽注射液治疗中老年骨质疏松症疗效观察[J].海南医学院学报,2004(6):404-405.
[37] 康靖东,陈娟,徐伟军,等.鲑降钙素与注射用骨肽联合超声药物透入治疗老年骨质疏松腰背痛的临床比较[J].颈腰痛杂志,2012,33(6):450-453.
[38] 杨大鹏.老年骨质疏松应用骨肽注射液治疗的临床分析[J].中国保健营养,2013(11):6773.
[39] 贾文.穴位注射骨肽注射液治疗原发性骨质疏松症的临床观察[D].武汉:湖北中医药大学,2015.
[40] 赵刚,张士坤.应用复方骨肽注射液治疗原发性骨质疏松症的临床观察[J].中国医院药学杂志,2009,29(6):478-479.
[41] 张辉.用骨肽注射液治疗原发性骨质疏松症的疗效研究[J].当代医药论丛,2014,12(16):221-222.
[42] 刘圳奋,陈军.注射用骨肽与依降钙素在老年性骨质疏松伴全身疼痛患者中的应用比较[J].中国社区医师(医学专业),2012,14(4):110-111.
[43] 黄洁玲,洪曼杰.注射用骨肽在骨质疏松症的防治作用[J].国际医药卫生导报,2009(17):57-59.
[44] Chaimani A,Caldwell DM,Li T,et al.Additional considerations are required when preparing a protocol for a systematic review with multiple interventions[J].Journal of Clinical Epidemiology,2017(83):65-74.
[45] 中华医学会骨质疏松和骨矿盐疾病分会.原发性骨质疏松症诊疗指南(2017)[J].中国实用内科杂志,2018,38(2):127-150.
[46] 屈永周,何绍烜,赵刚.原发性骨质疏松症的病因学研究进展[J].世界最新医学信息文摘,2018,18(35):36-37.
[47] 白璧辉,谢兴文,李鼎鹏,等.我国近5年来骨质疏松症流行病学研究现状[J].中国骨质疏松杂志,2018,24(2):253-258.
[48] 曾淋.足三里雷火灸联合耳穴贴压治疗原发性骨质疏松症的疗效观察[J].当代护士,2018,25(6):111-112.
[49] 赵志强,阎晓霞.中药补肾法改善原发性骨质疏松症临床症状的研究[J].中国骨质疏松杂志,2018,24(3):371-375.
[50] 冯建兵.原发性骨质疏松症30例患者诊疗体会[J].航空航天医学杂志,2018,29(5):579-580.
[51] 李琴.阿仑膦酸钠、唑来膦酸治疗原发性骨质疏松症临床比较[J].世界最新医学信息文摘,2018,18(44):99-101.
[52] 冯小兵,彭阳,吴天昊,等.藤黄健骨胶囊联合唑来膦酸治疗老年原发性骨质疏松的临床研究[J].现代药物与临床,2018,33(7):1788-1792.
[53] 马洁,宋燕青.骨肽注射液的临床应用及其药理作用[J].中国生化药物杂志,2016,36(2):16-18.
[54] 王维刚,王志刚,李大鹏.骨肽对成骨细胞成骨功能表达的影响[J].中国实验诊断学,2012,16(5):764-765.
[55] 王维刚,王志刚,李大鹏.骨肽对骨髓间充质干细胞TGF-1表达的影响[J].中国实验诊断学,2012,16(4):607-608.