[1]徐国柱,王建伟,王申.仙灵骨葆胶囊治疗绝经后骨质疏松症疗效和安全性的Meta分析[J].中医正骨,2021,33(12):19-26.
　XU Guozhu,WANG Jianwei,WANG Shen.Clinical efficacy and safety of Xianling Gubao Jiaonang(仙灵骨葆胶囊)for treatment of postmenopausal osteoporosis:a meta-analysis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2021,33(12):19-26.
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仙灵骨葆胶囊治疗绝经后骨质疏松症疗效和安全性的Meta分析()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第33卷
期数:
2021年12期
页码:
19-26
栏目:
文献研究
出版日期:
2021-12-20

文章信息/Info

Title:
Clinical efficacy and safety of Xianling Gubao Jiaonang(仙灵骨葆胶囊)for treatment of postmenopausal osteoporosis:a meta-analysis
作者:
徐国柱1; 王建伟1; 王申2
(1.长兴县中医院,浙江 长兴 313100; 2.浙江中医药大学,浙江 杭州 310053)
Author(s):
XU Guozhu1; WANG Jianwei1; WANG Shen2
1.TCM Hospital of Changxing County,Changxing 313100,Zhejiang,China2.Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China
关键词:
骨质疏松; 绝经后;  仙灵骨葆胶囊;  Meta分析
Keywords:
osteoporosis; postmenopausal;  Xianling Gubao Jiaonang;  Meta-analysis
摘要:
目的:评价仙灵骨葆胶囊治疗绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)的疗效和安全性。方法:应用计算机检索PubMed、Embase、The Cochrane Library、中国知网和万方数据库中关于仙灵骨葆胶囊治疗PMOP的随机对照研究文献,检索时限均为建库至2020年12月。联合治疗组采用仙灵骨葆胶囊联合骨化三醇或钙剂治疗,对照组采用单纯骨化三醇或钙剂治疗; 根据联合使用药物是否为骨化三醇将联合治疗组进一步分为联合骨化三醇治疗组和联合非骨化三醇药物治疗组2个亚组。由2名研究人员独立检索、筛选文献,提取数据资料并评价纳入研究的偏倚风险。采用Revman5.3软件进行Meta分析。结果:共检索到917篇文献,最终纳入11篇文献。Meta分析结果显示,联合治疗组患者的治疗有效率、股骨颈骨密度、股骨大转子骨密度、腰椎骨密度均高于对照组[I2=0%,RR=1.29,95%CI(1.19,1.39),P=0.000; I2=83%,SMD=0.89,95%CI(0.47,1.32),P=0.000; I2=33%,SMD=0.74,95%CI(0.51,0.98),P=0.000; I2=78%,SMD=0.75,95%CI(0.37,1.13),P=0.000],不良反应发生率与对照组比较,差异无统计学意义[I2=0%,RR=0.65,95%CI(0.35,1.20),P=0.170]。亚组分析结果显示联合骨化三醇治疗组、联合非骨化三醇药物治疗组患者的治疗有效率、股骨颈骨密度、股骨大转子骨密度、腰椎骨密度均高于对照组[治疗有效率:RR=1.23,95%CI(1.11,1.37),P=0.000; RR=1.32,95%CI(1.19,1.46),P=0.000; 股骨颈骨密度:SMD=0.55,95%CI(0.05,1.04),P=0.030; SMD=1.18,95%CI(0.57,1.80),P=0.000; 股骨大转子骨密度:SMD=0.81,95%CI(0.52,1.10),P=0.000; SMD=0.62,95%CI(0.22,1.02),P=0.002; 腰椎骨密度:SMD=0.72,95%CI(0.13,1.30),P=0.020; SMD=0.77,95%CI(0.23,1.30),P=0.005]; 不良反应发生率与对照组比较,差异均无统计学意义[RR=0.42,95%CI(0.15,1.13),P=0.090; RR=0.91,95%CI(0.41,2.00),P=0.810]。依次剔除1篇文献进行敏感性分析,结果无明显改变。利用治疗有效率和股骨颈骨密度分别作发表偏倚分析,漏斗图均显示各研究点分布不对称,提示可能存在发表偏倚。结论:仙灵骨葆胶囊治疗PMOP的疗效较好,且较为安全。
Abstract:
Objective:To evaluate the clinical curative effects and safety of oral application of Xianling Gubao Jiaonang(仙灵骨葆胶囊,XLGBJN)for treatment of postmenopausal osteoporosis(PMOP).Methods:All the randomized controlled trial(RCT)articles about oral application of XLGBJN for treatment of PMOP included from database establishing to December 2020 were retrieved from the PubMed,Embase,The Cochrane Library,China National Knowledge Internet and Wanfang Database through computer.The patients in combination treatment group were treated with oral applications of XLGBJN and calcitriol or XLGBJN and calcium,while the ones in control group with oral application of calcitriol or calcium alone.The patients in combination treatment group were further subgrouped into calcitriol treatment group and non-calcitriol treatment group according to whether calcitriol was used during the period of combination treatment.The articles were retrieved and screened and the information was extracted independently by two researchers according to the inclusion and exclusion criteria.The risk of bias of included researches in the articles was assessed according to Cochrane handbook and a Meta-analysis was conducted by using Revman5.3 software.Results:Nine hundred and seventeen articles were searched out.After screening,11 articles were included in the final analysis.The results of Meta-analysis revealed that the clinical effective rate,bone mineral density(BMD)of femoral neck,greater trochanter of femur and lumbar vertebrae were all higher in combination treatment group compared to control group(I2=0%,RR=1.29,95%CI(1.19,1.39),P=0.000; I2=83%,SMD=0.89,95%CI(0.47,1.32),P=0.000; I2=33%,SMD=0.74,95%CI(0.51,0.98),P=0.000; I2=78%,SMD=0.75,95%CI(0.37,1.13),P=0.000),while there was no statistical difference in incidence rate of adverse reactions between combination treatment group and control group(I2=0%,RR=0.65,95%CI(0.35,1.20),P=0.170).The results of subgroup analysis showed that the clinical effective rate,BMD of femoral neck,greater trochanter of femur and lumbar vertebrae were all higher in calcitriol treatment group and non-calcitriol treatment group compared to control group(clinical effective rate:RR=1.23,95%CI(1.11,1.37),P=0.000; RR=1.32,95%CI(1.19,1.46),P=0.000; BMD of femoral neck:SMD=0.55,95%CI(0.05,1.04),P=0.030; SMD=1.18,95%CI(0.57,1.80),P=0.000; BMD of greater trochanter of femur:SMD=0.81,95%CI(0.52,1.10),P=0.000; SMD=0.62,95%CI(0.22,1.02),P=0.002; BMD of lumbar vertebrae:SMD=0.72,95%CI(0.13,1.30),P=0.020; SMD=0.77,95%CI(0.23,1.30),P=0.005),while there was no statistical difference in incidence rate of adverse reactions between calcitriol treatment group and control group as well as between non-calcitriol treatment group and control group(RR=0.42,95%CI(0.15,1.13),P=0.090; RR=0.91,95%CI(0.41,2.00),P=0.810).The sensitivity analysis was performed through excluding the included articles in turn,and no obvious changes in meta-analysis results were found.Publication bias was analyzed according to funnel plots drawned based on clinical effective rate and BMD of femoral neck,and the asymmetrical funnel plots demonstrated that there might be publication bias.Conclusion:XLGBJN has good clinical curative effects and high safety in treatment of PMOP.

参考文献/References:

[1] KANIS J A,COOPER C,RIZZOLI R,et al.European guidance for the diagnosis and management of osteoporosis in postmenopausal women[J].Osteoporos Int,2019,30(1):3-44.
[2] 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].Ann Intern Med,2017,166(11):818-839.
[3] 中国老年学和老年医学学会骨质疏松分会.中国老年骨质疏松诊疗指南(2018)[J].中国老年学杂志,2019,39(11):2557-2575.
[4] 中华中医药学会.绝经后骨质疏松症(骨痿)中医药诊疗指南(2019年版)[J].中医正骨,2020,32(2):1-13.
[5] 石淇允,李无阴,张颖,等.老年髋部骨折危险因素的研究进展[J].中医正骨,2019,31(8):45-47.
[6] 许一帆,樊炳楷,黄金山,等.肌少-骨质疏松症的研究进展[J].中医正骨,2019,31(5):22-25.
[7] 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].中国骨质疏松杂志,2019,25(3):281-309.
[8] LEWIECKI E M,BINKLEY N,CLARK P,et al.Core principles for fracture prevention:North American Consensus from the National Osteoporosis Foundation,Osteoporosis Canada,and Academia Nacional de Medicina de Mexico[J].Osteoporos Int,2020,31(11):2073-2076.
[9] KHOSLA S,HOFBAUER L C.Osteoporosis treatment:recent developments and ongoing challenges[J].Lancet Diabetes Endocrinol,2017,5(11):898-907.
[10] 陈镜,冯正平.骨质疏松症治疗药物研究进展[J].中国骨质疏松杂志,2021,27(5):776-780.
[11] ABRAHAMSEN B,GROVE E L,VESTERGAARD P.Nationwide registry-based analysis of cardiovascular risk factors and adverse outcomes in patients treated with strontium ranelate[J].Osteoporos Int,2014,25(2):757-762.
[12] COMPSTON J,COOPER A,COOPER C,et al.UK clinical guideline for the prevention and treatment of osteopo-rosis[J].Arch Osteoporos,2017,12(1):43.
[13] 刘云,罗晓婷,李崇,等.雌激素治疗绝经后骨质疏松症的研究进展[J].实用临床医学,2020,21(10):91-96.
[14] 关健雷,王秋园,刘沛,等.基于网络药理学及分子对接探究复方“仙灵骨葆”治疗骨质疏松分子机制[J].辽宁中医药大学学报,2021,23(2):57-65.
[15] 安一方,章轶立,谢雁鸣,等.仙灵骨葆胶囊治疗绝经后骨质疏松症有效性的系统评价和Meta分析[J].中国骨质疏松杂志,2019,25(1):47-61.
[16] 李勇泉.仙灵骨葆胶囊联合醋酸钙胶囊对绝经期后妇女骨质疏松的疗效[J].世界复合医学,2020,6(5):183-185.
[17] 尚玉敏,刘艳艳,李惠萍.仙灵骨葆胶囊治疗绝经后骨质疏松症的临床观察[J].中国中西医结合急救杂志,2007,14(1):55.
[18] 屈静,诸葛勇华,边平达,等.仙灵骨葆胶囊对高龄女性OP患者BTMs和BMD的影响[J].浙江临床医学,2018,20(10):1683-1684.
[19] 聂达荣,彭美玉,林增如,等.仙灵骨葆胶囊合罗钙全治疗绝经后骨质疏松性疼痛35例临床观察[J].福建中医学院学报,2009,19(3):37-38.
[20] 王宇,盛晨曦.仙灵骨葆胶囊联合阿法骨化醇治疗绝经后骨质疏松患者疗效观察[J].国际医药卫生导报,2019,25(7):1099-1102.
[21] 李红.仙灵骨葆胶囊联合骨化三醇治疗绝经后骨质疏松症30例[J].河南中医,2015,35(12):3000-3001.
[22] 陈鑫,朱雄白,林文军,等.仙灵骨葆胶囊治疗绝经后骨质疏松的疗效及其机制研究[J].中国临床药理学杂志,2015,31(10):827-829.
[23] 宋小梅.仙灵骨葆胶囊治疗绝经期骨质疏松症临床研究[J].河南中医,2017,37(4):686-688.
[24] 李爱芝.仙灵骨葆胶囊治疗女性更年期骨质疏松症的可行性研究[J].中国社区医师,2018,34(18):100-101.
[25] 巴哈德尔,陶剑,崔永刚.仙灵骨葆联合钙尔奇D治疗绝经后骨质疏松症的临床研究[J].世界最新医学信息文摘,2012,12(9):46-47.
[26] 钟银燕,章源,包斐丰,中西药结合治疗绝经后骨质疏松症临床观察[J].新中医,2015,47(1):145-147.
[27] JACOBS K M,BHAVE S R,FERRARO D J,et al.GSK-3β:A bifunctional role in cell death p6athways[J].Int J Cell Biol,2012[2021-04-18].https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3364548/.DOI:10.1155/2012/930710.
[28] THAMILSELVAN V,MENON M,THAMILSELVAN S.Anticancer efficacy of deguelin in human prostate cancer cells targeting glycogen synthase kinase-3β/β-catenin pathway[J].Int J Cancer,2011,129(12):2916-2927.
[29] ZHAO J G,ZENG X T,WANG J,et al.Association between calcium or vitamin D supplementation and fracture incidence in community-dwelling older adult a systematic review and meta-analysis[J].JAMA,2017,318(24):2466-2482.
[30] 张冰彬,董克芳.骨萎汤配方颗粒治疗绝经后骨质疏松症(肾阳虚证)的临床观察[J].中医临床研究,2020,12(13):5-12.
[31] 吴海洋,索欢,王平.绝经后骨质疏松症的临床中药治疗进展[J].中国骨质疏松杂志,2015,21(2):241-244.
[32] 赵文昌,宋丽军,温凯航,等.淫羊藿抗骨质疏松症的研究进展[J].中国医药导报,2012,9(25):20-22.
[33] 陈柏龄,谢登辉,王宗伟,等.淫羊藿总黄酮对去卵巢大鼠骨组织OPG、OPGL mRNA表达的影响[J].中国骨伤,2009,22(4):271-273.
[34] 石丹宁,赵丕文.中药治疗绝经后骨质疏松症及其作用机制的研究进展[J].环球中医药,2018,11(4):600-604.

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　CAO Junqing,ZHENG Jiannan,ZHANG Lin.A clinical study of oral application of Yougui Wan(右归丸)and alendronate sodium for treatment of postmenopausal osteoporosis with kidney-yang deficiency syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2018,30(12):20.
[19]李中万,徐绍俊,杨广钢,等.健肾方联合碳酸钙D3咀嚼片(Ⅱ) 治疗绝经后骨质疏松症肾阳虚证[J].中医正骨,2018,30(08):11.
　LI Zhongwan,XU Shaojun,YANG Guanggang,et al.Oral application of Jianshen Fang(健肾方)and calcium carbonate and Vitamin D3 chewable tablets(Ⅱ)for treatment of postmenopausal osteoporosis with kidney-yang deficiency syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2018,30(12):11.
[20]赵凡,刘全,吴连国.口服强骨饮联合碳酸钙D3片治疗绝经后骨质疏松症的临床研究[J].中医正骨,2019,31(04):26.
　ZHAO Fan,LIU Quan,WU Lianguo.Oral applications of Qianggu Yin(强骨饮)and calcium carbonate and Vitamin D3 tablets for treatment of postmenopausal osteoporosis:a clinical study[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2019,31(12):26.

备注/Memo

备注/Memo:
通讯作者:王申 E-mail:244430214@qq.com
更新日期/Last Update: 1900-01-01