首页 | 官方网站   微博 | 高级检索  
     

仙灵骨葆胶囊治疗原发性骨质疏松症随机对照试验的系统评价及Meta分析
引用本文:王桂倩,廖星,章轶立,谢雁鸣.仙灵骨葆胶囊治疗原发性骨质疏松症随机对照试验的系统评价及Meta分析[J].中国中药杂志,2017,42(15):2829-2844.
作者姓名:王桂倩  廖星  章轶立  谢雁鸣
作者单位:中国中医科学院 中医临床基础医学研究所, 北京 100700,中国中医科学院 中医临床基础医学研究所, 北京 100700,中国中医科学院 中医临床基础医学研究所, 北京 100700,中国中医科学院 中医临床基础医学研究所, 北京 100700
基金项目:国家"重大新药创制"科技重大专项(2015ZX09501004-001-009,2015ZX09501004-001-002);中国中医科学院科技创新团队建设项目(PY1303)
摘    要:评价仙灵骨葆胶囊治疗骨质疏松症的有效性和安全性。检索中文和英文数据库共8个(均自建库至2017年2月),按照预先设定的纳入标准与排除标准筛选临床试验,应用风险评估工具进行研究质量评价,提取数据并运用Rev Man 5.3软件进行Meta分析。共检索到1 895篇文献,最终纳入54个研究,总样本数为5 030例,试验组2 543例和对照组2 487例。仙灵骨葆胶囊vs CT(常规治疗)的干预措施下,仙灵骨葆胶囊治疗OP,SOP有效率优于对照组,提高OP患者骨密度MD=0.08,95%CI(0.06,0.10)]。仙灵骨葆胶囊+CT vs CT的干预措施下,仙灵骨葆胶囊治疗OP,PMOP,SOP疗效优于对照组,提高OP患者骨密度MD=0.04,95%CI(0.03,0.05)],提高POP患者骨密度MD=0.08,95%CI(0.05,0.10)],提高SOP患者骨密度MD=0.06,95%CI(0.05,0.07)],减缓OP患者骨质疏松性疼痛MD=-0.93,95%CI(-1.16,-0.70)],提高OP患者碱性磷酸酶MD=7.53,95%CI(5.91,9.14)],提高OP患者血钙MD=0.03,95%CI(0.01,0.06)],提高OP患者骨钙素的含量MD=4.09,95%CI(3.20,4.98)],提高SOP患者血磷含量MD=0.03,95%CI(0.00,0.05)]。研究中报告的不良反应主要以肝损伤和胃肠道症状为主。仙灵骨葆胶囊单用或与其他西药联合使用,在治疗骨质疏松症方面的疗效优于单用西药治疗。但由于纳入研究存在潜在偏倚,研究结论仍需要更多高质量随机对照试验以提高证据级别。

关 键 词:仙灵骨葆胶囊  骨质疏松症  随机对照试验  系统评价  Meta分析
收稿时间:2017/6/5 0:00:00

Systemic evaluation and Meta-analysis of Xianling Gubao capsule in treatment of primary osteoporosis in randomized controlled trials
WANG Gui-qian,LIAO Xing,ZHANG Yi-li and XIE Yan-ming.Systemic evaluation and Meta-analysis of Xianling Gubao capsule in treatment of primary osteoporosis in randomized controlled trials[J].China Journal of Chinese Materia Medica,2017,42(15):2829-2844.
Authors:WANG Gui-qian  LIAO Xing  ZHANG Yi-li and XIE Yan-ming
Affiliation:Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China,Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China,Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China and Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
Abstract:To evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of osteoporosis (OP). Eight Chinese and English databases were retrieved (from establishment to February 2017), and clinical trials were screened according to the preset inclusion criteria and exclusion criteria. Then risk assessment tools were used for quality evaluation of the studies, and data extraction and analysis were conducted by using RevMan 5.3 software for Meta-analysis. A total of 1 895 articles were retrieved, and finally 54 studies were included. The total sample number was 5 030, including 2 543 cases in experimental group and 2 487 cases in control group. As compared with CT (routine therapy) intervention, Xianling Gubao capsules showed higher SOP efficiency and improved bone mineral density in patients with OPMD=0.08, 95%CI (0.06, 0.10)]. As compared with control group, Xianling Gubao capsule+CT showed higher efficiency in PMOP and SOP, increased bone mineral density in OP patientsMD=0.04, 95%CI (0.03, 0.05)], POP patientsMD=0.08, 95%CI (0.05, 0.10)], and SOP patientsMD=0.06, 95%CI (0.05, 0.07)], relieved osteoporotic pain in OP patientsMD=-0.93,95%CI(-1.16, -0.70), increased alkaline phosphatase level in OP patientsMD=7.53, 95%CI (5.91, 9.14), blood calcium in OP patientsMD=0.03, 95%CI (0.01, 0.06)], and osteocalcin level in OP patientsMD=4.09, 95%CI (3.20, 4.98)], and increased serum phosphorus level in SOP patientsMD=0.03, 95%CI (0.00, 0.05)]. The main adverse reactions reported were liver injury and gastrointestinal symptoms. Xianling Gubao capsule alone or combined use with other medicines had better efficacy than western medicine alone in the treatment of osteoporosis. However, because of potential bias in the included studies, more high-quality randomized controlled trials would be needed to improve the level of evidence.
Keywords:Xianling Gubao capsule  osteoporosis  randomized controlled trials  evaluation system  Meta-analysis
本文献已被 CNKI 等数据库收录!
设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司    京ICP备09084417号-23

京公网安备 11010802026262号