王桂倩++廖星++章轶立++谢雁鸣

[摘要]評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 RevMan 53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=008，95%CI（006，010）]。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=004，95%CI（003，005）]，提高POP患者骨密度[MD=008，95%CI（005，010）]，提高SOP患者骨密度[MD=006，95%CI（005，007）]，减缓OP患者骨质疏松性疼痛[MD=-093，95%CI（-116，-070）]，提高OP患者碱性磷酸酶[MD=753，95%CI（591，914）]，提高OP患者血钙[MD=003，95%CI（001，006）]，提高OP患者骨钙素的含量[MD=409，95%CI（320，498）]，提高SOP患者血磷含量[MD=003，95%CI（000，005）]。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

Systemic evaluation and Metaanalysis of Xianling Gubao capsule

in treatment of primary osteoporosis in randomized controlled trials

WANG Guiqian， LIAO Xing， ZHANG Yili， XIE Yanming*

（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 53 software for Metaanalysis 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 OP [MD=008， 95%CI （006， 010）] As compared with control group， Xianling Gubao capsule+CT showed higher efficiency in PMOP and SOP， increased bone mineral density in OP patients [MD=004， 95%CI （003， 005）]， POP patients [MD=008， 95%CI （005， 010）]， and SOP patients [MD=006， 95%CI （005， 007）]， relieved osteoporotic pain in OP patients [MD=-093，95%CI（-116， -070）， increased alkaline phosphatase level in OP patients [MD=753， 95%CI （591， 914）， blood calcium in OP patients [MD=003， 95%CI （001， 006）]， and osteocalcin level in OP patients [MD=409， 95%CI （320， 498）]， and increased serum phosphorus level in SOP patients [MD=003， 95%CI （000， 005）] 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 highquality randomized controlled trials would be needed to improve the level of evidenceendprint

[Key words]Xianling Gubao capsule； osteoporosis； randomized controlled trials； evaluation system； Metaanalysis

原发性骨质疏松症（primory osteoporosis，OP）是以骨量减少、骨的微观结构退化为特征的致使骨的脆性增加，以及易于发生骨折的一种全身性骨骼疾病[1]。原发性骨质疏松症[2]又分为绝经后骨质疏松症、老年性骨质疏松症、特发性骨质疏松症三大类。随着老龄化社会的到来，增龄引起的骨骼退化性疾病骨质疏松的发病率也随之增加。……