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

发布时间：2018-04-13 09:43

本文选题：仙灵骨葆胶囊 + 骨质疏松症　；参考：《中国中药杂志》2017年15期

【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。
[Abstract]:To evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of osteoporosis.A total of 8 databases in Chinese and English were retrieved (both self-built until February 2017). Clinical trials were screened according to pre-set inclusion and exclusion criteria, and risk assessment tools were used to evaluate the research quality.The data were extracted and Meta analysis was carried out with Rev Man 5.3 software.A total of 1 895 articles were retrieved and 54 studies were included. The total number of samples was 5 030 cases, 2 543 cases in the experimental group and 2 487 cases in the control group.Under the intervention of Xianling Gubao capsule vs CTL (routine treatment), the effective rate of Xianling Gubao capsule in the treatment of OPN SOP was better than that in the control group, and the bone mineral density of op patients was increased [MDO 0.08 ~ 95CIJ 0.06 0.10].The therapeutic effect of Xianling Gubao capsule on OPPMOPSOP was better than that of the control group under the intervention of CT vs CT, and the therapeutic effect of Xianling Gubao capsule was better than that of the control group.[MDT 4.09 + 95 + CI 3.20 + 4.98], to increase the blood phosphorus content of SOP patients [MDO 0.03 + 95 CI 0.005].The main adverse reactions reported in the study were liver injury and gastrointestinal symptoms.The therapeutic effect of Xianling Gubao capsule alone or in combination with other western medicine is superior to that of western medicine alone in the treatment of osteoporosis.However, due to the potential bias of inclusion, more high quality randomized controlled trials are needed to improve the evidence level.
【作者单位】：中国中医科学院中医临床基础医学研究所;
【基金】：国家“重大新药创制”科技重大专项(2015ZX09501004-001-009,015ZX09501004-001-002) 中国中医科学院科技创新团队建设项目(PY1303)
【分类号】：R259

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