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摘要
目的：系统评价仙灵骨葆胶囊联合常规疗法用于绝经后骨质疏松症（PMOP）的疗效差异。方法：计算机检索Cochrane图书馆、PubMed、Embase、ClinicalTrials、中国知网数据库、维普数据库、万方数据库、中国生物医学数据库，收集仙灵骨葆胶囊联合安慰剂和常规疗法（试验组）对比安慰剂和常规疗法或单用仙灵骨葆胶囊（对照组）用于PMOP的随机对照试验（RCT）。筛选文献，提取资料后采用Cochrane 系统评价员手册5.3推荐的偏倚风险评估工具对纳入文献进行质量评价。采用Stata 14.0软件及马尔科夫链-蒙特卡洛方法进行贝叶斯网状Meta分析。结果：共纳入16项RCT，共计1 360例患者，涉及单用仙灵骨葆胶囊、仙灵骨葆胶囊联合常规疗法和常规疗法等3种干预措施。Meta分析结果显示，在提高总有效率方面，与常规疗法比较，仙灵骨葆胶囊联合常规疗法[OR＝0.28，95％CI（0.12，0.64），P＜0.05]可显著提高总有效率，网状Meta排序结果为仙灵骨葆胶囊联合常规疗法＞单用仙灵骨葆胶囊＞常规疗法。在改善骨密度方面，与常规疗法比较，仙灵骨葆胶囊联合常规疗法[OR＝0.45，95％CI（0.24，0.84），P＜0.05]、单用仙灵骨葆胶囊[OR＝0.78，95％CI（0.32，0.84），P＜0.05]均可显著提高治疗后骨密度，网状Meta排序结果为仙灵骨葆胶囊联合常规疗法＞单用仙灵骨葆胶囊＞常规疗法。在改善血清钙水平方面，与单用仙灵骨葆胶囊[OR＝4.76，95％CI（2.14，10.59），P＜0.05]和常规疗法[OR＝0.45，95％CI（0.21，0.99），P＜0.05]比较，仙灵骨葆胶囊联合常规疗法可显著提高治疗后血清钙水平，网状Meta排序结果为仙灵骨葆胶囊联合常规疗法＞常规疗法＞单用仙灵骨葆胶囊。在改善血清磷水平方面，与单用仙灵骨葆胶囊比较，仙灵骨葆胶囊联合常规疗法[OR＝2.85，95％CI（1.81，4.48），P＜0.05]、常规疗法[OR＝2.93，95％CI（1.76，4.86），P＜0.05]均可显著提高治疗后血清磷水平，网状Meta排序结果为常规疗法＞仙灵骨葆胶囊联合常规疗法＞单用仙灵骨葆胶囊。结论：仙灵骨葆胶囊联合常规疗法可提高PMOP患者的疗效，可增加其治疗后骨密度及提高血清钙水平；但在改善血清磷水平方面，常规疗法的效果最佳。
Abstract
OBJECTIVE： To systematically evaluate the difference of therapeutic efficacy of Xianling gubao capsules combined with routine therapy for postmenopausal osteoporosis （PMOP）. METHODS： Retrieved from Cochrane Library， PubMed， Embase， ClinicalTrials， CNKI， VIP， Wanfang database and CBM， clinical randomized controlled trials （RCTs） about Xianling gubao capsules combined with placebo and routine treatment （trial group） versus placebo and routine treatment or Xianling gubao capsules （control group） alone in the treatment of PMOP were collected. After literature screening and data extraction， the quality of included literatures were evaluated with Cochrane system evaluator manual 5.3 recommend bias risk evaluation tool. Bayesian Network Meta-analysis was performed with Stata 14.0 software and Bayesian Markov Chain Monte Carlo. RESULTS： A total of 16 RCTs were included， involving a total of 1 360 patients and 3 intervention measures as Xianling gubao capsules alone， Xianling gubao capsules combined with routine treatment， routine treatment. Results of Meta-analysis showed that in respect of improving total response rate， compared with routine treatment， Xianling gubao capsules combined with routine treatment [OR＝0.28，95％CI（0.12， 0.64），P＜0.05]could significantly improve total response rate； network Meta-analysis ranking showed that Xianling gubao capsules combined with routine treatment＞Xianling gubao capsules alone＞routine treatment. In terms of increasing bone mineral density （BMD）， compared with routine treatment， Xianling gubao capsules combined with routine treatment [OR＝0.45，95％CI（0.24， 0.84），P＜0.05] and Xianling gubao capsules alone [OR＝0.78， 95％CI（0.32， 0.84），P＜0.05] could significantly improve BMD； network Meta-analysis ranking showed that Xianling gubao capsules combined with routine treatment＞Xianling gubao capsules alone＞routine treatment. In the term of improving serum calcium level， compared with Xianling gubao capsules alone [OR＝4.76，95％CI（2.14， 10.59），P＜0.05] and routine treatment [OR＝0.45， 95％CI（0.21， 0.99），P＜0.05]， Xianling gubao capsules combined with routine treatment could significantly improve serum calcium level； network Meta-analysis ranking showed that Xianling gubao capsules combined with routine treatment＞routine treatment＞Xianling gubao capsules alone. In the term of improving serum phosphorus level， compared with Xianling gubao capsules alone， Xianling gubao capsules combined with routine treatment [OR＝2.85，95％CI（1.81， 4.48），P＜0.05] and routine treatment [OR＝2.93，95％CI（1.76， 4.86），P＜0.05] could significantly improve serum phosphorus level； network Meta-analysis ranking showed that routine treatment＞Xianling gubao capsules combined with routine treatment＞Xianling gubao capsules alone. CONCLUSIONS： Xianling gubao capsules combined with routine treatment can significantly improve therapeutic efficacy of PP patients， increase BMD and serum calcium level after treatment， but routine treatment is the best in improving serum phosphorous level.
关键词
仙灵骨葆胶囊绝经后骨质疏松症疗效贝叶斯网状Meta分析
Keywords
Xianling gubao capsulesPostmenopausal osteoporosisTherapeutic efficacyBayesian network Meta-analysis
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