[关键词]
[摘要]
目的 系统评价口服淫羊藿类中成药治疗绝经后骨质疏松(postmenopausal osteoporosis,PMOP)的有效性和安全性的差异。方法 计算机检索Cochrane图书馆、PubMed、EMbase、中国知网、中国生物医学文献、万方和维普数据库,搜集淫羊藿类中成药治疗PMOP的随机对照试验(randomized controlled trial,RCT),检索时限从建库至2021年4月。由2位研究员独立筛选文献并提取资料后,评估纳入RCT的偏倚风险,应用GeMTC0.14.3和Stata15.1软件进行贝叶斯网状Meta分析。结果 最终纳入49篇文献,涉及9种中成药共18种用药方案。网状Meta分析表明,①提高总有效率方面,疗效排名前3的用药方案:仙灵骨葆(Xianling Gubao,XLGB)+西医常规治疗(conventional treatment of western medicine,Con)>补(益)肾健骨(Bushen/Yishen Jiangu,JG)+Con>加味二仙(Modified Erxian,EX)+Con;②提高骨密度(bone mineral density,BMD)方面,疗效排名前3的用药方案:骨疏康(Gushukang,GSK)+Con>JG+Con>密骨+Con;③降低视觉模拟(visual analogue scale,VAS)评分方面,疗效排名前3的用药方案:金乌骨通(Jinwu Gutong,JWGT)+Con>EX+Con>XLGB+Con;④提高血钙水平方面,疗效排名前3的用药方案:JG>XLGB+Con>GSK;⑤提高血磷水平方面,疗效排名前3的用药方案:补肾壮骨(Bushen Zhuanggu,BSZG)>GSK+Con>GSK;⑥不良反应发生率方面,GSK可能最低。结论 PMOP的治疗有效性方面,每种中成药都有其独特的优势;安全性方面,中成药总体较安全,GSK的安全性可能最高。受纳入研究的质量和方法学的局限性,该结论尚需更多高质量RCT进行验证。
[Key word]
[Abstract]
Objective To systematically evaluate the efficacy and safety of oral Chinese patent medicine of Epimedium in the treatment of postmenopausal osteoporosis (PMOP). Methods The Cochrane Library, PubMed, EMbase, CNKI, CBM, Wanfang and VIP databases were electronically retrieved to gather randomized controlled trials (RCT) of oral Chinese patent medicine of Epimedium in treatment of PMOP from their inception to Apr. 2021. After two researchers independently screened the literature and extracted the data, the risk of bias of included RCTs was assessed, bayesian network Meta-analysis was performed by GeMTC0.14.3 and Stata15.1. Results A total of 49 RCTs were included, involving 18 drug regimens of nine Chinese patent medicines. Network Meta-analysis showed that ①in terms of improving the total effective rate, the top three therapeutic regimens were Xianling Gubao (XLGB, 仙灵骨葆) + conventional treatment of Western medicine (Con)>Bushen/Yishen Jiangu[JG,补(益)肾健骨] + Con>Modified Erxian (EX) + Con; ②in terms of increasing the level of bone mineral density (BMD), the top three therapeutic regimens:Gushukang (GSK, 骨疏康) + Con>JG + Con>MIGU (密骨) + Con; ③in terms of reducing the visual analogue scale (VAS) score, the top three therapeutic regimens:Jinwu Gutong (JWGT, 金乌骨通) + Con>EX + Con>XLGB + Con; ④in terms of increasing serum calcium level, the top three therapeutic regimens:JG>XLGB + Con>GSK; ⑤in terms of increasing serum phosphorus level, the top three therapeutic regimens:Bushen Zhuanggu (BSZG, 补肾壮骨)>GSK + Con>GSK; ⑥GSK may have the lowest incidence of adverse reactions. Conclusion In terms of therapeutic effectiveness of PMOP, each Chinese patent medicine has its own unique advantages; In terms of safety, Chinese patent medicines are generally safe and GSK may have the highest safety. Due to the quality and methodological limitations of the included studies, more high quality RCTs are needed to validate the conclusions.
[中图分类号]
R285.64
[基金项目]
安徽省重点研究与开发计划项目(1804h08020296);安徽理工大学校级资助项目(QN2019141)