唑来膦酸联合仙灵骨葆胶囊治疗骨质疏松临床疗效的Meta分析

Meta-analysis of the clinical efficacy of zoledronic acid combined with Xianling Gubao Capsules in the treatment of osteoporosis

目的采用Meta分析系统评价唑来膦酸联合仙灵骨葆胶囊治疗骨质疏松的临床疗效。方法计算机检索中国知网、中国生物医学文献数据库、万方数据库、维普网、Cochrane图书馆、PubMed、Web of science和Embase,检索从建库至2022年11月所收录的唑来膦酸联合仙灵骨葆胶囊治疗骨质疏松的随机对照试验(randomized controlled trial,RCT)的研究,对符合纳入标准的文献参照Cochrane评价手册进行文献质量评估,运用RevMan 5.4软件进行Meta分析。结果研究共纳入10篇文献的随机对照试验,共1196例患者,试验组598例,对照组598例。对纳入数据进行Meta分析显示,采用唑来膦酸联合仙灵骨葆胶囊治疗骨质疏松,可有效提高临床总有效率[OR=4.81,95%CI(2.97,7.79),P<0.00001],增加腰椎骨密度[SMD=1.07,95%CI(0.66,1.49),P<0.00001]、股骨颈骨密度[SMD=0.73,95%CI(0.46,1.00),P<0.00001]、股骨前端骨密度[SMD=0.49,95%CI(0.18,0.80),P=0.002],降低不良反应发生率[OR=0.59,95%CI(0.35,0.98),P=0.04],降低Ⅰ型胶原交联C-末端肽[SMD=-0.74,95%CI(-1.08,-0.41),P<0.0001]和骨碱性磷酸酶[SMD=-1.22,95%CI(-2.01,-0.43),P=0.003],减轻患者视觉模拟评分(VAS评分)[SMD=-2.26,95%CI(-3.25,-1.28),P<0.0001]。结论采用唑来膦酸联合仙灵骨葆胶囊治疗骨质疏松患者可提高临床疗效,增加骨密度,降低Ⅰ型胶原交联C-末端肽和骨碱性磷酸酶水平,减轻患者疼痛,减少不良反应发生率。

Objective To evaluate the clinical efficacy of zoledronic acid combined with Xianling Gubao Capsules in the treatment of osteoporosis by Meta-analysis system.Methods Computer search was conducted on CNKI,China Biology Medicine disc,Wanfang Database,VIP Network,Cochrane Library,PubMed,Web of Science and Embase,and randomized controlled trial(RCT)study of zoledronic acid combined with Xianling Gubao Capsules in the treatment of osteoporosis included from the establishment of the database to November 2022 were searched,and the quality of the documents meeting inclusion criteria were evaluated by referring to the Cochrane evaluation manual,and RevMan 5.4 software was used for Meta-analysis.Results A total of 1196 patients(598 in experimental group and 598 in control group)were included in 10 randomized controlled trials.Meta-analysis of the included data showed that zoledronic acid combined with Xianling Gubao Capsules could effectively improve total clinical effective rate(OR=4.81,95%CI[2.97,7.79],P<0.00001),increase lumbar bone density(SMD=1.07,95%CI[0.66,1.49],P<0.00001),femoral neck bone density(SMD=0.73,95%CI[0.46,1.00],P<0.00001)and femoral front bone density(SMD=0.49,95%CI[0.18,0.80],P=0.002),reduce the incidence of adverse reactions(OR=0.59,95%CI[0.35,0.98],P=0.04),cross-linked C-terminal peptide of typeⅠcollagen(SMD=-0.74,95%CI[-1.08,-0.41],P<0.0001),bone alkaline phosphatase(SMD=-1.22,95%CI[-2.01,-0.43],P=0.003),and the visual analog score(VAS score)of patients(SMD=-2.26,95%CI[-3.25,-1.28],P<0.0001).Conclusion Zoledronic acid combined with Xianling Gubao Capsules in the treatment of osteoporosis can improve clinical efficacy,increase bone mineral density,reduce cross-linked C-terminal peptide of typeⅠcollagen and bone alkaline phosphatase,alleviate the pain of patients,and reduce the incidence of adverse reactions.