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[1]徐國(guó)柱,王建偉,王申.仙靈骨葆膠囊治療絕經(jīng)后骨質(zhì)疏松癥療效和安全性的Meta分析[J].中醫(yī)正骨,2021,33(12):19-26.
　XU Guozhu,WANG Jianwei,WANG Shen.Clinical efficacy and safety of Xianling Gubao Jiaonang(仙靈骨葆膠囊)for treatment of postmenopausal osteoporosis:a meta-analysis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2021,33(12):19-26.
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仙靈骨葆膠囊治療絕經(jīng)后骨質(zhì)疏松癥療效和安全性的Meta分析()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第33卷
期數(shù):
2021年12期
頁(yè)碼:
19-26
欄目:
文獻(xiàn)研究
出版日期:
2021-12-20

文章信息/Info

Title:
Clinical efficacy and safety of Xianling Gubao Jiaonang(仙靈骨葆膠囊)for treatment of postmenopausal osteoporosis:a meta-analysis
作者:
徐國(guó)柱1; 王建偉1; 王申2
(1.長(zhǎng)興縣中醫(yī)院,浙江 長(zhǎng)興 313100; 2.浙江中醫(yī)藥大學(xué),浙江 杭州 310053)
Author(s):
XU Guozhu1; WANG Jianwei1; WANG Shen2
1.TCM Hospital of Changxing County,Changxing 313100,Zhejiang,China2.Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China
關(guān)鍵詞:
骨質(zhì)疏松; 絕經(jīng)后;  仙靈骨葆膠囊;  Meta分析
Keywords:
osteoporosis; postmenopausal;  Xianling Gubao Jiaonang;  Meta-analysis
摘要:
目的:評(píng)價(jià)仙靈骨葆膠囊治療絕經(jīng)后骨質(zhì)疏松癥(postmenopausal osteoporosis,PMOP)的療效和安全性。方法:應(yīng)用計(jì)算機(jī)檢索PubMed、Embase、The Cochrane Library、中國(guó)知網(wǎng)和萬(wàn)方數(shù)據(jù)庫(kù)中關(guān)于仙靈骨葆膠囊治療PMOP的隨機(jī)對(duì)照研究文獻(xiàn),檢索時(shí)限均為建庫(kù)至2020年12月。聯(lián)合治療組采用仙靈骨葆膠囊聯(lián)合骨化三醇或鈣劑治療,對(duì)照組采用單純骨化三醇或鈣劑治療; 根據(jù)聯(lián)合使用藥物是否為骨化三醇將聯(lián)合治療組進(jìn)一步分為聯(lián)合骨化三醇治療組和聯(lián)合非骨化三醇藥物治療組2個(gè)亞組。由2名研究人員獨(dú)立檢索、篩選文獻(xiàn),提取數(shù)據(jù)資料并評(píng)價(jià)納入研究的偏倚風(fēng)險(xiǎn)。采用Revman5.3軟件進(jìn)行Meta分析。結(jié)果:共檢索到917篇文獻(xiàn),最終納入11篇文獻(xiàn)。Meta分析結(jié)果顯示,聯(lián)合治療組患者的治療有效率、股骨頸骨密度、股骨大轉(zhuǎn)子骨密度、腰椎骨密度均高于對(duì)照組[I2=0%,RR=1.29,95%CI(1.19,1.39),P=0.000; I2=83%,SMD=0.89,95%CI(0.47,1.32),P=0.000; I2=33%,SMD=0.74,95%CI(0.51,0.98),P=0.000; I2=78%,SMD=0.75,95%CI(0.37,1.13),P=0.000],不良反應(yīng)發(fā)生率與對(duì)照組比較,差異無(wú)統(tǒng)計(jì)學(xué)意義[I2=0%,RR=0.65,95%CI(0.35,1.20),P=0.170]。亞組分析結(jié)果顯示聯(lián)合骨化三醇治療組、聯(lián)合非骨化三醇藥物治療組患者的治療有效率、股骨頸骨密度、股骨大轉(zhuǎn)子骨密度、腰椎骨密度均高于對(duì)照組[治療有效率:RR=1.23,95%CI(1.11,1.37),P=0.000; RR=1.32,95%CI(1.19,1.46),P=0.000; 股骨頸骨密度:SMD=0.55,95%CI(0.05,1.04),P=0.030; SMD=1.18,95%CI(0.57,1.80),P=0.000; 股骨大轉(zhuǎn)子骨密度:SMD=0.81,95%CI(0.52,1.10),P=0.000; SMD=0.62,95%CI(0.22,1.02),P=0.002; 腰椎骨密度:SMD=0.72,95%CI(0.13,1.30),P=0.020; SMD=0.77,95%CI(0.23,1.30),P=0.005]; 不良反應(yīng)發(fā)生率與對(duì)照組比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義[RR=0.42,95%CI(0.15,1.13),P=0.090; RR=0.91,95%CI(0.41,2.00),P=0.810]。依次剔除1篇文獻(xiàn)進(jìn)行敏感性分析,結(jié)果無(wú)明顯改變。利用治療有效率和股骨頸骨密度分別作發(fā)表偏倚分析,漏斗圖均顯示各研究點(diǎn)分布不對(duì)稱,提示可能存在發(fā)表偏倚。結(jié)論:仙靈骨葆膠囊治療PMOP的療效較好,且較為安全。
Abstract:
Objective:To evaluate the clinical curative effects and safety of oral application of Xianling Gubao Jiaonang(仙靈骨葆膠囊,XLGBJN)for treatment of postmenopausal osteoporosis(PMOP).Methods:All the randomized controlled trial(RCT)articles about oral application of XLGBJN for treatment of PMOP included from database establishing to December 2020 were retrieved from the PubMed,Embase,The Cochrane Library,China National Knowledge Internet and Wanfang Database through computer.The patients in combination treatment group were treated with oral applications of XLGBJN and calcitriol or XLGBJN and calcium,while the ones in control group with oral application of calcitriol or calcium alone.The patients in combination treatment group were further subgrouped into calcitriol treatment group and non-calcitriol treatment group according to whether calcitriol was used during the period of combination treatment.The articles were retrieved and screened and the information was extracted independently by two researchers according to the inclusion and exclusion criteria.The risk of bias of included researches in the articles was assessed according to Cochrane handbook and a Meta-analysis was conducted by using Revman5.3 software.Results:Nine hundred and seventeen articles were searched out.After screening,11 articles were included in the final analysis.The results of Meta-analysis revealed that the clinical effective rate,bone mineral density(BMD)of femoral neck,greater trochanter of femur and lumbar vertebrae were all higher in combination treatment group compared to control group(I2=0%,RR=1.29,95%CI(1.19,1.39),P=0.000; I2=83%,SMD=0.89,95%CI(0.47,1.32),P=0.000; I2=33%,SMD=0.74,95%CI(0.51,0.98),P=0.000; I2=78%,SMD=0.75,95%CI(0.37,1.13),P=0.000),while there was no statistical difference in incidence rate of adverse reactions between combination treatment group and control group(I2=0%,RR=0.65,95%CI(0.35,1.20),P=0.170).The results of subgroup analysis showed that the clinical effective rate,BMD of femoral neck,greater trochanter of femur and lumbar vertebrae were all higher in calcitriol treatment group and non-calcitriol treatment group compared to control group(clinical effective rate:RR=1.23,95%CI(1.11,1.37),P=0.000; RR=1.32,95%CI(1.19,1.46),P=0.000; BMD of femoral neck:SMD=0.55,95%CI(0.05,1.04),P=0.030; SMD=1.18,95%CI(0.57,1.80),P=0.000; BMD of greater trochanter of femur:SMD=0.81,95%CI(0.52,1.10),P=0.000; SMD=0.62,95%CI(0.22,1.02),P=0.002; BMD of lumbar vertebrae:SMD=0.72,95%CI(0.13,1.30),P=0.020; SMD=0.77,95%CI(0.23,1.30),P=0.005),while there was no statistical difference in incidence rate of adverse reactions between calcitriol treatment group and control group as well as between non-calcitriol treatment group and control group(RR=0.42,95%CI(0.15,1.13),P=0.090; RR=0.91,95%CI(0.41,2.00),P=0.810).The sensitivity analysis was performed through excluding the included articles in turn,and no obvious changes in meta-analysis results were found.Publication bias was analyzed according to funnel plots drawned based on clinical effective rate and BMD of femoral neck,and the asymmetrical funnel plots demonstrated that there might be publication bias.Conclusion:XLGBJN has good clinical curative effects and high safety in treatment of PMOP.

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通訊作者:王申 E-mail:[email protected]
更新日期/Last Update: 1900-01-01