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[1]張智龍,崔鑫,呂健,等.金天格膠囊治療原發(fā)性骨質(zhì)疏松癥有效性和安全性的Meta分析[J].中醫(yī)正骨,2023,35(03):15-24.
　ZHANG Zhilong,CUI Xin,LV Jian,et al.A Meta-analysis of efficacy and safety of Jintiange Capsules in the treatment of primary osteoporosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2023,35(03):15-24.
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金天格膠囊治療原發(fā)性骨質(zhì)疏松癥有效性和安全性的Meta分析()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第35卷
期數(shù):
2023年03期
頁碼:
15-24
欄目:
文獻(xiàn)研究
出版日期:
2023-03-20

文章信息/Info

Title:
A Meta-analysis of efficacy and safety of Jintiange Capsules in the treatment of primary osteoporosis
作者:
張智龍1; 崔鑫1; 呂健2; 席俊羽1; 謝雁鳴1
(1.中國中醫(yī)科學(xué)院中醫(yī)臨床基礎(chǔ)醫(yī)學(xué)研究所,北京 100700; 2.中國中醫(yī)科學(xué)院西苑醫(yī)院,北京 100091)
Author(s):
ZHANG Zhilong1; CUI Xin1; LV Jian2; XI Junyu1; XIE Yanming1
1.Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China 2.Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China
關(guān)鍵詞:
骨質(zhì)疏松;  金天格膠囊;  專題Meta分析;  有效性;  安全性
Keywords:
osteoporosis;  Jintiange capsule;  meta-analysis as topic;  efficacy;  safety
摘要:
目的:系統(tǒng)評(píng)價(jià)金天格膠囊治療原發(fā)性骨質(zhì)疏松癥(primary osteoporosis,POP)的有效性和安全性。方法:以計(jì)算機(jī)檢索中國知網(wǎng)、萬方數(shù)據(jù)庫、中國生物醫(yī)學(xué)文獻(xiàn)服務(wù)系統(tǒng)、維普網(wǎng)、Cochrane Library、PubMed、Embase、Web of Science,篩選金天格膠囊治療POP的隨機(jī)對(duì)照試驗(yàn),試驗(yàn)組應(yīng)用金天格膠囊或金天格膠囊聯(lián)合常規(guī)療法治療,對(duì)照組采用常規(guī)療法治療。采用RevMan5.4.1軟件對(duì)最終納入的研究進(jìn)行Meta分析。結(jié)果:共納入25項(xiàng)研究,包括1項(xiàng)多臂試驗(yàn)。①針對(duì)老年性骨質(zhì)疏松癥(senile osteoporosis,SOP)有效性的分析結(jié)果。采用金天格膠囊治療SOP,治療后試驗(yàn)組的臨床總有效率高于對(duì)照組[RR=1.22,95%CI(1.09,1.36),P=0.001],疼痛視覺模擬量表(visual analogue scale,VAS)評(píng)分低于對(duì)照組[MD=-0.53,95%CI(-0.79,-0.27),P=0.000]; 采用金天格膠囊聯(lián)合常規(guī)療法治療SOP,治療后試驗(yàn)組的臨床總有效率、骨密度均高于對(duì)照組[RR=1.19,95%CI(1.12,1.26),P=0.000; MD=0.06,95%CI(0.03,0.08),P=0.000]。②針對(duì)絕經(jīng)后骨質(zhì)疏松癥(postmenopausal osteoporosis,PMOP)有效性的分析結(jié)果。采用金天格膠囊治療PMOP,治療后2組患者骨密度的差異無統(tǒng)計(jì)學(xué)意義[MD=0.08,95%CI(0.00,0.16),P=0.060]; 采用金天格膠囊聯(lián)合常規(guī)療法治療PMOP,治療后試驗(yàn)組的臨床總有效率、骨密度、血清鈣水平、骨鈣素水平均高于對(duì)照組[RR=1.18,95%CI(1.10,1.26),P=0.000; MD=0.10,95%CI(0.05,0.15),P=0.000; MD=0.05,95%CI(0.02,0.08),P=0.001; MD=2.17,95%CI(1.80,2.54),P=0.000],疼痛VAS評(píng)分低于對(duì)照組[MD=-1.81,95%CI(-2.64,-0.97),P=0.000]。③針對(duì)安全性的分析結(jié)果。無證據(jù)表明金天格膠囊可導(dǎo)致嚴(yán)重不良反應(yīng)。結(jié)論:現(xiàn)有證據(jù)表明,單獨(dú)應(yīng)用金天格膠囊或在常規(guī)療法基礎(chǔ)上聯(lián)合應(yīng)用金天格膠囊治療POP的療效均優(yōu)于常規(guī)療法,而且具有較高的安全性。
Abstract:
Objective:To systematically evaluate the efficacy and safety of Jintiange Capsules in the treatment of primary osteoporosis(POP).Methods:CNKI,Wanfang Data,SinoMed,VIP,Cochrane Library,PubMed,Embase,and Web of Science were searched for randomized controlled trials(RCTs)of Jintiange Capsules in the treatment of POP.The patients in the experimental group were treated with Jintiange Capsules or Jintiange Capsules combined with conventional therapy,and those in the control group were treated with conventional therapy.RevMan5.4.1 software was employed for the Meta-analysis of the included RCTs.Results:Twenty-five RCTs were enrolled,including one multi-arm trial.①Efficacy analysis of senile osteoporosis(SOP).After the treatment of SOP with Jintiange Capsules,the total clinical response rate of the experimental group was higher than that of the control group(RR=1.22,95%CI(1.09,1.36),P=0.001),and the visual analogue scale(VAS)score was lower than that of the control group(MD=-0.53,95%CI(-0.79,-0.27),P=0.000).After the treatment of SOP with Jintiange Capsules combined with conventional therapy,the total clinical response rate and bone mineral density of the experimental group were higher than those of the control group(RR=1.19,95%CI(1.12,1.26),P=0.000; MD=0.06,95%CI(0.03,0.08),P=0.000).②Efficacy analysis of postmenopausal osteoporosis(PMOP).After the treatment of PMOP with Jintiange Capsules,there was no significant difference in bone mineral density between the two groups(MD=0.08,95%CI(0.00,0.16),P=0.060).After the treatment of PMOP by Jintiange Capsules combined with conventional therapy,the total clinical response rate,bone mineral density,serum calcium level,and osteocalcin level of the experimental group were higher than those of the control group(RR=1.18,95%CI(1.10,1.26),P=0.000; MD=0.10,95%CI(0.05,0.15),P=0.000; MD=0.05,95%CI(0.02,0.08),P=0.001; MD=2.17,95%CI(1.80,2.54),P=0.000),and the pain VAS score was lower than that of the control group(MD=-1.81,95%CI(-2.64,-0.97),P=0.000).③Safety analysis.No evidence supported that Jintiange Capsules could cause severe adverse reactions.Conclusion:As indicated by existing evidence,the efficacy of Jintiange Capsules alone or combined with conventional therapy in the treatment of POP is superior to that of conventional therapy,with good safety.

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備注/Memo

備注/Memo:
基金項(xiàng)目:國家重點(diǎn)研發(fā)計(jì)劃“中醫(yī)藥現(xiàn)代化研究”項(xiàng)目(2018YFC1707400) 通訊作者:謝雁鳴 E-mail:[email protected]
更新日期/Last Update: 1900-01-01