[1]张智龙,崔鑫,吕健,等.金天格胶囊治疗原发性骨质疏松症有效性和安全性的Meta分析[J].中医正骨,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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金天格胶囊治疗原发性骨质疏松症有效性和安全性的Meta分析()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第35卷
期数:
2023年03期
页码:
15-24
栏目:
文献研究
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:
张智龙1; 崔鑫1; 吕健2; 席俊羽1; 谢雁鸣1
(1.中国中医科学院中医临床基础医学研究所,北京 100700; 2.中国中医科学院西苑医院,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
关键词:
骨质疏松;  金天格胶囊;  专题Meta分析;  有效性;  安全性
Keywords:
osteoporosis;  Jintiange capsule;  meta-analysis as topic;  efficacy;  safety
摘要:
目的:系统评价金天格胶囊治疗原发性骨质疏松症(primary osteoporosis,POP)的有效性和安全性。方法:以计算机检索中国知网、万方数据库、中国生物医学文献服务系统、维普网、Cochrane Library、PubMed、Embase、Web of Science,筛选金天格胶囊治疗POP的随机对照试验,试验组应用金天格胶囊或金天格胶囊联合常规疗法治疗,对照组采用常规疗法治疗。采用RevMan5.4.1软件对最终纳入的研究进行Meta分析。结果:共纳入25项研究,包括1项多臂试验。①针对老年性骨质疏松症(senile osteoporosis,SOP)有效性的分析结果。采用金天格胶囊治疗SOP,治疗后试验组的临床总有效率高于对照组[RR=1.22,95%CI(1.09,1.36),P=0.001],疼痛视觉模拟量表(visual analogue scale,VAS)评分低于对照组[MD=-0.53,95%CI(-0.79,-0.27),P=0.000]; 采用金天格胶囊联合常规疗法治疗SOP,治疗后试验组的临床总有效率、骨密度均高于对照组[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针对绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)有效性的分析结果。采用金天格胶囊治疗PMOP,治疗后2组患者骨密度的差异无统计学意义[MD=0.08,95%CI(0.00,0.16),P=0.060]; 采用金天格胶囊联合常规疗法治疗PMOP,治疗后试验组的临床总有效率、骨密度、血清钙水平、骨钙素水平均高于对照组[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评分低于对照组[MD=-1.81,95%CI(-2.64,-0.97),P=0.000]。③针对安全性的分析结果。无证据表明金天格胶囊可导致严重不良反应。结论:现有证据表明,单独应用金天格胶囊或在常规疗法基础上联合应用金天格胶囊治疗POP的疗效均优于常规疗法,而且具有较高的安全性。
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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备注/Memo

备注/Memo:
基金项目:国家重点研发计划“中医药现代化研究”项目(2018YFC1707400) 通讯作者:谢雁鸣 E-mail:ktzu2018@163.com
更新日期/Last Update: 1900-01-01