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　FAN Yisong,YU Guisong,TANG Zhenkun,et al.Systematic review on Bushen Huoxue Tang(补肾活血汤)for treatment of osteonecrosis of the femoral head[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(03):26-34.
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补肾活血汤治疗股骨头坏死的系统评价()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期数:
2020年03期
页码:
26-34
栏目:
文献研究
出版日期:
2020-03-20

文章信息/Info

Title:
Systematic review on Bushen Huoxue Tang(补肾活血汤)for treatment of osteonecrosis of the femoral head
作者:
范奕松1; 俞桂松1; 唐振坤1; 肖鲁伟2; 童培建2
(1.浙江中医药大学第一临床医学院,浙江 杭州 310053; 2.浙江省中医院,浙江 杭州 310006)
Author(s):
FAN Yisong1; YU Guisong1; TANG Zhenkun1; XIAO Luwei2; TONG Peijian2
1.The First Clinical Medical College of Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China 2.Zhejiang Provincial Hospital of Traditional Chinese Medicine,Hangzhou 310006,Zhejiang,China
关键词:
股骨头坏死;  补肾活血汤;  Meta分析;  系统评价
Keywords:
femur head necrosis;  Bushen Huoxue Tang;  meta-analysis;  systematic review
摘要:
目的:评价补肾活血汤治疗股骨头坏死(osteonecrosis of the femoral head,ONFH)的临床疗效和安全性。方法:计算机检索中国生物医学文献数据库、中国知网、万方医学网、维普网建库至 2019年2月收录的所有补肾活血汤治疗ONFH的随机对照研究文献。筛选文献后提取数据,采用Cochrane文献质量评价标准和Jadad评分量表对纳入的文献进行质量评估,采用Revman5.3软件进行Meta分析。结果:纳入19篇文献,涉及1717例ONFH患者。19篇文献研究质量均较低,Jadad评分均≤2分。Meta分析结果显示,治疗组的总有效率高于对照组[I2=0%,OR=3.53,95%CI(2.63,4.75)]; 治疗后的Harris评分总分、Harris髋关节疼痛评分、Harris髋关节活动度评分及Harris髋关节功能评分均高于对照组[I2=98%,WMD=10.62,95%CI(5.55,15.69); I2=87%,WMD=5.03,95%CI(3.02,7.04); I2=98%,WMD=0.82,95%CI(0.06,1.58); I2=47%,WMD=5.17,95%CI(3.60,6.75)]; 治疗后的低密度脂蛋白胆固醇、总胆固醇及甘油三酯均低于对照组[I2=31%,WMD=-0.47,95%CI(-0.66,-0.27); I2=50%,WMD=-0.31,95%CI(-0.51,-0.12); I2=0%,WMD=-0.16,95%CI(-0.23,-0.10)]; 治疗后的血浆黏度、全血黏度高切值、全血黏度低切值和红细胞比容均低于对照组[I2=0%,WMD=-0.20,95%CI(-0.27,-0.12); I2=80%,WMD=-0.75,95%CI(-1.24,-0.26); I2=96%,WMD=-1.43,95%CI(-3.12,-0.25); I2=76%,WMD=-3.29,95%CI(-4.63,-1.95)]; 治疗后的髋关节疼痛视觉模拟量表评分低于对照组[I2=0%,WMD=-1.65,95%CI(-1.82,-1.48)]; 5篇文献对不良反应发生情况作了说明,其中只有2篇文献描述了不良反应的具体情况,2组的不良反应发生率比较,差异无统计学意义[I2=0%,OR=1.00,95%CI(0.34,2.98)]。以总有效率进行发表偏倚分析,偏倚漏斗图显示两侧分布不均,提示可能存在发表偏倚。结论:现有的证据表明,采用补肾活血汤治疗ONFH,能有效缓解患者的髋关节疼痛症状、改善髋关节功能、降低血脂及血浆黏度,临床疗效确切; 现有研究对干预措施的安全性重视程度不够,关于补肾活血汤治疗ONFH的安全性仍需更多临床研究予以验证; 纳入的研究质量较低、证据等级强度不足,所得结论需要更多高质量文献和更加科学合理的证据加以印证。
Abstract:
Objective:To evaluate the clinical curative effects and safety of Bushen Huoxue Tang(补肾活血汤,BSHXT)for treatment of osteonecrosis of the femoral head(ONFH).Methods:All randomized controlled trial(RCT)articles about BSHXT for treatment of ONFH included from database establishing to February 2019 were retrieved from Chinese biomedical literature database,China national knowledge internet,WanFang Database and VIP Database through computer.The articles were screened and the information was extracted.The methodological quality of research in the articles was evaluated by using Cochrane literature quality evaluation criteria and Jadad scale and a Meta-analysis was conducted by using Revman 5.3 software.Results:Nineteen articles(1717 ONFH patients)were included in the final analysis.The Jadad scores of included articles were ≤2 points,and it suggested that the quality of these articles was poor.The results of Meta-analysis demonstrated that the total effective rate was higher in treatment group compared to control group(I2=0%,OR=3.53,95%CI(2.63,4.75)).The posttreatment Harris hip scores including total scores,pain scores,ROM scores and function scores were higher in treatment group compared to control group(I2=98%,WMD=10.62,95%CI(5.55,15.69); I2=87%,WMD=5.03,95%CI(3.02,7.04); I2=98%,WMD=0.82,95%CI(0.06,1.58); I2=47%,WMD=5.17,95%CI(3.60,6.75)).The posttreatment low density lipoprotein cholesterol,total cholesterol and triglyceride were lower in treatment group compared to control group(I2=31%,WMD=-0.47,95%CI(-0.66,-0.27); I2=50%,WMD=-0.31,95%CI(-0.51,-0.12); I2=0%,WMD=-0.16,95%CI(-0.23,-0.10)).The posttreatment plasma viscosity,high and low shear whole blood viscosity and hematocrit were lower in treatment group compared to control group(I2=0%,WMD=-0.20,95%CI(-0.27,-0.12); I2=80%,WMD=-0.75,95%CI(-1.24,-0.26); I2=96%,WMD=-1.43,95%CI(-3.12,-0.25); I2=76%,WMD=-3.29,95%CI(-4.63,-1.95)).The posttreatment hip visual analogue scale scores were lower in treatment group compared to control group(I2=0%,WMD=-1.65,95%CI(-1.82,-1.48)).The occurrence of adverse reactions were described in 5 articles,while the specific adverse reactions were described in only 2 articles.There was no statistical difference in the incidence rate of adverse reactions between treatment group and control group(I2=0%,OR=1.00,95%CI(0.34,2.98)).Publication bias was analyzed according to the total effective rate,and the asymmetrical funnel plot demonstrated that there might be publication bias.Conclusion:Available evidences suggest that oral application of BSHXT can effectively relieve hip pain,improve hip function and reduce blood lipid and plasma viscosity in treatment of ONFH,and its clinical effect is definite.However,less attention is paid to the safety of interventions in present studies,therefore,the safety of BSHXT in treatment of ONFH need to be further verified by more clinical studies.The quality of included articles is poor and the level of evidence is insufficient,so the obtained conclusions need to be confirmed by more high-quality articles and more scientific and rational evidences.

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备注/Memo

备注/Memo:
(收稿日期:2019-06-25 本文编辑:李晓乐)基金项目:国家自然科学基金项目(81873325) 通讯作者:肖鲁伟 E-mail:519512415@qq.com
更新日期/Last Update: 2020-03-10