中国中药杂志

2018, v.43(02) 227-233

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川草乌复方联合西药治疗类风湿性关节炎的有效性与安全性Meta分析
Meta-analysis on efficacy and safety of combination therapy of Aconitum and Western medicine in treatment of rheumatoid arthritis

张晓朦;张冰;李凡;田志平;
ZHANG Xiao-meng;ZHANG Bing;LI Fan;TIAN Zhi-ping;Beijing University of Chinese Medicine;

摘要(Abstract):

Meta分析含川草乌中药复方联合西药治疗类风湿性关节炎(RA)的有效性与安全性,以期为临床提供RA治疗用药参考与依据。系统检索中国知网、维普、万方、中国生物医学文献数据库以及Pub Med、Cochrane Library等期刊文献数据库,时间从建库截至2017年7月。依据既定的纳入标准,共获得含川草乌中药复方联合西药治疗RA的随机对照试验(RCT)8项。按照川草乌入药种类不同,分为川乌亚组(6RCTs)、草乌亚组(1RCT)、川草乌叠加亚组(1RCT)。结果显示,较西医常规用药,联合应用含川乌、草乌、川草乌叠加的中药复方均可提高RA临床疗效总有效率,结果分别为(6RCTs,RR=1.19,95%CI[1.10,1.28],P<0.000 01),(1RCT,RR=1.43,95%CI[1.18,1.73],P=0.000 2),(1RCT,RR=1.27,95%CI[1.02,1.58],P=0.03)。联合用药对患者关节肿胀数、晨僵时间、双手握力以及血沉、C反应蛋白、类风湿因子等均有改善作用,但对关节压痛数的作用不显著。同时,纳入RCT中联合应用川草乌不良反应/事件(ADR/ADE)34例,常规西药治疗ADR/ADE 86例,川乌、川草乌叠加用药亚组ADR/ADE发生率更低,草乌亚组则与常规西药对照组无异。现有临床研究显示,含川草乌中药复方与西药联合应用治疗RA的疗效与安全性均较单独应用西药具有一定的优势,但受RCT质量不高、缺少大规模多中心研究等局限,该结果还有待临床进一步验证。
To analyze the efficacy and safety of the combination therapy of Aconitum and Western medicine in the treatment of rheumatoid arthritis( RA) by Meta-analysis,and provide evidence for its clinic application for RA. The random clinical trials( RCTs) regarding the combination therapy for treating RA were retrieved in the database of China National Knowledge Infrastructure database,China Science and Technology Journal database,Wan Fang,Chinese Biomedical Medical Database,Pub Med,and Cochrane Library up to July 2017. According to the given inclusion criteria,8 RCTs involving 659 participants were included,and the included RCTs could be further divided into three subgroups according to the herb type,which were Aconiti Radix( Chuanwu) subgroup( 6 RCTs),Aconiti Kusnezoffii Radix( Caowu) subgroup( 1 RCT),and Chuanwu-Caowu subgroup( 1 RCT). The Meta-analysis results indicated that as compared with Western medicine,the combined use of Aconitum and Western medicine,no matter Chuanwu,Caowu or Chuanwu-Caowu subgroups,could improve the total effective rate of RA( 6 RCTs,RR = 1. 19,95 % CI [1. 10,1. 28 ],P < 0. 000 01),( 1 RCT,RR = 1. 43,95 % CI [1. 18,1. 73 ],P = 0. 000 2),( 1 RCT,RR = 1. 27,95 % CI [1. 02,1. 58 ],P = 0. 03) respectively. The combined use of Aconitum and Western medicine was also effective on the number of joint swelling,duration of morning stiffness,patients' handgrip,and the erythrocyte sedimentation rate,C-reactive protein and rheumatoid factor. However,its action was not significant on joint tenderness. And also,in the included RCTs,there were 34 cases of adverse drug reactions/events( ADR/ADE) in the Chuanwu subgroup,while 86 cases in the Western medicine control group. The ADR/ADE incidence was even more lower in Chuanwu-Caowu subgroup,but no difference between Caowu subgroup and Western medicine group. Based on the included RCTs,the combined use of Aconitum and Western medicine could achieve more satisfying efficacy and lower ADRs incidence for RA as compared with Western medicine alone. However,due to the limitation in the not-high quality of included RCTs and the lack of large-scale multi-center research,the results still need to be further validated in the clinic application.

关键词(KeyWords): 川草乌;类风湿性关节炎;有效性;安全性;Meta分析
Aconitum;rheumatoid arthritis(RA);efficacy;safe;Meta-analysis

Abstract:

Keywords:

基金项目(Foundation): 国家食品药品监督管理局药品评价中心项目(2020071420118);; 北京中医药大学新奥优秀传承团队建设项目(1000062720028/001)

作者(Author): 张晓朦;张冰;李凡;田志平;
ZHANG Xiao-meng;ZHANG Bing;LI Fan;TIAN Zhi-ping;Beijing University of Chinese Medicine;

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