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
投稿时间:2017-10-30  修订日期:2017-10-31  责任编辑:  点此下载全文
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作者中文名作者英文名单位中文名单位英文名E-Mail
张晓朦 ZHANG XIAOMENG 北京中医药大学 Beijing University of Chinese Medicine zhangxm0320@163.com 
张冰* ZHANG BING 北京中医药大学 Beijing University of Chinese Medicine zhangb@bucm.edu.cn 
李凡 Li Fan 北京中医药大学 Beijing University of Chinese Medicine  
田志平 Tian Zhiping 北京中医药大学 Beijing University of Chinese Medicine  
基金项目: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)
中文摘要:Meta分析含川草乌中药复方联合西药治疗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PubMed、Cochrane Library等期刊文献数据库,时间截止至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<0.00001]、[1RCT, RR=1.43, 95%CI(1.18,1.73),P=0.0002]、[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、类风湿因子等均有作用,但对关节压痛数的改善作用不显著。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/ADE86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。
中文关键词:川草乌  类风湿关节炎  有效性  安全性  Meta分析
 
Meta-analysis on the efficacy and safety of the combination therapy of Aconitum and western medicine in the treatment of Rheumatoid Arthritis
Abstract:Aiming to provide evidence to clinic, this meta-analysis was conducted an evaluation on the efficacy and safety of the combination therapy of Aconitum and western medicines (WM) in the treatment of Rheumatoid Arthritis (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, Wanfang, Chinese Biomedical Medical Database, PubMed, and Cochrane Library, which time limited from the beginning of library construction to July 2017. According to the inclusion criteria, 8 RCTs involved 659 participants were included. The included RCTs could be devided into three subgroups, which were Radix Aconiti (Chuanwu) subgroup (6RCTs), Radix Kusnezoff Monkshood (Caowu) subgroup (1RCT), and Chuanwu & Caowu subgroup (1RCT). The meta-analysis results indicated that comparing with WM, the combination use of Aconitum and WM, no matter Chuanwu, Caowu or Chuanwu & Caowu subgroups, could improve the total effective rate of RA, which merged results were [6RCTs, RR=1.19, 95%CI(1.10,1.28),P<0.00001], [1RCT, RR=1.43, 95%CI(1.18,1.73),P=0.0002] and [1RCT, RR=1.27, 95%CI(1.02,1.58), P=0.03]. The combination use of Aconitum and WM could also act on the number of joint with swelling, duration of morning stiffness, patients’ handgrip, and the content of 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 adverse drug reactions/events (ADR/ADE) occurred in the Chuanwu and Chuanwu & Caowu subgroups, while 86 cases in the WM control group. There was more lower ADR/ADE incidence in the Chuanwu and Chuanwu & Caowu subgroups, but no differece in the Caowu subgroup. Based on the included RCTs, for RA, the combination using of Aconitum and WM could achieve more satisfying efficacy and lower ADRs incidence. But due to the limitation in the not-high quality of included RCTs and the lack of large-scale multi-center research, the results need to be further validated in the clinic.
keywords:Aconitum  Rheumatoid arthritis (RA)  efficacy  safe  Meta-analysis
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