中医药治疗风湿病的多中心随机对照试验研究概况
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摘要
目的:评价中医药治疗风湿病的多中心随机对照试验(randomized controlled trial, RCT)的文献质量,为临床研究提供参考。方法:检索PubMed、Cochrane Library、维普(VIP)、中国知网(CNKI)、万方(WanFang)等数据库的多中心RCT研究,采用Cochrane偏倚风险评估工具对纳入文献进行质量评价。结果:共纳入RCT文献37篇,包含类风湿关节炎16篇、骨关节炎8篇、痛风4篇、强直性脊柱炎2篇、原发性干燥综合征3篇、风湿性关节炎2篇、系统性红斑狼疮1篇、纤维肌痛综合征1篇;质量评价发现偏倚风险主要集中于随机序列的产生、分配隐藏、受试者与研究者盲法,结局评价盲法方面。结论:目前中医风湿病的多中心RCT研究除试验设计不足外,存在缺少中医疗效评价标准、统计分析不够系统等问题。文章系统综述了中医风湿病的多中心RCT研究,发现严谨的试验设计是获得高质量循证依据的关键,并展望通过大数据来提高多中心RCT的研究质量。
Objective To evaluate the literature quality of Multi-center RCT research of Rheumatism in traditional Chinese medicine(TCM), and to provide reference for clinical research. Methods The multi-center RCT studies were retrieved in databases such as PubMed, Cochrane Library, VIP,CNKI and Wanfang, and the quality of literature was evaluated by Cochrane bias risk assessment tool.Results 37 articles were included,including 16 rheumatoid arthritis,8 osteoarthritis,4 gout,2 ankylosing spondylitis,3 Sjogren syndrome,2 rheumarthritis,1 systemic lupus erythematosus,1 fibromyalgia syndrome.The quality evaluation found that the risk of bias was mainly focused on random sequences generation,allocation concealment,blinding of participants and personnel and blinding of outcomes assessment.Conclusion At present, in addition to the insufficient experimental design, there are some problems such as lack of evaluation standard of TCM curative effect and insufficient statistical analysis in the study of multi-center RCT of rheumatism in TCM.In this paper,the Multi-center RCT research of Rheumatism in TCM is systematically reviewed, and it is found that rigorous experimental design is the key to obtain high quality evidence-based basis,and look forward to improving the research quality of multi-center RCT through big data.
Objective To evaluate the literature quality of Multi-center RCT research of Rheumatism in traditional Chinese medicine(TCM), and to provide reference for clinical research. Methods The multi-center RCT studies were retrieved in databases such as PubMed, Cochrane Library, VIP,CNKI and Wanfang, and the quality of literature was evaluated by Cochrane bias risk assessment tool.Results 37 articles were included,including 16 rheumatoid arthritis,8 osteoarthritis,4 gout,2 ankylosing spondylitis,3 Sjogren syndrome,2 rheumarthritis,1 systemic lupus erythematosus,1 fibromyalgia syndrome.The quality evaluation found that the risk of bias was mainly focused on random sequences generation,allocation concealment,blinding of participants and personnel and blinding of outcomes assessment.Conclusion At present, in addition to the insufficient experimental design, there are some problems such as lack of evaluation standard of TCM curative effect and insufficient statistical analysis in the study of multi-center RCT of rheumatism in TCM.In this paper,the Multi-center RCT research of Rheumatism in TCM is systematically reviewed, and it is found that rigorous experimental design is the key to obtain high quality evidence-based basis,and look forward to improving the research quality of multi-center RCT through big data.
引文
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[25]庄继川.痛风胶囊治疗急性痛风性关节炎(湿热蕴结证)的疗效与安全性的临床试验[D].福建:福建中医药大学.2017.
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[28]蔡骏逸.内清外透法对湿热痹阻型急性痛风性关节炎的止痛抗炎效应及作用机制研究[D].广州:广州中医药大学,2012.
[29]冯兴华,姜泉,刘宏潇,等.中医辨证治疗强直性脊柱炎的临床疗效评价[J].中国中西医结合杂志,2013,33(10):1309-1314.
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[31]袁涛.生津润燥养血法治疗原发性干燥综合征提高生活质量的临床观察[D].南京:南京中医药大学,2013.
[32]钱先,胡伟,郭峰,等.生津润燥养血颗粒治疗干燥综合征的临床研究[J].中华中医药杂志,2014,29(11):3663-3666.
[33]王琬茹.补肾育阴清热法治疗燥痹(原发性干燥综合征)的临床研究[D].北京:北京中医药大学,2015.
[34]王海燕,张磊,张亚芳,等.雪山金罗汉止痛涂膜剂治疗风湿性关节炎瘀血痹阻证66例临床观察[J].天津中医药,2014,3(13):151-153.
[35]党晓伟,宋跃进,郭金甲,等.腰痛宁胶囊治疗慢性风湿性关节炎(寒湿瘀阻证)多中心临床研究[J].中成药,2016,38(3):510-514.
[36]何兆春.解毒祛瘀滋肾法治疗系统性红斑狼疮的安全性研究[D].杭州:浙江中医药大学,2010.
[37]蒋振亚,李常度,邱玲,等.针罐药结合治疗纤维肌痛综合征:多中心随机对照研究[J].中国针灸,2010,30(4):265-269.
[38]阎小妍,董冲亚,姚晨.大数据时代的循证医学研究[J].中国循证医学杂志,2017,17(3):249-254.
[2] 何晓红.类风湿关节炎中医治疗方案的安全性研究[D].广州:广州中医药大学,2005.
[3] 何羿婷.类风湿关节炎治疗方案研究[D].广州:广州中医药大学,2005.
[4] 查青林,林色奇,何羿婷,等.从舌象的动态变化看中、西药作用之差异[J].江西中医药,2005,36(266):28-30.
[5] Liu Jian,Wang Yuan,Huang Chuanbing,et al.Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis:a multi-center parallel-group double-blind randomized controlled trial[J].Journal of Traditional Chinese Medicine,2015,35(5):487-498.
[6] 白人骁.痹祺胶囊治疗类风湿关节炎临床疗效评价研究[C].全国第七届中西医结合风湿病学术会议论文集[A].北京:中国中西医结合学会,2008:28-30.
[7] 郑新春,杨德才,彭江云,等.薏芎除湿胶囊治疗类风湿关节炎疗效观察[J].湖北中医杂志,2013,35(9):8-10.
[8] 叶飞,杨洪彬,徐永旭.独一味胶囊治疗类风湿性关节炎69例的临床研究[J].世界中医药,2007,2(6):339-340.
[9] 郑新春,杨德才.痹痛舒胶囊治疗类风湿关节炎疗效观察[J].湖北中医杂志,2013,35(10):13-14.
[10]林昌松,杨岫岩,戴冽,等.昆仙胶囊治疗类风湿关节炎多中心临床研究[J].中国中西医结合杂志,2011,31(6):769-773.
[11]康信忠,王康惠,吴启富,等.尪痹片治疗类风湿关节炎的临床研究[J].中国中医风湿病学杂志,2009,12(3,4):233-236,240.
[12]公保吉.地乌风湿安胶囊用于类风湿性关节炎Ⅲ期临床研究[J].内蒙古中医药,2017,6(11):18-19.
[13]辛措吉,公保吉,索南才旦.清风痛胶囊治疗类风湿性关节炎Ⅱ期临床研究[J].青海医药杂志,2011,41(4):63-64.
[14]寇秋爱,李亮,要金元,等.消炎止痛膏治疗类风湿关节炎关节疼痛的临床观察[J].中国中西医结合杂志,2013,33(10):1320-1322.
[15]照日格图,伍镝,古洁乃特,等.寒湿透骨散治疗寒湿痹阻证类风湿关节炎随机对照多中心临床研究[J].中国现代医学杂志,2009,19(18):2828-2830.
[16]胡玲,郝峰,钟峰,等.艾灸治疗类风湿关节炎的多中心随机对照临床研究[J].环球中医药,2011,4(6):401-405.
[17]王柏公,王丽萍,白人骁.痹祺胶囊治疗膝骨性关节炎的多中心随机对照临床试验[J].中华中医药杂志,2017,32(8):3840-3843.
[18]马骁,杨舒,阎小萍,等.基于“肾虚”的膝骨关节炎“寒热为纲”辨治临床研究[J].中华中医药杂志,2015,30(12):4264-4267.
[19]高焕焕.骨痹合剂对不同体质下膝骨关节炎患者疼痛及其运动功能疗效观察[D].昆明:云南中医药大学,2017.
[20]韦佳佳.骨痹合剂治疗膝骨关节炎及其瘀血体质患者的临床观察[D].昆明:云南中医药大学,2017.
[21]倪爽爽,陈英,姜泉.复方雪莲胶囊和葡立胶囊治疗膝骨关节炎(寒湿痹阻证)的临床对比研究[J].新疆中医药,2016,34(4):6-8.
[22]王文岳,谢利民,张跃,等.芍灵消增贴治疗骨性关节炎(肝肾不足、瘀血阻络证)的疗效及安全性评价[J].中国中医骨伤科杂志,2013,21(6):21-24.
[23]元七骨痛酊临床研究协作组.元七骨痛酊治疗膝骨关节炎(筋脉瘀滞证)多中心随机对照临床试验[J].亚太传统医药,2017,13(16):139-143.
[24]顾峥嵘,程少丹,徐菁,等.维药阿萨润霜治疗膝骨关节炎的多中心随机对照临床试验[J].风湿病与关节炎,2015,4(7):15-17,77.
[25]庄继川.痛风胶囊治疗急性痛风性关节炎(湿热蕴结证)的疗效与安全性的临床试验[D].福建:福建中医药大学.2017.
[26]谢志军.痛风间歇期中医治疗方案的多中心临床评价[C].第三届江浙沪中西医结合高峰论坛论文汇编[A].浙江省中西医结合学会、江苏省中西医结合学会、上海市中西医结合学会、浙江省科学技术协会,2011:5.
[27]李志炜.痛风内服外敷方对急性痛风性关节炎的临床与IL-lβ、XOD相关研究[D].广州:广州中医药大学,2011.
[28]蔡骏逸.内清外透法对湿热痹阻型急性痛风性关节炎的止痛抗炎效应及作用机制研究[D].广州:广州中医药大学,2012.
[29]冯兴华,姜泉,刘宏潇,等.中医辨证治疗强直性脊柱炎的临床疗效评价[J].中国中西医结合杂志,2013,33(10):1309-1314.
[30]金笛儿,张楠,张英泽,等.补肾强督法治疗强直性脊柱炎184例多中心双盲随机对照临床研究[J].中医杂志,2016,57(23):2011-2016.
[31]袁涛.生津润燥养血法治疗原发性干燥综合征提高生活质量的临床观察[D].南京:南京中医药大学,2013.
[32]钱先,胡伟,郭峰,等.生津润燥养血颗粒治疗干燥综合征的临床研究[J].中华中医药杂志,2014,29(11):3663-3666.
[33]王琬茹.补肾育阴清热法治疗燥痹(原发性干燥综合征)的临床研究[D].北京:北京中医药大学,2015.
[34]王海燕,张磊,张亚芳,等.雪山金罗汉止痛涂膜剂治疗风湿性关节炎瘀血痹阻证66例临床观察[J].天津中医药,2014,3(13):151-153.
[35]党晓伟,宋跃进,郭金甲,等.腰痛宁胶囊治疗慢性风湿性关节炎(寒湿瘀阻证)多中心临床研究[J].中成药,2016,38(3):510-514.
[36]何兆春.解毒祛瘀滋肾法治疗系统性红斑狼疮的安全性研究[D].杭州:浙江中医药大学,2010.
[37]蒋振亚,李常度,邱玲,等.针罐药结合治疗纤维肌痛综合征:多中心随机对照研究[J].中国针灸,2010,30(4):265-269.
[38]阎小妍,董冲亚,姚晨.大数据时代的循证医学研究[J].中国循证医学杂志,2017,17(3):249-254.