通络开痹片治疗关节炎(类风湿关节炎、膝骨关节炎)疗效及安全性的真实世界研究  

Real-world study of effectiveness and safety of Tongluo Kaibi Tablet intreatment of arthritis (rheumatoid arthritis, knee osteoarthritis)

作　　者：何晓红[1,2] 史玉媛[3] 周晓莉[4] 张剑勇[5] 李娟[6] 何东仪 郭刚[8] 谷占卿 张玉慧 李振彬 张震坤[12] 黄清春[1,2] HE Xiao-hong;SHI Yu-yuan;ZHOU Xiao-li;ZHANG Jian-yong;LI Juan;HE Dong-yi;GUO Gang;GU Zhan-qing;ZHANG Yu-hui;LI Zhen-bin;ZHANG Zhen-kun;HUANG Qing-chun(The Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou 510000,China;Department of Rheumatology,Guangdong Hospital of Chinese Medicine,Guangzhou 510000,China;Linfen People’s Hospital,Linfen 041081,China;Shanxi Hospital of Traditional Chinese Medicine,Taiyuan 030012,China;Shenzhen Hospital of Traditional Chinese Medicine,Shenzhen 518033,China;Nanfang Hospital,Southern Medical University,Guangzhou 510515,China;Shanghai Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine,Shanghai 200052,China;Hebei Yiling Hospital,Shijiazhuang 050090,China;The First Hospital of Hebei Medical University,Shijiazhuang 050030,China;Bozhou People’s Hospital,Bozhou 236804,China;980 Hospital of PLA Joint Logistics Support Force,Shijiazhuang 050051,China;Dongguan Houjie Hospital,Dongguan 523945,China)

机构地区：[1]广州中医药大学第二临床医学院,广东广州510000 [2]广东省中医院风湿科,广东广州510000 [3]临汾市人民医院,山西临汾041081 [4]山西省中医院,山西太原030012 [5]深圳市中医院,广东深圳518033 [6]南方医科大学南方医院,广东广州510515 [7]上海市光华中西医结合医院,上海200052 [8]河北以岭医院,河北石家庄050090 [9]河北医科大学第一医院,河北石家庄050030 [10]亳州市人民医院,安徽亳州236804 [11]中国人民解放军联勤保障部队第九八〇医院,河北石家庄050051 [12]东莞市厚街医院,广东东莞523945

出　　处：《中草药》2023年第17期5657-5664,共8页Chinese Traditional and Herbal Drugs

摘　　要：目的评价真实世界中通络开痹片治疗关节炎[类风湿关节炎(rheumatoid arthritis,RA)、膝骨关节炎(knee osteoarthritis,KOA)]的效果及安全性,产生大样本量临床循证数据,为临床合理用药提供依据。方法采取前瞻性研究方法,纳入12家中心2021—2022年收治的1001例RA及KOA患者,分为RA组和KOA组,均采用通络开痹片治疗,访视点是0、4、8、12周。随访并评估患者治疗12周的有效性[疼痛视觉模拟评分(visual analogue scale,VAS)、28个关节疾病活动性评分(disease activity score-28,DAS28)、健康评定问卷(health assessment questionnaire,HAQ)评分、中医症状评分、西安大略麦克马斯特大学(Western Ontario and McMaster University,WOMAC)骨关节炎指数评分等]及安全性。采用SAS9.4软件进行统计分析。结果RA组基线时疼痛VAS评分为(5.09±1.70)分,治疗12周后下降至(2.75±1.51)分(P<0.0001);DAS28评分基线为(4.97±1.31)分,治疗12周后下降至(3.55±1.12)分(P<0.0001),提示治疗前大多数患者处于中高活动度,治疗后36.68%患者达到低疾病活动度和病情缓解;临床疾病活动性指数(clinical disease activity index,CDAI)评分基线为(22.45±13.35)分,表明82.03%的受试者处于中高度活动,治疗12周后CDAI评分降低至(10.82±7.87)分(P<0.0001),表明57.29%的患者达到低度疾病活动度。KOA组基线时疼痛VAS评分为(5.14±1.64)分,治疗12周后降至(2.95±1.33)分(P<0.0001);WOMAC评分基线为(63.44±33.91)分,治疗12周后降低至(35.21±21.77)分(P<0.0001)。两组的HAQ和中医症状评分均较基线改善,差异具有统计学意义(P<0.0001)。治疗期间发生的不良反应主要为神经系统不良发应(占比1%),其次为消化系统(0.7%)、皮肤(0.6%)、肝胆(0.5%)、心血管(0.5%)及全身整体不良反应(0.5%)。结论通络开痹片可有效降低RA、KOA患者的疼痛程度,不增加不良事件的发生率,值得临床推广。Objective To evaluate the therapeutic effect and safety of Tongluo Kaibi Tablet(通络开痹片)in the treatment of arthritis[rheumatoid arthritis(RA),knee osteoarthritis(KOA)]in the real world to produce a large sample size of clinical evidence-based data,so as to provide a basis for clinical rational drug use.Methods Using the prospective study method,1001 patients with RA and KOA were enrolled in 12 centers from 2021 to 2022.All patients were treated with Tongluo Kaibi Tablet.The visits were 0,4,8 and 12 weeks.Patients were followed up and evaluated for effectiveness[pain visual analogue scale(VAS)score,disease activity score-28(DAS28)score,health assessment questionnaire(HAQ)score,traditional Chinese medicine(TCM)symptom score,Western Ontario and McMaster University(WOMAC),etc.]and adverse event data for 12 weeks.The SAS9.4 software was used for statistical analysis.Results The pain VAS score of RA group was 5.09±1.70 at baseline,and gradually decreased after treatment to 2.75±1.51(P<0.0001),DAS28 score decreased from 4.97±1.31 at baseline to 3.55±1.12 at week 12(P<0.0001),indicating that most patients were in the middle and high activity before treatment,and 36.68%were in low activity and remission after treatment;The clinical disease activity index(CDAI)score with baseline of 22.45±13.35 showed that 82.03%of subjects were moderately active,which decreased to 10.82±7.87 at 12 weeks after treatment(P<0.0001),indicating that 57.29%of patients achieved low disease activity after treatment.The pain VAS score of the KOA group was 5.14±1.64 at baseline,and decreased to 2.95±1.3312 weeks after treatment(P<0.0001),WOMAC score was 63.44±33.91 at baseline and significantly decreased to 35.21±21.7712 weeks after treatment(P<0.0001).HAQ and TCM symptom scores improved from baseline in both groups,and the differences were statistically significant(P<0.0001).The main adverse reactions were nervous system(1%),followed by digestive system(0.7%),skin(0.6%),liver and gallbladder(0.5%),cardiovascular(0.5%)and systemi

关 键 词：通络开痹片 类风湿关节炎 膝骨关节炎 真实世界研究 疼痛视觉模拟评分 安全性 

分 类 号：R285.64[医药卫生—中药学]