[1]李克嵩,姜泉△,李惠玲,等.基于真实世界研究评价尪痹胶囊治疗类风湿关节炎的临床疗效[J].中国中医骨伤科杂志,2024,32(10):26-31+39.[doi:10.20085/j.cnki.issn1005-0205.241005]
　LI Kesong,JIANG Quan,LI Huiling,et al.Evaluation of Clinical Efficacy of Wangbi Capsules on the Treatment of Rheumatoid Arthritis Based on Real-World Research[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2024,32(10):26-31+39.[doi:10.20085/j.cnki.issn1005-0205.241005]
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基于真实世界研究评价尪痹胶囊治疗类风湿关节炎的临床疗效()
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《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第32卷
期数:
2024年10期
页码:
26-31+39
栏目:
临床研究
出版日期:
2024-10-15

文章信息/Info

Title:
Evaluation of Clinical Efficacy of Wangbi Capsules on the Treatment of Rheumatoid Arthritis Based on Real-World Research
文章编号:
1005-0205(2024)10-0026-06
作者:
李克嵩1; 姜泉1△; 李惠玲2; 郭洪涛3; 张剑勇4; 孟庆良5; 巩勋1; 刘蔚翔1; 王海东6; 张俊莉7; 郝杰8; 李素蘋9
1中国中医科学院广安门医院(北京,100053)
2湖北省中医院
3河南中医药大学第一附属医院
4深圳市中医院
5河南中医药大学第二附属医院
6甘肃省中医院
7西安市第五医院
8沧州市人民医院
9温州市中心医院
Author(s):
LI Kesong1; JIANG Quan1△; LI Huiling2; GUO Hongtao3; ZHANG Jianyong4; MENG Qingliang5; GONG Xun1; LIU Weixiang1; WANG Haidong6; ZHANG Junli7; HAO Jie8; LI Suping9
1Guang’anmen Hospital of China Academy of Chinese Medical Sciences,Beijing 100053,China; 2Hubei Provincial Hospital of Traditional Chinese Medicine,Wuhan 430060,China; 3First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450099,China; 4Shenzhen Traditional Chinese Medicine Hospital,Shenzhen 518033,Guangdong China; 5Second Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450002,China;...
关键词:
类风湿关节炎;  尫痹胶囊;  临床疗效评价;  真实世界研究;  队列研究
Keywords:
rheumatoid arthritis;  Wangbi capsules;  clinical efficacy;  real-world research;  cohort study
分类号:
R684.3
DOI:
10.20085/j.cnki.issn1005-0205.241005
文献标志码:
A
摘要:
目的:基于真实世界前瞻性队列研究,评价尫痹胶囊治疗类风湿关节炎的临床疗效及安全性。方法:共纳入1 000例类风湿关节炎患者,分为暴露组(尫痹胶囊+基础治疗)和非暴露组(基础治疗),各500例。所有病例分别于基线、治疗后第4周、第12周、第24周进行现场随访。统计分析:主要结局指标达到或维持临床缓解或低疾病活动度(DAS28评分≤3.2)的受试者比例; 次要结局指标达到ACR20和ACR50标准的受试者比例; 血清学指标,即血沉(ESR)、C反应蛋白(CRP)、血小板计数(PLT)、D-二聚体; 各次访视时健康评估问卷(HAQ)结果相对于基线的变化值; 各次访视时各临床症状积分变化值。最后进行安全性评价。结果:一般资料:两组患者在性别、年龄、体重、病程方面差异无统计学意义(P>0.05)。主要结局指标:两组患者达到或维持临床缓解或低疾病活动度的受试者比例在治疗后第12周和第24周差异有统计学意义(P<0.01)。次要结局指标:ACR 20和ACR 50标准,在治疗后第4周两组患者ACR 20和ACR 50达标率差异有统计学意义(P<0.05); 血清学指标,在治疗后第4周两组患者C反应蛋白和血沉水平差异均有统计学意义(P<0.05),在治疗后第24周两组患者D-二聚体水平差异有统计学意义(P<0.05); HAQ评分,在治疗后第4周、第12周及第24周两组患者HAQ评分差异有统计学意义(P<0.05); 中医症状评分,在治疗后第4周两组患者失眠多梦评分差异有统计学意义(P<0.05),在治疗后第4周及第12周两组患者心烦不安评分差异有统计学意义(P<005),在治疗后第12周及第24周两组患者怕风怕冷评分差异有统计学意义(P<0.05),在治疗后第4周及第12周两组患者神疲乏力评分差异有统计学意义(P<0.05)。安全性评价两组患者差异无统计学意义(P>0.05)。结论:尫痹胶囊可较快改善患者关节肿胀疼痛,改善疾病不适,降低炎性水平,改善血液高凝状态,降低血栓风险,降低疾病活动度,持续改善患者肢体活动功能,提高患者生活质量,控制疾病进展,改善疾病预后,且安全性好。
Abstract:
Objective:To evaluate the clinical efficacy and safety of Wangbi capsule on the treatment of rheumatoid arthritis based on real-world prospective cohort study.Methods:1 000 patients with rheumatoid arthritis were included and divided into exposed group(Wangbi capsule+basic treatment)and non-exposed group(basic treatment),with 500 cases in each group.All cases were followed up on-site at baseline,4th week,12th week,and 24th week after treatment.Main outcome measure:The proportion of participants who achieved or maintained clinical remission or low disease activity(DAS28 scores≤3.2).Secondary outcome measures:The proportion of subjects who met the ACR20 and ACR50 criteria; Serological indicators,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),platelet count(PLT),D-dimer; Changes in health assessment questionnaire(HAQ)results relative to baseline at each visit; Changes in clinical symptom scores during each visit.Finally,the safety evaluation was carried out.Results:General information:There was no statistically significant difference between the two groups of patients in terms of gender,age,weight,and disease course(P>0.05).Main outcome measure:The proportion of subjects who achieved or maintained clinical remission or low disease activity between the two groups showed significant statistical differences at 12th and 24th week after treatment(P<0.01).Secondary outcome measures:ACR20/ACR50 standard,the comparison of ACR20/ACR50 compliance rates between the two groups at 4th week after treatment was statistically significant(P<0.05); Serological indicators,at the 4th week after treatment,there was a statistically significant difference in CRP and ESR levels between the two groups(P<0.05),the difference in D-dimer levels between the two groups at the 24th week after treatment was statistically significant(P<0.05); HAQ score,there was a statistically significant difference in HAQ scores between the two groups at the 4th,12th,and 24th week after treatment(P<0.05); Traditional Chinese medicine symptom score,there was a statistically significant difference in the scores of insomnia and multiple dreams between the two groups at the 4th week after treatment(P<0.05); There was a statistically significant difference in the scores of anxiety between the two groups at the 4th and 12th week after treatment(P<0.05),and there was a statistically significant difference in the scores of fear of wind and cold between the two groups at the 12th and 24th week after treatment(P<0.05).The difference in fatigue scores between the two groups in the 12th week was statistically significant(P<0.05).Safety evaluation:There was no statistically significant difference between the two groups(P>0.05).Conclusion:Wangbi capsules can quickly improve joint swelling and pain in patients,alleviate disease discomfort,reduce inflammatory levels,improve blood hypercoagulability,reduce the risk of thrombosis,reduce disease activity,continuously improve limb mobility,improve patient quality of life,effectively control disease progression,improve disease prognosis,and have good safety.

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备注/Memo

备注/Memo:
基金项目:中国中医科学院优秀青年科技人才培养专项(ZZ16-YQ-016)
中华中医药学会风湿病分会“青年培英计划”项目(202327-002)
国家自然科学基金项目(82104837)
国家重点研发计划项目(2018YFC1705202)
△通信作者 E-mail:doctorjq@126.com
更新日期/Last Update: 2024-10-05