Evaluation of Clinical Efficacy of Wangbi Capsules on the Treatment of Rheumatoid Arthritis Based on Real-World Research
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;Serologi-cal 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 dur-ing each visit.Finally,the safety evaluation was carried out.Results:General information:There was no statistically signifi-cant 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 out-come 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 differ-ence 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 af-ter 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 pro-gression,improve disease prognosis,and have good safety.
rheumatoid arthritisWangbi capsulesclinical efficacyreal-world researchcohort study
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维普
