宋梦歌, 姜泉, 焦娟, 王北, 顾文, 程永静, 王钱, 陶庆文, 金笛儿, 刘小平, 郑新春, 刘佳, 黄清春, 赵越, and 林昌松
Objective We aimed to evaluate the clinical efficacy and safety of Luofushan Rheumatic Plaster in the treatment of rheumatoid arthritis(RA) combined with wrist inflammation. Methods A multicenter, block-randomized, double-blind, placebo-controlled clinical trial was conducted including 180 patients with RA combined with wrist tenosynovitis and/ or synovitis from eight hospitals who were randomly divided into the Luofushan group (90 cases) and the control group (90 cases). Patients in both groups were given basic treatment such as disease-modifying antirheumatic drugs (DMARDs). Patients in the Luofushan group were given Luofushan Rheumatic Plaster, while patients in the control group were given Luofushan Rheumatic Plaster simulant. The core trial duration was 4 weeks, and the extended trial was conducted in three centers (participants could voluntarily choose to continue to receive Luofushan Rheumatic Plaster for an additional 4 weeks). Follow-up of local symptoms of the wrist joint ( VAS score, swelling degree, duration of morning stiffness ), bilateral wrist joint ultrasound (tenosynovitis, synovitis, synovial hyperplasia), overall evaluation of disease ( DAS28-CRP score, Health Assessment Questionnaire Disability Index [HAQ-DI], and Chinese Patient-Reported Activity Index with Rheumatoid Arthritis [CPRI-RA]), and erythrocyte sedimentation rate(ESR)was conducted one or two times, and skin irritation and adverse events during the experiment were recorded. Effectiveness was analyzed using the per-protocol set, and the safety indicators were analyzed using the safety set. Results Compared to pre-treatment, adjuvant therapy with Luofushan Rheumatic Plaster for 4 weeks can improve the VAS score (P <0. 05), the degree of swelling (P <0. 05), morning stiffness duration (P<0. 05), wrist tenosynovitis (P<0. 05), synovitis (P<0. 05), DAS28-CRP (P<0. 05), HAQ-DI(P <0. 05), and CPRI-RA(P <0. 05), but there were no statistically significant difference compared to the control group. Compared to the control group, pain was alleviated in the Luofushan group after 8 weeks of treatment(P <0. 05). Compared to pre-treatment adjuvant therapy for 8 weeks can provide additional improvement in the synovial hyperplasia of the wrist joint (P <0. 05), and the ESR level (P <0. 05), but there were no statistically significant difference compared to the control group. There was no increase in the incidence of skin irritation and adverse events between the two groups (P > 0. 05). Conclusion Luofushan Rheumatic Plaster has a definite analgesic effect in the treatment of wrist rheumatoid arthritis, and it improves ultrasound imaging result, the degree of joint swelling, and ESR. Moreover, it is safe and suitable for long-term clinical use. [ABSTRACT FROM AUTHOR]