Zhang Rouman, Tang Xiao-Po, Wang Jian, Liu Wei-Xiang, Liu Jian, Wang Yue, Liu Wei, Fang Yong-Fei, He Dong-Yi, Liu Ying, Gao Ming-Li, Wu Qing-Jun, Li Zhen-Bin, Chen Shi, Huang Qing-Chun, Xie Yan-Ming, Zhang Jun-Li, Zhou Cai-Yun, Ma Li, Wang Xin-Chang, Jiang Quan, Gong Xun
Rheumatology, Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing 100053, China.
Rheumatology, University of Chinese Medicine, Hefei 230038, China.
Evid Based Complement Alternat Med. 2022 Apr 12;2022:5808400. doi: 10.1155/2022/5808400. eCollection 2022.
Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). QingreHuoxue treatment (QingreHuoxue decoction [QRHXD]/QingreHuoxue external preparation [QRHXEP]) is a Chinese medicine treatment for RA. To date, very few studies have compared the long-term effects of QRHXD with those of conventional disease-modifying antirheumatic drugs on RA disease activity and radiological progression. QRHXD delayed the radiological progression and showed long-term clinical efficacy of RA. In clinical experiments, the clinical evidence of delaying the radiological progression of RA patients was obtained. A portion of the patients who participated in the "Traditional Chinese Medicine QingreHuoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis" study were followed up for 52 weeks, and intention-to-treat (ITT) and compliance protocol (PP) analyses were used to collect and compare the clinical indicators and imaging data between baseline and week 52. Two radiologists who were blind to treatment scored the images independently. Of the 468 subjects, 141 completed the 52-week follow-up. There were no significant differences among the three groups: the traditional Chinese medicine comprehensive treatment group, the Western medicine treatment group, and the integrated traditional Chinese and Western medicine treatment group. There were no differences in the total Sharp score, joint space stenosis score, and joint erosion score at baseline or 52 weeks. In the comparison of the estimated annual radiographic progression (EARP) and the actual annual Sharp total score changes among the three groups, the actual changes were much lower than the EARP at baseline. The radiological progress in all three groups was well controlled. Results of the ITT and PP data sets showed that the disease activity score 28 level of the three groups at 52 weeks was significantly lower than that at baseline. During the 52-week treatment period, the clearance of heat and promotion of blood circulation controlled disease activity and delayed the radiological progress of active RA.
传统中医（TCM）已成功用于治疗类风湿性关节炎（RA）。清热活血疗法（清热活血汤[QRHXD]/清热活血外用制剂[QRHXEP]）是一种治疗RA的中医疗法。迄今为止，很少有研究比较QRHXD与传统抗风湿药物对RA疾病活动度和放射学进展的长期影响。QRHXD延缓了放射学进展，并显示出对RA的长期临床疗效。在临床实验中，获得了延缓RA患者放射学进展的临床证据。对部分参与“清热活血中医疗法与甲氨蝶呤和羟氯喹联合疗法治疗活动期类风湿性关节炎”研究的患者进行了52周的随访，并采用意向性治疗（ITT）和符合方案（PP）分析来收集和比较基线与第52周之间的临床指标和影像数据。两名对治疗不知情的放射科医生独立对影像进行评分。468名受试者中，141名完成了52周的随访。中医综合治疗组、西医治疗组和中西医结合治疗组这三组之间无显著差异。在基线或第52周时，总Sharp评分、关节间隙狭窄评分和关节侵蚀评分均无差异。在三组之间估计的年度放射学进展（EARP）和实际年度Sharp总分变化的比较中，实际变化远低于基线时的EARP。所有三组的放射学进展均得到良好控制。ITT和PP数据集的结果显示，三组在第52周时的疾病活动评分28水平显著低于基线时。在52周的治疗期内，清热活血控制了疾病活动度，并延缓了活动期RA的放射学进展。
