藏药浴综合疗法治疗类风湿关节炎的临床研究

Clinical research of Tibetan medicated bathing integrative therapy for rheumatoid arthritis

目的评价藏药浴综合疗法治疗类风湿关节炎(RA)的疗效、安全性和经济性。方法采用前瞻性、多中心的临床研究设计,于2019年8月至2021年8月在甘肃省和青海省的4家医院纳入RA住院患者88例,采用藏药浴(五味甘露药浴颗粒)治疗,平均住院天数为(10.3±4.0)d。采用症状、量表评分和实验室检查指标评价疗效,比较治疗前后的结局指标变化。结果关节压痛数量、关节肿胀数量、晨僵时间、RA临床结局量表评分、类风湿因子较治疗前减少,差异有统计学意义(P<0.05)。血沉、C反应蛋白在治疗前后比较,差异无统计学意义(P>0.05)。无不良事件报告;医疗费用为3200~6000元。结论藏药浴治疗有助于缓解RA患者症状、改善功能,并有良好的安全性和经济性。

Objective To evaluate the efficacy,safety,and economy of Tibetan medicated bathing integrative therapy for rheumatoid arthritis(RA).Methods A prospective,multi-center clinical study design was applied to enroll 88 patients with RA in 4 hospitals in Gansu and Qinghai provinces for treatment with Tibetan medicated bathing(Wuwei Ganlu medicated bathing granules)from August 2019to August 2021,all patients with a mean hospital stay of(10.3±4.0)d.The efficacy was assessed based on symptoms,scale scores and laboratory test indexes,and the changes in outcome indexes before and after treatment were compared.Results After treatment,the number of joints with pressure pain,number of joints with swelling,duration of morning stiffness,scores of Clinical Outcome Scale for RA,and rheumatoid factors were fewer than those before treatment,with statistically significant differences(P<0.05).There were no statistically significant differences in the changes in blood sedimentation and C-reactive protein before and after treatment(P>0.05).No adverse events were reported.The treatment costs ranged from 3200 to 6000 RMB.Conclusion Tibetan medicated bathing is helpful to relieve the symptoms and improve the function of RA patients,with sound safety and economy.