来源：风湿病与关节炎,2023,12（9）:22-26.

热痹颗粒联合甲氨蝶呤、双氯芬酸钠治疗活动期类风湿关节炎湿热痹阻证26例临床观察（临床研究）

李江红¹，刘昌昊²

　　【摘　要】目的：观察热痹颗粒联合甲氨蝶呤、双氯芬酸钠治疗活动期类风湿关节炎湿热痹阻证的临床疗效。方法：将52例活动期类风湿关节炎湿热痹阻证患者采用随机对照法分为治疗组和对照组，每组26例。对照组予以甲氨蝶呤、双氯芬酸钠缓释胶囊口服治疗，治疗组在对照组治疗基础上加用热痹颗粒。2组均以12周为1个疗程，治疗结束后4周进行随访。观察2组临床疗效，以及治疗前、治疗后4周关节压痛数、关节肿胀数、晨僵时间、类风湿因子（RF）、红细胞沉降率（ESR）、C反应蛋白（CRP）、疼痛视觉模拟评分法（VAS）评分、28个关节疾病活动度评分（DAS28评分），并观察2组不良反应。结果：治疗组临床缓解16例，显效4例，有效3例，无效3例，总有效率为88.46%；对照组临床缓解10例，显效2例，有效4例，无效10例，总有效率为61.54%。2组比较，差异有统计学意义（P < 0.05）。治疗后4周，2组关节压痛数、关节肿胀数、晨僵时间、RF、ESR、CRP、VAS评分、DAS28评分较治疗前均有明显改善（P < 0.05），且治疗组优于对照组（P < 0.05）。不良反应发生率治疗组为15.38%，对照组为23.08%，2组比较，差异无统计学意义（P > 0.05）。结论：与甲氨蝶呤、双氯芬酸钠缓释胶囊治疗活动期类风湿关节炎湿热痹阻证相比，联用热痹颗粒亦能改善患者主要症状、体征及理化指标，且能获得更好的临床效果。

　　【关键词】　类风湿关节炎；湿热痹阻证；热痹颗粒；活动期；临床观察

Clinical Observation on 26 Cases of Active Rheumatoid Arthritis with Damp-heat Obstruction Syndrome Treated with Rebi Keli（热痹颗粒）Combined with Methotrexate and Diclofenac Sodium

LI Jiang-hong,LIU Chang-hao

　　【ABSTRACT】Objective:To observe the clinical efficacy of Rebi Keli（热痹颗粒）combined with methotrexate and diclofenac sodium in the treatment of damp-heat obstruction syndrome in active rheumatoid arthritis.Methods:Fifty-two patients with damp-heat obstruction syndrome of active rheumatoid arthritis were randomly divided into a treatment group and a control group,with 26 cases in each group.The control group received oral treatment with methotrexate and diclofenac sodium sustained-release capsules,while the treatment group received additional treatment with Rebi Keli base on the treatment as that in the control group.Both groups were treated for twelve weeks as a course,and follow-up was conducted four weeks after the end of the treatment,observing the clinical efficacy of two groups,as well as the number of joint tenderness,joint swelling,morning stiffness time,RF,ESR,CRP,VAS and DAS28 score before and after four weeks of treatment,and observing the adverse reactions of the two groups.Results:In the treatment group,16 cases were clinically relieved,4 cases were significantly improved,3 cases were effective,and 3 cases were ineffective,with a total effective rate of 88.46%;In the control group,10 cases were clinically relieved,2 cases were significantly improved,4 cases were effective,and 10 cases were ineffective,with a total effective rate of 61.54%.The difference between the two groups was statistically significant（P < 0.05）.After four weeks of treatment,the number of joint tenderness,joint swelling,morning stiffness time,RF,ESR,CRP,VAS score,and DAS28 score in both groups were significantly improved compared to before treatment（P < 0.05）,and the treatment group was better than the control group（P < 0.05）.The incidence of adverse reactions was 15.38% in the treatment group and 23.08% in the control group.There was no statistically significant difference between the two groups（P > 0.05）.Conclusion:Compared with methotrexate and diclofenac sodium sustained-release capsules in the treatment of damp-heat obstruction syndrome in active rheumatoid arthritis,the combination of Rebi Keli can also improve the main symptoms,physical signs,and physicochemical indicators of patients,and can achieve better clinical effects.

　　【Keywords】 rheumatoid arthritis;damp-heat obstruction syndrome;Rebi Keli（热痹颗粒）;activity period;clinical observation