来源：风湿病与关节炎,2020,9（12）:14-18.

基于IL-1Ra/IL-1β平衡理论探讨中药熏蒸Ⅰ号方联合来氟米特及塞来昔布治疗活动期类风湿关节炎的机制（临床研究）

陈煜宇¹，齐张旸¹，赵宇杉²，吴宽裕¹，赵钟文¹，张志明¹，戴大玲¹

　　【摘　要】目的：观察自拟中药熏蒸Ⅰ号方联合来氟米特及塞来昔布治疗活动期类风湿关节炎的临床疗效，并探讨其改善类风湿关节炎的作用机制。方法：将91例类风湿关节炎患者按照随机数字表法分为对照组30例、治疗组30例、联合组31例。对照组给予来氟米特片联合塞来昔布胶囊口服，治疗组给予中药熏蒸Ⅰ号方熏蒸，联合组采用西药口服联合中药熏蒸Ⅰ号方熏蒸，3组疗程均为4周。观察3组临床疗效，以及治疗前后肿胀关节数、晨僵时间、握力、DAS28评分，检测红细胞沉降率（ESR）、C-反应蛋白（CRP）、白细胞介素（IL）-1Ra、IL-1β含量。结果：联合组显效5例，有效25例，无效1例，总有效率为96.77%；治疗组显效0例，有效18例，无效12例，总有效率为60.00%；对照组显效1例，有效18例，无效11例，总有效率为63.33%。联合组总有效率优于治疗组和对照组，差异有统计学意义（P < 0.05）。治疗后，3组肿胀关节数、晨僵时间、DAS28评分、ESR、CRP明显降低，握力增加，IL-1Ra含量、IL-1Ra/IL-1β比值升高，IL-1β含量下降（P < 0.05），且联合组优于治疗组和对照组（P < 0.05）。结论：自拟中药熏蒸Ⅰ号方联合来氟米特及塞来昔布能明显改善活动期类风湿关节炎的症状、体征及炎症指标，无明显不良反应，这种疗效可能是通过升高IL-1Ra含量、IL-1Ra/IL-1β比值，抑制IL-1β含量实现的。

　　【关键词】　关节炎，类风湿；活动期；中医药治疗；中药熏蒸；IL-1Ra；IL-1β；IL-1Ra/IL-1β

On the Mechanism of No.1 Chinese Medicine Fumigation Combined with Leflunomide and Celecoxib in the Treatment of Active Rheumatoid Arthritis Based on the Balance Theory of IL-1Ra/IL-1β

CHEN Yu-yu,QI Zhang-yang,ZHAO Yu-shan,WU Kuan-yu,ZHAO Zhong-wen,ZHANG Zhi-ming,DAI Da-ling

　　【ABSTRACT】Objective:To observe the clinical efficacy of self-made No.1 Chinese Medicine Fumigation combined with leflunomide and celecoxib in the treatment of active rheumatoid arthritis（RA）,and discuss its mechanism.Methods:Ninety-one cases with rheumatoid arthritis were randomly divided into a control group（30 cases）,a treatment group（30 cases）and a combination group（31 cases）.The control group was treated with leflunomide combined with celecoxib capsules,the treatment group with No.1 Chinese Medicine Fumigation,and the combination group with western medicine combined with No.1 Chinese Medicine Fumigation.The three groups were treated for 4 weeks.The clinical efficacy,swelling joint number,morning stiffness time,grip strength,and DAS28 score were observed,and ESR,CRP,IL-1Ra and IL-1β were measured before and after treatment.Results:In the combination group,5 cases were markedly effective,25 cases were effective,one case was ineffective,and the total effective rate was 96.77%.In the treatment group,no cases were markedly effective,18 cases were effective,12 cases were ineffective,and the total effec-tive rate was 60.00%.In the control group,1 case was markedly effective,18 cases were effective,and 11 cases were ineffective,with the total effective rate of 63.33%.The total effective rate of the combined group was better than that of the treatment group and the control group and the difference was statistically significant（P < 0.05）.After treatment,the swelling joint number,morning stiffness time,DAS28 score,ESR and CRP in the three groups decreased significantly,the grip strength increased,the ratio of IL-1Ra and IL-1β increased,the content of IL-1β decreased（P < 0.05）,and the combination group was better than the treatment group and the control group（P < 0.05）.Conclusion:No.1 Chinese Medicine Fumigation combined with leflunomide and celecoxib can significantly improve the symptoms,signs and inflammatory indexes of active rheumatoid arthritis without obvious adverse reactions.This effect may be achieved by increasing the content of IL-1Ra and the ratio of IL-1Ra/IL-1β,and inhibiting the content of IL-1β.

　　【Keywords】 arthritis,rheumatoid;active stage;treatment with Chinese medicine;Chinese medicine fumigation;IL-1Ra;IL-1β;IL-1Ra/IL-1β