藤莓汤联合传统改善病情抗风湿药治疗中/高活动度类风湿关节炎患者的疗效观察

Efficacy Observation of Tengmei Decoction Combined with cDMARDs in Treatment of Rheumatoid Arthritis Patients with Moderate and High Disease Activity

目的观察藤莓汤(Tengmei Decoction,TMD)联合传统改善病情抗风湿药(cDMARDs)治疗中/高活动度类风湿关节炎(RA)患者的临床疗效。方法选取198例中/高疾病活动度RA患者临床资料进行回顾性分析,根据用药方案分为对照组97例,口服甲氨蝶呤(MTX)、来氟米特(LEF)联合治疗;治疗组101例,口服TMD、MTX、LEF联合治疗,干预时间12周。观察治疗前后28个关节疾病活动评分(DAS28)、RA活动度、28个关节压痛数(TJC28)、28个关节肿胀数(SJC28)、患者对疾病的整体评估(PGA),类风湿因子(RF)、血沉(ESR)、CRP、PLT情况,同时观察WBC、ALT、AST、BUN、SCr水平。结果与本组治疗前比较,两组治疗后DAS28、TJC28、SJC28、PGA降低(P<0.01),对照组CRP、ESR、RF以及治疗组CRP、ESR、RF、PLT水平降低(P<0.01)。与对照组比较,治疗组DAS28、TJC28、SJC28、PGA、CRP及ESR水平降低(P<0.05,P<0.01)。治疗后,治疗组中/高疾病活动度者比例降低,临床缓解及低疾病活动度者比例升高,两组整体比较,差异有统计学意义(Z=-2.308,P=0.021)。治疗组不良反应发生率[2.97%(3/101)]较对照组低[9.28%(9/97)],但差异无统计学意义(P>0.05)。结论 TMD联合cDMARDs改善中/高活动度RA患者的临床效果优于单纯cDMARDs治疗。

Objective To observe the efficacy of Tengmei Decoction（TMD） combined with con- ventional disease-modifying anti-rheumatic drugs （cDMARDs） in treatment of rheumatoid arthritis （RA） pa- tients with moderate and high disease activity. Methods Clinical data of 198 RA patients with moderate and high disease activity were retrospectively analyzed, which were divided into the control group （97 ca- ses） ,treated with methotrexate （MTX） and leflunomide （ LEF~, and the treatment group （101 cases ）, trea- ted with TMD combined with MTX and LEF. The study duration of observation was for 12 weeks. Effect indi- cators including disease activity score-28（ DAS28）, RA activity, 28 tender joint count （TJC28）, 28 swollen joint count（SJC28）, patient global health assessment （ PGA）, rheumatoid factor （ RF）, erythrocyte sedi- mentation rate （ESR）, C-reactive protein （CRP）, platelet （PLT） and safety index including white blood cell （WBC）, alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, blood urea nitrogen （BUN） and serum creatinine （SCr） were observed before and after treatment. Results Compared with those be- fore treatment,scores of DAS28, TJC28, SJC28 and PGA in the two groups were significantly decreased after treatment（P 〈0.01）, and the levels of CRP, ESR and RF in the control group and CRP, ESR, RF and PLT in the treatment group were decreased （P 〈0.01 ）. Compared with the control group, the levels of DAS28, TJC28, SJC28, PGA, CRP and ESR in the treatment group were decreased （P 〈0.05, P 〈0.01 ）. Proportion of patients with moderate and high disease activity in the treatment group were decreased, while that of clinical remission, low disease activity were increased. The differences between the two groups were significant （Z= -2.308, P =0.021）. The incidence of adverse events in the treatment group [2.97%（3/101 ）~ was lower than that in the control group E9.28% （9/97）1 ,nevertheless there was no significant difference （P 〉0.05）.Conclusion TMD combined with cDMARDs improves the clinical out- come of RA patients with moderate and high disease activity ,which is superior to that of cDMARDs alone.