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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 clinical efficacy of Tengmei Decoction (TMD) in combination with conventional anti-rheumatic drugs (cDMARDs) in the treatment of patients with moderate / high rheumatoid arthritis (RA). Methods A retrospective analysis was performed on the clinical data of 198 cases of RA with moderate / high disease activity. According to the drug regimen, 97 cases were divided into control group, methotrexate (MTX) and leflunomide (LEF) group. The treatment group 101 cases, oral TMD, MTX, LEF combined treatment, intervention time of 12 weeks. The changes of disease activity score (DAS28), RA activity, 28 joint tenderness (TJC28), 28 joint swelling (SJC28), overall disease assessment (PGA), rheumatoid factor ), ESR, CRP and PLT, and WBC, ALT, AST, BUN and SCr levels were also observed. Results Compared with those before treatment, the levels of DAS28, TJC28, SJC28 and PGA in the two groups were decreased (P <0.01), CRP, ESR, RF in the control group and CRP, ESR, . Compared with the control group, the levels of DAS28, TJC28, SJC28, PGA, CRP and ESR in the treatment group decreased (P <0.05, P <0.01). After treatment, the proportion of patients with moderate / high disease activity in the treatment group decreased, the proportion of patients with clinical remission and low disease activity increased. There was a significant difference between the two groups (Z = -2.308, P = 0.021). The incidence of adverse reactions in the treatment group [2.97% (3/101)] was lower than that in the control group [9.28% (9/97)], but the difference was not statistically significant (P> 0.05). Conclusion The clinical effect of TMD combined with cDMARDs in improving mid / high activity RA is better than that of cDMARDs alone.