通痹胶囊治疗类风湿关节炎(寒湿痹阻型)临床疗效及安全性观察

Observation of clinical curative effect and security of Tongbi capsule in treating rheumatoid arthritis(syndrome of colddampness blocking the channals and collaterals)

[目的]观察通痹胶囊治疗寒湿痹阻型类风湿关节炎的临床疗效及安全性。[方法]100例类风湿关节炎(寒湿痹阻型)的患者随机分为两组,每组50例。对照组口服来氟米特+甲氨蝶呤治疗;治疗组在对照组的基础上加用通痹胶囊。观察两组在治疗前后中医证候疗效、中医临床症状积分、美国风湿病学会评分(ACR 20、ACR50)、白介素-1(IL-1)、白介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)的变化,同时观察血常规、肝肾功能等安全性指标的变化以了解其临床应用安全性。[结果]治疗组能明显降低中医临床症状积分(P<0.05),尤其在麻木、怕凉等症状改善尤为显著;治疗1 a后治疗组ACR20、ACR50分别为88%、74%,显著高于对照组66%、60%(P<0.05);通痹胶囊能够更好降低IL-1、IL-6、TNF-α含量。两组在肝肾功能等安全性指标的比较中无明显差异。[结论]联合应用通痹胶囊及慢作用药改善怕凉、麻木等症状有较好的临床疗效及安全性。

[Objective] To observe the clinical effectiveness and safety of the Tongbi capsule in treating rheumatoid arthritis（syndrome of cold-dampness blocking the channals and collaterals）. [Methods] The 100 cases of rheumatoid arthritis（syndrome of cold-dampness blocking the channals and collaterals） of patients were randomly divided into two groups, 50 cases in each group. The control group were treated with LEF＋MTX, while the treatment group were based on the Tongbi capsule treatment. Observed two groups of curative effect of TCM syndrome before and after therapy, Chinese medicine clinical symptoms integral, ACR20, ACR50, IL-1, IL-6, the changes of TNF-α, at the same time observe the blood routine, liver and kidney function safety indexes such as changes in order to understand the clinical application of security. [Results] Treatment group can significantly reduce the clinical symptoms of traditional Chinese medicine integral（P0.05）, especially in the numbness, afraid of cold symptoms such as improving. Performance was particularly significant difference. One year after treatment in treatment group ACR20, ACR50 respectively 88%, 74%, significantly higher than the control group were 66%,60%（P0.05）. Tongbi capsule can better reduce the IL-1, IL-6, the content of TNF-α, can significantly reduce and alleviate the clinical symptoms of patients. In the two groups in safety indexes such as liver and kidney function, no significant differences in the comparison of the safety tips curative effect of two groups. [Conclusion] Based on joint slow-acting drug treatment with Tongbi capsule treat syndrome of cold-dampness blocking the channals and collaterals arthritis with syndrome of cold-dampness blocking the channals and collaterals to improve the chills, numbness syndrome of traditional Chinese medicine has good effect, has good clinical efficacy and safety.