独活寄生汤配方颗粒与传统饮片汤剂治疗类风湿关节炎的疗效比较

Comparison of the clinical effects between compatible granule and traditional decoction of Duhuo-Jisheng Tang in treating patients with rheumatoid arthritis

目的:对独活寄生汤配方颗粒与传统饮片汤剂治疗类风湿关节炎(RA)的临床疗效进行对比研究。方法:将确诊为RA的250例患者随机分成对照组和治疗组,每组各125例。治疗组用独活寄生汤配方颗粒联合小剂量甲氨蝶呤(MTX)治疗,对照组用独活寄生汤饮片汤剂联合小剂量MTX治疗,连续服用8周为一疗程。分别于治疗前及治疗后检测血沉(ESR)、C-反应蛋白(CRP)、类风湿因子(RF)及细胞因子(IL-1β、IL-6及TNF-α)的含量,观察晨僵时间、关节肿胀数、关节疼痛数的变化及有无不良反应,并评定其临床疗效。结果:2组在治疗后ESR、CRP、RF及IL-1β、IL-6及TNF-α含量等指标均有明显降低,治疗组总有效率81.6%,对照组总有效率78.4%,2组均安全有效,差异无统计学意义。结论:独活寄生汤配方颗粒与饮片汤剂治疗RA临床疗效相似,配方颗粒较饮片汤剂使用方便、质量稳定,为临床治疗RA提供了一种新的中药配方剂型。

OBJECTIVE To study the differentiation of clinical effects between compatible granule and traditional decoction of Duhuo-Jisheng Tang in treating patients with rheumatoid arthritis （RA）. METHODS 250 cases diagnosed with RA were randomly divided into two groups, 125 cases of each group. The study group were treated with combination of compatible granule of Duhuolisheng Tang and low dose methopterin （MTX） ,while the control group were treated with combination of tradi tional decoction of Duhuo-Jisheng Tang and low dose MTX. And the course of treatment was eight weeks. Before and after treatment,the erythrocyte sedimentation rate（ESR） ,C reactive protein （CRP） ,rheumatoid factor （RF） and cytokine（CK）（such as IL-113,1L-6 and TNF-α） were tested, while the clinical indicators such as time of morning stiffness, clinical indicators joint swelling and joint pain were observed respectively. And their adverse reactions and clinical efficacy were evaluated as well. RE- SUL＇IN The index of ESR, CRP, RF, ILl 13, IL-6, TNF-aand so on of post treatment were obvious lower than that of pre-treat- ment in both groups. The total effective rate of study group was 81.6% ,while that of the control group was 78. 4%. They were all safe and effective there was no significant difference between them. CONCLUSION Clinical effect of compatible granule of Duhuo-Jisheng Tang on RA was similar to that of traditional decoction of Duhuo-Jisheng Tang. The compatible granule is easi er to be taken, has stable quality, and can be used as a new form of Chinese medicine formula for treating RA in clinic.