Objective To investigate the different clinical efficacy of formula granule of Duhuo Jisheng decoction and traditional prepared drug in pieces on patients with rheumatoid arthritis, and explore the effect of the biochemical index and clinical symptoms. Methods 82 cases of patients with rheumatoid arthritis were randomly divided into control group of 41 cases and observation group of 41 cases from March 2011 to May 2014. Patients in the control group were treated with traditional Duhuo Jisheng decoction combined with methotrexate tablets, 10mg each time, 1time each week. While patients in the observation group were treated with formula granule of Duhuo Jisheng decoction on the basis of methotrexate tablets, 1agent each day, 2 weeks was 1 course of treatment, and they received continuous 6 courses for treatment. We observed the improvement of clinical symptoms, mainly including joint pain, swelling, morning stiffness, adverse joint flexion and extension, aversion to cold, and so on. We evaluated the main symptom score, especially the pain with VAS, and observed the change of the scores. We tested the level of ESR, CRP, RF, IL-6 and IL-βafter treatment. We calculated the effective rate and the adverse event rate of the two groups. Results The clinical symptoms of the patients in two groups were improved clearly, the symptom scores and VAS score went down clearly compared with before treatment, and the difference was significant (P<0. 05), but comparing with the scores of the two groups after treatment, the difference was not significant ( P >0. 05 ) . The level of ESR, CRP, RF, IL-6 and IL-β of the patients went down compared with before treatment, and the difference was significant (P<0. 05), but the difference of the two groups after treatment was not significant (P>0. 05). The effective rate the control group was 82. 9%, which was slightly lower than 87. 8% of the observation group, and the difference was not significant (P>0. 05). The patients in two groups had the unwell symptom of gastrointestinal discomfort, nausea and vomiting, and the adverse event rate of the control group was 17. 1%, which was slightly higher than 12. 2% of the observation group, and the difference was not significant (P>0. 05). Conclusion The formula granule of Duhuo Jisheng decoction and traditional prepared drug in pieces can relieve the clinical symptoms, relieve the pain, improve the patient’ s biochemical index, decrease the patients’ factor level, which had the satisfactory clinical effect, but the two groups showed similar curative effect. The formula granule of Duhuo Jisheng decoction was more convenient, which was an effective way for treating rheumatoid arthritis, and was worthy of further research and development.%目的：观察独活寄生汤配方颗粒与传统饮片治疗类风湿关节炎患者的不同效果,并探讨其对患者生化指标的不同影响。方法选取2011年3月至2014年5月就诊于我院的类风湿关节炎患者82例为研究对象,将患者按照随机数字表法分为对照组和观察组患者各41例。对照组患者给予独活寄生汤传统饮片联合甲氨蝶呤片10mg/次口服治疗,1次/周；观察组患者则在甲氨蝶呤片内服治疗的基础上联合独活寄生汤配方颗粒治疗,1剂/d ,2周为1个疗程,连续治疗6个疗程。观察两组患者经治疗后关节疼痛、肿胀、晨僵、关节屈伸不利、喜暖恶寒等临床症状的改善情况,对临床证候给予评分,观察评分的变化情况；用疼痛视觉模拟评分VAS对患者的痛感进行评分,观察疼痛的变化情况；检查患者治疗前后血沉( ESR)、C反应蛋白( CRP)、类风湿因子( RF)、白细胞介素-6(IL-6)、白细胞介素-β(IL-β)水平的变化情况,计算临床治疗的有效率,观察治疗后的不良反应发生率。结果两组患者经治疗后关节疼痛、肿胀、晨僵、关节屈伸不利、喜暖恶寒等临床症状均较治疗前有所改善,证候积分有所下降,痛感缓解明显,VAS疼痛积分下降明显,同组治疗前后比较差异有统计学意义(P<0．05),但是治疗后组间比较,差异性不显著(P>0．05)；两组患者经治疗后血沉(ESR)、C反应蛋白(CRP)、类风湿因子(RF)、白细胞介素-6(IL-6)、白细胞介素-β(IL-β)水平均有所降低,同组治疗前后比较差异有统计学意义(P<0．05),但是治疗后组间比较,差异性不显著(P>0．05)；对照组患者的有效率为82．9%,治疗组患者的有效率为87．8%,治疗组的有效率略高于对照组,两组患者的有效率比较无显著的差异性( P>0．05)；两组患者治疗后均出现胃肠不适、恶心呕吐等症状,对照组患者的不良反应发生率为17．1%,略高于治疗组患者的不良反应发生率12．2%,组间比较无显著的差异性(P>0．05)。结论独活寄生汤配方颗粒与传统饮片均能有效改善类风湿关节炎患者的临床症状,缓解患者的痛感,改善患者的生化指标,降低患者的因子水平,安全可靠,疗效确切,二者疗效相当,以配方颗粒的使用更为方便,是治疗类风湿关节炎的有效方式,值得临床深入研究运用。
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