| Objective:to observe the clinical efficacy and safety of the use of the modified soup with cassia twigs, chinese herbaceous peony and rhizoma anemarrhenae to treat the mixed-type of rheumatoid arthritis caused by cold and heat in active stage.Methods:1.Obeserved objects:60 cases selected from the Rheumatic Department and wards in Fujian Medical University Second Affiliated People's Hospital from Febuary 1st,2010 to November 30th,2010, according to the diagnostic criteria and inclusion criteria.2. Group division:to divide qualified subjects of 60 cases into a treatment group and control group with 30 patients in ratio of 1 : 1 by means of random number table. In comparison of these two groups from their general situations (age, gender and duration of symptoms) and information of their illness (joint function classification, disease activity, DAS28, the main laboratory parameters:ESR, CRP, RF and main symptoms and signs:tender joint count, swollen joint count, patient's overall health status of VAS scores GH, duration of stiffness in the morning, grip strength of both hands on average),no big difference is found and thus these two groups are comparable with each other.3.Treatment:the treatment group are treated with the modified soup with cassia twigs, chinese herbaceous peony and rhizoma anemarrhenae plus diclofenac sodium enteric capsules(DAS28); the control group are treated with leflunomide(LEF) plus diclofenac sodium enteric capsules.4 weeks a course of treatment,3 courses respectively for each group. After 3 courses, compare the main laboratory parameters and the main symptoms and signs in the same group before and after the treatment and to compare these of the two group, with the DAS28 Evaluation Software System to calculate the value of DAS28 to use as indicators of disease activity and efficacy and adverse to assess, and complete the collections of adverse reactions to compare the efficacy and safety.4. All data are analyzed by the use of SPSS13.0.Results:1. Comparison of main laboratory parameters:before and after treatment, both groups of patients can be significantly improved according to laboratory markers:ESR, CRP and RF (P<0.05), but the treatment group can be improved more significantly better than the control group (P< 0.05);2.Comparison of main symptoms and signs:before and after treatment, patients in the main symptoms and signs of these two group:TJC, SJC, GH, duration of morning stiffness and grip strength of both hands on average (P<0.05) can be improved, but the treatment group can be improved more significantly than the control group (P<0.05);3. Disease activity and clinical efficacy comparison:before and after treatment, the disease activity and DAS28 valuen of the two groups are significantly decreased; to compare the clinical efficacy of these two groups,26 marked cases,0 effective cases and 4 ineffective cases in the treatment group, the total effective rate is 86.67%; 19 marked cases,5 effective cases and 6 ineffective cases in the control group, the total effective rate is 80.00%. Statistical analysis shows that there is a significant difference (P< 0.05) between these two groups and the efficacy of treatment group is better than that of the control group;4. Comparison of adverse reactions:the rate of adverse reactions in treatment group is 16.67% with main damage to the digestive system and reproductive system; the rate of adverse reactions in the control group is 26.66% with main damage to performance-based digestive system. The symptoms of adverse reactions in these two groups are mild, and on basis of supportive and symptomatic therapy, symptoms of patients can become normal with no effect unpon their treatment.Conclusion:the use of the modified soup with cassia twigs, chinese herbaceous peony and rhizoma anemarrhenae can effectively improve disease activity of patients with RA, reduce laboratory parameters, improve clinical performance and achieve good clinical efficacy with fewer adverse reactions. This treatment is worthy clinical spreading and applying. |
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