| Objectives According to randomized-controlled principle, the research is conducted to evaluate clinical effect of Shexiangwulong Pills(SP)on rheumatoid arthritis patients of cold-dampness syndrome,to provide the basis for the pills clinical application,by observing the influence of SP on rheumatoid factor(RF), erythrocyte sedimentation rate(ESR), creactive protein(CRP) and ring resistance citrulline peptide antibody(Anti-CCP),together with clinical signs and symptoms score which includes the number of swelling joints and tenderness joints,the average hands grip strength, morning stiffness time, HAQ scores, the pain and fatigue index, overall assessment of the patients and the doctors and TCM syndrome.Methods 120 cases with RA were randomly assigned to treatment group(60 cases) and controlled group(60 cases). All patients were given conventional western medicine as the basis of treatment. Patients in treatment group was administered with Shexiang Wulong pill, 3g each time, twice a day; Patients in controlled group combined with total glucosides of paeony capsules, 0.6g each time, three times a day; Patients in the 2 groups were treated for 2months. Comparison on clinical efficacy of patients after treatment, symptoms and signs changes and laboratory indexes which includes RF, ESR, CRP and Anti-CCP were observed within the 2 groups before and after treatment finally, adverse reactions during treatment were recorded.Results 1 This study included 120 cases with RA.Because some patients can’t medication adherence, 6 cases falled off(1 case in treatment group,5 cases in controlled group). Effective number of the trial was 114 cases, and the loss rate was 5%.2 The following indexes in treatment group were better than those in controlled group, showing statistically significant(P < 0.05) at different observation time points, including tenderness joint, pain index, the improvement of the overall assessment of the illness condition, the doctor’s assessment of the condition and the patients with TCM syndrome integral. At different observation time points,the difference between two groups in the number of swollen joints, the morning stiffness of the time, average hands grip strength, HAQ scores and fatigue index were not statistically significant(P>0.05).3 Laboratory indexes of two groups of patients after treatment was obviously improved, the difference showing statistically significant(P < 0.05); Compared between groups, 1 laboratory related index difference showed no statistical significance(P >0.05).4 Syndrome curative effect rate of TCM, in the treatment group and controlled group were 91.53% and 89.09% respectively, the difference showing statistical significance(P< 0.05).5 DAS28-3 curative effect in treatment group and control group total effective rate were 89.83%and 81.82% respectively, the difference showing statistical significance(P < 0.05).6 Safety evaluation aspects during the study, within the two groups did not appear abnormal in blood routine, urine routine, liver function, and renal function. 3 cases in treatment group appeared nausea, anorexia, symptom being slight, and disappearing automatically. 14 cases in controlled group appeared abdominal pain, diarrhea, symptoms being slight and relieving automatically.Conclusions Shexiang Wulong pills has significant anti-inflammatory analgesic effect, contributing to relieve acute symptoms of RA patients of cold-dampness syndrome types quickly, to reduce the disease activity and clinical curative effect, showing good security. |
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