| Objective: This study evaluated the effectiveness and safety of Zhuang Medicine's stereoscopic comprehensive therapy in the treatment of rheumatoid arthritis(RA)through clinical observation.This study intends to provide the preliminary clinical research evidence for the large sample,multi-center clinical research in later period.Methods: According to the inclusion criteria and exclusion criteria,60 patients with RA who met the criteria were selected and randomly divided into the experimental group(30 cases)and the control group(30 cases).The control group received conventional treatment with methotrexate(MTX),leflunomide(LEF)and other western drugs.On the basis of routine western medicine treatment in the control group,the experimental group was given Zhuang Medicine stereoscopic comprehensive therapy(internal use of Longzuan Tongbi Granules,external use of Zhuang Medicine thermo probe point acupuncture combined with Fa Wang diet prescription of Zhuang Medicine).This study treatment observation time for eight weeks,with patients' disease activity indexes such as rheumatoid factors(RF),erythrocyte sedimentation rate(ESR),c-reactive protein(CRP),tender joint count(TJC),swollen joint count(SJC),morning stiffness time,patient's global assessment(Pt GA),the Health Assessment Questionnaire(HAQ),Disease Activity Score 28 joints(DAS28),syndrome score of Zhuang Medicine and safety indexes such as liver function and renal function,compared with before treatment,mid-term(treatment of 4 weeks)and 8 weeks after treatment to observe changes in both groups,comprehensive evaluation of the effectiveness and safety of Zhuang Medicine's stereoscopic comprehensive therapy.Results:(1)Clinical observation of 30 cases in the experimental group and the control group was completed.There was no significant differences in the baseline level of each indicator before treatment between the two groups,which were comparable.(2)Comparison results of laboratory indicators: at the completion of the 4-week treatment,RF,CRP and ESR in the two groups were significantly lower than that before the treatment(P<0.01).RF,CRP and ESR in the test group were lower than those in the control group,but there was no statistically significant difference between the two groups(P>0.05).After 8 weeks of treatment,RF,CRP and ESR in the two groups were significantly lower than that at the completion of 4 weeks of treatment and before treatment(P<0.01).RF,CRP and ESR in the test group were lower than those in the control group,and the differences between the ESR groups were statistically significant(P<0.05).(3)Comparison results of observation and scoring indicators: at the completion of 4 weeks of treatment,TJC,SJC,morning stiffness time,Pt GA,HAQ,DAS28,syndrome score of Zhuang Medicine of the two groups were significantly lower than those before treatment(P<0.01).TJC,SJC,morning stiffness time,Pt GA,HAQ,DAS28,syndrome score of Zhuang Medicine of the test group were all lower than those of the control group,but there was no statistically significant difference between the two groups(P>0.05).In 8 weeks after treatment,two groups of TJC,SJC,morning stiffness time,Pt GA,HAQ,DAS28,syndrome score of Zhuang Medicine is after 4 weeks treatment and before treatment were significantly decreased(P<0.01),the experimental group TJC,SJC,morning stiffness time are lower than the control group,but no statistically significant difference were observed in the comparison between the two way(P>0.05),treatment group Pt GA,HAQ,DAS28,syndrome score of Zhuang Medicine are lower than the control group and Pt GA,HAQ,DAS28,syndrome score of Zhuang Medicine comparative differences between groups were statistically significant(P<0.05).(4)Efficacy evaluation results: two groups after treatment for 8 weeks,through disease activity curative effect evaluation of the effectiveness of experimental group and the control group were 93.33%,80.00%,the zhuang medicine syndromes curative effect evaluation of the effectiveness of experimental group and the control group were 96.67%,80.00%,two efficient curative effect evaluation of test group were higher than control group in efficient,two groups of curative effect of disease activity and the curative effect of Zhuang Medicine syndrome differences were statistically significant(P<0.05).(5)Safety evaluation results: severe infection,renal failure and other serious adverse reactions were not observed in both groups during the observation period;The adverse reactions of the two groups were mainly gastrointestinal reactions and abnormal liver function.The incidence of adverse reactions in the test group was 10.00% lower than that in the control group(30.00%),and the difference between groups was statistically significant(P<0.05).Conclusion: On the basis of MTX and LEF treatment,the application of Zhuang Medicine stereoscopic comprehensive therapy for RA can more effectively reduce the RF,CRP,ESR,DAS28 and symptoms of patients with RA,and improve their physical function,significantly reduce the incidence of adverse reactions,and thus significantly improve the overall efficacy and safety of treatment. |
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