Clinical Study On YiShenHuoXieTongBi Recipe Combined With Methotrexate And Leflunomide In The Treatment Of Rheumatoid Arthritis

Objective Investigating the therapeutic effect and side-effect of YiShenHuoXieTongBi Recipe combined with Methotrexate(MTX) and Leflunomide(LEF) in treatment of rheumatoid arthritis patients.Methods Disease effect, TCM symptom effect, Main index effect, Erythrocyte sedimentation rate(ESR), Rheumatoid factor(RF), C-reactive protein(CRP), X-ray of hands, blood routine, liver and kidney function of RA patients were analyzed after 12 weeks of treatment with the experimental group and the control group. The adverse effect was recorded.Results There was significant difference in disease effects after 8 and 12 weeks of treatment and in total effective rate of disease effect after 12 weeks of treatment between the two groups (P＞0.05). The effective rate of disease effect was 63.3%,83.3%,93.1%respectively in the experimental group and 60.0%,72.4%,86.2% respectively in the control group after 4,8,12 weeks of treatment. The experimental group got more abvious disease effects and the total effective rate of the disease effect than those of the control group. But there was no significant difference in disease effects after 4 weeks of treatment between the two groups (P＞0.05). There was significant difference after 12 weeks of treatment in the TCM symptom effect and the total effective rate of the TCM symptom effect after 12 weeks of treatment between the two groups (P＜0.05). The experimental group got more TCM symptom effect and total effective rate of the TCM symptom effect than those of the control group. The total effective rate of TCM symptom effect was 53.3%,66.7%,86.2% respectively in the experimental group and 56.7%,66.7%,72.4 % respectively in the control group after 4,8,12 weeks of treatment, there was no significant difference in TCM symptom effect after 4 and 8 weeks of treatment between the two groups (P＞0.05). There was significant difference in main index effect after 4,8,12 weeks of treatment in contrast to pretreatment in the experimental group (P＜0.05). There was significant difference in joint pain degree, swollen joint degree, morning stiffness time, swollen joint count after 4,8,12 weeks of treatment in contrast to pretreatment in the control group and in joint function after 8,12 weeks of treatment in contrast to pretreatment in the control group (P＜0.05). There was significant difference in joint pain degree and morning stiff time after 8 and 12 weeks of treatment and swollen joint degree,swollen joint count,joint function,grip strength after 12 weeks of treatment between the two groups(P＜0.05), The experimental group was more effective than the control group. While there was no significant difference in tender joint count after 4,8,12 weeks of treatment between the two groups (P＞0.05). There was no significant difference in swollen joint degree,joint function,swollen joint count,grip strength after 4 and 8 weeks of treatment between the two groups (P＞0.05). There was significant difference in ESR, RF,CRP after 4,8,12 weeks of treatment in contrast to pretreatment in the experimental group and in RF after 8,12, in ESR,CRP after 4,8,12 weeks of treatment in contrast to pretreatment in the control group (P＜0.05). The experimental group was more effective than the control group. There was no significant difference in RF after 4 weeks of treatment in contrast to pretreatment in the control group (P＞0.05). There was significant difference in CRP after 8,12 weeks of treatment and in RF,ESR after 12 weeks of treatment between the two groups (P＞0.05.). While there was no significant difference in RF,ESR after 4,8 weeks of treatment and in CRP after 4 weeks of treatment between the two groups (P＞0.05). There was no significant difference in blood routine, liver function and kidney function of the RA patients in pretreatment between the two groups and so was it after 12 weeks of the end of treatment between the two groups (P＞0.05). There was significant difference in digestion dysfunction after 12 weeks of treatment between the two groups(P＜0.05). The digestion dysfunction patients of the experimental group was less than that of the control group.Conclusion The experimental group had obvious effect and better safety in the treatment of RA.