| Rheumatoid arthritis(RA) is a autoimmune disease charactered with chronic and symmetric inflammation in Small joint synovial. The main pathological feature is pannus which can attack cartilage and bone.This disease will make patients disabled and miserable.The incidence rate of RA is0.2-2.4%in our country.Its pathogenesis is not very clear.Most people believe that RA is related with gene and ectogenic incentive.Because the pathogenesis is not clear so that there is no targeted drugs for RA. The immunity inhibitors and biologicals are effective,but harmful for long term usage.In Chinese medicine,RA is classified as arthralgia syndrome. RA is located in the muscles and bones and related with kidney and liver. It is a disease of deficiency in origin and excess in superficiality. a large number of clinical practice has proved that Chinese medicine is very useful for relieving symptoms and preventing joint damage and improving quality of life of RA patients.This study was designed to evaluate the clinical effects of Bu Shen Tong Du Capsule for Treating Patients with RA(TCM of syndrome of kidney-deficiency with cold).It is also used for studying the mechanism of preventing bone damage through the OPG/RANKL/RANK system and regulation of the immune system and metabolism of lipidemia.This dissertation is comprised of two main parts:clinical study and laboratory study.The clinical study include five parts:the clinical research of Bu Shen Tong Du capsule for treating patients with rheumatoid arthritis(TCM of syndrome of kidney-deficiency with cold), the effect on OPG/RANKL/RANK system and bone metabolism, the effect of Bu Shen Tong Du capsule on peripheral Thl/Th2ratio of patients with rheumatoid arthritis, the effect of Bu Shen Tong Du capsule on peripheral Th17/Treg ratio and the effect of Bu Shen Tong Du capsule on lipids metabolism and related cytokines of patients with rheumatoid arthritis.In laboratory study,we study the effect of Bu Shen Tong Du capsule on OPG/RANKL/RANK pathway of collagen induced arthritis rat.Part I The clinical studySection I The Clinical Research of Bu Shen Tong Du Capsule for Treating Patients with Rheumatoid Arthritis(TCM of syndrome of kidney-deficiency with cold)Objective:To investigate the effect of Bu Shen Tong Du capsule for treating patients with rheumatoid arthritis(RA,TCM of syndrome of kidney-deficiency with cold).Method:RA patients were divided randomly into treatment group(36cases) that was treated with Bu Shen Tong Du capsule and control group(35cases) that was treated with Tripterygium glycosides tablet.Both groups were treated for12weeks.The improvement of symptoms and laboratory index were observed by two groups before and after the treatments. Results: The total effective rate was72.22%in the treatment group,and62.86%in the control group.There was no significant different between two groups(P>0.05). Ater treatments,SDAI,CDAI,DAS28,TJC,SJC,HAQ,QOL,PGA,EGA, morning stiffness, average hands grip strength,Chinese medical syndrome integrals and CRP)significantly improved in both groups(P<0.01or P<0.05). Compared with control group, Chinese medical syndrome integrals changed more significantly(P<0.05). Conclusion:Bu Shen Tong Du capsule can relieve symptoms and signs of RA patients(TCM of syndrome of kidney-deficiency with cold) effectively. Section Ⅱ The effect of Bu Shen Tong Du capsule on OPG/RANKL/RANK system and bone metabolism of patients with rheumatoid arthritisObjective:To investigate the effect of Bu Shen Tong Du capsule on OPG/RANKL/RANK system and bone metabolism of patients with rheumatoid arthritis(RA).Method:RA patients were divided randomly and double-blind into treatment team(36cases) that was treated with Bu Shen Tong Du capsule and control team(35cases) that was treated with Tripterygium glycosides tablet.Both teams were treated for12weeks.The changes of serum OPG,RANKL,M-CSF,PINP,BGP and BAP were observed by ELISA and BMD were observed by DTX-200DXA in two teams before and after the treatments. Results:Ater treatments, serum OPG,BGP significantly evaluated(P<0.01)and RANKL,M-CSF,PINP,BAP significantly decreased(P<0.01) in treatment team. Compared with control team serum OPG,RANKL changed more significantly(P<0.05),and PINP,BAP,BGP changed much more significantly(P<0.01).There were no statistical differences in BMD between two teams(P>0.05).Conclusion:Bu Shen Tong Du capsule can regulate RA patients’OPG/RANKL/RANK system and bone metabolism effectively. Section Ⅲ The effect of Bu Shen Tong Du capsule on peripheral Thl/Th2ratio of patients with rheumatoid arthritisObjective:To investigate the effect of Bu Shen Tong Du capsule on peripheral Thl/Th2ratio and serum IFN-γ,IL-4, TNF-a and IL-1β of patients with rheumatoid arthritis(RA).Method:RA patients were divided randomly and double-blind into treatment team(36cases) that was treated with Bu Shen Tong Du capsule and control team(35cases) that was treated with Tripterygium glycosides tablet.Both teams were treated for12weeks.The changes of peripheral blood Thl/Th2ratio and serum IFN-y,IL-4, TNF-a and IL-1β were observed by flow cytometry and ELISA in two teams before and after the treatments. Results:Ater treatments,Peripheral Thl%, Thl/Th2ratio significantly decreased and Th2%significantly evaluated (P<0.01) in both teams. Compared with control team Peripheral Th2%evaluated more (P<0.01), Thl%decreased less (P<0.01) and Thl/Th2ratio were not statistically significant (P>0.05). Serum IFN-γ,TNF-a, IL-1β significantly decreased and IL-4significantly evaluated (P<0.01). Compared with control team,IL-4evaluated more (P<0.01),IFN-γ and TNF-a decreased less (P<0.01),IL-1β were not statistically significant (P>0.05).Conclusion:Bu Shen Tong Du capsule can improve the balance of Thl/Th2cell of RA patients. Section IV The study of effect of Bu Shen Tong Du capsule on peripheral Th17/Treg ratio of patients with rheumatoid arthritisObjective:To investigate the effect of Bu Shen Tong Du capsule on peripheral Th17/Treg ratio and serum IL-17A,TGF-(31and IL-10of patients with rheumatoid arthritis(RA).Method:RA patients were divided randomly and double-blind into treatment team(36cases) that was treated with Bu Shen Tong Du capsule and control team(35cases) that was treated with Tripterygium glycosides tablet.Both teams were treated for12weeks.The changes of peripheral blood Th17/Treg ratio and serum IL-17A,TGF-β1and IL-10were observed by flow cytometry and ELISA in two teams before and after the treatments. Results:Ater treatments,Peripheral Th17%, Thl7/Treg ratio significantly decreased and Treg%significantly evaluated (P<0.01) in both teams.Compared with control team there were not statistically significant (P>0.05).Serum IL-17A significantly decreased,TGF-β1and IL-10significantly evaluated (P<0.01). Compared with control team, TGF-β1and IL-10evaluated more(P<0.01), IL-17Awere not statistically significant (P>0.05).Conclusion:Bu Shen Tong Du capsule can reduce RA patients’peripheral Th17/Treg ratio and serum IL-17A content also can evaluate serum TGF-(31and IL-10content. Section V The effect of Bu Shen Tong Du capsule on lipids metabolism and related cytokines of patients with rheumatoid arthritisObjective:To investigate the effect of Bu Shen Tong Du capsule on lipids metabolism and related cytokines of patients with rheumatoid arthritis(RA).Method:RA patients were divided randomly and double-blind into treatment team(36cases) that was treated with Bu Shen Tong Du capsule and control team(35cases) that was treated with Tripterygium glycosides tablet.Both teams were treated for12weeks.The changes of serum LP,IL-6,lipids and hemorheology were observed in two teams before and after the treatments. Results:Ater treatments,serum LP,TC,LDL-C,RE,TK and plasma viscosity significantly decreased(P<0.01)and Apo-Al significantly evaluated(P<0.01) in treatment team. Compared with control team serum Apo-Al,HDL-C changed more significantly(P<0.05) and serum LP,RE changed much more significantly(P<0.01). Conclusion:Bu Shen Tong Du capsule can regulate RA patients’ lipids metabolism and related cytokines. Part II The laboratory study Section Ⅵ The Effect of Bu Shen Tong Du Capsule on TRAP of CIA ratObjective:To investigate the effect of Bu Shen Tong Du capsule(BS) on TRAP of collagen induced arthritis rat. Method:42rats were randomly assigned to six groups, normal control(C), Model(M), Low dose of BS (BSL), Medium dose(BSM), High dose(BSH) and Tripterygium glycosides(TG).CIA rat modeling is established by CⅡ and IFA. TRAP pathological section were made. Results:BS could reduce TRAP pathological scores (p<0.01).Conclusion:BS can alleviate the level of bone destruction of CIA rat. Section Ⅶ The Effect of Bu Shen Tong Du Capsule on OPG/RANKL/RANK pathway of CIA ratObjective:To investigate the effect of Bu Shen Tong Du capsule(BS) on OPG/RANKL/RANK pathway of collagen induced arthritis rat. Method:42rats were randomly assigned to six groups, normal control(C), Model(M), Low dose of BS (BSL), Medium dose(BSM), High dose(BSH) and Tripterygium glycosides(TG).CIA rat modeling is established by CⅡ and IFA.RANKL,OPG and M-CSF were observed by ELISA. Results:BS could lower RANKL and M-CSF level,raise OPG and OPG/RANKL level in a dose-dependence manner (p<0.01).Conclusion:BS can regulate the OPG/RANKL/RANK pathway of CIA rat Significantly.
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