ObjectiveTo observe the safety and efficacy of Simiao Xiaoling Zhiwang prescription in the treatment of Rheumatoid Arthritis with damp-heat and blood-stasis syndrome,to investigate the effect of patients’ clinical conditions and activity levels,and to form a Traditional Chinese Medicine treatment prescription with curative effect.MethodsIn this research,a randomized controlled study method was used to include 66 patients.Control group 32 cases,given to methotrexate +folic acid tablets.Treatment group 34 cases,adding Simiao Xiaoling Zhiwang prescription to the control group.The observation time was 12 weeks.To watch the variations of patients’ clinical conditions,therapeutic properties,and changes in laboratory and security targets before and after treatments in two groups.Putting to use the software of SPSS26.0 to analyze the study numbers of two teams and assess clinical effectiveness and safety.Results1.Intra-group comparison of the two groups all can reduce the scores of TCM syndromes(P<0.01),intergroup comparison showed that the scores of sweating,thirst and disadvantageous joint flexion and extension had no statistically significant difference(P>0.05);explaining there has no apparent discrepancy of the calculus in sweating,thirst and disadvantageous joint flexion and extension,comparison between two groups of arthritic pain,swelling,tenderness,joint fever,morning stiffness,showing that the scores were statistically significant(P<0.05),instructing treatment group enhance the arthritic pain,swelling,tenderness,joint fever,morning stiffness,the effect was better than control group,among the two groups,the scores of the joint fever symptoms had a statistically significant difference(P<0.01),instructing treatment group could enhance the joint fever symptoms apparently.2.The overall quality frequency of Chinese Medicine evidence in treatment group was 88.23%,it is higher than control group 68.75%(P<0.05);the improvements frequency of ACR20 in treatment subjects was 85.29%,it is higher than control group62.50%(P<0.05).The total improvements frequency of treatment surpass control subjects.3.Both subject was able to enhance the resting pains,joint pressure pain and number of swelling,PGA,MDGA,PRO,HAQ score,blood rheology level,intergroup comparison between two groups,instructing the improvements frequency of treatment group surpass control group(P<0.05).4.Both the treatment group and the control group could reduce the inflammatory indicators ESR and CRP.Intergroup comparison between two groups showing that the treatment group reduce the level of CRP and ESR surpass the control group(P<0.05),the anti-inflammatory efficacy of treatment group was better than control group.5.The preclinical total improvements frequency of the treatment group was88.23%,control subjects was 71.88%,comparing two groups,quality of preclinical in the treatment group was better(P<0.05).6.Both two groups unable to bring down the diagnostic mark in RF fractionation and CCP,intergroup comparison between two groups,had no statistically significant difference(P>0.05).7.Both two groups oral analgesic aceclofenac tablets,contrasting the number of people and days,differences hadn’t analytics significance(P>0.05).Both two groups combined with aceclofenac tablets has no implications for the research results.8.Before and after curing,the basic vital signs,urinary routine,stool routine+occult blood,electrocardiography and chest anteroposterior film of the two groups were recorded respectively,none of two subjects occur abnormality.Comparing the security indicators of intra-group and inter-group in both groups.Statistical differences in the above safety indicators did not affect the results of the study(P>0.05).9.Contrasting the adverse effects in two groups,the results exposed no statistically significant difference(P>0.05),the two groups were not arise severe side effects.Conclusions1.The preclinical efficacy of Simiao Xiaoling Zhiwang Decoction united with western drug in the cure of RA with damp-heat and blood-stasis obstruction was better than western drugs alone.The treatment group improved TCM syndromes and clinical efficacy,TCM syndrome points and total points,ACR20,rest pain,PGA,MDGA,reduced joint tenderness and swelling,shortened morning stiffness time,and reduced ESR,CRP,hemorheology,DAS28,PRO,HAQ,the healing efficacy of treatment group was better than control group.2.Simiao Xiaoling Zhiwang Soup has less adverse effects and little toxic and side effects in the treatment of RA damp-heat stasis syndrome.It has the well security,worth researching in depth and promoting for use. |