| BackgroundRheumatoid arthritis(RA)is a chronic,systemic autoimmune disease with joint pain and swelling as its main clinical manifestations.Affected by climate,environment,geography and other factors,patients can be induced by temperature changes.Qianggui rheumatism patch is my department many experts by the "spring and summer Yang,autumn and winter Yin" "cure no disease" "heaven and man unity"thought inspired,after years of digging ancient books,combined with clinical observation,the theory and practice combined,gradually improve and form for the treatment of BI disease unique winter disease summer acupoint paste prescription,in my department has more than 10 years of clinical application history,the effect has been recognized.Our preliminary clinical study found that applying Qianggui rheumatism patch for two consecutive years in the dog days of summer could improve the symptoms such as cold limbs and fatigue of RA patients,but there was no systematic study on the immediate efficacy,safety and effect of Qianggui rheumatism patch on the inflammatory indexes of patients.Therefore,this study adopted retrospective analysis and prospective trials to comprehensively evaluate the safety and immediate efficacy of Qianggui rheumatism patch in patients with rheumatoid arthritis.ObjectiveThe safety and immediate efficacy of Qianggui rheumatism patch on patients with rheumatoid arthritis were comprehensively evaluated through retrospective safety evaluation studies and prospective and self-controlled clinical trials,providing evidence-based medical evidence for the clinical application of Qianggui rheumatism patch,an experienced prescription in rheumatology department.Methods1.Retrospective study:Clinical data of RA patients who received whole-course treatment of acupoint application for winter disease and summer treatment(Qianggui rheumatism patch)in the rheumatology outpatient Department of Guanganmen Hospital,China Academy of Chinese Medical Sciences from July 2019 to September 2021 were selected,and a total of 278 patients meeting the criteria were included.SPSS 23.0 was used to statistically analyze the general data,blood routine,liver and kidney function,and urine routine indexes of patients before and after application.And recorded the possible skin irritation and adverse reactions during the application through wechat.2.Prospective study:A single-center self-controlled clinical trial was used to include 80 patients with rheumatoid arthritis who received Qiang-gui-rheumatic plaster treatment.The treatment method was once every 10 days in summer dog days,Stick to the back Ganshu(double),Pishu(double),Shenshu(double)a total of 6 acupoints,2-6 hours/time,a total of 4 times.The evaluation points were 0 weeks of treatment,4 weeks of follow-up up to 12 weeks.Joint pain VAS and cold VAS were used as the main efficacy evaluation indexes,and RA-PRO scale and TCM symptom score of RA were used as the secondary efficacy evaluation indexes.The changes of efficacy before and after treatment were evaluated.Meanwhile,blood routine,urine routine,liver and kidney function indexes and skin irritation reaction were recorded at week 0 and week 4 to evaluate safety.SPSS 23.0 was used for statistical analysis.3.Serological study:Venous blood samples were collected at week 0 and week 4 to detect ESR,CRP and RF,and ELISA was used to detect the expression levels of MMP-3 and MMP-9 in serum,and the changes of indicators before and after treatment were compared,there were 30 cases in all.Spearman correlation analysis was used to analyze the correlation among ESR,CRP,RF,MMP-3 and MMP-9.SPSS 23.0 was used for statistical analysis.Results1.Retrospective study:(1)General data:A total of 278 patients with RA who met the standard of nanation were included in this study,including 38 males and 240 females,with an average age of 52 years.The longest course of the disease was 100 months and the shortest was 5 months.The largest number of patients with a treatment period of 1-3 years was 236 cases,accounting for 84.9%of the total number,and 7 patients with a treatment period of more than 6 years.(2)Safety indicators:①Blood routine:there was no statistical significance in WBC,RBC and PLT in blood routine between patients before and after head fall(P>0.05).The HGB index after application was higher than that before application,and the difference was statistically significant(P<0.01).②Liver and kidney function:There was no significant difference in ALT,AST,BUN,Cr in liver and kidney function between anterior and postcephalic patients(P>0.05).③Urine routine:There was no significant difference in LEU,PRO and ERY indexes in urine routine between patients before and after head fall(P>0.05).④Adverse events:Among the 278 patients in this study,9 patients reported mild pruritus,erythema and edema irritation,but all of them were relieved by self-treatment and did not stop the application treatment.2.Prospective study:(1)General data:A total of 100 RA patients meeting the exclusion criteria were included,and a total of 80 patients actually completed the study.Among them,there were 5 males and 75 females.The average age was 55 years old,and 55-65 years old accounted for the highest proportion.The longest course of disease was 14 years,and the shortest was 5 months.The number of patients who had been applying for 1-3 years was the largest,with 66 cases,accounting for 82.5%of the total number.There were 4 cases who had been applying for more than 6 years.In the distribution of TCM syndrome types,wind-dampness obstruction and cold-dampness obstruction were the most common,accounting for 65%,followed by phlegm-stasis obstruction,accounting for 13.75%.(2)Main therapeutic effect evaluation indexes①VAS score of joint pain:There were significant differences at week 0,4 and 12(F=17.371,P<0.001),Bonferroni multiple mean comparison results showed that the VAS score of joint pain at week 4 was significantly lower than that at week 0(P<0.001),and the VAS score at week 12 was also significantly lower than that at week 0(P<0.00)1).②VAS score for fear of wind and cold:there were significant differences in scores at week 0,4 and 12(F=94.685,P<0.001).Bonferroni multiple mean comparison results showed that VAS score for fear of wind and cold at week 12 was significantly lower than that at week 0(P<0.001)and that at week 4(P<0.001),and fear of wind at week 4 Cold VAS score was significantly lower than 0 week(P<0.001).(3)Secondary efficacy evaluation indexes①RA-PRO scale score:At week 0,week 4 and week 12,there were significant differences(F=16.207,P<0.001).Bonferroni multiple mean comparison results showed that RA-PRO score at week 4 and week 12 was significantly lower than that at week 0,and the difference was statistically significant(P<0.001).②TCM symptom score of RA:there were significant differences at week 0.week 4 and week 12,F=20.397,P<0.001.Bonferroni multiple mean comparison results showed that the TCM symptom score at week 4 was significantly lower than that at week 0(P<0.001),and that at week 12(P=0.002),the TCM symptom score at week 12 was significantly lower The score was lower than 0 weeks,the difference was statistically significant(P<0.05).(4)Safety analysis①Compared with 0 weeks,after 4 weeks of treatment,there was no statistical significance in WBC,RBC,PLT in blood routine,ALT,AST,BUN.Cr in liver and kidney function,LEU,PRO,ERY in urine routine(P>0.05).HGB index was higher than before treatment,the difference was statistically significant(P<0.05).②Among the 80 patients in this study,7 patients reported mild pruritus,erythema and edema irritation,but all of them were relieved by self-treatment and did not stop the application treatment.Meanwhile,no serious adverse events were reported.3.Serological study:(1)Inflammation indicators of ESR,CRP,RF,MMP-3 and MMP-9①After 4 weeks of treatment,the levels of MMP-3 and MMP-9 in ESR,RF and serum were decreased,and the difference was statistically significant(P<0.01).There was no significant difference in CRP index compared with week 0(P>0.05).②Spearman correlation analysis showed that serum MMP-3 level was positively correlated with ESR,CRP and RF(P<0.05),and the correlation was strong(r values were 0.463,0.445 and 0.707,respectively).Serum MMP-9 level was not significantly correlated with ESR and CRP(P>0.05),but was positively correlated with RF(P<0.001)(r=0.734).Conclusion1.Retrospective study:Qianggui rheumatism patch has good safety,and only mild irritation of pruritus,erythematosis and edema were observed as adverse reactions,and no other adverse reactions occurred,and no abnormal laboratory safety indicators were observed.2.Prospective study:Qianggui rheumatism patch can immediately improve the symptoms of joint pain,fear of wind and cold in patients with rheumatoid arthritis,and the curative effect can be maintained for a long time.3.Serological study:Qianggui rheumatism patch can affect the inflammation level of patients with rheumatoid arthritis,reduce inflammatory response,and has a synergistic effect of reducing disease activity. |
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