| ObjectiveTo observe the clinical efficacy and safety of Dumai needle row combined with Tongbiling tablet in the treatment of ankylosing spondylitis and its effect on quality of life through a randomized,controlled and prospective trial,with routine acupuncture combined with Tongbiling tablet as the control group,so as to provide clinical evidence for the comprehensive treatment of ankylosing spondylitis,which is conducive to the promotion and spread of traditional Chinese medicine in China and Thailand and even the world.Method1.In a randomized controlled clinical study,patients with ankylosing spondylitis were randomly divided into 4 groups.The treatment group was treated with Dumai needle row combined with Tongbiling tablet,the control group 1 with routine acupuncture combined with Tongbiling tablet,the control group 2 with Dumai needle row,and the control group 3 with Tongbiling tablet.The course of treatment was 4 weeks for a total of 28 days.Before and after treatment,the laboratory indexes(ESR,CRP,TNF-α)of AS patients,VAS score of spinal pain,patient global asessment(PGA),disease activity index of Bath ankylosing spondylitis((BASDAI)),functional index of Bath ankylosing spondylitis((BASFI)),Bath ankylosing spondylitis measurement index(BASMI),TCM syndrome score,Ankylosing spondylitis quality of life scale((ASQo L))was used to compare the clinical efficacy and adverse reactions of each group.2.Statistics:the data were analyzed by SPSS22.0 software package.The data were analyzed by?~2 statistically,variance(normal distribution)or rank sum test(non-normal distribution).The test level was set toα=0.05(P≤0.05).It was considered that the difference was statistically significant.Result1.A total of 132 AS patients were enrolled in the Department of Acupuncture and Rheumatology of the first affiliated Hospital of Guangzhou University of traditional Chinese Medicine from February 2019 to March 2020.There were 9cases of falling out and 123 cases of effective cases in the Department of Acupuncture and Rheumatology of the first affiliated Hospital of Guangzhou University of traditional Chinese Medicine,Nakonglakai,Thailand.There were31 cases in the treatment group,30 cases in the control group 1,32 cases in the control group 2 and 30 cases in the control group 3.2.There was no significant difference in gender,age,course of disease,laboratory index(ESR,CRP,TNF-α),TCM syndrome score,spinal pain VAS score,patient global asessment(PGA),BASFI score,BASDAI score,BASMI score,ASQo L,etc.before treatment in the four baseline groups.3.After the end of the treatment,there was no clinical cure in the four groups.in the treatment group,15 cases were significantly effective,14 cases were effective,2 cases were ineffective,and the total effective rate was93.55%.Control group 1 was significantly effective in 2 cases,effective in21 cases,ineffective in 7 cases,the total effective rate was 76.67%.Control group 2 was significantly effective in 0 cases,effective in 19 cases,ineffective in 13 cases,the total effective rate was 59.38%.Control group3 was significantly effective in 0 cases,effective in 20 cases,ineffective in 10 cases,the total effective rate was 66.67%.There was significant difference in effective rate among the four groups(P<0.05).4.Laboratory indicators:(1)In terms of erythrocyte sedimentation rate(ESR),the ESR of the four groups decreased before and after treatment,but did not decrease to the normal value during the treatment period,and the difference was statistically significant(P<0.05).Compared with the treatment group after treatment,there was significant difference among Dumai needle row,Tongbiling tablet and Dumai needle row combined with Tongbiling tablet(P<0.05).The comparison of difference was significant difference among control group 1,control group2,control group 3 and treatment group before and after treatment,and there was significant difference between control group 1 and control group 3 before and after treatment(P<0.05).(2)In terms of C-reactive protein(CRP),there was a decrease in CRP in the four groups before and after treatment,but it did not decrease to the normal value during the treatment period,and the difference was statistically significant(P<0.05).The comparison between the four groups was compared with that of the treatment group after treatment,between the Dumai needle row combined with Tongbiling tablet and the other three groups of control group,and between routine acupuncture combined with Tongbiling tablet and Tongbiling tablet after treatment.Compared with the difference before and after treatment between control group 1,control group 2,control group 3 and treatment group 3,there was significant difference between control group 1and control group 3(P<0.05).(3)In terms of tumor necrosis factor-α(TNF-α),TNF-αdecreased in all the four groups before and after treatment,but did not decrease to the normal value during the treatment period,and the difference was statistically significant(P<0.05).In the comparison between the three groups,there was significant difference between routine acupuncture combined with Tongbiling tablet and Tongbiling tablet(P<0.05).The comparison of difference before and after treatment in the treatment group was significantly different from that in the control group 2 and control group 3(P<0.05).There was statistical difference between the control group 1 and control group 3(P<0.05).5.Spinal pain VAS and patient global asessment(PGA)(1)In spinal pain VAS score,there were significant differences among the four groups before and after treatment.Compared with the treatment group after treatment,there was significant difference between Dumai needle row combined with Tongbiling tablet and routine acupuncture combined with Tongbiling tablet and Tongbiling tablet(P<0.05).There were significant differences between control group 1,control group 2,control group 3 and treatment group before and after treatment(P<0.05).(2)In terms of patient global asessment(PGA),there were significant differences among the four groups before and after treatment.It was found that there was significant difference between the control group and the treatment group after treatment and before and after treatment(P<0.05).6.AS related scale score(1)In ankylosing spondylitis disease activity index(BASDAI),ankylosing spondylitis disease function index(BASFI),ankylosing spondylitis disease measurement index(BASMI),there were significant differences among the four groups before and after treatment.It was found that there was significant difference between the control group and the treatment group after treatment and before and after treatment(P<0.05).(2)In terms of of quality of life assessment scale for ankylosing spondylitis(ASQo L),there were significant differences among the four groups before and after treatment,including Dumai needle row method combined with Tongbiling tablet,routine acupuncture combined with Tongbiling tablet and Dumai needle row method(P<0.05),there was significant difference between Dumai needle row combined with Tongbiling tablet and Dumai needle row(P<0.05).7.In terms of TCM syndrome scores,there were significant differences among the four groups before and after treatment in joint swelling,limitation of lumbar spine movement,joint pain,heavy fatigue of limbs,soreness and weakness of waist and knees,fever and sweating,and the total score of TCM syndrome scores(P<0.05).After treatment,there was significant difference between the control group and the treatment group in relieving joint swelling(P<0.05).There was no significant difference between the control group and the treatment group in relieving joint swelling(P<0.05).In improving the limitation of lumbar movement,joint pain,limb tiredness,sore waist and knees,fever and sweating,and the total score of TCM syndrome,there were significant differences between the Dumai needle row combined with Tongbiling tablet and the other three groups(P<0.05).Conclusion1.In the treatment of AS with Dumai needle row combined with Tongbiling tablet,Dumai Pai Needle can effectively improve the inflammatory indexes of ESR,CRP and TNF-α,especially in reducing the level of ESR,relieving body pain such as spine and joint,and improving motor dysfunction.2.Taken Tongbiling tablet can reduce the levels of inflammatory factors ESR,CRP and TNF-α,It can effectively improve the activity dysfunction,and relieve spinal pain,but it has no obvious effect on relieving body pain.3.In the treatment of AS with routine acupuncture,acupuncture can effectively reduce inflammatory factors ESR,CRP and TNF-α,but compared with Dumai needle row,it has more obvious effect on reducing ESR,while routine acupuncture has no significant effect on relieving pain and improving activity dysfunction.To sum up,Dumai needle row combined with Tongbiling tablet in the treatment of AS can reduce the level of inflammatory factors,relieve symptoms such as joint swelling and pain,and improve the activity function of AS patients;it is more effective than single therapy,and can improve the symptoms and signs of AS patients as a whole.This therapy has the advantages of high safety,wide clinical application and low economic burden,which is helpful to improve patient compliance,control the disease process more effectively and improve the quality of life of AS patients,so it is worth further popularizing and applying. |
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