| Objective1.To study the clinical efficacy and safety of mini-moxibustion for ankylosing spondylitis(AS),and correlation of mini-moxibustion affecting sacroiliac joint blood flow and vascular elasticity index;2.Discussing the efficacy of power Doppler ultrasound(PDUS)technique with minimoxibustion treating for AS.MethodsDesigned as a randomized controlled clinical trial,recruiting 76 patients with Ankylosing Spondylitis,they were randomly divided into two groups:treatment group(1 group),control group(2 groups)according to 1:1 ratio,the treatment group was treated with mini-moxibustion,the control group was treated only with basic western medicine,do not accept any other acupuncture treatment intervention.The total course of treatment in both groups was 12 weeks,Set 5 observation points for 0,2,4,6 and 12 weeks,Time window for observation time±2 days.The efficacy was evaluated by ESR(ESR),C-reactive protein(CRP),PDUS ultrasound results,ASDAS-CRP score,quality of life assessment scale for ankylosing spondylitis(ASQoL),disease activity index(BASDAI)for Bath ankylosing spondylitis,function index(BASFI)for Bath ankylosing spondylitis,measurement index(BASMI)for Bath ankylosing spondylitis,symptom score,adverse reactions,in order to obtain clinical efficacy.Applying SPSS 25.0 to statistical analysis of measurements,Analysis of results using intent processing,Fill the missing value according to the ITT principle.Statistical analysis is conducted by third parties,Descriptive analysis of measurement data;Comparison of measurement data using a t test(or paired symbol rank sum test),Comparison between groups using ANOVA(or rank sum test),The rank sum test was used to compare the grade data between groups;The counting data are expressed by composition ratio,rate,The chi-square test was used to compare the total effective groups;The composition ratio between groups was compared by 2×C or 3×C chi-square test.Using bilateral tests,Baseline comparison test level α=0.10,Comparison of efficacy between groups α=0.05.Results1.General AnalysisA total of 65 patients were included in this study,including 32 in treatment group and 33 in control group,with a loss rate of 14.47%.Among the subjects,the mean age of the patients was 38.49× 10.70 years,with the oldest 59 years and the youngest 22 years;the mean disease duration was 9.92 × 6.03 years,and the mean age of onset was 28.59 士 9.34 years.In gender,there were 48 males(73.8%)and 17 females(26.2%),with the ratio of about 3:1,and TCM syndrome is the main syndrome.with 53 cases,accounting for 81.5%.After statistical analysis,there was no significant difference between the general data(P>0.05),indicating that the balance between the two groups was comparable.2.Analysis of the main outcome indicators(1)Analysis of ASDAS-CRP resultsASDAS-CRP is a calculated measure with higher accuracy after testing the results of CRP in the blood in the laboratory.In this study.the ASDAS-CRP measurement showed that before and after clinical intervention,the mean ASDAS-CRP in both groups was more than 1.3,but less than 3.5,indicating that the disease was still in a certain degree of activity,the difference between the mean groups(P<0.05),and the difference between the two and 4 weeks of intervention(P>0.05),and the treatment group score decreased,while the control group showed a rising trend.After the measurement analysis,the effect of time factors on the ASDAS-CRP score is significantly different(P=0.000),and the different groups will also affect the ASDAS-CRP score(P=0.041),so it is inferred that the efficacy of the treatment group will be better than the control group over time.The difference between ASDAS-CRP was calculated between the two groups,and the difference between the two groups was significant(P<0.05).After 2 weeks of treatment,it was inferred that the change in ASDAS-CRP measurement in the treatment group was better than that of the control group,indicating that the disease activity in the treatment group was more mild than that of the control group.(2)Bath ankylosing spondylitis activity index(BASDAI)BASDAI is a widely used indicator of disease activity assessment in AS.According to the statistical results,in the measurement with Bath ankylosing spondylitis disease activity index(BASDAI)as the evaluation index,the difference(P<0.05)was significant at 6 and 12 weeks of treatment,and the treatment component value was decreased,while the control group showed an upward trend.The difference between the BASDAI of the two groups was calculated respectively.Finally,the difference between the two groups was significant(P<0.05).It was inferred that the BASDAI measurement change of the treatment group was better than that of the control group,indicating that the disease activity in the treatment group was more mild than that of the control group.The repeated measurements suggested that P=0.000 for time,indicating that the influence of each time factor on BASDAI scores was statistical significant,and the BASDAI scores measured at different time points varied at at least two time points.Although there is an interaction effect between time and group,the slope of the treatment group is larger than that of the control group,and the effect test between the subjects(different groups)showed P=0.047,indicating that the treatment plan of different groups will affect the BASDAI score,which means that with the extension of the treatment time,the intervention program of the treatment group and the control group of the BASDAI decreased differently.3.Secondary outcome indicator analysisThe secondary outcome indicators used in this study included the ankylosing spondylitis quality of life evaluation scale(ASQoL).PDUS ultrasound results,the bath ankylosing spondylitis function index(BASFI),and the bath ankylosing spondylitis measurement index(BASMI),all of which are currently widely used clinical evaluation scales to assess the clinical efficacy of this study from multiple perspectives,except the PDUS measurement is the first time using in acupuncture and moxibustion studies of AS.(1)Analysis of PDUS resultsThis study for the first time using high sensitivity of PDUS laboratory detection index as the effect of acupuncture clinical intervention treatment,before treatment,2 weeks.4 weeks.6 weeks,12 weeks of 5 points,mainly to observe the sacroiliac joint blood flow changes,including flow display,flow grade,flow resistance index,etc.The results showed that the vast majority(over 93%)of patients showed flow,but no significant difference between groups(P>0.05)and flow resistance index(P>0.05).However,on the measured mean value,the blood grade in the treatment group decreased and the flow resistance index increased 6 weeks after treatment,and the B ultrasound chart of the treatment group showed a significant decrease in the local blood grade of the sacroiliac joint after intervention,but not a significant decrease in the control group.Repeated measurement analysis showed P=0.000 for the time factor,indicating that a statistically significant effect of each time factor on the flow resistance index score measured at different time points varied at at least two time points.The P=0.000 indicates that the interaction effect between time and group is significant,indicating that the utility of time factors is different with the group.Meanwhile,the inter-subject effect test showed P=0.383,thus indicating that different groups showed significant differences in flow resistance index after 12 weeks of intervention(P=0.025).the repeated measurement results do not indicate the treatment group than the control group.In terms of correlation analysis,the results of blood grade level and ASDAS-CRP were P<0.05,and the correlation coefficient r was positive(statistical value range is 0.350,0.610),indicating that blood rating level and ASDAS-CRP score,and the correlation was moderately related,that is,blood rating level increased with the ASDAS-CRP score,indicating more severe inflammation and higher blood grade level.The correlation analysis of flow resistance index and ASDAS-CRP showed both P<0.05,significant,the correlation coefficient r range-value(-0.603,-0.509),both negative,indicating that flow resistance index and ASDAS-CRP score,moderate correlation,i.e.,flow resistance index decreased with increasing ASDAS-CRP score,indicating more severe inflammation and lower flow resistance index.In the detection of vascular elastic function,the arterial tension of the treatment group was significant(P<0.05),and the arterial expansion index after 2 weeks was significant(P<0.05);on the measured mean.the vascular elastic function index(arterial tension and arterial inflation index)of the two groups was increasing.The results show that both interventions can improve the local vascular compliance and vascular elasticity.and the treatment group with refined moxibustion is more obvious,which is better than the simple basic treatment plan.(2)Bath ankylosing spondylitis functional index(BASFI)In the results of this study,the two groups compared BASFI as the clinical evaluation index,after 4 weeks,6 weeks,and 12 weeks(P<0.05),repeated measures showed P=0.000,Ptime=0.015,and the mean of the two groups,the treatment group was a downward trend,the control group was a rising trend,indicating the comprehensive function of patients,and the treatment group was better than the control group.For two groups of BASFI before and after the intervention,4 weeks after treatment is significant difference(P<0.05),can be inferred after at least 4 weeks of intervention,BASFI is lower than the control group,indicating that the functional improvement of the treatment group is better than the control group,suggesting that refined moxibustion treatment of the disease can improve the physical function.(3)Measurement index of Bath ankylosing spondylitis(BASMI)The results showed that there was no significant difference between BASMI measurements in the treatment group(P>0.05).Repeated measurements suggested that the group was intersubject effect,P=0.611,but the time factor as intersubject effect,P=0.000,indicating that the influence of each time factor on BASMI score was significant.The BASMI score was different at at least two time points.The results showed that the intervention programs of the two groups were effective,but there was no significant difference between the groups.The BASMI was calculated between the two groups.Finally,the difference between the two groups was significant(P<0.05)after 6 weeks of treatment.It can be inferred that the BASMI measurement in the treatment group was lower than that of the control group,indicating that the spinal activity was better in the treatment group.The clinical manifestations of the disease mainly involves the axial joints,with the development of inflammation,joint fusion,thus lose the joint mobility,the study results suggest that on the basis of western medicine treatment,add fine moxibustion intervention clinical intervention,can more effectively improve the spinal mobility of patients,combined with the previous results,infer more ideal related to the controlled inflammation of the disease.(4)Quality of life assessment scale for ankylosing spondylitis(ASQoL)In this study,in terms of the measured quality of life of patients with this disease,the data obtained were subject to the normality test(P<0.05),which did not obey the normal distribution,and the homogeneity of variance test(P>0.05),so the non-parametric test was used.In terms of quality of life of patients with this disease,the difference between the two groups was statistically significant before treatment(P=0.017<0.05)and baseline was unbalanced.Therefore,the baseline data were used as covariates for repeated measures,and P=0.064 of time,indicating that the influence of each time factor on ASQoL score was not statistically significant.Inter-subject effect(group)test showed that P=0.000 showed a significant difference,indicating that the treatment regimen of different groups will affect the ASQoL score value.(5)Results of TCM efficacy indicatorsThe study results showed that the difference in the mean between the two groups(P>0.05).After calculating the efficacy index of the two groups,the difference between the two groups(P<0.05).After intervention,the efficacy index of the treatment group was better than that of the control group,indicating that refined moxibustion has good clinical effect in improving the clinical symptoms of ankylosing spondylitis.(6)Analysis of basic treatment resultsThe basic treatment plan(control group)in this study is:indimexin 25～50mg qd,sulfasalazine 2.0-4.0g qd,2-4 oral doses.Although the specific plan was issued by the rheumatology department and regular follow-up of the basic program,the results of this study showed that the efficacy of the program was poor,and the main course index(ASDAS-CRP,BASDAI)showed that the outcome was even worse.Combined with the literature study,the study period of this study was 12 weeks,and because the included subjects were non-acute patients,so the possibility of insufficient drug duration,and the slow effect of antirheumatic drugs,the study outcome of basic treatment regimen is poor.In addition,the literature research indicates that the efficacy evaluation of this disease is usually tracked for more than 2 years,while the time of this study is limited and fails to conduct long-term tracking,and it needs to continue to supplement the relevant data in the later studies.Based on the above analysis,this study shows that in the poor effect of basic treatment regimen,refined moxibustion interventional treatment can produce a certain clinical effect in a short period of time(within 12 weeks),which can be inferred that refined moxibustion may have a good effect in improving the progress of the disease,which is worth in-depth study.4.Time-efficacy analysis of acupunctureIn this study,five time points were established before treatment,2 weeks after treatment,4 weeks after treatment.6 weeks after treatment,and 12 weeks after treatment.In the evaluation of each index,in repeated measures with time as the within-subject effect,Ptime=0.000,indicating that the influence of time factors on clinical effect was statistically significant.The clinical effects measured at different time points were different at at least two time points,indicating that the two intervention programs were effective for patients with the disease.In the evaluation with ASDAS-CRP and BASDAI score as the main efficacy indicators,and in the repeated measurement test with different groups as the effects between subjects,the treatment group could control the disease activity degree of the disease more effectively than the control group after 6 weeks of intervention.Energy Doppler ultrasound(PDUS)measured blood flow display,flow grade,flow resistance index as outcome evaluation,the two groups after 12 weeks of intervention failed to show significant difference,and vascular elasticity after 4 weeks of intervention.suggesting 4 weeks intervention,treatment group can improve the vascular elasticity index,but the remaining Doppler measures may need more than 12 weeks of intervention time.In the assessment with BASFI as the outcome indicator,and in the repeated measurement test with different groups as effects between subjects,the treatment group could improve the comprehensive function of the patients with this disease after 4 weeks of intervention than the control group.In the assessment with BASMI as the outcome indicator,and in the repeated measures test with different groups as the effects between subjects,the treatment group could more effectively improve the spinal mobility of the patients with this disease after 6 weeks of intervention.5.security analysisIn the aspect of safety evaluation,it was found that 4 patients fell off due to the influence of epidemic situation,and the other patients completed the experiment.In this study,there were 4 adverse events,2 cases in the treatment group and 2 cases in the control group,and all of them were abdominal pain or diarrhea,the degree was mild,the short time was selfimprovement(1 hour-1 day),there was no sequelae,and there was no obvious correlation with moxibustion treatment.Therefore,the patient compliance was good and there were no serious adverse events.In conclusion,the results suggest that on the basis of standardized treatment of western medicine,the application of fine moxibustion technology intervention in the clinical treatment of the disease,through the detection of relevant indicators found that after more than 6 weeks of fine moxibustion treatment,can effectively control the inflammation of the disease,reduce the activity of the disease,to slow the progress of the disease,improve the patient’s body function,increase the mobility of spine joints,finally improve the quality of life of patients.In the evaluation of PDUS as the outcome index,the intervention treatment of blood flow classification,blood flow resistance index and blood flow display of refined moxibustion should be greater than 12 weeks,while the vascular elasticity index only needs more than 4 weeks of intervention to show a significant difference.Conclusion:1.Compared with the simple standardized drug treatment of western medicine,refined moxibustion technology treatment of stable ankylosing spondylitis clinical safety,curative effect affirmation,and related to local blood flow,vascular elasticity,is worthy of clinical promotion and application.2.The monitoring of vascular elasticity indexes under energy Doppler(PDUS)is scientific and feasible as a new method for the objective evaluation of the clinical efficacy of acupuncture,which deserves further research. |
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