Clinical Efficacy Observation And Rs?f Mri Study On The Acupuncture Treatment Of Perennial Allergic Rhinitis (AR) Based On Zelen's Design

Objective:Based on the Zelen's design,we observed the clinical efficacy of acupuncture in the treatment of patients with perennial allergic rhinitis(perennial allergic rhinitis,PAR,the following abbreviated AR),comparing with the Desloratadine Citrate Disodium.The acupoints of Yin Tang,Ying Xiang,Qu Chi,Hegu and Zusanli were selected In this trial.The Rs?fMRI technique was used to observe the changes of brain function of the acupuncture points in the treatment of AR patients,providing a preliminary basis for explaining the mechanism of acupuncture treatment of allergic rhinitis,and providing theoretical support for the acupuncture point extraction of allergic rhinitis in clinical treatment.Method:1.clinical studyAccording to the inclusion and exclusion criteria,60 patients with perennial allergic rhinitis were selected,and the patients were randomly divided into acupuncture group(treatment group)and drug group(control group)by Zelen's design.Those enrolled in the drug group were directly admitted to the drug group,and those who were enrolled in the acupuncture group entered the acupuncture group after entering the group's informed consent.(1)InterventionAcupuncture group: The main points are Yingxiang(double),Quchi(left),Hegu(left),Zusanli(double).The other points,Feishu,PIshu,Shenshu,Dazhui,are based on syndrome differentiation selection.After instering the needle,twist the needle 1 times after 15 min and withdraw the needle 30 minutes later.The acupuncture group received acupuncture treatment 1 times every two days,3 times a week,for 12 times.Drug group: take Desloratadine Citrate Disodium Tablets 1 times a day for 4 weeks.(2)EvaluationBefore treatment,second weeks and fourth weeks(end of treatment)in the course of treatment,second weeks and forth weeks after treatment,5 nodes were recorded and evaluated respectively.The total score of nasal symptoms(TNSS)and the total score of nasal concomitant symptoms(TNNSS)were recorded and evaluated respectively.The total score and the each score of TNSS and TNNSS were observed.Assess the record of adverse events.(3)StatisticsThe Chinese version of SPSS20.0 was used for statistical analysis.Measurement data were analyzed by means of mean and standard deviation,and classification variables were analyzed by rate and proportion.Chi square test was used to analyze categorical variables.For the analysis of measurement data,the data accord with normal distribution and homogeneity of variance.The independent group T test was used to analyze the inter group analysis.Paired sample T test was used to detect changes in the same group before and after treatment.When data did not conform to normal distribution,non?parametric tests were used.2.Rs?fMRI researchAccording to the principle of random stratification,20 patients with AR in the acupuncture group were selected in the clinical study.17 healthy subjects were enrolled according to the Inclusion and exclusion criteria.(1)Aupuncture scheme for AR patients was the same with the method mentioned above.There was no acupuncture treatment for the healthy subjects.(2)Equipment and measurement timeData acquisition was performed by GE7503.0T MRI scanner and its standard head coil.The time point of scanning by functional magnetic resonance imaging was following: before acupuncture,from the end of treatment to 48 hours after the end of the treatment3.data analysis and processing(1)preprocessing: data analysis is based on MATLAB platform,using DPARSFA software based on SPM and REST1.8 to preprocess Rs?fMRI raw data,including the removal of the first 10 time points,interlayer time correction,head motion correction,space standardization,spatial smoothing,de linear drift and filter,and so on.Then,the whole brain low frequency amplitude(ALFF)and local consistency(ReHo)were analyzed by REST1.8.(2)statistical analysis used REST1.8 software to compare the standard ALFF values and ReHo values between normal subjects and AR patients before acupuncture,using independent sample t test.The standard ALFF values and ReHo values at before and after acupuncture in AR patients were compared by paired sample t test.The probability of statistical broad?values which was set by xjview8.0 is 0.05.AlphaSim was used to correct(P < 0.05 FDR,continuum =228)to obtain the changes of ReHo and ALFF in the brain region before and after the acupuncture and the statistical significance of the brain region was presented in the form of image.Results:1.clinical studyAccording to the results of informed consent,2 cases of the acupuncture group were enrolled into the drug group,and 28 cases of AR patients were included in the acupuncture group.In the acupuncture group,2 cases were eliminated and 26 patients finally completed the test and the statistics.A total of 32 patients were included in the drug group and 2 cases were excluded.Finally,30 patients completed the trial and were included in the statistics.1.1 Intra group comparison(1)there were significant differences for AR patients treated by acupuncture in the total scores of TNSS and TNNSS before terament,the second weeks in the course of treating,fourth weeks in the course of treating,the first follow?up and the second follow?up(P<0.05).The scores of TNSS and TNNSS were statistically significant(P<0.05)when each score was valued before treatment,the second weeks in the course of treating,fourth weeks in the course of treating,first follow?up and second follow? up.(2)there were significant differences for AR patients treated by durg in the total scores of TNSS and TNNSS before terament,the second weeks in the course of treating,fourth weeks in the course of treating,the first follow?up and the second follow?up(P<0.05).The scores of TNSS and TNNSS were statistically significant(P<0.05)when each score was valued before treatment,the second weeks in the course of treating,fourth weeks in the course of treating,first follow?up and second follow? up.1.2Comparison among groups(1)There was no significant difference in baseline data between the two groups(P > 0.05),which was comparable.(2)The data statistics related to the total scores of TNSS and TNNSS before treatment and the scores of TNSS and TNNSS before treatment were no significant differences between the two groups(P > 0.05),which were comparable.(3)After 2 and 4 weeks of treatment,there was no significant difference in the total scores of TNSS and TNNSS(P > 0.05).(4)After 2 and 4 weeks of treatment,there was no statistically significant difference in nasal congestion and nasal itching(P > 0.05),and there was statistical difference between runny and sneezing(P < 0.05)in TNSS scores(P < 0.05),and there was no significant difference in each score of TNNSS.(5)In the first follow?up,there was no significant difference in the total scores of TNSS and TNNSS(P > 0.05).The data analysis of the each score of TNSS and TNNSS was also no significant difference(P > 0.05).In the second follow?up,there was significant difference in the total scores of TNSS and TNNSS(P < 0.05),except for the itching of the nose.The data analysis of the each score of TNSS and TNNSS was also significant difference(P <0.05),except for the itching of the nose.2.Rs?fMRI research(1)comparison of AR patients and healthy subjects before treatmentThe ALFF values of right medial prefrontal lobe and Right orbital frontal gyrus in AR patients were significantly higher than those in normal subjects.The ALFF values of AR patients in the right auxiliary motor area,the left thalamus,the right thalamus and the left putamen were significantly lower than those in the normal subjects.The ReHo values of the right first sensory area,left insula,right parahippocampal gyrus,right putamen and left putamen were significantly higher than those of the normal subjects,while the right thalamus and the left orbital frontal gyrus were significantly lower than those of the normal subjects.(2)comparison of before and after acupuncture of AR patientsALFF value of the left first sensory area,right first sensory area,left ventral insula,right right temporal gyrus,left anterior cingulate,left occipital lobe,right occipital lobe,left thalamus,right thalamus in AR patients were significantly higher than those in normal subjects,while ALFF value of left orbital frontal gyrus,left cerebellum and right cerebellum in AR patients were significantly lower than those in normal subjects.Conclusion:1.the treatment of perennial allergic rhinitis patients with acupuncture of traditional Chinese medicine can relieve their nasal and nasal concomitant symptoms,and the treatment of oral trloratadine can also effectively improve the patients' nasal symptoms and nasal concomitant symptoms.2.The drug group compared with the acupuncture group was better in improving thesymptoms of runny nose,sneezing In the second and the fourth week of treatment.It shows that the short?term effect of desloratadine citrate disodium is superior to that of acupuncture at acupoints,such as Hegu,Yingxiang,Zusanli and so on.In terms of improving nasal itching and nasal congestion symptoms,the therapeutic effect of acupuncture group was similar to that of drug group.After second,fourth weeks of treatment,the curative effect of acupuncture was similar to that of desloratadine citrate disodium.Therefore,in clinical practice,oral desloratadine citrate disodium should be used for patients with localized nasal symptoms of nasal discharge andsneezing.3.After 2 weeks of treatment,acupuncture and desloratadine citrate disodium showed a stable effect on the control of local and systemic symptoms in the AR patients,but after 4 weeks of treatment,the control of the nasal local(except itching)and systemic symptoms in AR patients was better than that of desloratadine citrate disodium,showing that the effect of acupuncture is more lasting than that of desloratadine citrate disodium in the treatment of allergic rhinitis.4.AR patients had significant changes in the orbital frontal gyrus,the putamen,the right auxiliary motor area and the thalamus,and there were significant changes in the first sensory center,bilateral thalamus,bilateral occipital lobe,bilateral cerebellum,cerebral Island,right superior temporal gyrus and left anterior cingulate gyrus before and after acupuncture.These brain regions may be the relevant to the pathogenesis of AR.Stimulating the brain regions of the accessory motor areas,insula,superior temporal gyrus and cingulate gyrus by acupuncture at Hegu,Yingxiang,Quchi,Hegu,Zusanli produced the target effect,Which may be the central mechanism of acupuncture in the treatment of AR.