| Objective1.By reviewing the previous literatures,systematic review and m eta-analysis,the evidence-based for the effectiveness of transcranial magnetic stimulation in the treatment of major depressive disorder w as explored;2.A randomized clinical controlled study was conducted to evalua te the efficacy and safety of electroacupuncture plus repetitive tran scranial magnetic stimulation in the treatment of major depressive di sorder.And initially explore the relevant factors that affect its ef ficacy evaluation.Methods1.literature ResearchFrom January 1999 to December 2017,electro-acupuncture and trans cranial magnetic stimulation treatment of major depression in domesti c and international clinical randomized controlled trials of quality evaluation and meta-analysis of the literature,an objective evaluati on of unilateral / bilateral transcranial magnetic stimulation of the disease Clinical efficacy,the current research problems and future research prospects.CNKI,CBM,VIP,WANFANG;Foreign Language Databas e: Pubmed,Web of Science,Cochrane Library Database.Retrieval of e lectro-acupuncture and transcranial magnetic stimulation to improve t he major depression related literature,the use of literature managem ent software NoteExpress to check the inclusion of the original scree ning screening;by reading the topic,abstract and full-text screenin g out the inclusion criteria of randomized controlled literature,design Literature data extraction table,Meta-analysis using RevMan 5.3 and stata12.0.2.Clinical research(1)Research objectDuring the period from August 2017 to January 2018,we recruited patients from West China Hospital of Sichuan University for outpatien t treatment.(2)Research typeIn accordance with the inclusion criteria,82 patients with major depressive disorder were divided into two groups according to a 1:1 ratio: a magnetic group and a needle magnetic group,and another 35 n ormal controls.Efficacy evaluation and data analysts were blinded.H idden allocation scheme adopts the complete allocation scheme hiding method,sign patient informed consent form for treatment,coded and s ealed in sequence,blind-bottomed into opaque kraft envelope,sealed at the seal,and the cover indicates “blind coding and clinical "Tes t emergency letter" was stored by a person in the drug clinical resea rch base.The normal control group was the patient’s family,the pati ent’s accompanying nurses,nursing workers,etc.(3)Interventions(1)magnetic groupThe China Reid company to produce CCY-I transcranial magnetic sti mulator was used to treat.The motor threshold(MT)was measured befo re the first treatment.The treatment room temperature was controlled between 16 degrees Celsius and 23 degrees Celsius.The patients were lie on the side or lie on the treatment bed,and the center of the f igure of 8 coil was placed on the cortex of the temporal cortex,stim ulation was performed and the amplitude of the MEPs was recorded by t he myoelectric amplifier.The stimulation site was adjusted during th e stimulation.In 10 stimulations,the amplitude of the MEPs induced not less than 5 times was greater than 50 microvolts(μV).The posit ion of the amplitude of the MEPs elicited by the position is MT,and then the figure of 8 coil was put advances 4-5 cm horizontally.This part is the rTMS treatment site,ie the dorsolateral prefrontal corte x(DLPFC).The left and right dorsolateral prefrontal lobes were stimulated by 90% MT,and the right and left dorsolateral frontal lobes w ere given 1Hz low frequency(10 pulse/string,10 sec string interval)rTMS stimulation;left dorsolateral prefrontal lobe 20 Hz high frequen cy(20 pulses/string,20 sec Intermittent stimuli,divided a total of 1600 stimulation pulses into two equal shares,that is,the total num ber of left and right stimulation pulses was 800.One rTMS treatment was performed once a day,two days after 5 days of treatment,and a t otal of 20 days.(2)Acupuncture magnectic groupThe method of shugantiaoshen is used.The points are Baihui,Yint ang,Fengchi,Hegu,Shenmen,Neiguan,Taichong,Zhongwan,Xiawan,Qih ai and Guanyuan.And according to the different clinical symptoms of patients choose point symptomatic treatment.The treatment is perform ed once every other day,followed by one rest day after three consecu tive treatments.The actual treatment is 10 times.Acupuncture methods: needle Baihui,needle and scalp was 30 Angle,quickly piercing the scalp,into the needle 0.5 inch;needle Yin Tan g,flat thorn 0.5 inch.Baihui,Yintang mention uniform twist,got an gry,Baihui hole flat thorn,Yin Tang hole flat thorn.After the gas was received by the needle(Dhajia needle instrument,model 6805-D),low frequency 2Hz,the waveform for the density of dense waves or con tinuous wave.The remaining points straight piercing 0.5 to 1 inch.N eiguan,Taichong line twist twisting method,the rest of the points i n accordance with the virtual make up,but in principleof tonifying d eficiency,treating excess with purgation needle 20 minutes.Transcra nial magnetic stimulation therapy was the same with the magnetic grou p.(3)normal control groupNormal control group did not receive any treatment,they were need ed to avoid coffee and tea,and to ensure adequate sleep 12 hours bef ore the test please.(4)basic treatment:All patients continued to receive adequate selective serotonin re uptake inhibitor(SSRI)antidepressants from the day of observation: paroxetine,sertraline,citalopram,fluoxetine,no increase or decrease in the course of treatment and replacement of drugs,according to the patient’s sleep condition given to benzodiazepine(alprazolam,cl onazepam)drugs.(5)evaluation index(1)24 Hamilton Depression Rating Scale(HAMD)(2)14 Hamilton Anxiety Scale(HAMA)(3)side effects scale(treatment emergent symptom scale,TESS)(4)TCM Symptom Inventory(5)event-related potential detection: MMN,P300 and P50 detection u sing MEB-9200 EMG/evoked potentiometer produced by Japan Nihon Kohden Company.tea,coffee were ban 12 hours before the experiment ban,to ensure adequate sleep.a.MMN and P300 detection: electrode placement According to the international EEG 10-20 system method,the recording electrodes are placed in Cz and Fz,the reference electrodes are arra nged in parallel on the left and right mastoid,and the grounding ele ctrodes are placed in FPz MMN and P300 detection: According to the In ternational EEG 10-20 System Method,Cz,Fz as the recording electrod e,both sides of the mastoid as a reference electrode,FPz as the gro und electrode.Induced testing of mismatch negaticetiy(MMN)and P300(potential 300)was stimulated using the oddball auditory model and given a high probability(80%)of standard stimuli(1000 Hz audio,60dB)by the MB2300 instrument program,Out-of-bound stimuli(2000Hz a udio,80dB)with lower probability(20%).Excitation rate 1Hz,analys is time 100ms/div,sensitivity 20μV/div,recorded passband 0.1-100 Hz.The test was performed in two rounds: subjects were told in the MMN test that they did not need to respond to the stimulus,and ERPs devi ated from the stimulus signal for a total of 40 repetitions and event ually deviated from the stimulus wave subtracted from the standard st imulus-evoked wave The maximum up-going negative wave is the mismatch negative wave(MMN).The MMN waveform measured by Fz is used as a ref erence to determine the Mz latency and baseline amplitude of Cz to de termine the brain’s automatic processing function.At P300 The subjec ts were asked to make a key reaction to the deviation stimulation(ta rget stimulation)while ignoring the standard stimulation(non-target stimulation).The target stimulation-induced ERPs signals were superimposed 30 times.With reference to the ERPs waveform of the Fz lead,the Cz lead P300 In the N1,P2,N2 and P3 wave components of the inc ubation period and the baseline amplitude to determine the subject’s brain control process and cognitive function.b.P50 test: The S1 condi tioned stimulus-S2 test stimulus(short-sighted auditory)was made in to a pair of stimulation mode test with a stimulus sound pressure set ting of 105 dB and an interval of 500 ms as S1 and S2 stimulus with a n interval of 10 s.The analysis time is 30ms/div,the passband of filt ering is 0.01-1000 Hz,the sensitivity is 10μV/div,the stimulation r eaction of S1 and S2 is superposed 16 times,the patient is not requi red to make any reaction to the stimulus.The amplitude of S1-P50 amp litude,S2-P50/S1-P50 amplitude ratio,and P50 inhibition ratio(S2-P50/S1-P50≥0.5)were measured to determine the central inhibitory eff ect of brain on irrelevant stimulation information.(3)HAMA,HAMD scal e evaluation by a qualified professional commissioner to assess.(6)evaluation timeEach treatment group before treatment,treatment of 10 days and t reatment of 20 days,30 days after the end of treatment follow-up rev iew,each review were in the last 24 hours after treatment to elimina te the immediate effect of magnetic stimulation.(7)StatisticsUse SPSS17.0 software for analysis.Measurement data(such as age,course of disease,scale measurements,etc.)are expressed as(sx ±),the group comparisons using Multivariate analysis using one-way ana lysis of variance paired t test(or paired symbol rank sum test),th e comparison,repeated measures ANOVA were used to measure the data of multiple time points.The comparisons of data were made using compos ition ratio and rate,and the total effective rate was compared by ch i-square test(Fisher’s exact test).Composition comparison between g roups using 2×C table or 3×C table chi-square test.Statistical tes ts using two-sided test,the difference was significant level of α=0.05.Research result:1.Documentation system evaluationA total of 183 documents were searched,157 in Chinese and 26 in English.The Chinese literature excluded 72 titles,61 readings exclu ded,and 12 articles excluded.The final 0 articles were included.In the English literature,12 articles were excluded from the reading t itle,3 articles were excluded from reading the abstract,2 articles were read in the full text,and 9 articles were finally included.Response rate assessment resultsThe efficacy of unilateral rTMS therapy is comparable to that of bilateral rTMS therapy.Recovery rate assessment resultsThe efficacy of unilateral rTMS therapy is comparable to that of bilateral rTMS therapy.Subgroup analysis resultsResponse rate subgroup analysis resultsThe efficacy of rTMS on the left side is comparable to that of bi lateral rTMS.Right rTMS treatment is comparable to bilateral rTMS therapy;The combination of two subgroup analyses showed that unilateral r TMS treatment was comparable to bilateral rTMS treatment.Recovery rate subgroup analysis resultsThe efficacy of rTMS on the left side is comparable to that of bi lateral rTMS.Right rTMS treatment is comparable to bilateral rTMS therapy;The combination of two subgroup analyses showed that unilateral r TMS treatment was comparable to bilateral rTMS treatment.Drop rate analysis resultsThe rates of unilateral rTMS and bilateral rTMS treatment were si milar.2.Clinical research(1)Baseline resultsA total of 82 patients were enrolled,of which 76 cases were in c ompliance with the protocol and 6 patients were exfoliated or exclude d.Among them,46 patients completed all treatment plans and follow-u p,30 patients completed 80% treatment,and 42 patients included need le magnetic group.The magnetic group was included in 40 cases,the needle magnetic group was lost in 2 cases,and the magnetic group was lost in 4 cases.There was no statistically significant difference be tween the two groups.All dropped or excluded patients were included in the statistical analysis by the last evaluation.There were no sig nificant differences between the two groups in terms of age,sex,occ upation,course of disease,and treatment history,general side-by-si de chi-square test,or analysis of variance(P>0.05);before treatme nt,HAMD and HAMA were no Statistical differences between two groups(P>0.05),there was no significant difference between the three grou ps and the total score group of ERP indicators(P>0.05).The two gro ups can be considered comparable before treatment.(2)Hamilton Depression Rating Scale(HAMD)Total group comparison:Acupuncture magnetic group,magnetic group after treatment scores were lower than before treatment,the decline was statistically sign ificant(P=0.000).On the 10 th day of treatment,there was significant difference be tween the acupuncture magnetic group and the reluctance.(P=0.000);On the 20 th day of treatment,there was a significant difference between the magnetic reed and the reluctance.P=0.000)After treatment for 30 days,there was significant difference bet ween acupuncture group and magnetic group(P=0.002).Intra-group comparison:The scores of magnetic groups and needle magnetic groups decrease d at each time after treatment compared with that before treatment,a nd the decrease range was statistically significant(P<0.05).HAMD7 facotrsAnxiety/somatization: The scores of the magnetic group and needle magnetic group decreased at each time point after treatment compared with before treatment,and the decrease range was statistically sign ificant(P<0.05).Needle magnetic group is superior to magnetic grou p(P=0.003);Body weight: The scores of magnetic group and needle magnetic gro up decreased at each time after treatment compared with that before treatment,and the decrease range was statistically significant(P<0.05).Needle magnetic group is comparable to magnetic group(P=0.789)Cognitive impairment: The scores of magnetic and magnetic groups decreased at each time point after treatment compared with before tre atment,and the decline was statistically significant(P<0.05).The needle magnetic group was superior to the magnetic group(P=0.022);Changes day and night: The scores of magnetic groups and acupunct ure magnetic groups decreased at each time point after treatment comp ared with before treatment,and the decrease range was statistically significant(P<0.05).The needle magnetic group is comparable to the magnetic group(P=0.604);Block: The scores of the magnetic group and needle magnetic group decreased at each time after treatment compared with before treatmen t,and the decrease range was statistically significant(P<0.05).Ne edle magnetic group is superior to magnetic group(P=0.028);Sleep disorders: The scores of the magnetic and magnetic groups d ecreased at each time point after treatment compared with before trea tment,and the decrease range was statistically significant(P<0.05).The needle magnetic group is superior to the magnetic group(P=0.009);Feeling of despair: The scores of the magnetic group and needle m agnetic group decreased at each time after treatment compared with th at before treatment,and the decrease range was statistically signifi cant(P<0.05).The needle magnetic group is superior to the magnetic group(P=0.03);(2)Hamilton Anxiety Scale(HAMA)comparison between groupsIn comparison,there was a statistically significant difference b etween the magnetic group and the needle magnetic group(P=0.016).On the 10 th day of treatment,there was a statistically significa nt difference between the magnetic group and the needle magnetic grou p.(P=0.003);On the 20 th day of treatment,there was a statistically significa nt difference between needle magnetic group and magnetic group.(P=0.002);Follow-up 30 days after treatment,the difference between needle m agnetic group and magnetic group was statistically significant(P=0.005);Intra-group comparison:The scores of needle magnetic group and magnetic group decreased at each time point after treatment compared with before treatment,an d the decrease range was statistically significant(P<0.05).HAMA 2 large factorSomatic factors: The scores of the magnetic group and needle magn etic group decreased at each time point after treatment compared with before treatment,and the decrease range was statistically significa nt(P<0.05).The needle magnetic group is superior to the magnetic g roup(P=0.024);Spiritual factors: The scores of magnetic group and needle magnet ic group decreased at each time after treatment compared with that be fore treatment,and the decrease range was statistically significant(P < 0.05).Magnetic needle group and equivalent magnetic group(P>0.05);(3)event-related potential detection:(1)mismatch negative wave(MMN)Comparison between groups:Overall,there was a statistically significant difference betwee n the magnetic group and the needle magnetic group(P=0.044).On the 10 th day of treatment,there was a statistically significan t difference between the magnetic group and the needle magnetic grou p.(P=0.008);On the 20 th day of treatment,there was a statistically significan t difference between the magnetic group and the needle magnetic grou p.(P=0.027);After 30 days of follow-up after treatment,there was no signific ant difference between magnetic group and needle magnetic group(P>0.05).Intra-group comparison: The scores of magnetic groups and needle magnetic groups decreased at each time after treatment compared with before treatment,and the decline was statistically significant.(P<0.05).(2)P3aComparison between groups:Overall,there was no significant difference between the magnetic group and the needle magnetic group(P>0.05).On the 10 th day of treatment,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05);On the 20 th day of treatment,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05);After 30 days of follow-up after treatment,there was no signific ant difference between the magnetic group and the needle magnetic gro up(P>0.05).Intra-group comparison:The scores at each time point after the magnetic group treatment decreased compared with those before treatment,and there was no stati stically significant drop in the magnetic group.(P>0.05);There was statistical significance at each time point after needl e magnetic group treatment(P all less than 0.05)(3)P3bComparison between groups:Overall,there was a statistically significant difference betwee n magnetic and needle magnetic groups(P=0.038).On the 10 th day of treatment,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05);On the 20 th day of treatment,there was a statistically significa nt difference between the magnetic group and the needle magnetic gro up.(P=0.010);After 30 days of follow-up after treatment,there was no signifi cant difference between the magnetic group and the magnetic group(P>0.05).intragroup comparisonsThe scores of magnetic group and needle magnetic group decreased at each time after treatment compared with that before treatment,a nd the decrease range was statistically significant(P<0.05).(4)Response timeComparison between groups:Overall,there was no significant difference between the magnetic group and the magnetic group(P=0.141).On the 10 th day of treatment,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05);On the 20 th day of treatment,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05);After 30 days of follow-up after treatment,there was no signific ant difference between the magnetic group and the magnetic group(P>0.05).Intra-group comparison:The scores of magnetic group and needle magnetic group were highe r than those before treatment.The increase of magnetic group was not statistically significant(P>0.05).The magnetic group had no statist ical significance for 10 days.The treatment for 20 days and followed up for 30 days have statistical significance(P<0.05)(5)Accuracy rate Comparison between groups:Overall,there was no significant difference between the magneti c group and the needle magnetic group(P=0.131).On the 10 th day of treatment,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05);On the 20 th day of treatment,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05);After 30 days of follow-up after treatment,there was no signifi cant difference between the magnetic group and the magnetic group(P>0.05).Intra-group comparison:The scores of the magnetic group and needle magnetic group were higher than those before treatment,and the difference was statistic ally significant(P<0.05).(6)P50 gated suppressionComparison between groups:On the 10 th day of treatment,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05);On the 20 th day of treatment,there was a statistically significa nt difference between the magnetic group and the needle magnetic gro up.(P=0.04);At the follow-up of 30 days,there was no significant difference between the magnetic group and the needle magnetic group.(P>0.05)(4)Correlative Analysis of Incidence Ratio of Event-related Potential MMN,P300,P50 and Clinical SymptomsThe spearman correlation analysis found that the objective indic ators of MMN latency,P300 latency and clinical symptoms are not rel ated,and P50 gating inhibition ratio and clinical symptoms have a c ertain correlation,performance in the HAMD scale cognitive impairme nt factors,despair factors,HAMA The scale is related to the spirit ual factors.(5)adverse reactionsThe adverse reactions associated with western medicine in needle magnet group and magnetic group were nausea(14.47%),dry mouth(9.21%),dizziness(10.53%),constipation(3.95%),loss of appetite(13.16%),and fatigue(6.58%),restles(1.32%),they can continue to be tested a fter interpretation;adverse reactions associated with acupuncture in the needle magnet group occur in 1 patient with local hematoma,hem atoma within 1 week of remission,can continue the trial with The adv erse effects related to magnetic stimuli include tingling of the sca lp at the stimulation site of the coil,tinnitus,lateral headache,an d hypomanic symptoms.The symptoms are transient.After interpretation, the test can be continued.Conclusion1.On the basis of taking SSRI drugs,electro-acupuncture combined with rTMS can significantly improve the physical symptoms,cognitive impairment,retardation,sleep disorders,despair,and anxiety symptoms in patients with depressive disorder,latency in MMN,P3 b.while the P3 a,reaction time,accure rate was comparable.2.At the end of the treatment,as the subjective evaluation index,the efficacy of the HAMD scale was evaluated.Electroacupuncture combined with rTMS was equivalent to rTMS alone,but electroacupuncture combined with rTMS may be more advantageous;objective assessment w as based on MMN latency,P3 b,and P50 gating inhibition ratios,elec tro-acupuncture combined rTMS was superior to rTMS alone;3.Electroacupuncture combined with rTMS and rTMS can improve the clinical symptoms of patients with depressive disorders and the elec trophysiological indicators of cognitive function of MMN,P300,P50-based.Electro-acupuncture combined with rTMS may enhance long-term potentiation/long-term depression-like plasticity effect of rTMS,an d make brain function dynamically stably. |
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