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1 pissn / eissn ORIGINAL ARTICLE Korean Journal of Acupuncture Vol.30, No.4, pp , 당뇨병성말초신경병증통증환자에서사암침법의유효성 : 무작위배정대조군사전예비연구 전언주 1 ㆍ권효정 2 ㆍ신임희 3 ㆍ정의달 1 ㆍ강석봉 4 ㆍ손호상 1 대구가톨릭대학교의과대학내과학교실 1, 대구한의대학교한의과대학침구학교실 2, 대구가톨릭대학교의과대학통계학교실 3, 대구한의대학교한의과대학내과학교실 4 Efficacy of Saam Acupuncture for Diabetic Peripheral Neuropathy - A Pilot, Randomized Controlled Study Eonju Jeon 1 *, Hyojung Kwon 2, Imhee Shin 3, Euidal Jung 1, Seokbong Kang 4, Hosang Shon 1 1 Department of Internal Medicine, Catholic University of Daegu School of Medicine, 2 Department of Acupuncture and Moxibustion, College of Oriental Medicine, Daegu Haany University, 3 Department of Medical Statistics, Catholic University of Daegu School of Medicine, 4 Department of Oriental Internal Medicine, College of Oriental Medicine, Daegu Haany University Objectives : Diabetic peripheral neuropathy(dpn), generally considered to be the most symptomatically distressing complication of diabetes, affects more than 50% of people with diabetes. However, no consistently effective treatment for DPN is available and patients are forced to struggle with medications that provide only partial relief. In this pilot study, we evaluated the clinical effects of Saam acupuncture for the treatment of painful DPN. Methods : A total of 10 patients with painful DPN were included in the study; 6 subjects with Saam acupuncture treatment and 4 subjects without it. Subjects were defined as having painful DPN if they had at least 2 points using total symptom score(tss). Treatments were delivered three times a week for 4 weeks. Vitamin B 12 was orally administrated in the all subjects. At initial(0 week) and follow-up after 4 weeks and 8 weeks, all subjects underwent TSS, Michigan Neuropathy Screening Instrument(MNSI), and nerve conduction test. Results : After initial(0 week) and follow-up(8 weeks), TSS and MNSI were not significantly different between the two groups(p=0.400 and p=0.830, respectively). However, in both two groups, according to time, there was a significant difference in TSS as well as MNSI(p=0.001 and p=0.004, respectively). Conclusions : Saam acupuncture may be considered as the effective treatment for the patients of DPN although the changes of the symptoms were of limited significance in this study. Further investigations are required to elucidate the role of Saam acupuncture for the pain control of DPN. Key words : acupuncture, diabetic neuropathy, Saam 서론 당뇨병성신경병증은미세혈관합병증중에서가장흔한합병증으로제2형당뇨병환자의약 50% 까지보고가되며모든부위의 감각신경, 운동신경및자율신경계에도영향을끼치며그중말초신경병증이가장흔한유형으로알려져있다 1,2). 또한, 이로인한이환율과사망률이증가한다는것은잘알려져있다. 당뇨병성신경병증은조절되지않는고혈당이지속되는경우에흔하게발생하 Received December 3, 2013, Revised December 17, 2013, Accepted December 17, 2013 Corresponding author: Hosang Shon Department of Internal Medicine, Catholic University of Daegu School of Medicine, , Daemyung-4 dong, Nam-gu, Daegu , Korea Tel: , Fax: , hsson@cu.ac.kr This study was supported by a grant from the Ministry of Health & Welfare, Republic of Korea(Project No: ). CC This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright 2013, SOCIETY FOR MERIDIAN AND ACUPOINT 289

2 전언주ㆍ권효정ㆍ신임희ㆍ정의달ㆍ강석봉ㆍ손호상 며다양한임상양상으로나타난다 3). 환자에따라서는증상이없는경우도있지만일부환자에서는아주심한통증으로인해환자의삶의질이떨어지고이통증은절대치료되지않는다는생각을가지게되는경우도있어서적절한통증조절이중요하다. 당뇨병에의한신경병증성통증의치료는철저한혈당조절과아울러삼환계항우울제나항경련제를서서히증량해서필요한기간동안유지하는대증치료가주된치료이다 4). 그러나당뇨병성신경병증으로인한통증완화를위한진료지침및알고리즘도있으나상당수의환자가단계적인치료를시행하였을때증상의호전을보이지않는경우가많기때문에여러약제들을병합하여투여하는경우가많다. 이로인해부작용의빈도가증가할수있고심한경우에약물을중단하게된다는한계점이있다. 따라서, 당뇨병성신경병증의발생과진행경과에대한연구와새로운치료전략및예방이필요한실정이다. 침술은 2000 년이상중국및아시아에서치료의중요한부분으로시행되어왔지만, 서양에서는중국어의제약, 동서의학의이해와견해차등으로인해실행에어려움이있었다. 1997년, 잘디자인된임상결과들을바탕으로미국국립보건연구원합의회의 (NIH consensus conference) 이후통증, 오심및구토와같은치료에효과에대해더욱보편화할수있는계기가되었다 5). 특히, 침술의진통효과 (acupuncture analgesia) 는우수한것으로알려져있다 6,7). 한의학에서는당뇨병성말초신경병증에정확하게부합하는병태는없으나, 당뇨병성신경병증환자에서침술통증치료에대한최근보고들에서도효과가입증되고있다 8-10). 사암침법은 400년전통을가지고있는한국고유의침법으로음양오행 ( 陰陽五行 ) 의원리에입각하여, 장부 ( 臟腑 ) 의허실 ( 虛實 ) 에따른침구 ( 鍼灸 ) 보사법 ( 補瀉法 ) 을활용하여경락의기운을조절함으로써만성질환이나내과질환등의치료등임상 ( 臨床 ) 에활용하도록창시된우리민족고유의독창적인침법이다 11). 사암침법의가장큰특징은같은질병을가진환자라도각기다른증상을가지고있고, 그날의상태가다르기때문에, 장부와경락의허실을파악하여허증에는보법을실증에는사법을적용하는침법을시행하게된다. 사암침법에서는주로인체의 361개의혈자리중주관절, 슬관절아래에위치한오수혈을활용하며시술하게된다 12). 당뇨병성말초신경병증은병인증상이아주다양하므로, 환자개개인에개별화된치료가더욱요구되는실정이다. 따라서, 본연구에서는당뇨병성말초신경병증통증을호소하는제2형당뇨병환자를대상으로사암침법의유효성을알아보았다. 대상및방법 1. 연구대상 2012년 9월부터 2013년 1월사이에제2형당뇨병성말초신경병증으로대구가톨릭대학교병원을방문한환자를대상으로하였다. 총 12명이모집되어선별과정에서선정기준에맞지않아 2명이탈락되고, 총 10명 ( 시험군 6명, 대조군 4명 ) 의환자가연구를종료하였다. 당뇨병성말초신경병증은제2형당뇨병을진단받은 18세이상, 80세미만으로대칭성원위부신경병증중지각신경병증의임상증상이있는환자로서 TSS(total symptom score)(table 1) 가 2 이상으로정의하였다. ALADIN 연구 13) 에서사용했던 TSS 는통증, 작열감, 이감각증, 무감각증에대한각각의질문을하여증상의빈도 (Frequency; Occasional, Frequent, Continuous) 와강도 (Intensity; Absent, Slight, Moderate, Severe) 따라기준에따라점수를산정한다. 제외대상으로는부전마비, 근위축또는적어도 5부위에서진동또는온열감각이손상된진행성감각장애를가진중증의신경병증, 말초동맥폐색성질환, 당뇨이외의원인에의한신경병증, 시험기간내에시험결과에중대한영향을미치는약물의사용을변경할계획이있는자 ( 항우울제, 항전간제, 아편제제, mexiletine, capsaicine, 신경이완제, r-linolenic acid, aldose-reductase inhibitor, 항산화제 ), 현재진행중인암또는신장질환같은다른심각한질환을가지고있는자, 임신부, 수유부, 적절한피임을하지않는가임여성이해당하였다. 2. 연구디자인단일기관, 전향적, 공개, 비교, 중재예비임상시험으로진행하였다. 당뇨병성말초신경병증통증을호소하는제2형당뇨병환자를대상으로하여대조군과사암침군으로무작위배정되어통증완화효과를비교평가하였다. 무작위배정방법은균형무작위배정방법 (Block randomization) 으로시행하여무작위배정코드가군간에할당되었다. 사암침은오사병형 ( 五邪病形 ) 으로변증한후사암도인침구요결 Table 1. Symptom and Scoring of the Total Symptoms Score(TSS) Frequency Intensity No. Mild Moderate Severe Occasionally Often Continuous

3 Saam Acupuncture for Diabetic Peripheral Neuropathy Table 2. Five Pathogenic qi Five patterns of pathogenic qi Symptoms Pathophysiology Saam acupuncture Orthodox pathogenic qi( 正邪 ) Disturbance of appetite(ex. anorexia), dyspepsia, diarrhea, stomach-gas Stagnation of damp (coldness) of spleen Defficient pathogenic qi( 虛邪 ) Stagnant qi(ex. depression), coldness Heart is transmitted to of body, circulatory disturbance, spleen-dampness myocardial infarction Mild pathogenic qi( 微邪 ) Edema, fatigue Kidney is transmitted to spleen-dampness Enemy pathogenic qi( 敵邪 ) Myasthenia, muscle spasm Liver is transmitted to spleen-dampness Excessive pathogenic qi( 實邪 ) Dyspnea, hidrosis Lung is transmitted to spleen-dampness heatness of spleen meridian heatness of heart meridian heatness of kidney meridian heatness of liver meridian heatness of lung meridian Fig. 1. Consultation chart. 의침처방에따라개개인에적합한침법을시행하였다 ( 임상경력이 5년이상된한의사 1인이실시 ) 14). 오사병사 ( 五邪病形 ) 으로변증하되, 맥진과주요증상을기준으로변증한후에허실한열을구분하여사암침을운용하였다. 즉, 진맥결과에따라파악된병소의육기를치료하는사암침처방 ( 정격, 승격, 열격, 또는변방 ) 으로매회마다진맥후침치료를하였다 (Table 2). 시술자는침구과전문의가시행하였고. 침시술자는연구에서정해진방법 (Fig. 1. Consultation chart) 에따라침시술을할수있도록워크샵프로그램을이수 한후연구에참여하였다. 침시술자는침시술전에 6부위맥의부침을통하여장또는부의병소를파악하고, 맥의대소와유무력으로허실을파악하고, 맥의지삭을통하여한열을파악하였다. 또한, 맥의형태를통하여현맥은풍의상태, 단맥은한의상태, 침맥은습의상태, 삽맥은조의상태등의육기변증을하였다. 침은소독된 1회용스테인레스침 ( 동방침구제작소, 충청남도, 대한민국 ) mm를사용하였다. 침은 mm의깊이로자침하였으며자입후득기를유발하였다. 비타민 B12 제제 ( 비타메진 1캡슐 1일 1회경구복용 ) 는실험군과대조군모두에게 8주간투여하였다. 단, 기존에피험자가복용중인당뇨병성말초신경병증치료약또는기타복용약물은중단하지않고그대로유지하였다. 선정된모든환자들통증과감각이상의심한정도와양상 ( 작열감, 통증, 이감각증, 무감각증 ), 그리고진동감각이상등의이학적검진과신경전도검사, 심장자율신경검사 (DICAN) 이상을연구시행전과사암침치료종료후 4주에시행하여통증조절효과를비교하였다. 신경전도검사는감각신경으로는비복신경 (Sural nerve), 운동신경으로는정강신경 (Tibial nerve) 을구획별로검사하였다. 각각말단잠복기, 활동전위와신경전도속도를측정하였다. 침술요법은주3회 4주간총 12회시행하였다. 시술전, 4주후와 8주후총 3차례 TSS, MNSI(Mishigan Neuropathy Screening Instrument) 를확인하여두군을비교하였다. 이프로토콜은대구가톨릭대학교임상시험심사위원회심의를통과하의승인받았다 (MDCR ). 모든참가자들로부터자발적인임상시험동의서를받았다. 3. 유효성평가 1) 1차유효성평가 : 침술요법이당뇨병성신경병증에미치는영향을평가하기위한 1차유효성평가변수는침술요법전과후 (4 주와 8주 ) 에통증조절관련하여서 TSS와 MNSI 를확인하였다

4 전언주ㆍ권효정ㆍ신임희ㆍ정의달ㆍ강석봉ㆍ손호상 2) 2차유효성평가 : 침술요법전후피험자의신경전도속도검사, 자율신경검사 (DICAN) 의실험실적검사를이용하여평가하였다. 4. 통계분석환자군에서침술요법전후측정한변수들의차이는중앙값을구하여, 양군간의비교는비모수적방법인 Mann Whitney U-test 를시행하였다. 통계분석은 IBM SPSS 19.0 을이용하였다. 인구통계학적기초정보, 병력, 선행당뇨병성신경병증치료약물종류, 병용약물유무, 당뇨유병기간등에관하여기술통계분석을수행하였다. 질적변수는빈도 ( 퍼센트 ) 를제시하였고양적변수는평균 ( 표준편차 )/ 중앙값 ( 사분위수범위 ) 를제시하였다. p<0.05를통계학적으로의미가있다고정의하였다. 반복된 3회방문의결과비교는시 점, 그룹그리고시점과그룹의교호작용의효과차이를비교하기위해반복측정이요인분석 (Repeated Measure Two Factor Analysis) 방법으로검정하였다. 이에대한다중비교는대비를이용하여분석하였다. 결과 1. 대상환자의특성총 12명을스크리닝하여선정기준에서제외된 2명이탈락하고 10명이최종선정되었다 (Fig. 2). 선정된피험자는무작위로사암침군은 6명 ( 남자 3명, 여자 3명 ) 과대조군은 4명 ( 남자 2명, 여자 2명 ) 으로배정되었다 (Table 3). 2. 사암침군과대조군의 TSS 변화당뇨병성말초신경병증환자 10명에서 1차평가변수인 TSS는감소하는경향이있었다 (Fig. 3). 0주, 4주, 8주차의 TSS는사암침군이대조군에비해감소하였고 12회침치료완료후인 4주에가장호전을보였으다. 8주에다시통증점수가상승하는양상을보였으나사암침군과대조군의차이는유지되었다. 그러나, 사암침법에따른두군과시간의교호작용 (interaction) 이통계적으로유의한효과차이는없었다 (Table 4, Fig. 4). TSS는사암침군과대조군모두에서4주차, 8주차시점간의효과는통계적으로유의한차이를보였다 (p=0.025). 시점을고려하지않은두군간의차이는통계적으로유의한차이가없었다 (p=0.597). 그룹과시점을동시에고려하였을때시점의차이는통계적으로유의한차이가없었다 (p=0.100). Fig. 2. Flowchart of this trial. Table 3. Clinical Characteristics of the Subjects Variables Saam intervention(n=6) Control(n=4) U orχ 2 (p-value) Age 060.5(5.6)/61.5(10.5) 57.5(8.7)/57.5(15.0) (0.762) Gender(M:F) 3(50.0):3(50.0) 2(50.0):2(50.0) 0.00 (1.000) DM duration(yr) 10.7(5.0)/10.5(9.3) 010.8(5.6)/11.0(10.8) (0.914) Neuropathy duration(yr) 3.6(3.0)/3.5(5.4) 4.3(3.0)/4.0(5.8) (0.762) Hb A1c 7.6(1.3)/7.4(2.0) 7.3(1.1)/7.7(1.8) (0.914) TSS 7.1(2.7)/6.8(5.6) 6.0(3.7)/4.8(6.3) (0.762) MNSI 5.8(1.6)/5.0(1.8) 5.8(1.7)/5.5(3.3) (0.914) Medications Anticounvulsant(pregabalin, gabapentin), TCA (amitriptyline), opioid(tramadol), NSAID, antioxidant(a-lipoic acid) Anticounvulsant(pregabalin), opioid(tramadol), NSAID, antioxidant(a-lipoic acid) Result of Mann Whitney U-test, Result of Chi-square test. n : number of patients, yr : years, TSS; total symptom score, MNSI : michigan neuropathy screening instrument, TCA : tricyclic, NASAID : non-steroidal anti-inflammatory drug

5 Saam Acupuncture for Diabetic Peripheral Neuropathy 3. 사암침군과대조군의 MNSI 변화당뇨병성말초신경병증환자 10명에서 1차평가변수인 MNSI 는감소하는경향이있었다 (Fig. 5). 0주, 4주, 8주차의 MNSI 변화는사암침군과대조군에서 4주에유사하게감소하였으나 8주차에다소차이를보였다, MNSI 에서는사암침치료에따른두군과시간의교호작용 (interaction) 이통계적으로유의한효과차이는없었다 (Table 5, Fig. 6). MNSI 는그룹을고려하지않은시점간의변화는통계적으로유의한호전을보였다 (p=0.004). MNSI 는시간을고려하지않은그룹간변화는통계적으로유의한차이가없었다 (p=0.801). MNSI 는그룹과시점을모두고려하였을때통계적으로유의한차이가없었다 (p=0.830). 4. 사암침군과대조군의신경전도검사변화감각신경으로비복신경, 운동신경으로는정강신경에서 2차평가변수인신경전도검사를시행하였다. 사암침시행전과 12회침술완료하고 4주가지난후인 8주에시행한잠복기, 진폭, 속도에서왼쪽 정강신경의진폭 (p=0.011) 을제외하고는통계적으로유의한차이는없었다 (Table 6). 5. 이상반응본연구에서이상반응은보고되지않았다. 고찰 본연구에서는당뇨병성말초신경병증이동반된제2형당뇨병환자에서기존의대증치료로증상조절이안되는환자를대상으로오사병형으로변증한후사암도인침구요결의침처방에따라개개 Fig. 3. TSS changes according to time of the subjects. Fig. 4. TSS changes according to time between the tow groups. Table 4. TSS Change According to Time and Group Group Time, Mean(S.D.) F(p-value) Screening V1 (4 weeks) V2 (8 weeks) Time Group Time*group Saam Control 6.82(1.64) 4.83(0.23) 1.50(0.23) 3.33(0.47) 2.33(1.41) 4.33(2.35) (0.025)* *Statistically significant with p<0.05. TSS : total symptom score (0.597) (0.100) Table 5. MNSI Changes According to Time and Group Group Time, Mean(S.D.) F(p-value) Screening V1 (4 weeks) V2 (8 weeks) Time Group Time*group Saam 5.833(1.602) 3.5(2.345) 4.167(2.137) 8.094(0.004)* 0.068(0.801) 0.188(0.830) Control 5.75(1.708) 3.75(0.5) (0.957) 1>2,3 *Statistically significant with p<0.05. Multiple comparison result by contrast. MNSI : michigan neuropathy screening instrument

6 전언주ㆍ권효정ㆍ신임희ㆍ정의달ㆍ강석봉ㆍ손호상 인에적합한침술요법을시행하여통증조절효과를확인하고자하였다 15). 사암침법유효성에대한예비임상연구로사암침전후로당뇨병성말초신경병증환자들에서증상완화가효과가대조군에비교하여통계적으로유의한차이가없었다. 당뇨병성말초신경병증은제2형당뇨병환자의약 50% 까지보고가되며 1,2), 환자에따라서는증상이없는경우도있지만일부환자에서는아주심한통증으로인해환자의삶의질의문제로이어질수있다 3,16). 당뇨병이진행함에따라당뇨병성신경병증의유병률이증가하고, 이환기간이길어질수록증가하는것은명백한사실이다. 당뇨병환자에서자율신경병증이발생한 5 10 년후에사망률은 50% 에달한다 17-19). 지금까지알려진유일한발병기전은고혈당이므로혈당을엄격히조절하는것외에는아직확실한치료법이없는실정이다 20-22). 이와같이신경병증성통증은만성병적통 증을대표하는난치성통증이며, 그원인및병태생리가다양하여기전이다른여러가지약제를병합하여사용하여병인론적치료와대증치료를하지만, 잘조절되지않을뿐아니라적절히치료되지않거나적극적으로대처하지않으면결국에는치료불가능한난치성통증으로진행하게되고일상생활에지장을초래하게되는경우도많다 23). 최근몇몇연구에서침치료가당뇨병성말초신경증을개선시키는효과가있는것으로보고되고있다 24-27). 당뇨병성말초신경병증환자 80명을침술그룹과약물그룹으로동등하게나누어치료를하였다 28). 침술그룹에는지기 (Sp8), 혈해 (Sp10), 음릉천 (Sp9), 곡지 (LI11), 합곡 (LI4), 중완 (CV12), 족삼리 (S36) 에하루 1회 4주동안 Fig. 5. MNSI changes according to time of the subjects. Fig. 6. MNSI changes according to time between the tow groups. Table 6. Comparison of Pre-Post Values Between Two Groups for the Efficacy of Nerve Conduction Study Variable Saam Group Control U(p-value) Tibial MNCV Lt Diff_Latency (0.623)/0.025(0.950) (0.802)/0.050(1.375) 11.50(0.915) Diff_amplitute (1.318)/-0.100(2.125) (1.097)/1.250(1.825) 00.00(0.011)* Diff_velocity (2.018)/0.550(3.450) (1.900)/0.150(3.475) 11.50(0.915) Rt Diff_Latency (0.480)/0.075(0.725) (1.441)/-0.550(2.738) 08.50(0.454) Diff_amplitute (2.496)/0.500(2.100) (0.726)/0.950(1.350) 08.00(0.394) Diff_velocity (1.292)/-0.150(2.300) (1.539)/0.650(2.925) 07.50(0.336) Sural SNCV Lt Diff_Latency (0.170)/-0.025(0.300) (0.319)/-0.200(0.575) 08.00(0.389) Diff_amplitute (3.364)/-0.500(7.000) (0.918)/0.500(1.625) 10.00(0.67) Diff_velocity (1.877)/0.150(2.975) 5.625(10.735)/1.800(18.375) 08.00(0.394) Rt Diff_Latency (0.188)/-0.125(0.350) (0.202)/-0.175(0.375) 11.00(0.83) Diff_amplitute (2.698)/-0.250(3.400) (1.100)/-0.85(2.075) 07.00(0.286) Diff_velocity (2.070)/1.000(3.425) (1.817)/2.450(3.000) 07.00(0.286) F wave Lt Diff_Lt (1.466)/-0.525(2.688) (1.742)/-2.125(3.188) 03.00(0.055) Rt Diff_Rt (1.977)/0.950(3.275) (2.342)/0.100(4.463) 08.50(0.454) *Statistically significant with p<0.05, Result of Mann Whitney U-test. MNCV : moter nerve conduction velocity, SNCV : sensory nerve conduction velocity, Lt : left, Rt : right, Latency : ms, Amplitute : mv, Velocity : m/s

7 Saam Acupuncture for Diabetic Peripheral Neuropathy 자침을하였고, 약물그룹에는 Mecobalamine(500 microgram, 비타민 B12 제제 ) 를매일한차례 4주동안투여를한결과침술군환자들의치료효과가더뛰어난것으로나타났다. 진짜침술과가짜침술군의두그룹으로나누어 42명의환자를대상으로침술의당뇨병성말초신경병증에대한효과를알아본연구에서도가짜침술군에서는운동신경, 지각신경의변화가없었다 27). 반면침술군에는사지의저림, 통증, 상지의고정성, 온도인지에상당한효과가있었다. Zhang 등은당뇨병성말초신경병증환자 65명을 32명의치료그룹과 33명의대조그룹으로나누어치료하였다. 치료그룹은침술을사용하였고, 대조그룹은 inositol 이투여되었다. 그결과치료그룹이대조그룹에비해더좋은치료효과를나타났다 24). 당뇨병성신경병증을겪고있는환자에게한약치료와병행하여팔풍, 태충 (LV3), 임읍 (GB41), 절골 (GB39), 승산 (UB57), 족삼리 (ST36), 양릉천 (GB34) 에침구치료를한결과 2 3 주일후현저한치료효과가나타났다 29). 당뇨병성신경병증환자 1명에게빈소산가미방과더불어족삼리 (ST36), 양릉천 (GB34), 절골 (GB39), 음릉천 (Sp9), 부류 (K7), 삼음교 (SP6), 태충 (LV3), 태계 (K3), 팔풍혈에 1개월간침구치료를한결과양하지동통과양하지마비감의효과가현저하였다 26). Ahn 등은 Traditional Chinese Acupuncture와 Japanese Style Acupuncture 을비교한소규모연구를통하여 Japanese Style 침술치료에서통증조절효과가더좋았고, 전통적인 Chinese 침술은신경감각을호전되었다고보고하였다 30). 전통적치료법이나약물치료에비해침치료는거의위험성이없는것으로알려졌었는데, 전세계에서발생하여보고된침치료에대한부작용사례를검색해본메타결과에서주로감염, 기타반응 ( 멍, 통증, 현기증등 ) 의가벼운증상이었다 31). 당뇨병성말초신경병증통증환자에서사암침법의통증조절효과그리고혈액화학변수에대한결과를시험군과대조군에따라서스크리닝방문과 4주째방문 (Visit 1), 8주째방문 (Visit 2) 의시점을기준으로반복측정이요인분석 (Repeated Measure Two Factor Analysis) 방법으로통증관련변수에대한검정을하였다. 통증의유효성지표로사용된 TTS 와 MNSI 에있어사암침군과대조군양군모두에서시점간에는통계적으로유의하게호전을보였다 ( 각각 TSS p=0.001, MNSI p=0.004). 그러나, 사암침군이대조군에비해증상이감소하는경향을보였지만그룹간에통계적으로유의한차이는없었다 ( 각각 TSS p=0.400, MNSI p=0.830). TSS와 MNSI 모두사암침법 12회치료를마친 4주째감소하는경향을보였고, 사암침종료후 4주뒤인 8주에는다시상승하여처음과사암침 12 회완료시점인 4주에효과여부에대한추가적인분석이필요하다. 또한, 신경전도검사에서양군간의유의한차이는없었다. 본연구의제한점으로는단일기관의단기간, 소규모예비임상연구로일반당뇨집단을대변하는데한계가있다. 신경병증은변화가있기까지는상당한시간이걸릴수있고치료반응에대한명확한평가가어렵다. 또한, 반응평가에사용된신경전도검사는음성으로나타날수있는제한이있다. 이번임상연구를통해, 당뇨병성신경병증으로인한통증을조절하기위해서흔히사용되는약제와오사병형으로변증한후사암도인침구요결의침처방에따라개개인에적합한침술요법을시행하여환자의통증이완화효과및안정성을확인하였다. TTS와 MNSI 에있어사암침치료완료직후통증이대조군에비해더감소경향을보였으나통계적으로유의하지않았다. 사암침법에따른부작용은없었다. 향후대규모, 장기간, 다기관연구가이루어진다면당뇨병성말초신경병증환자를증상에따라분류후개별화된침술요법을통해통증완화의효과와기전에대해규명되어져야할것이다. 또한, 신경병증합병증치료의긍정적파급효과를통해매년증가하고있는가정, 사회, 경제적부담과손실 32) 을감소시킬수있을것이다. 결론 본연구는당뇨병성말초신경병증환자에서약물요법에도불구하고통증이조절되지않는환자를대상으로오사병형으로변증한후사암도인침구요결의침처방에따라개개인에적합한침법인사암침을시행하여환자의통증이완화및안정성을확인하였다. 사암침치료군이대조군에비하여시점에따른 TTS 와 MNSI 가통계적으로유의하지는않았지만더감소하는경향을보였다 ( 각각 TSS p=0.400, MNSI p=0.830). 이에대해서향후대규모, 다기관연구가이루어져야할것이다. 감사의글 This study was supported by a grant from the Ministry of Health & Welfare, Republic of Korea(Project No: )

8 전언주ㆍ권효정ㆍ신임희ㆍ정의달ㆍ강석봉ㆍ손호상 References 1. Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, et al. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care ; 33(10) : Vinik AI, Mehrabyan A. Diabetic neuropathies. Med Clin North Am ; 88(4) : , xi. 3.Galer BS, Gianas A, Jensen MP. Painful diabetic polyneuropathy: epidemiology, pain description, and quality of life. Diabetes Res Clin Pract ; 47(2) : American diabetes association. Standards of medical care in diabetes Diabetes Care ; 36 Suppl 1 : S NIH Consensus Conference. Acupuncture. JAMA ; 280 : Foster JM, Sweeney BP. The mechanisms of acupuncture analgesia. Br J Hosp Med ; 38(4) : Lin JG, Chen WL. Review: acupuncture analgesia in clinical trials. Am J Chin Med ; 37(1) : Ewins DL, Vileikyte L, Borg-Costanzi J, Carrington A, Boulton AJM. Acupuncture: a novel treatment for painful diabetic neuropathy. In : Diabetic Neuropathy: New Concepts and Insights. Amsterdam : Excerpta Medica : Goodnick PJ, Breakstone K, Wen XL, Kumar A. Acupuncture and neuropathy. Am J Psychiatry ; 157(8) : Chen YL, Ma XM, Hou WG, Cen J, Yu XM, Zhang L. [Effects of penetrating acupuncture on peripheral nerve conduction velocity in patients with diabetic peripheral neuropathy: a randomized controlled trial]. Zhong Xi Yi Jie He Xue Bao ; 7(3) : Ahn CB, Jang KJ, Yoon HM, Kim CH, Min YK, Song CH, et al. Sa-Ahm Five Element acupuncture. J Acupunct Meridian Stud ; 3(3) : Yin C, Park HJ, Chae Y, Ha E, Park HK, Lee HS, et al. Korean acupuncture: the individualized and practical acupuncture. Neurol Res ; 29 Suppl 1 : S Ziegler D, Hanefeld M, Ruhnau KJ, Meissner HP, Lobisch M, Schutte K, et al. Treatment of symptomatic diabetic peripheral neuropathy with the anti-oxidant alpha-lipoic acid. A 3-week multicentre randomized controlled trial(aladin Study). Diabetologia ; 38(12) : DH K. Saam acupuncture method. Sokang, Busan Ahn CB, Jang KJ, Yoon HM, Kim CH, Min YK, Song CH, et al. A study of the Sa-Ahm Five Element acupuncture theory. J Acupunct Meridian Stud ; 2(4) : Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain ; 18(6) : Vinik AI, Park TS, Stansberry KB, Pittenger GL. Diabetic neuropathies. Diabetologia ; 43(8) : Levitt NS, Stansberry KB, Wynchank S, Vinik AI. The natural progression of autonomic neuropathy and autonomic function tests in a cohort of people with IDDM. Diabetes Care ; 19(7) : Rathmann W, Ziegler D, Jahnke M, Haastert B, Gries FA. Mortality in diabetic patients with cardiovascular autonomic neuropathy. Diabet Med ; 10(9) : Graf RJ, Halter JB, Pfeifer MA, Halar E, Brozovich F, Porte D Jr. Glycemic control and nerve conduction abnormalities in non-insulin-dependent diabetic subjects. Ann Intern Med ; 94(3) : Kuwabara S, Ogawara K, Harrori T, Suzuki Y, Hashimoto N. The acute effects of glycemic control on axonal excitability in human diabetic nerves. Intern Med ; 41(5) : Callaghan BC, Little AA, Feldman EL, Hughes RA. Enhanced glucose control for preventing and treating diabetic neuropathy. Cochrane Database Syst Rev ; 6 : CD Ziegler D. Painful diabetic neuropathy: advantage of novel drugs over old drugs? Diabetes Care ; 32 Suppl 2 : S Zhang C, Ma YX, Yan Y. Clinical effects of acupuncture for diabetic peripheral neuropathy. J Tradit Chin Med ; 30(1) : HT Y. Acupuncture at five Shu points for treatment of 126 cases of numbness of hands and feet induced by peripheral diabetic neuropathies. Zhongguo Zhen Jiu ; 26(3) : Park SK, Kwon EH, Shin HC, Kang SB. One case of diabetic peripheral polyneuropathy improved by binsosan-gamibang. Korean J Orient Int Med ; 26(4) : Tong Y, Guo H, Han B. Fifteen-day acupuncture treatment relieves diabetic peripheral neuropathy. J Acupunct Meridian 296

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Lumbar spine

Lumbar spine CT 32 111 DOI : 10.3831/KPI.2010.13.2.111 Lumbar Spine CT 32 Received : 10. 05. 23 Revised : 10. 06. 04 Accepted : 10. 06. 11 Key Words: Disc herniation, CT scan, Clinical analysis The Clinical