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1 Journal of Korean Medicine Rehabilitation Vol. 27 No. 4, October 2017 pissn eissn Review Article 이수환 윤정원 김순중세명대학교부속한방병원한방재활의학과 A Comparative Review on Carthmi-Flos Pharmacopuncture Treatment - Focused on Clinical Study Soo-Hwan Lee, K.M.D., Jeong-Won Yoon, K.M.D., Soon-Joong Kim, K.M.D. Department of Rehabilitation Medicine of Korean Medicine, Semyung University Korean Medicine Hospital RECEIVED September 14, 2017 REVISED September 30, 2017 ACCEPTED October 10, 2017 CORRESPONDING TO Soon-Joong Kim, Department of Rehabilitation Medicine of Korean Medicine, Semyung University Korean Medicine Hospital, 66 Semyung-ro, Jecheon 27136, Korea TEL (043) FAX (043) kimsj@semyung.ac.kr Copyright 2017 The Society of Korean Medicine Rehabilitation Objectives The purpose of this review is to analyze results of case studies and controlled studies about Carthmi-Flos pharmacopuncture. Based on the review, authors desire to suggest the study model including precise information and evident the effect of Carthmi-Flos pharmacopuncture objectively in treating clinical disorders. Methods We search 44 studies about Carthmi-Flos pharmacopuncture from 6 Korean web databases, using words Carthmi-Flos pharmacopuncture in Korean alphabet. This study had been conducted throughout 1 month (July, 2017). We selected case studies and controlled trials in investigated 44 thesis, excluding experimental research and thesis not using the Carthmi-Flos pharmacopuncture for major treatment. Results We analyze 13 case reports and 7 controlled trials. As a result, Carthmi-Flos Pharmacopuncture was used mostly in musculoskeletal, neurological diseases. But this can be applied to internal diseases. Disorders reported effectively were carpal tunnel syndrome, degenerative knee joint arthritis, posterior neck pain, low back pain, radial nerve palsy, shoulder pain, lumbar compression fracture, alopecia areata, chronic daily headache, duverney fracture, oligomenorrhea, cervical disc herniation, rheumatoid arthritis and cervical headache. Conclusions As we analyzed, Carthmi-Flos pharmacopuncture is specifically effective in musculoskeletal and neurologic diseases. But there are various problems in study design. To design accurately, the study design should include much more specific information. And the result can be more precise by excluding other methods. (J Korean Med Rehabil 2017;27(4):55-65) Key words Carthmi-Flos, Pharmacopuncture, Herbal acupuncture, Case study, Controlled study 서론»»» 藥鍼療法은침구요법과약물요법이결합된새로운치료방법으로, 임상한의사들에의해호침을이용한치료방법과겸하여다용되고있다. 주입기를사용하고있으나, 한약추출물에의해만들어진약침액을경혈에주입한다 는면에서서양의학적주사요법과비교해독특한특징을지닌다. 약침중윤제는녹용 (CC), 호도육 (JsD), 홍화 (CF) 등기름이주성분인약침을말한다 1). 윤제약침중특히홍화는본초학적으로性味가溫辛하여주로心 肝經의血分으로들어가活血通絡, 散瘀止痛하는효능이있다. 각종瘀血阻滯로인한병증에사용 55

2 이수환 윤정원 김순중 하며, 內科, 婦人科, 外科, 傷科의活血方중에상용하는약물이다 2). 홍화의潤한성질과통증을억제하는효능을바탕으로홍화약침은노인, 潤부족이심한경우에다용하며, 임상적으로는척추질환, 관절질환, 연부조직손상등에활용한다고기재되어있다 1). 현재임상에서다용되고있는자하거약침 3), 오공약침 4) 등은학계에보고된임상논문을체계적으로분석및고찰한논문이보고되고있다. 하지만, 홍화약침은다양한증례연구 5-17), 대조군연구 18-24), 실험연구 27-29) 가발표되고있음에도불구하고보고된임상논문의체계적인고찰은부재하다. 따라서, 본연구는홍화약침의임상적효과에대해보고된논문들을종합적으로고찰하여, 보다정확한정보들을포함하도록연구설계방향성을제시하고, 홍화약침을임상적으로응용함에있어올바르고효과적인적응증을확인하여치료효과를증진시키고, 한의학의근거중심의학화에기여하고자본연구를진행하게되었다. 본론»»» 1. 대상및방법 1) 자료수집 본논문의자료수집은국내전자데이터베이스검색을토대로시행하였다. 한국전통지식포탈, 학술연구정보서비스, 국회도서관, 한국의학논문데이터베이스, 과학기술정보통합서비스 (NDSL), 오아시스 등을통해검색하였다. 검색어는한자표기를제외하였으며, 한글로표기된 홍화약침 으로제한하였다. 논문검색은 2017년 7월 1 Table I. Search Sites to Investigate Korean Traditional Medicine Issues Sites Domain Korean Traditional Knowledge Portal Research Information Sharing Service National Assembly Library Korean Medical Database National Digital Science Library OASIS Total 6 개월동안시행하였으며, 검색논문은 2017년 7월이전출간된논문으로한정하였다 (Table I). 2) 대상논문선정기준상기데이터베이스를통해검색된논문중홍화약침을주치료방법으로하여환자를치료한증례보고 (Case report), 비교임상시험 (Non-Randomized Controlled Trials, NRCT), 무작위배정비교임상시험 (Randomized Controlled Trials, RCT) 논문을선정하였다. 부작용보고, 실험연구, 문헌고찰그리고홍화약침이주치료방법이아닌논문은선정대상에서제외하였다. 3) 대상논문선정결과상기데이터베이스에 홍화약침 검색결과총 44편의논문이검색되었다. 이중실험연구논문 18편, 홍화약침과관련성저하되는논문 1편, 홍화약침이주치료가아닌논문 5편을제외한논문 20편을선정하였다 (Fig. 1). 결과»»» 1. 대상논문분석본임상논문고찰의모집단논문이된 20편논문중증례연구가 13편 5-17), 대조군연구 7편 18-24) 이었다. 각논문의저자, 연구형태, 적용된질환, 각증례의모집단규모, 시술방법, 병행된치료, 효과혹은부작용등에대해분석하였고, 결과는다음의표와같다 (Table II, III). 2. 홍화약침적용질환분류 20편의논문에서밝혀진현재까지적용된질환은주로근골격계및신경계질환이다수를차지하였으며, 단일질환으로는수근관증후군 2편 12,20), 퇴행성슬관절염 2편 21,24), 경항통 2편 19,22), 요통치료효과에대한논문이 2편 9,23) 으로보고되었고, 요골신경마비 5), 견비통 6), 요추압박골절 7), 원형탈모증 8), 만성매일두통 10), 장골익골절 (Duverney fracture) 11), 희발월경 13), 경추디스크탈출증 14), 요골두아탈구 15), 류마티스관절염 16), 만성변비 18), 경추성두통 17) 에대한논문이각 1편씩보고되었다. 56 J Korean Med Rehabil 2017;27(4):55-65

3 Fig. 1. A flow chart describing the trial selection process. 3. 홍화약침증례보고모집단분석증례보고 13편의논문중 1례논문이 6편 5,7,8,11,12,15) (46%), 2례논문이 1편 13) (8%) 으로 10예미만의논문이약 54% 를차지하는것으로조사되었다. 조사된모집단논문중반수이상의논문이단편적증례보고형식을취하고있었다. 10례논문이 1편 9) (8%), 15례논문이 1편 10) (8%), 20례논문이 1편 14) (8%), 30례논문이 2편 6,16) (14%), 61례논문이 1편 17) (8%) 이었다. RCT 및 NRCT 7편의논문의경우, 피험자평균인원수는 35명이었으며, 가장적은피험자수는 10명 20), 가장많은피험자수는 70명 23) 으로조사되었다. 4. 홍화약침시술분석 1) 시술부위홍화약침증례보고 13편논문중자침경혈을정확히명시한논문은 11편 5,6,9-17), 아시혈등해부학적부위를사용한논문 6편 6,8,9,11,14,17), 경혈과해부학적부위를모두활용한논문 5편 6,9,11,14,17), 경혈을사용하였으나정확한혈위명을명시하지않은논문 1편 7) 으로조사되었다. RCT 및 NRCT 7편논문중시술한경혈명을정확히명시한논문이 7편 18-24), 아시혈등해부학적부위를사용한논문 2편 21,22), 경혈과아시혈및압통점을같이사용한논문은 2편 21,22) 이었다. 57

4 이수환 윤정원 김순중 Table II. Information of Case Studies Author (Yr) Study Design Applied Disease Number of Patient Acupoint/Dosage Frequency of Treatment Other Treatment Outcome Mun Case (2004) 5) report Jeong Case (2002) 6) report Lee Case (2004) 7) Kim report Case (2004) 8) report Cho Case (2001) 9) report Kim Case (2010) 10) report Moon Case (2003) 11) report Choi Case (2009) 12) report Yang Case (2005) 13) report Lee Case (2006) 14) report Lee Case (2004) 15) report Park Case (2002) 16) report Cho Case (2001) 17) report Radial Nerve Palsy 1 LI (04,10,11,15), TE05/0.1 cc 2 3 times/week *2 weeks Shoulder Pain 30 Site of Pain, GB21, LI (11, 14, 15), TE14/0.02 cc Lumbar Compression Fracture (LCF) 1 Acupoints Near The Site of LCF/ 0.05 cc Alopecia Areata 1 Center And Margin of The Lesion/0.5 cc Low Back Pain 10 Trigger Point Related To Low Back Pain, BL (23,24,25,26)/0.1 cc Chronic Daily Headache 1. Dong-Qi Acupuncture Treatment 2. Acupuncture 3. Herbal Medication 4. Physical Therapy 1. Improvement of Clinical Information 1 time/2 day - 1. Patient State Measurement - Gr. I, II, III, IV 2. Treatment Evaluation - Martin.A.N Method 1 time/day, Total 15 days 1 time/1 2 week, Total 20 Times 15 GB (20.21) EX-HN5/0.1 cc 2 times/week *4 weeks Duverney Fracture 1 GB30, related Sites/0.05 cc *6 points Carpal Tunnel Syndrome With Raynaud's Phenomenon 1. SAAM Acupuncture 2. Herbal Medication 1. Bee Venom 2. Acupuncture 1 time/5 days 1. Acupuncture 2. Herbal Medication 3. Physical Therapy 1 time/2 days *26 days 1 PC (6,7)/0.1 cc 2 times/week *1.5 month Oligomenorrhea 2 SP6/0.05 cc Frequency una ccurate*2 months Cervical Disc Herniation Subluxation of The Head of The Radius Rheumatoid Arthritis 20 GV (13,14), B (10,11), BL (11,12,62), SI (3,9,14,15), GB (20, 21,34), ST36 A-shi acupoint/1 cc 1 LI (10,11) TE10/0.3 cc 1 time/2 days *2 weeks 1. Administrating Existed Medication 1. SAAM Acupuncture 2. Medication Treatment 1. Sweet BV Pharmacopuncture 2. Acupuncture 1. Herbal Medication 2. Acupuncture 3. Moxibustion 1. Criteria To Evaluating Patient State And Effect of Treatment - Gr. I, II, III, IV 2. QVAS 1. Evaluation of The Effect On Alopecia Areata 1. Oswestry Disability Index 1. Headache Impact Test 2. SF Health Survey 4. Headache-Free Days 1. Pain Grade 1. VAS 1. Change of Clinical Symptom QVAS 2. Grade Classification of Recovery Degree 1. Acupuncture 2. Joint Kinesitherapy 30 LI11, ST (35,36) SI16/ cc 2 3 times/week 1. Ursi Fel Bovis Calculus Acuaacupuncture Cervical Headache 61 Anatomical Point, GB (12,20), BL10, GV16/0.8 cc 2 times/week *6 weeks 1. VAS 2. ROM 1. RA Factor Level, CRP Level, ESR level 2. Treatment Index 3. Mean Treatment Index 4. Patient Satisfaction 1. Herbal Medication 1. Wormans Shealy M.D's Classification Method 58 J Korean Med Rehabil 2017;27(4):55-65

5 Table III. Information of Controlled Studies Author (Yr) Study Design Applied Disease Intervention Control Acupoint/Dosage Frequency of Treatment Other Treatment Outcome Park RCT Chronic (2008) 18) Constip-ation Park RCT Posterior Neck (2011) 19) Pain Choi NRCT Carpal Tunnel (2005) 20) Syndrome Hur NRCT Osteoartiritis In (2002) 21) Knee Joint CF (n=10) CF+OT (n=10) CF+OT (n=5) CF+OT (n=16) N/S (n=10) OT (n=10) OT (n=5) OT (n=16) ST (25,27), BL52, CV6/0.1 cc 2 times/week *4 weeks (Total 8 times) GB (20,21)/0.05 cc 1 time/2 Days 1. Acupuncture 2. Physical Treatment 3. Medication Treatment PC (5,6,7)/0.2 cc 1 time/come To Clinic *5 times Site Of Solidification, LE (110,202), SP9,S36, Tender Point/0.1 cc 3 times/week *4 weeks - 1. Evaluating Number Of Defecation And Associated Symptom 2. Measuring HRV 1. VAS 2. NDI 3. Menopause-Specific Quality Of Life Questionnaire (MENQOL) 1. Acupuncture 1. Subjective Symptom (0,1,2,3,4) 2. Phalen's Test (0,1,2,3,4) 1. Acupuncture 2. Medication Treatment 3. Physical Treatment 4. Kinesitherapy 1. Baumgaertne's Function Evaluating Method of knee joint 2. VNRS 3. DITI Kim RCT Neck pain CF+OT (2002) 22) (n=17) Yoon NRCT Low Back Pain CF+OT (2002) 23) (n=30) Lee RCT Degenerative (2006) 24) Knee Osteoarthritis CF (n=16) OT (n=17) OT (n=40) N/S (n=15) GB (20,21), BL11, SI (03,09,11), TE14, LI (04,11), TE (03,05), A-shi Point / cc GV4, BL (4,23,24,25, 26,27,52,57,62), GB (34,39), SI (3,6), TE3, LI4/ 0.4 cc 1 cc ST35, LR8, SP9/0.1 cc 1 time/2 Days *3 times 3 times/week *different number due to patient condition 3 times/1 week *2 weeks (Total 6 times) 1. Acupuncture 2. Infrared Treatment 3. Cupping Treatment 4. Physical Treatment 1. Acupuncture 2. Moxibustion 3. Cupping Treatment 4. Physical Treatment 5. Herbal Medicine 6. Physical Treatment 1. VAS 2. ROM 3. Evaluating Criteria Of Clinical Symptom - Gr. 0, I, II, III, IV 1. Classification Of Stauffer And Park - 1. WOMAC 2. VAS 3. Lysholm Score 4. Baumgaertner Score 5. SF-36 CF: Carthmi-Flos Herbal Acupuncture Therapy, N/S: Normal Saline, OT: Other Treatment. 59

6 이수환 윤정원 김순중 2) 시술방법 증례보고논문 13편에있어, 홍화약침주입기방향을언급한경우는없었으며, 자침깊이를명시한논문은 3 편 5,8,11), 시술자의숙련도는명시되어있지않았다. 총주입량은 cc의범위를보였고, 총주입량이불분명한논문은 2편 8,16) 이었다. 혈위별주입량이동일한논문 8 편 5-7,9-13), 주입량이동일한지확인불가한논문 5편 8,14-17) 이었다. RCT 및 NRCT 논문 7편에있어, 홍화약침주입기방향을언급한논문 1편 20), 자침깊이를명시한논문 4 편 18,21,23,24), 시술자의숙련도를명시한논문은없었다. 논문별대상질환치료에있어총주입량은 cc였으며, 혈위별주입량이동일한논문 4편 18-20,24), 주입량동일여부확인불가한논문 2편 21,23), 주입량이동일하지않은논문 1편 22) 으로조사되었다. 3) 시술횟수및기간 증례보고논문 13편에있어, 시술횟수가명시되지않은논문 2편 13,14) 이었으며, 명시된논문 11편 5-12,15-17) 이었다. 시술횟수가매일인논문 1편 7), 주 2 3회인논문 8 편 5,6,10-12,15-17), 주 1회인논문 2편 8,9) 으로조사되었다. 시술기간이명시되지않은논문 4편 6,9,14,16), 시술기간이명시된논문 9편 5,7,8,10-13,15,17) 이었다. 시술기간이 2주인논문 3편 5,7,15), 4주인논문 2편 10,11), 6주인논문 2편 12,17), 8주와 20주인논문각 1편 8,13) 으로조사되었다. 대조군연구논문 7편에있어, 시술횟수가정확히명시되지않은논문 1편 20), 명시된논문 6편 18,19,21-24) 이었으며, 6편모두주 2 3회시술빈도를보였다. 시술기간의경우명시되지않은논문 2편 19,23), 2주인논문 1편 24), 4주인논문 2편 18,21), 3 5회시술한논문 2편 20,22) 으로조사되었다. 시술횟수, 기간과환자증상호전과의객관적인상관관계는분석되지않았다. 5. 대상질환의韓方辨證 홍화약침검색을통한 20편의논문에있어각각의질환에대한한방변증을조사한결과, 風寒濕 12), 痰飮, 氣血凝滯 18), 打撲 7), 瘀血 7), 瘀血阻落 12), 疲勞 10), 飮食傷 10), 外感 10), 寒濕淫筋 12), 不愼跌挫 12), 氣血不通 9), 血室의氣血凝滯 13), 血虛 8) 13), 血寒등으로조사되었다. 6. 홍화약침의효과분석증례연구 13편논문및 RCT 및 NRCT 7편논문모두임상적또는통계적으로유의한호전이있다고보고되었다. 그중증례보고와 NRCT 논문중각 1편 6,21) 은시술과정에서나타난미열등대상자가자각하였던불편감에대해보고하였다. 대상질환치료결과에대한평가도구로는증례연구 13편중오직임상증상으로호전을보고한증례연구 1편 5), 객관적수치만을통해효과를도출한논문 2 편 8,13), 주관적증상의객관화만을통해효과를도출한논문 6편 7,9,11,12,14,17), 객관적수치및주관적내용의객관화를모두사용하여효과를증명한논문 4편 6,10,15,16) 로조사되었다. RCT 및 NRCT 논문 7편중객관적수치만을사용하여효과를증명한논문 1편 24), 주관적증상의객관화만을통해효과를증명한논문 3편 19,21,23), 객관적수치와주관적증상을객관화한수치를모두사용한논문 3 편 18,20,22) 로조사되었다. RCT 연구중단 1편 18) 만이추적관찰을하였고, 그기간은치료종료후 2주로제한되었다. 논문결과도출후개선점을명시한논문은증례보고 10편 5-10,13,14,15), RCT 및 NRCT 6편 18-24) 이었다. 7. 병행치료에대한분석증례 13편중홍화약침단독사용은 2편 6,14) 로전체모집단중 17% 에그쳤다. 호침치료를병행한논문 8편 5,7-9,11-13,15), 약물치료를병행한논문 6편 5,7,9,11,13,17), 물리치료를병행한논문 2편 5,9) 로조사되었다. 타약침치료를병행한증례연구논문은 3편이며, 봉약침 2편 8,12), 웅담우황약침 1편 16) 으로확인되었다. 기타병행된요법으로는동기요법 1편 5), 기존약물지속적으로복용하도록한논문 1편 10), 구법을병행한논문 1편 13), 관절운동요법병행한논문 1편 15) 이었다. RCT 및 NRCT 7편논문중홍화약침단독사용은 2 편 18,24) 이었으며, 호침치료를병행한논문 5편 19-23), 약물치료병행논문 3편 19,21,23), 물리치료를병행한 4편 19,21-23) 의논문이조사되었다. 기타병행치료로부항치료 2편 22,23), 구법 1편 23), 운동치료 1편 21) 로확인되었다. 60 J Korean Med Rehabil 2017;27(4):55-65

7 8. Controlled study 연구설계 7편의 RCT 및 NRCT 연구중 2편 18,24) 만이대조군집단에 Normal saline 을위약으로사용하였다. 나머지 5편의논문에는홍화약침치료군과체침단독치료군으로구분되어있다 (Table IV). 9. 대조군논문의질및오류평가 논문을고찰함에있어, 두명의독립적인연구자가독립적으로비뚤림평가를진행하였으며, 의견이일치하지않을경우충분한논의를통해결론을도출하였다. 본논문에서 Table IV. Type of Group in Controlled Trials Experimental group Control group Number CF NS 2 CF+OM OM 5 Total 7 CF: Carthami Flos Pharmacopuncture, OM: Other method, NS: Normal saline. 선정한대조군연구 7편 18-24) 의질평가를하기위해, 4편의 RCT 18,19,22,24) 에는 Risk of bias (RoB) 를적용하였으며, 3편의 NRCT 20,21,23) 에는 Risk of Bias for Nonrandomized Studies (RoBANS) 를적용하여평가하였다. 무작위대조군연구 4편 18,19,22,24) 의경우, 무작위배정순서생성항목에있어 1편 19) 은번호표추첨방식을사용하여 낮음 으로평가되었으며, 잔여 3편 18,22,24) 의논문은 불확실 로평가되었다. 배정순서은폐항목, 맹검항목의경우 4편 18,19,22,24) 모두 불확실 로평가되었다. 불충분한결과자료및선택적보고항목에있어, 4편 18,19,22,24) 모두결측치가없으며측정한수치를모두기재하였기에 낮음 으로평가되었다. 기타비뚤림제거항목에있어 4편 18,19,22,24) 모두명시되지않아 불확실 로평가되었다 (Table V). 비무작위배정대조군연구들은 3편 20,21,23) 이었으며, 대상군비교가능성, 대상군선정항목에있어모두 불확실 로평가되었다. 교란변수항목에있어, 3편의논문 20,21,23) 모두홍화약침치료외타치료를병행하여 높음 으로평가되었다. 맹검항목에서는 3편 20,21,23) 모두 불확실 판정이었으며, 불완전한자료, 선택적결과보고항목에있어, 연구자료가모두순차적이며체계적으로기재되어있어서 낮음 으로평가되었다 (Table VI). Table V. Quality Assessment of Each Included Randomized Controlled Trials Risk of bias First author (year) Adequate sequence generation Allocation concealment Blinding of participants and personnel Blinding of outcome assessment Incomplete outcome data addressed Free of selective reporting Free of other bias Park (2008) 18) U U U U L L U Park (2011) 19) L U U U L L U Kim (2002) 22) U U U U L L U Lee (2006) 24) U U U U L L U Risk of bias: low risk of bias (L), high risk of bias (H), unclear (U). Table VI. Quality Assessment of Each Included Non-Randomized Controlled Trials Risk of Bias for Non-randomized Studies First author (year) Confounding variables Selection of participants Measurement of intervention Blinding of participants and personnel Blinding for outcome assessment Incomplete outcome data Selective outcome reporting Choi (2005) 20) U U H U U L L Hur (2002) 21) U U H U U L L Yoon (2002) 23) U U H U U L L Risk of bias: low risk of bias (L), high risk of bias (H), unclear (U). 61

8 이수환 윤정원 김순중 고찰»»» 藥鍼療法은침구요법과약물요법을결합시킨치료법으로서여러가지유효하고특이한經穴刺戟을제공할뿐만아니라필요한약물투여의捷徑을제공함으로써약물의사용량을줄이면서치료효과를높일수있는방법으로약침액을질환과연관된경혈과체표촉진에의해얻어진양성반응점및혈관에약침주입용주사기를사용하여시술하는방법이다 25). 홍화는本草분류상活血祛瘀藥으로분류되며, 紅花辛溫消瘀熱, 多則通經少養血 이라고요약되어있다. 心 肝經으로들어가活血通經, 祛瘀止痛에작용하므로, 血瘀經閉, 痛經, 癥瘕, 難産, 死胎, 産後惡露不全과타박상의瘀血腫痛, 瘀血脇痛, 癰腫등에쓰인다 26). 2017년 7월까지발표된실험연구에따르면홍화약침시술이초기류마티스성관절염유발관련 cytokines 발현을감소시키고, 추가적으로무릎윤활관절막내조직손상, 모세혈관분포및섬유화가유의성있게감소함으로써윤활관절막손상을억제하고 27), 혈청내 IL (Interleukin) 등의 cytokine 을감소시킴으로써관절염증상을완화시키며 28), 혈소판수와 fibrinogen 수를감소시킴으로써항혈전등의효능 29) 이있다고증명되었다. 이와같이문헌적근거와다양한목적의실험논문이있으며, 증례보고및대조군연구형식의논문이보고되고있다. 오공약침, 자하거약침등다른종류의약침에대해서는국내데이터베이스검색을통한임상논문고찰이대한한방재활의학과학회지에보고되었으며, 약침주입부위, 시술방법, 출처및부위별주입량, 증례및대조군연구에서의효과와부작용및병행치료에대한분석등구체적인내용들이보고되어있다 3,4). 그에따라임상에서오공약침과자하거약침을응용함에있어, 임상논문들을근거로하여환자들을대상으로보다객관적인진료를할수있게되었다. 그러나, 홍화약침에대해서는임상논문을대상으로한비교연구는이루어지지않았다. 이에저자는국내전자논문검색데이터베이스를이용하여홍화약침시술결과에대해보고된논문들을수집하였다. 추가적으로, 이에대한임상연구현황의체계적인고찰을진행하였고, 다음과같은결과를얻었다. 5개의국내전자데이터베이스검색을통해모집된 20 편논문중증례연구가 13편 5-17), 대조군연구가 7편 18-24) 이었으며, 질환, 효과, 부작용에대한내용들이명시되어있었다. 홍화약침을적용하여효과가보고된질환은근골격계및신경계질환이다수를차지하였다. 상세질환으로수근관증후군 12,20), 퇴행성슬관절염 14,24), 경항통 19,22), 요통 9,23), 요골신경마비 5), 견비통 6), 요추압박골절 7), 원형탈모증 8), 만성매일두통 10), Duverney Fracture 11), 희발월경 13), 경추디스크탈출증 14), 류마티스관절염 16), 만성변비 18), 경추성 두통 17) 등 15 개질환이보고되었다. 위와같이단일과 진료영역이아닌다양한영역의질환을치료한증례가있었다. 하지만, 연구설계자체또는수행과정에서미비한점을확인할수있었다. 증례보고논문 13편중절반이상에해당하는 7 편 5,7,8,11-13,15) 의논문이 10례미만으로조사되었다. 증례가충분하지않아각질환에있어보편적인치료방법으로고려하기어려운점이있다. 따라서향후연구시단일질환에있어충분한증례확보가이루어진다면임상진료에서홍화약침시술시더욱구체적인근거자료가될수있다. 또한홍화약침시술에있어, 주입방향및시술자의숙련도를명시한증례연구는없었으며, 자침깊이를언급한논문도전체증례연구 13편중 3편 18,21,23,24) 에그쳤다. 대조군연구에서도시술자의숙련도를명시한논문은없었고, 주입기방향명시 1편 20), 깊이를명시한논문은 3편 5,8,11) 에그쳤다. 경혈에따른약침깊이및시술자의숙련도가다를경우환자의질환에있어호전도의차이를보일수있다. 따라서차후연구설계시연구의재현성을위하여이를명시해야한다. 추가적으로증례보고논문 13편에있어, 시술횟수가명시되지않은논문 2편 13,14) 이었으며, 명시된논문 11편 5-12,15-17) 이었다. 대조군연구논문 7편에있어, 시술횟수가정확히명시되지않은논문 1편 20), 명시된논문 6편 18,19,21-24) 이었다. 보다정확한임상논문연구결과도출을위해시술횟수와기간이정확하게명시될필요성이있다. 홍화약침검색을통한 20편의논문에있어각각의질환에대한한방변증을조사한결과, 風寒濕 12), 氣血凝滯 18), 打撲 7), 瘀血 7), 瘀血阻落 12), 疲勞 10), 飮食傷 10), 外感 10), 寒濕淫筋 12), 不愼跌挫 12), 氣血不通 9), 血室의氣血凝滯 13), 血虛 8), 血寒 13) 등으로조사되었다. 향후에도정확한辨證을통하여임상진료에있어홍화약침을선택하는근거를마 62 J Korean Med Rehabil 2017;27(4):55-65

9 련한다면진료시약침치료의효율성을높일수있을것이다. 홍화약침의효과를직접적으로증명하기위해서는단독으로홍화약침만사용해야하고, 타병행요법을배제해야한다. 하지만, 홍화약침임상논문 20편중, 증례연구 2 편 6,14), RCT 2편 18,24) 만이단독으로홍화약침을단독치료수단으로사용하였고, 기타논문들은타약침치료, 호침치료, 약물치료, 물리치료등다양한치료를병행하였다. 이에따라, 치료결과가홍화약침만의효능인지단정하기어렵다. 그러므로차후연구설계시약침단독의효능을증명하기위해타병행요법을배제하는방향으로개선해야할것이다. RCT 및 NRCT 분석시 RCT 연구 4편 18,19,22,24) 모두무작위배정방법을언급하였으며, RCT 및 NRCT 7편모두단일맹검을시행하였다. 7편중 2편 18,24) 은대조군으로 Normal saline 을사용하였지만 5편은호침및기타치료만시행되었다. 향후연구설계시에는대조군집단에약침과외형이동일한 Normal saline 등을주입하는것으로대체하여맹검을강화하고가능하면보조자를두어이중맹검을시행하여환자및시술자에따른변수를최소화하도록개선해야한다. 또한 20편의논문중오직 RCT연구 1편 18) 만이시술후추적관찰을 2주간진행하였다. 향후시술종료후치료의부작용이없는상태인지확인하고약침의효과지속성을알아보기위하여추적관찰을한다면치료에대한신뢰도를높일수있을것이다. 추가적으로선정논문의오류및질평가를하였으며, 선정한대조군연구 7편 18-24) 의질평가를하기위해, 4편의 RCTs 18,19,22,24) 에는 RoB를, 3편의 NRCT 20,21,23) 에는 RoBANS 를적용하여평가하였다. 무작위대조군연구 4 편 18,19,22,24) 의경우, 무작위배정순서생성항목에있어 1 편 19) 의논문을제외하고는 불확실 판정이었으며, 배정순서은폐항목, 맹검, 비뚤림제거항목의경우 4 편 18,19,22,24) 모두 불확실 로평가되었다. 불충분한결과 자료및선택적보고항목에있어, 4편 18,19,22,24) 모두결측치가없으며측정한수치를모두기재하였기에 낮음 으로평가되었다. 비무작위배정대조군연구들은 3편 20,21,23) 이었으며, 대상군비교가능성, 대상군선정, 맹검항목에있어모두 불확실 로평가되었다. 교란변수항목에있어, 3편의논문 20,21,23) 모두홍화약침치료외타치료를병행 하여 높음 으로평가되었다. 불완전한자료, 선택적결과보고항목에있어, 연구자료가모두순차적이며체계적으로기재되어있어서 낮음 으로평가되었다. 위와같은결과를토대로, 불확실 판정된항목들을추후연구에서구체적으로명시하여연구의질을향상시킬수있으리라기대한다. 본논문을통해저자는현재까지연구된홍화약침증례보고논문및대조군연구논문을통해홍화약침의효과및연구설계분석을목적으로연구를진행하였다. 홍화약침의임상사용에있어증례보고와대조군연구들은다수보고되어있으나, 이를종합적으로비교연구한논문은전무하다. 본논문은상기연구들을종합하여비교연구한첫논문이라는것, 그리고이와같은연구설계를바탕으로연구되지않은타약침의증례보고, 대조군연구를비교분석할수있다는점에도의의가있다. 문헌고찰을한결과물을토대로향후홍화약침을임상적으로적절히사용하며, 보다진전된연구를설계함에있어바탕이되고자하였다. 하지만, 제한된임상정보및단위가통일되지않은시술횟수등으로인해정확한비교연구가이루어지기는곤란하였다. 이와같은결점들을보완해, 발생할수있는변수를최소화하여신뢰도가높은다수의임상논문이학계에보고되어야한다. 또한, 본비교연구는논문내용을정리하여경향성을분석한한계가있으므로, 추가적으로홍화약침의임상사용에대해체계적논문고찰이필요하리라사료된다. 결론»»» 2017년 7월까지임상에서환자를대상으로홍화약침을시술한결과보고된논문 20편을비교연구한결과, 다음과같은결론을얻었다 편논문중증례연구가 13편, 대조군연구 7편이었다 편의논문중홍화약침은임상에서주로근골격계및신경계질환에적용되었으며, 단일질환으로는수근관증후군, 퇴행성슬관절염, 경항통, 요통이각 2편씩보고되어가장다수를차지하였다. 3. 증례보고 13편의논문중 1례논문이미만의논문이약 54% 를차지하는것으로나타났다. RCT, NRCT 논문의 63

10 이수환 윤정원 김순중 피험자는 명의분포를보였다. 4. 시술부위의경우약침증례보고 13편논문중 1편을제외한 12편의논문에서경혈또는정확한해부학적부위를명시하였다. 대조군연구논문 7편은모두경혈또는아시혈등의해부학적부위를명시하였다. 5. 시술방법의경우증례보고논문 13편에있어, 주입기의방향과시술자의숙련도를언급한논문은없었다. 주입량이불분명한논문은 2편이었으며, 나머지 11편의논문에서총주입량은 cc의범위를보였다. 대조군연구논문 7편에있어, 시술자의숙련도를명시한논문은없었으며, 주입기방향을언급한논문 1편, 자침깊이를명시한논문 4편으로조사되었다. 주입량이불분명하거나동일하지않은논문 3편이었으며, 잔여 4편논문에서총주입량은 cc 분포를보였다. 6. 홍화약침이적용된질환의한방변증을조사한결과風寒濕, 痰飮, 氣血凝滯, 打撲, 瘀血, 瘀血阻落, 疲勞, 飮食傷, 外感, 寒濕淫筋, 不愼跌挫, 氣血不通, 血室의氣血凝滯, 血虛, 血寒등으로조사되었다. 7. 홍화약침효과분석한결과증례연구 13편논문및 RCT 및 NRCT 7편논문모두임상적또는통계적으로유의한호전이있다고보고되었다. 8. 홍화약침을사용한임상논문증례연구 13편중홍화약침단독사용은 2편으로 20% 미만으로조사되었으며, 80% 이상의논문이타한방치료및물리요법을병행하였다. 대조군연구 7편논문중홍화약침단독사용은 2편으로약 30% 를차지하였으며, 잔여논문은약물치료등의한방치료와물리요법등의행위를병행하였다. 9. 대조군연구설계에있어 2편 18,24) 만이대조군집단에 Normal saline 을위약으로투여하였으며, 나머지 5편의논문에는홍화약침치료군과체침단독치료군으로구분하였다. 10. 대조군연구에있어, Risk of bias와 Risk of Bias for Non-randomized Studies 를통해논문의오류와질을평가한결과항목에대해적절한정보를알수없는 불확실 로판정된논문이대다수였다. 11. 본논문은홍화약침이임상에서응용된질환의경향성을파악하고, 향후보완되어야하는점에대해고찰하였다. 고찰결과, 증례연구에있어 10례미만이 50% 이상으로보고되어보다충분한증례확보가필요한것으로사료된다. 또한, 더명확한시술내용을포함하기위해자 입방향, 주입량, 시술자의숙련도가명시되어야하며, 홍화약침단독효과를알기위해연구과정에서기타요법들을배제하여야한다. 더욱이 불확실 판정을받은항목이대다수이므로, 향후연구설계에있어오류발생확률감소와논문의질향상을위해필수적으로확인해야하는항목을반드시검토해야할것이며, 증례연구와대조군연구에있어, 정확한정보의명시및통일된단위의필요성이요구된다. 마지막으로, 본논문은홍화약침임상논문을단순히정리한비교연구논문이므로, 추후체계적문헌고찰이필요하리라사료된다. References»»» 1. Korean Pharmacopuncture Institute Science Committee. Pharmacopucture. Seoul: Elsvier Korea. 2008:3-8, Kim IR, Kim HC, Kuk YB, Park SJ, Park YK, Park JH, Seo BI, Seo YB, Song HJ, Shin MG, Lee YJ, Lee YC, Lee JC, Lim KH, Cho SI, Jung JG, Joo YS, Choi HY, Bonchohak, Seoul:Younglim Publishing Inc. 2008: Lee JH, Jo DC, Moon SJ, Kong JC, Park TY, Ko YS, Song YS, Lee JH. Narrative Review of Clinical Trial on Hominis Placenta Pharmacopuncture in Korean Literature. J Oriental Rehab Med. 2012;22(3): Jo DC, Lee JH, Kim CG, Jung WS, Moon SJ, Park TY, Lee JH. Narrative Review of Clinical Trial on Scolopendrid Pharmacopuncture in Korean Literature. The Journal of Korean Medicine Rehabilitation. 2013;23(4): Mun KS, Lee KH, Kim TW, Jang BH, Kweon OS, Ryu CR, Cho MR. A Case of Radial Nerve Palsy. The Journal of Pharmacopuncture. 2004;7(3): Jeong DH, Ahn HJ, Hwang KS, Moon JH, Yun KB, Kim TW, Baek JY, Lee SM. Clinical Study on Effect of Carthmi-Flos Herbal acupuncture theraphy on shoulder pain. The journal of Korean Acupuncture & Moxibustion Society. 2002;19(6): Lee KS, Lee GM, Yeom SC. Clinical Study on the case of Lumbar compression fracture with Traditional Korean Medicine, Especially the SAAM Acunpture, Carthami-Flos Herbal Acupuncture. The Journal of physiology & pathology in Korean Medicine. 2004;18(4): Kim KW, Seo JC, Lee KM, Lim SC, Jung TY, Han SW. A Case of Alopecia Areata Treated with Bee Venom and Carthami Flos Herbal Acupuncture. The Journal of Pharmacopuncture. 2004;7(2): Cho TS, Seo JC, Son IC, Kwon HY, Youn HM, Jan KJ, Song CH, Ahn CB. The Effect of CF Herbal Acupuncture by Oswestry Disability Index. The Journal of Pharma- 64 J Korean Med Rehabil 2017;27(4):55-65

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