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인공고관절전치환술후 간헐적공기압박장치의정맥혈전색전증 예방효과 2016 년 1 월 서울대학교대학원 의학대학원정형외과학전공 1
조재호 인공고관절전치환술후 간헐적공기압박장치의정맥혈전색전증예방효과 지도교수김희중 이논문을의학석사학위논문으로제출함 2016 년 1 월 서울대학교대학원 의학과정형외과학전공 조재호 조재호의석사학위논문을인준함 2016 년 1 월 위원장김한수 ( 인 ) 2
부위원장이상민 ( 인 ) 위원김희중 ( 인 ) 초록 간헐적공기압박장치의 인공고관절전치환술후정맥혈전색전증 예방효과 조재호 의과대학정형외과학 서울대학교의학대학원 연구배경 : 정맥혈전색전증은주요고관절수술후비교적흔하며생명을위협 3
할수있는합병증이다. 이에대하여화학적및기계적예방법이있는 데화학적예방법은매우유용하지만상처부위나기타장기의출혈 같은부작용이있을수있다. 반면에기계적예방법은출혈의위험성 은적으나효과가떨어질수있다. 우리는정맥혈전색전증이비교적 적은아시아인환자에서기계적예방법이효과적일것이라가정하였 다. 우리는이연구에서주요고관절수술후정맥혈전색전증의예방 을위해간헐적공기압박장치가가지는유용성을평가하고자하였다. 연구방법 : 고관절전치환술후공기압박장치사용유무에따라증상이있는정 맥혈전색전증의발생률을비교하였다. 379 명의환자들이포함되었으 며공기압박장치사용그룹은 233 명 ( 남자 106 명, 여자 137 명 ) 이었고 평균 54 세였다. 비교군은 146 명 ( 남자 80 명, 여자 67 명 ) 으로평균연령 은 53 세였다. 모든환자들은수술후 6 주간저용량의아스피린을투여 받았다. 간헐적공기압박장치는수술후양다리에착용시켰으며퇴 원시까지하루종일유지하였다. 족부나하퇴의부종및발적같은정 맥혈전색전증이나, Homan`s sign 이나호흡곤란등의폐색전증의심증 4
상이있을때 CT 혈관조영이나초음파로검사하였다. 연구결과 : 수술후 3 개월동안공기압박장치사용그룹에서는 3 명, 비사용그룹에 서는 6 명의정맥혈전색전증환자가발생하였다. 공기압박장치사용그 룹에서정맥혈전색전증의발생률은 1.3% 로비사용그룹의 4.1% 에비 하여낮았으나통계적유의성은없었다. 공기압박장치사용에있어서 환자에게발생하는부작용은없었다. 정맥혈전색전증이발생한환자 들은그렇지않은환자들에비하여나이가많았고입원기간이길었다. 연구결과 : 간헐적공기압박장치는수술후정맥혈전색전증의예방을위한효과 적이며안전한방법이라판단된다. 주요어 : 고관절전치환술, 정맥혈전색전증, 간헐적공기압박장치, 폐색전증, 대 퇴골두무혈성괴사 5
6
Abstact Effect of intermittent pneumatic compression device for prevention of deep vein thrombosis after primary total hip arthroplasty Cho JAI HO Department of orthopedic surgery The Graduate School Seoul National University Background: Venous thromboembolism is a relatively common and potentially life threatening complication after major hip surgeries. There are two main types of prophylaxis, chemical and mechanical. Chemical prophylaxis is very effective but has bleeding complications in surgical wound and remote organs. On the other hand, mechanical methods are free of hemorrhagic complications, but less effective. We hypothesized that mechanical prophylaxis is effective enough for Asian people in whom VTE occurs less frequently. The purpose of this study is to evaluate the effect of intermittent pneumatic compression (IPC) in the prevention of VTE after major hip surgery. Methods: Incidences of symptomatic VET after primary total hip arthroplasty with and 7
without application of IPC were compared. A total of 379 patinets were icluded in the final analysis. IPC group included 233 patients of 106 men and 137 women with mean age of 54 years. Control group included 146 patients of 80 men and 67 women with mean age of 53 years. All patients took low dose aspirin for 6 week after surgery. IPC was applied to both legs just after surgery and kept all day long until discharge. When a symptom or a sign suspicious of VTE such as swelling or redness of foot and ankle Homans' sign and dyspnea was detected, CT angiogram or duplex sonogram was performed. Results: Until 3 months after surgery, symptomatic VTE occurred in 3 patients of IPC group and in 6 patients of control group. The incidence of VTE in IPC group (1.3%) was much lower than that in control group (4.1%), but the difference was not statistically significant. In no patients, any remarkable complication associated with the application of IPC was detected. Patients affected by VTE were older in age and hospitalized longer than unaffected patients. Conclusion: The results of this study suggest that IPC is an effective and safe method for the prevention of postoperative VTE. Keywords: Total Hip Arthroplasty, venous thromboembolism, intermittent pneumatic compression, pulmonary embolism, Osteonecrosis, Student Number : 2007-21977 8
Contents A b s t r a c t i n K o r e a n 1 A b s t r a c t 4 C o n t e n t s 6 L i s t o f t a b l e s 7 L i s t o f f i g u r e s 8 I n t r o d u c t i o n 9 M a t e r i a l s a n d M e t h o d s 1 1 R e s u l t s 1 7 D i s c u s s i o n 2 7 C o n c l u s i o n 3 0 R e f e r e n c e s 3 1 9
List of Tables Table 1. The comparison of patient demographics in group I and II 13 Table 2. Etiologic disease of total hip arthroplasty. 18 Table 3. The comparison of operation related factor in group I and II 19 Table 4. Anatomical sites of thrombi in venous thrombo-embolism of each patient. 21 Table 5. Incidence of VTE, PE, and DVT 24 Table 6. Risk factor of VTE 26 10
List of Figures F i g u r e 1 1 5 11
서론 정맥혈전색전증은인공고관절수술이나고관절골절수술후발생하는주 요합병증중하나로심부정맥혈전증과폐색전증을포함한다. 1-3) 이중폐색 전증은심부정맥혈전증보다드물게발생하지만고관절수술후에사망을초래 하는주요합병증중하나이다. 1,4-7) 고관절수술중혈관및연부조직에가해지는 물리적손상과수술후침상안정은혈류의속도를느리게하고혈전생성을초 래하여정맥혈전색전증의발생위험을높이는것으로이해되고있는데, 8,9) 예방 조치를하지않는경우인공고관절전치환술후 45~57% 에서정맥혈전색전증 이발생하는것으로알려져있다. 8,10,11) 발생률이높고, 드물기는하나치명적인결과가초래될수있으며자주혈전 후증후군 (post-thrombotic syndrome) 으로이행되기때문에적극적이예방조치가 강조되고있다. 6,12,13) 예방방법으로는크게화학적방법과기계적방법의두가 지가있다. 화학적방법은항응고제를사용하는것으로헤파린이나와파린과같 은전통적인약물이외에최근에는사용이편리한저분자량헤파린과 Xa 인자를 억제하는오당류 (pentasaccharide) 가주요예방제로사용되고있다. 12,14) 이들항응 12
고약물들의예방효과는매우우수하나창상에문제가생길수있고, 위장관출 혈이나뇌출혈과같이수술과무관한부위에서출혈을일으킬수있다. 9,12) 또한 일부약물은효과를보이면서부작용을줄일수있는혈중농도의영역이좁아 서, 이를감시하기위해잦은채혈을해야한다. 52) 기계적방법으로는 graduated compression stocking 과같은탄력스타킹이나 foot pump 등과같은간헐적공기압박장치가있다. 15,16) 간헐적공기압박장치는출 혈의위험은없으며수술중에도반대측다리에는적용이가능하다는장점이있 다. 수술후에도배액관의유무와상관없이언제든적용을시작할수있다. 하지 만그효과에대해서는일부논란의여지가있어, 미국흉부의사학회 (American College of Chest Physicians) 에서는정맥혈전색전증의예방가이드라인제 8 판까 지간헐적공기압박장치를출혈위험도가높은경우에한해서만단독사용을 권장하였다. 10,14) 전통적으로동양인의경우서양인에비하여정맥혈전색전증의빈도가낮은 것으로평가되어왔기때문에동양에서는정형외과수술후그예방, 특히항응 고제를사용한예방법에대하여관심을가지고있지않았다. 2,17-20) 그러나 2005 년 13
동양인을대상으로한 2 건의다기관연구에서동양인에서정형외과수술후정 맥혈전색전증의발생빈도가과거에인식되었던것보다높아서서양인에못지 않았다는결과가발표된이후예방에대한관심이높아지고항응고제를이용한 적극적인예방이필요하다는주장까지나오게되었다. 21-24) 이후아시아인에대하 여도정형외과수술후항응고제를이용한적극적인예방의시행이증가하여왔 으나, 상대적으로발생빈도가낮음에도출혈의위험을감수하면서까지항응고제 를사용하여야하는지에대하여논란이많았다. 25-28) 이에따라간헐적공기압박 과같은기계적방법에대한관심이높아지고있는데, 그간아시아인에서의간헐 적공기압박의예방효과에대하여는다양한결과가보고되어왔다. 29-38) 저자들은고관절수술후정맥혈전색전증의예방책으로저용량아스피린 (1 일 100mg 1 회 ) 만을투여하다가 2010 년 3 월부터일부환자들에게간헐적공기압박장 치를추가로적용하기시작하여같은해 12 월부터는모든환자에게추가적용하 였다. 이번연구에서는간헐적공기압박장치의적용이후에정맥혈전색전증 발생빈도의감소여부와정맥혈전색전증이합병된환자들의인구학적특성을 알아보고자하였다. 14
대상및방법 이연구는서울대학교병원정형외과에서주요고관절수술인인공고관절전 치환술을받은환자들을대상으로한후향적연구로서울대학교병원의학연구윤 리심의위원회의승인을받았다 (H-1403-050-565). 2008 년 3 월부터 2012 년 12 월까지인공고관절전치환술을받은환자들중 17 세미만, 수술전에정맥혈전색전증의병력이있던환자, 수술전에아스피린 보다상위의항응고제를사용하던환자, 3 개월이상추시가불가하였던환자, 외 상으로응급수술을시행한환자들은제외하였다. 2008 년 3 월부터 2010 년 2 월까지 수술을받은환자들은간헐적공기압박장치사용없이저용량아스피린만투여 한대조군으로, 2011 년 1 월부터 2012 년 12 월까지수술을받은환자들은저용량 아스피린투여에간헐적공기압박장치사용을추가한시험군으로하였다. 전체 379 명의환자가최종분석대상에포함되었다. 대조군은 146 명으로남자 80 명여 자 67 명으로평균나이는 53 세였고, 시험군은 233 명으로남자 106 명여자 127 명으 로평균나이는 54 세였다 (Table 1). 15
Table 1. The comparison of patient demographics in group I and II Pump X Pump O p-value Number 146 233 Sex (M:F) 80:66 106:127 0.091 Age (year) 52.9 ± 14.3 53.8 ± 14.1 0.551 BMI (kg/m 2 ) 24.4 ± 3.6 24.2 ± 3.5 0.650 Comorbidity index 0.889 0 90 (61.6%) 130 (55.8%) 1 46 (31.5%) 69 (29.6%) 2 10 (6.8%) 26 (11.2%) 3 0 (0.0%) 7 (3.0%) 4 0 (0.0%) 1 (0.4%) BMI; body mass index 수술은 2 명의술자가대부분척추마취하에시행하였고, 아스피린의투여는음 압배액관제거후인수술후 2, 3 일째에시작하여술후 6 주까지지속하였다. 시 험군의모든환자들은같은간헐적공기압박장치를사용하였다 (Kendall SCD EXPRESS TM ; Covidien, Mansfield, MA, USA)(Figure 1). 16
Figure 1. Main body (left) and cuff (right) of the intermittent pneumatic pump used in this study. 이장치는하지의혈관에혈액이차는시간에따라압박시기를스스로조절할 수있으며, 45mmHg 까지압박을가할수있다. 양측하지모두에하루종일적용 하는것을원칙으로하였다. 모든환자에서수술후병실에도착하면서장치적 용을시작하여퇴원시까지지속하였는데수술중에는적용하지않았다. 마취에 서회복되는대로능동적발목운동과대퇴사두근수축운동을시작하였고하지 직거상을시도하도록하였으며가능한빨리보행훈련을시작하였다. 환자들은 목발이나보조기를이용하여스스로보행이가능해지면퇴원하였는데대조군의 환자들은수술후평균 11.9 일, 시험군의환자들은평균 10.1 일간입원하였다. 수술후에족부족관절의부종이나발적, 하퇴부통증등심부정맥혈전증의 17
심소견이나호흡곤란등폐색전증을의심할만한소견이발견되면, 정맥혈전색 전증확인을위하여전산화단층촬영을이용한혈관조영술을시행하였다. 신기 능저하등으로혈관조영술이어려운경우에는초음파검사를이용하여혈관을 평가하였다. 퇴원후에술후 6 주, 술후 3 개월및술후 9 개월, 이후연 1 회추 시시에도정맥혈전색전증의심소견이있는경우확인검사를시행하였다. 정 맥혈전색전증이확진된환자는발생위치에따라혈액질환내과, 호흡기내과, 혈관외과에의뢰하여치료를하였다. 수술후 3 개월까지의정맥혈전색전증의발생빈도를양군간에비교하였으며, 환자의나이, 성별, 기저질환, 마취방법, 수술시간등이정맥혈전색전증의 발생과연관성이있는지확인하였다. 39-44 통계적으로정맥혈전색전증의발병률과같은범주형자료는 Fisher 의정확성 검정을이용하여비교하고, 수술시간및나이와같은연속형자료에대해서는 독립 t 검정을이용하여비교하였다. 정맥혈전색전증의발생여부에따라집단 을나누어성별, 나이, 체질량지수, 입원기간, 수술시간, 기저질환지수등을 동일한방법으로비교하여유의한차이를보이는위험인자를찾고자하였다. p 18
값이 0.05 보다작은경우를통계적으로유의한것으로판단하였다. 결과 양군간에수술후입원기간이외에남녀비, 연령분포, 체질량지수, 인공고 관절전치환술의원인질환종류, 기저질환지수, 마취방법과수술시간등에유 의한차이는없었다 (Table 1, 2, 3). Table 2. Etiologic disease of total hip arthroplasty. Pump X (146) Pump O (233) P-value Avascular necrosis 84 (57.5%) 136 (58.4%) 0.915 Degenerative arthritis 32 (21.9%) 47 (20.2%) 0.698 Septic hip sequelae 8 (5.5%) 15 (6.4%) 0.826 Dysplasia 5 (3.4%) 14 (6.0%) 0.337 Rheumatic disease 7 (4.8%) 10 (4.3%) 0.804 LCP sequelae* 6 (4.1%) 7 (3.0%) 0.574 Miscellaneous** 4 (2.7%) 4 (1.7%) 0.491 Total 146 (100%) 233(100%) *LCP; Legg-Calve-Perthes disease. **Miscellaneous includes SIF(1:2), PVNS(0:2), post-traumatic AVN(1:0), 2ndary DA d/t unknown cause(1:1). 수술후입원기간은대조군이 11.9 ± 5.3 일로시험군의 10.1 ± 2.8 일보다유 의하게길었다 (p=0.000)(table 3). 19
Table 3. The comparison of operation related factor in group I and II Pump X (146) Pump O (233) p-value Operation time (minute) 104.3 ± 30.1 105.3 ± 25.5 0.747 Hospitalization period (day) 11.9 ± 5.3 10.1 ± 2.8 0.000 Anesthesia (%) Spinal 129 (88.4%) 196 (84.1%) Epidural combined 2 (1.4%) 5 (2.1%) General 15 (10.3%) 32 (13.7%) 0.539 시험군에서압박대착용으로인해피부수포나궤양등의심각한합병증이발 생한예는없었다. 시험군에서는총 3 예에서정맥혈전색전증이진단되었는데이중 1 예는근위 및원위심부정맥혈전증과함께폐색전증이있었고, 2 예는근위심부정맥혈전 증이었고이들중 1 예에서폐색전증이동반되었다. 대조군에서는총 6 예에서정 맥혈전색전증이진단되었는데이중 2 예는근위및원위심부정맥혈전증, 1 예 는근위심부정맥혈전증, 3 예는원위심부정맥혈전증이었는데폐색전증이동 반된예는없었다 (Table 4). 20
Table 4. Anatomical sites of thrombi in venous thrombo-embolism of each patient. Proximal Distal PE DVT DVT DVT Pump X X O O O X O O O X O O X X O X O X O X O X O X O Pump O O O O O O O O X X O O X PE; pulmonary embolism, DVT; deep vein thrombosis. 정맥혈전색전증의발생률은시험군 1.3%, 대조군 4.1% 로시험군이낮았으나 그차이가통계적으로유의하지않았다 (p=0.093). 근위심부정맥혈전증발생률 은시험군 1.3%, 대조군 4.1% 로시험군이낮았고, 폐색전증의발생율은시험군 0.9% 로대조군보다높았으나통계적으로의미있는차이는아니었다. 원위심 부정맥혈전증의발생률은시험군 0.4% 로대조군 4.1% 보다통계적으로의미있 게낮았다 (p=0.015)(table 5). 21
Table 5. Incidence of VTE, PE, and DVT Pump X (146) Pump O (233) p-value VTE 6 (4.1%) 3 (1.3%) 0.093 PE 0 (0%) 2 (0.9%) 0.525 DVT 6 (4.1%) 3 (1.3%) 0.093 Proximal DVT 3 (2.1%) 3 (1.2%) 0.680 Distal DVT 6 (4.1%) 1 (0.4%) 0.015 VTE; venous thrombo-embolism, PE; pulmonary embolism, DVT; deep vein thrombosis. 정맥혈전색전증이발생한환자들과발생하지않은환자들사이에서성별, 체 질량지수, 수술시간, 기저질환지수에는차이가없었고, 연령과수술후입원 기간만의미있는차이를보여발병군의연령이높고 (p=0.030) 입원기간이길었 다 (p=0.013)(table 6). 22
Table 6. Risk factor of VTE Non-VTE VTE p-value Number 370 9 Gender (Male : Female) 184:186 2:7 0.175 Age (years) 53.2 ± 14.2 63.6 ± 7.9 0.030 BMI (kg/m 2 ) 24.3 ± 3.5 25.0 ± 4.3 0.532 Hospitalization period (day) 10.7 ± 4.0 14.1 ± 2.1 0.013 Operation time (minute) 105.0 ± 27.5 102.4 ±18.5 0.785 Underlying disease index 0.088 0 218 (58.9%) 2 (22.2%) 1 110 (29.7%) 5 (55.6%) 2 34 (9.2%) 2 (22.2%) 3 7 (1.9%) 0 (0%) 4 1 (0.3%) 0 (0%) 9 예의정맥혈전색전증에대해 2 례는경과관찰만으로, 3 례는 3 개월에서 13 개월 간 warfarin 등의약물로치료하였다. 1 예에서는기계적정맥혈전제거술시행후 3 년간약물치료를시행하였다. 23
고찰 이번연구에서간헐적공기압박장치를적용한군에서의정맥혈전색전증의 발생률은적용하지않은군에서의발생률의 30% 이하로상당히뚜렷한차이를 보였다. 비록통계적으로유의하지는않았으나이결과는간헐적공기압박이정 맥혈전색전증의예방효과가있음을시사한다. 족부나하지의공기압박은 30 여년전부터정맥혈전색전증의예방법으로사용되어왔으며, 45,46) 효과적인방법 이라는보고가많았음에도많은수의환자를대상으로한잘통제된전향적연구 결과가없다는이유로미국흉부의사학회의정형외과주요수술후예방지침에서 출혈위험이높은경우이외에는단독예방법으로인정되지못하다가, 10,14,47) 2012 년에와서야미국흉부의사학회의예방지침에정형외과주요수술후단독예방법 으로포함되었다. 48,49) 이후간헐적공기압박의효과가과거발표된연구에대한 메타분석과전향적연구를통해보고되고있다. 46,50-54) 아시아인에서의예방효과 에대한연구는많지않은데 Sugano 등 30) 과 Yokote 등 34) 이각각 2009 년과 2011 년 에일본인에서효과가인정된다고, 2010 년 Mehta 등 31) 이싱가폴인에서효과가확 인되었다보고한바있다. 24
간헐적공기압박장치사용으로압박대에의해피부에수포가발생하거나적 용부위에구획증후군의발생된증례보고는있으나심각한부작용은매우드문것 으로판단되는데이연구대상에서도특기할만한부작용은발생하지않았다. 55,56) 또한그적용에대한환자들의순응도도매우좋은것으로보고된바있는데이 연구에서도불편감으로적용을포기한예는없었다. 57-59) 우리나라에서정형외과수술후정맥혈전색전증의발생빈도에대한연구는 많지않은데인공고관절수술후유증상의정맥혈전색전증발생빈도는 0~2.2% 로보고된바있다. 2,41,42,44,60-62) 이번연구에서의유증상정맥혈전색전증의발생 빈도는기존의보고와비교하여상당히높은편이라하겠다. 특히기본적으로저 용량아스피린을사용한것을고려하면그러하다. 이번연구는후향적연구이기 는하나대상기간의시작부터현재까지똑같이적용되고있는정맥혈전증예 방지침에따라기본적으로조금이라도정맥혈전색전증의의심소견이있는환 자들에대하여전산화단층촬영을이용한혈관조영술이나초음파검사를시행 하였기때문에상대적으로발견율이높았던것으로판단된다. 검사를시행하게 된주된증상은하퇴부종창이었는데뚜렷하지않더라도의심이되면검사를시 25
행하였고이들중하퇴부압통이나 Homans 징후가동반된경우는거의없었다. 정맥혈전색전증발생의위험인자로정맥혈전색전증의과거력, 심혈관계질환, 동반질환지수, 비만, 고령, 하지정맥류, 장기간의침상안정등이제기된바 있으나, 39-44) 고관절수술과관련하여분석한연구들에서의결과는매우일정치 않아서연령, 여성, 비만, 장시간의수술등이위험인자로보고된바있다. 39-41,44) 이연구에서도성별, 연령, 비만, 수술시간, 입원기간, 동반질환지수가발생과 관련이있는지분석하였는데발병군에서여성비율이훨씬높고, 평균연령이 높았으며, 입원기간이길었으나연령과입원기간의차이만이통계적인의미가 있었다. 환자수가 9 명으로매우작은것이분석에제한이되었던것으로 판단된다. 이연구의경우상대적으로작은수의환자를대상으로한후향적연구라는것 이주요한제한점이라하겠다. 그러나단일기관에서일관된원칙하에수술전 후처치가시행된연속적인수술예들전체를대상으로하였기때문에실질적으 로는전향적연구라할수있겠다. 전체환자가아닌정맥혈전색전증을의심할 만한증상이있는경우에만확진검사를시행한것도제한점일수있겠으나연 26
구의주된목적이간헐적공기압박장치의정맥혈전색전증에대한예방효과 를확인하는것이기때문에일관된원칙에따라시행된검사결과를비교하는것 으로분석에큰제한점은아니라고생각한다. 이번연구에서인공고관절전치환술후에저용량아스피린투여와함께간헐 적공기압박장치를적용한예에서의정맥혈전색전증발생률은 1.3%(233 례중 3 례 ) 였다. 서양에서의보고에의하면화학적예방법을이용하면인공고관절전치 환술후의정맥혈전색전증의발병을 1~2.5% 로낮출수있다. 7,63,64) 화학적예방 법을사용할때나타나는출혈과같은합병증을고려한다면, 저용량아스피린투 여와함께간헐적공기압박장치를적용하여안전하면서도효과적으로정맥혈전 색전증을예방할수있을것으로판단된다. 결론 이번연구결과는통계적으로는유의한차이가확인되지않았지만간헐적공기 압박장치가정맥혈전색전증의예방효과가있음을시사한다. 또한향후더많 은환자군을대상으로연구를지속할필요가있다. 27
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