병원약사회지 (2012), 제 29 권제 2 호 J. Kor. Soc. Health-Syst. Pharm., Vol. 29, No. 2, 149 ~ 160 (2012) 회원학술보고 통원치료센터단기항암요법환자의부작용양상및 약사의중재활동효과 경성대학교약학대학 Adverse Drug Reaction Profile in Patients with Cancer Chemotherapy and Pharmacist's Intervention in the Ambulatory Care Unit Kie Ho Sohn College of Pharmacy, KyungSung University, Busan, 608-736, Korea Abstract : Adverse drug reactions (ADRs) to cancer chemotherapy are common, and it can lead to noncompliance or even discontinuation of the therapy. The purpose of this study was to assess the suspected ADR profiles of cancer chemotherapy, and to evaluate the pharmacist s intervention in a tertiary care hospital. A retrospective, observational review of electronic medical records and pharmacist records were performed in a single department of an ambulatory oncology care unit. The collected dataset was analyzed for ADR profiles, dosage regimens, demographic profiles, causality, severity and pharmacist's intervention. Patients were included (n=157, 17-80 Y, median age 58 Y, male/female(2/1)) if they were prescribed cancer chemotherapy, and have had an intervention by the pharmacist, between July 2009 and June 2010. The most common ADRs were neutropenia (95.4%), thrombocytopenia (81.8%), nausea (84.1%), anorexia (84.1), constipation (52/3%), hand-foot syndrome (50%), neuropathy (50%), stomatitis (47.7%), diarrhea (27.3%), hiccups (20.5%) by XP (capecitabibe/cisplatin) regimen; neutropenia (46.3%), thrombocytopenia (41.9%), nausea (54.8%). anorexia (38.7%), constipation (50%), myalgia - 149 -
JKSHP, VOL.29, NO.2 (2012) (75.8%), neuropathy (9.7%), diarrhea (12.9%) by TC (Paclitaxel/Carboplatin) regimens; and neutropenia (73.6%), thrombocytopenia (41.5%), nausea (39.6%), anorexia (13%), constipation (24.5%), myalgia (3.8%), neuropathy (73.6%), stomatitis (35.2%), and diarrhea (13.2%) by R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisolone) regimen. ADRs commonly occur in chemotherapy patients and the pharmacist s intervention was helpful. Improvement rates by the pharmacist's intervention were 80.8% (hiccup), 32.8% (constipation), 32% (myalgia), 19.6% (anorexia), 16.3% (nausea), 7.7% (neuropathy) and 6.4% (stomatitis). In conclusion, this indicates the need for rigid ADR monitoring in chemotherapy patients to ensure safety of the drug therapy. [Key words] Adverse drug reaction. Chemotherapy, Pharmacist's intervention 투고일자 2012. 1. 24; 심사완료일자 2012. 2. 21; 게재확정일자 2012. 4. 6 통원치료센터는진료영역별로필요한침상수를갖추고외래진료중에처치및관찰을요하는환자나응급상황발생시에집중치료를할수있도록운영하고있다. 그중에서단기항암치료실과같은경우에는외래환자가운데 6시간이내로소요되는항암주사및처치가이루어지는공간으로활용되고있다. 또한단기항암치료실에서는 6시간이상소요되는항암치료및중심정맥관삽입술등의시술이이루어지기도하고 1일입원치료를위해서는전날밤에수액요법또는전처치용약복용등의준비가필요하여예약제로운영된다. 이러한임상환경에서근무중인약사는환자를직접방문하여교육및상담을통하여약물에대한정확한정보를제공함과동시에복약지도를하기도한다. 이곳에서주로투여되고있는항암화학요법제는암세포뿐만아니라정상세포중분열과증식이활발한위장관 ( 구강, 식도, 위, 장 ) 의점막세포, 모공세포, 골수에서만들어지는혈액세포 등이영향을받기때문에건강한세포의손상은항암화학요법의중요한부작용의원인이기도하다. 이외에도각항암화학요법제가가지고있는특이한부작용이심장, 콩팥, 방광, 폐그리고신경계, 생식기관등에손상을줄수있다 1-5). 더구나이러한부작용은약물의종류에따라다르며환자마다, 매주기마다부작용의양상이다르기때문에항암치료를진행하면서부작용의발생을예방하고경감시키기위한여러가지조치가함께이루어지기도하고부작용이심한경우에는투여용량을줄이거나약물의종류를변경하기도한다 6). 따라서치료에대한부작용을잘이해하고이겨나가기위해서는항암제가투여되는동안이나투여된후에느끼는불편감을반드시전문가와상의하여적절한대처방법을강구할필요가있다 7). 이와더불어대부분의중증도높은부작용은병원환경에서일어나는경우가대부분이기때문에병원약사의부작용관리는대단히중요하다 8). - 150 -
손기호 : 통원치료센터단기항암요법환자의부작용양상및약사의중재활동효과 부작용에대한대처법으로는발생한부작용을단순히보고하는수동적인역할에서벗어나서예상되는부작용을긴밀하게모니터링하여부작용을조기에발견하여조기에조치를취함으로서더이상의임상적인악화를방지하는것이대단히중요하다 9). 이러한조치들가운데에는임상약사가처방약물의적정성을검토함과동시에복약상담을통하여부작용을조기에파악하고시의적절한중재를하는프로그램이도입되어일찍이시행중에있다. 이프로그램에서부작용의예방을위한전처치요법은이미다빈도로사용중에있는 dosage regimen에포함시켜표준치료지침으로적용하고있으나이러한표준치료지침을적용함에도불구하고발생되는부작용은임상약사가일정한범위내의치료약품군을자율적으로환자에게조제처방토록조치함과아울러복약상담활동을통하여환자의삶의질향상에기여하고있다. 본연구에서는최근에한개의상급전문종합병원에서활발하게운영중인통원치료센터내의단기항암치료실에서환자들에게발생된부작용의양상을분석하고약학적인관점에서조치한부작용의중재효과를파악함으로서종양전문약사의업무개발방향성을설계하고환자의삶의질향상에이바지하는데필요한지견을얻고자하였다. 연구대상및방법가. 용어의정의본연구에서사용하는 3가지의항암화학요법 regimen은각각다음과같다. D2-D3 Aprepitant 80 mg/d D2-D4 Dexamethasone 8 mg/d (2) TC(Paclitaxel/Carboplatin) regimen D1 Paclitaxel 150-175 mg/m 2 D1 Carboplatin AUC 5.0-5.5 D1 Dexamethasone 20 mg Chlorpheniramine 4 mg / Ranitidine 50 mg / 5-HT3 antagonist D2-D6 5-HT3 antagonist/d (3) R-CHOP(Rituximab/Cyclophosphamide/ Doxorubicin/Vincristine/Prednisolone) regimen D1 Rituximab 375 mg/m 2 D1 Cyclophosphamide 750 mg/m 2 D1 Doxorubicin 50 mg/m 2 D1 Vincristine 1.4 mg/m 2 (max.2mg) D1-D5 Prednisolone 100 mg/d D1 Chlorpheniramine 4 mg / Acetaminophen 650 mg / Aprepitant 125 mg / 5-HT3 antagonist D2-D3 Aprepitant 80 mg/d (1) XP(Capecit abine/cisplat in) regimen D1-D14 Capecitabine 1,000 mg/m 2 bid D1 Cisplatin 75 mg/m 2 D1 Aprepitant 125 mg / Dexamethasone 10 mg / 5-HT3 antagonist 나. 연구대상서울에소재한한개의상급전문종합병원에서운영중인통원치료센타의단기항암치료실에서 2009년 7월 1일부터 2010년 6월 30일까지총 12개월동안에 XP(Capecitabine/Cisplatin) regimen, TC (Paclitaxel/Carboplatin) regimen 및 R- - 151 -
JKSHP, VOL.29, NO.2 (2012) CHOP(Rituximab/Cyclophosphamide/Doxorub icin/vincristine/prednisolone) regimen 중에서한개의항암화학요법 regimen을투여받은환자들가운에약사에의한약학적인중재를받은환자를최종연구대상으로하였다. 다. 부작용진단부작용의진단은환자와의 1:1 상담을통해서점검하고조치한내용을기록한약무기록과의사의진료행위를기록한전자의무기록을바탕으로판단하였다. 부작용의용어사용은가급적한글 WHO-ART(World Health Organization-Adverse Reaction Terminology, 092version) 를근거로하여표기하였으나 10) 수족증후군 (hand-foot syndrome) 의경우에는위용어집에등재되어있지않기때문에증후군으로서따로진단명을기재하였고부작용진단에대한최종적인판단은인과성평가를통하여확정하였다. 라. 인과성평가항암화학요법에의해서발생한부작용의인과성평가는한국형알고리즘 (Ver2.0) 을사용하였으며평가점수가 6점이상 ( 가능성있음, probable) 인경우에만인과성이있는것으로간주하였다 11). 마. 부작용의중증도평가각항암화학요법의 regimen별로나타나는부작용의종류별중증도평가는 Common Terminology Criteria for Adverse Events(CTCAE) 를기준으로확정하였다 12). 바. 활동도 (Performance status) 대상환자의활동도는 ECOG(Cooperative Oncology Group) 법에준하여판단하였다 13). 사. 자료분석방법연구대상환자의주진단명분포, 각 regimen별부작용발생률등은 cycle별및환자수를기준으로하여백분율로표기하였다. 또한각 regimen별연령별오심 (nausea) 의부작용발생률차이는 SPSS 18을이용하여 Chi-Square test, Fisher s Exact test로검정하였으며 p-value 0.05이하를통계적으로유의한것으로판단하였다. 아. 약사에의한약학적중재항암화학요법의경우부작용이다빈도로발생을하기때문에대부분의경우에는각항암화학요법 regimen에표준예방요법을포함시켜두고있다. 그럼에도불구하고추가로발생하는부작용이있을경우에는환자와의 1:1 복약상담을통해서전담전문약사가다음과같은범위내에서증상별로중재약물을투여하고있다. 오심 : Setron계약물, Metoclopramide제제, Lorazepam제제, Domperidone제제딸꾹질 : Baclofen제제, Chlorpromazine제제근육통 : Mypol(Acetaminophen 250 mg, Ibuprofen 200 mg, Codeine Phosphate 10 mg 복합제 ), Cetama dol(acetaminophen 325mg, Trama dol 37.5mg복합제 ) 구내염 : 가글제 (Chlorhexidine Gluconate Solution 0.5% 제제, Benzethonium 0.01% 제제 ) 변비 : MgO, Lactulose 67% 제제, Bsa codyl/docusate sodium 제제, 무타실 ( 차전자피제제 ) 등식욕부진 : 메게스트롤현탁액, 트레스탄 (Cyproheptadine Orotate 1.5 mg, DL-Carnitine Hydrochloride 150 mg, Cyanocobalamin 1 mg, Lysine HCl 150 mg 복합제 ), 단 Megestrol 제제의 - 152 -
손기호 : 통원치료센터단기항암요법환자의부작용양상및약사의중재활동효과 사용이불가능한경우에투여함신경병증 : 주로 Amitriptyline제제, Gabapentine 제제이러한중재활동으로다빈도로발생한부작용인딸꾹질, 변비, 근육통, 식욕부진, 오심, 신경병증및구내염이호전된정도 ( 호전율 ) 를조사하였다. 나타내고있다. 진단명으로는비호치킨성임파종이 53명, 폐암이 46명, 위암이 43명및기타 15명의순서로나타났으며항암화학요법을시행하기전에시행한치료방법으로는수술한경우가 90명, 이미다른종류의항암화학요법을받은적이있던환자가 15 명, 방사선치료를받은경우가 11명이었으나다른치료를전혀받지않고처음으로항암화학요법을시작한경우가거의 50% 에해당하는 75명이었다. 연구결과및고찰 1. 연구대상환자의특성 3. 각 regimen 별부작용종류와중증도별발생률 Table 3은 XP regimen을투여받은환자에게나타난부작용의중증도별발생률을나타낸것이다. 이 Table 1은대상환자총 157명의특성을나타내고있다. 나이분포는 17세이상, 80세이하로구성되어있었으며중간나이는 58세였다. 남녀성별비율은약 2:1로여성에비하여남성의비율이상대적으로높았다. 활동도 (performance status) 는대부분의환자 (129명, 82.2%) 가상대적으로양호한편에속하였다. 이러한것은입원치료가필요하지않은통원치료센타환자의특징을잘반영한다고볼수있다. 2. 연구대상환자의진단명분포 Table 2는연구대상환자들의주진단명의분포를 Table 1. Characteristics of study patients (n=157) Characteristics No. of patients (%) Age Median 58 years Range 17-80 years Sex Female 60 (38.2) Male 97 (61.8) Performance Status 0 26 (16.6) 1 103 (65.6) 2 7 (4.4) Unknown 21 (13.4) Table 2. Distribution of patients based on diagnosis and pretreatment (n=157) Diagnosis and pretreatment XP TC R-CHOP No. of patients (%) Diagnosis Non-Hodgkin s Lymphoma 53 53 (33.8) Lung cancer 46 46 (29.2) Gastric cancer 43 43 (27.4) Other (ovary, cervix, breast, MUO, malignant melanoma, thymic, epithelial) 1 14 15 (9.6) N=44 N=60 N=53 N=157 Pretreatment Surgical Operation 90( 57.3) Radiation 11 (7.0) Chemotherapy 15 (9.6) None 75 (47.8) - 153 -
JKSHP, VOL.29, NO.2 (2012) 표에서보는바와같이호중구감소증이나혈소판감소증과같은혈액학적부작용의경우전체환자가운데각각 95.4%, 81.8% 에서나타나대부분의환자에게나타나는부작용으로확인되었다. 또한호중구감소증의경우주로중증도 1-2의부작용이전체사이클의중반기에나타난것으로확인되었으며전체환자가운데약 1:1의비율로중증도 1-2와 3-4가발생하였다. 그러나혈소판감소증의경우에는 grade 3-4의부작용이사이클초반에나타났으며전체환자가운데거의대부분 (79.5%) 의중증도는 grade 1-2수준으로경미한수준으로발생하였다. 비혈액학적부작용의경우에서는 50% 이상의환자에서나타난부작용은오심, 식욕부진, 변비, 수족증후군및신경병증이었다. 이러한부작용의경우대부분의환자에게 grade 1-2 정도로상대적으로경미한정도의부작용이발생하였다. 또한 50% 미만으로나타난부작용은구내염, 설사및딸꾹질이었으며이역시발생한부작용의대부분이 grade1-2 정도로상대적으로경미한것으로확인되었다. 이는국내에서실시한이수정의임상연구에서 grade 3-4등급의호중구발생이전체환자 18명가운데 2명에서발생했고여타의부작용은발견하지못했다는보고와비교하면다소차이가있으며이러한차이는적응증과사용량의차이에기인하는것으로도해석될여지는있다 14). 또한본 regimen을사용한 Chua DT 등의연구에서보고된결과에의하면 grade 3-4 수준의부작용으로호중구감소증 (50%), 구토 (10%), 혈소판감소증 (9%), 오심 (7%) 이나타난것과도다소차이가있는것으로판단된다 15). 이외에도국내에서진행된여러연구결과와는부작용발생부분에대해서는차이를나타내고있는데연구의대부분은각적응증별유효성검정에방점을둔것과는달리부작용파악과약학적인관리를염두에둔본연구의목적성과는다소차이가있다는점에기인하는것으로보인다 16,17). Table 4는 TC regimen을투여받은환자에게나타난부작용의중증도별발생률을나타낸것이다. 본 regimen에서나타난부작용의경우혈액학적인부작용은전체환자가운데 50% 미만에서나타났으며주로 grade 1-2로상대적으로경미한수준이었고 Table 3. Common ADRs and severity with the XP Regimen (n=157) Grade (% of cycle) Grade (% of patients) Total Grade no. 1-2 3-4 1-2 3-4 Hematological ADR Neutropenia 52.7 18.2 47.7 47.7 95.4 Thrombocytopenia 43.2 0.5 79.5 2.3 81.8 Non-hematological ADR Nausea 39.5 0.9 79.5 4.5 84.1 Anorexia 15.5 0.0 56.8 4.5 84.1 Constipation 13.6 0.0 52.3 0.0 52.3 Hand-foot syndrome 22.3 0.0 50.0 0.0 50.0 Neuropathy 18.2 0.0 50.0 00 50.0 Stomatitis 17.3 0.5 45.5 2.3 47.7 Diarrhea 6.8 0.9 22.7 4.5 27.3 Hiccup 7.3 0.0 20.5 0.0 20.5 % of cycles: cycle no./total cycles % of patients: no. of patient in ADR/total patient number ADR (adverse drug reaction) - 154 -
손기호 : 통원치료센터단기항암요법환자의부작용양상및약사의중재활동효과 치료주기의초반부에집중하여나타났다. 또한비혈액학적인부작용의경우에는근육통이투여환자의 75.8% 에서나타났으며대부분의경우 grade 1-2 수준의경미한부작용이었다. 또한구내염이나설사의경우각각 9.7%, 12.9% 로상대적으 로적은환자에게그것도경미한수준의부작용이나타난것으로확인되었다. 이는고위험자궁경부암의수술후보조요법으로서의 paclitaxel과 carboplatin을사용한조현일등의연구에서나타난부작용에서, 전체 56주기중 22주기에서호중구감소증 Table 4. Common ADR and severity with the TC Regimen (n=60) Grade no. 1-2 3-4 1-2 3-4 Hematological ADR Neutropenia 11.17 2.2 37.1 9.7 46.8 Thrombocytopenia 15.0 0.0 41.9 0.0 41.9 Non-hematological ADR Nausea 25.6 0.0 54.8 0.0 54.8 Anorexia 11.7 0.0 38.7 0.0 38.7 Constipation 17.2 0.0 50.0 0.0 50.0 Myalgia 46.1 0.6 74.2 1.6 75.8 Neuropathy 27.8 0.6 48.4 1.6 50.0 Stomatitis 1.7 0.0 9.7 0.0 9.7 Diarrhea 3.9 0.0 12.9 0.0 12.9 % of cycles: cycle no./total cycles % of patients: no of patients with ADR/total patient number ADR (adverse drug reaction) Grade (% of cycle) Grade (% of patients) Total Table 5. Common ADR and severity with the R-CHOP Regimen (n=53) Grade (% of cycle) Grade (% of patients) Total Grade no. 1-2 3-4 1-2 3-4 Hematological ADR Neutropenia 20.8 24.9 18.9 54.7 73.6 Thrombocytopenia 18.9 0.4 39.6 1.9 41.5 Non-hematological ADR Nausea 17.7 0.0 39.6 0.0 39.6 Anorexia 4.5 0.0 13.0 0.0 13.0 Constipation 11.3 0.0 24.5 0.0 24.5 Myalgia 0.8 0.0 3.8 0.0 3.8 Neuropathy 22.3 24.9 18.9` 54.7 73.6 Stomatitis 12.5 0.8 31.5 3.7 35.2 Diarrhea 1.9 0.4 11.3 1.9 13.2 % of cycles: cycle no./total cycles % of patients: no of patient with ADR/total patient number ADR (adverse drug reaction) - 155 -
JKSHP, VOL.29, NO.2 (2012) 이발생했고이중에서 grade 3-4의중증도가상대적으로높은것들이각각 10주기와 5주기에나타났으며비혈액학적인부작용은대부분경미하였고주로말초신경증과위장관관련증상으로대체로미미하였다고결론짓는것과는약간의차이를보여주고있다 18). 또한양성우등이연구한결과에서 67세의노인에게복통과설사를동반한위막대장염을보고한것 19) 에비춰보면많은연구에서부작용의발생에대해서는상대적으로가볍게다루고있는편이다. Table 5는 R-CHOP regimen을투여받은환자에게나타난부작용의중증도별발생률을나타낸것이다. 본 regimen을투여받은환자의경우에는호중구감소증과신경병증의경우상대적으로높은수치인 73.6% 의환자에서나타났을뿐만아니라주로 grade 3-4의높은중증도의부작용이었다. 그러나오심, 식욕부진, 변비, 근육통, 구내염, 설사의경우에는모두상대적으로적은숫자의환자에게부작용이나타났고 Fig. 1 Neuropathy prevalence and severity in R-CHOP regimen cycles. 그것도상대적으로중증도가낮은 grade 1-2 수준의부작용이었다. 그중에서도신경병증의경우에는투여주기를반복함에따라중증도가그에비례하여증가하는경향을보여주었다 (Fig. 1). 이역시같은 regimen을사용한다른연구자의보고에서중증도높은호중구감소증을보고 20) 한것과중증의호흡기계합병증 21), 신경계부작용인왼쪽팔의통증, 안면편마비, 눈근육마비를보고한것 22) 과비교하면본연구에서는부작용의발생양상이훨씬다양하고발생율도높았다. 한편, 항암화학요법시에다빈도로발생하는부작용중의하나가오심, 구토이다. 이러한오심, 구토의부작용은치료학적인예후에도많은영향을미치기때문에대부분의표준항암요법에는오심, 구토를제어할약물을포함시켜두고있다. 본연구에서도 3가지의표준요법에오심, 구토를제어할약물을포함시켜두고있지만이것만으로는충분하지않은것으로타나났다. Table 6은각 regimen별로대상환자를나이 60세를기준으로전체치료주기를통해오심의발생유무를비율로파악한결과를보여주고있다. 예를들어, XP regimen에서는전체대상환자 44 명가운데총 84.1% 의환자에게오심부작용이발생했으며그중에서 60세이상의환자총 17명가운데 70.6% 의발생률이, 60세미만의환자총 27명가운데에서는 92.6% 의발생률을나타냈다. 또한 TC regimen의경우에는총 60명의환자가운데 54.8% 의발생률을보였으며그중에서 60세이상에서 52.6%, 60세미만에서 63.6% 가발생하였고, R- CHOP regimen의경우에는 60세이상에서 25.0%, 60세미만에서 43.2% 가발생한것으로나타났다. 비록60세미만군과이상군간의오심의부작용발 Table 6. Nausea prevalence between age groups (60 and <60) Regimen XP regimen (n=44) TC regimen (n=60) R-CHOP regimen (n=53) 60Y 70.6% (17) 52.6%( 38) 25.0% (16) 60Y< 92.6% (27) 63.6% (22) 43.2% (37) P value 0.089 0.306 0.412 %: nausea prevalence, (number of patients) - 156 -
손기호 : 통원치료센터단기항암요법환자의부작용양상및약사의중재활동효과 생율의차이가통계적인유의성은없었으나상대적으로 60세미만의환자군이 60세이상의환자군보다는오심의부작용발생률이높은경향을보여주었다. 이러한결과는낮은연령군의환자군에게는오심의부작용에대한좀더적극적인관리가필요함을나타내주고있다. 이상과같은결과는기존에보고된것과는많은차이를보여주고있다. 이러한차이는임상연구의경우에는동반질환을충분히배제한가운데서나온결과인것과는달리실제임상에서는여러가지동반질환을가지는환자가많기때문에그만큼부작용의발생가능성이높다는점을들수가있다 23). 또한항암화학요법의연구들에서는유효성에비해서부작용에대한환자들의불편감에대해서는상대적으로인식이낮은것과도무관하지않아보인다 24). 2. TC regimen 용표준치료지침 *Premedication D1 D1 D1 D1 D2-D3 Dexamethasone 20mg IV + D5W 50mL MIV - 1hr before Taxol, Avil 1A + D5W 50mL MIV 30mins before Taxol Ranitidine 50mg IV + D5W 50mL MIV 30mins before Taxol Ramosetron 1 Amp + D5W 50mL MIV (setron 계열에서다른약선택가능 ) Ramosetron 1 tab po qd 3. R-CHOP regimen 용표준치료지침 4. 약사에의한약학적중재효과항암화학요법의경우에는부작용이다빈도로발생하기때문에이를관리하기위해서통상적으로각 regimen별로표준치료지침을정해두고있다. Regimen별표준치료지침내용은각각다음과같다. 1. XP regimen 용표준치료지침 <Premedication>: D1 D1 D2-D3 Avil 1 A IVS and acetaminophen 1T po before Rituximab Tropisetron 1A + D5W 100mL MIV (setron 계열에서다른약선택가능 ) Aprepitant 125mg po (lorazepam 1mg IVS) Aprepitant 80mg qd D0 NS 1500mL IV overnight hydration D1 DNK2 1000mL IV over 2 hours,(x2, pre & post hydration (if Mg <WNL, mix MgSO4 1 amp) Aprepitant 125mg po 1hr before cisplatin Dexamethasone 10mg + D5W 50ml MIV Palonosetron 1Amp IVS (setron 계열에서다른약선택가능 ) 20% Mannitol 70mL IV full dripping, 30mins before cisplatin D2-D3 Aprepitant 80mg PO qd, D2-D4 Dexamethasone 8mg PO qd 이상과같은표준치료지침에의한전 후처치에도불구하고약사는환자와의 1:1 복약상담과정에서부작용등환자불편사항을발견하는경우가많다. 이러한경우를대비하여임상약사는다음과같은정해진범위내의처치약물을사용하여약학적인중재활동을하게된다. 통상적으로시행하는증상별중재약물은다음과같다. 오심 : Setron계약물, Metoclopramide / Lorazepam, Domperidone 딸꾹질 : Baclofen, Chlorpromazine 25-50mg 근육통 : 주로 Mypol(COPI), Cetamadol (R) 325mg/37.5mg - 157 -
JKSHP, VOL.29, NO.2 (2012) 구내염 : 가글제 ( 헥사메딘, 케어가글 ) 변비 : MgO, 듀파락시럽, Bisacodyl/Docusate sodium, 무타실등식욕부진 : 메게스트롤현탁액, 트레스탄 ( 메게스트롤사용불가환자 ) 신경병증 : 주로 Amitriptyline, Gabapentin 이외통증, 소화불량, 속쓰림등에대해서도적절한투약과생활습관조정과같은약학적인중재활동을함. Table 7은각부작용별발생한환자수와약사의중재로인하여호전된환자수를나타낸호전율을보여주고있다. 이표에서보는바와같이딸꾹질의경우에는대부분의환자 (80.8%) 에서증상개선을나타내었으나식욕부진, 오심, 신경병증및구내염의경우에는상대적으로 20% 미만의환자에게만증상개선을보였으며변비와근육통의경우에는 30% 대의증상개선을보여주었다. 이러한결과는기보고된결과보다는실제로발생되는부작용의종류와내용이훨씬많이그리고광범위하며이를완전히제어하여환자만족도를높이기위해서는좀더진일보된중재활동이필요함을나타내고있다 15-23). 결론서울에소재한한개의상급전문종합병원에서운영하고있는통원진료센타의단기항암치료실에서 3종류의병합항암화학요법을투여받은환자에게발생한부작용의유형과약사의중재활동으로인한호전율을조사하여다음과같은결과를얻었다. 1) 문헌보고에근거하여예측되는부작용의유형과중증도와비교하여실제로는훨씬더다양하고높은빈도의부작용이발생되었다. 2) 예측되는부작용에대비하여준비한표준치료지침과약학적인중재활동만으로는만족할만한부작용관리가되지않았다. 3) 약사의중재활동으로인해서딸꾹질의경우에는대부분의환자에서호전되었으나변비, 근육통, 식욕부진, 오심, 신경병증및구내염의경우에는모두 35% 미만의호전율을나타냈다. 이상과같은결과는비록의료현장과는사정이많이다르지만건설현장의재해율절감을위한개선방안연구에서제시한것을참고로할필요도있을것이다 25). 향후완성도높은부작용관리를위해서는부작용감소를위한제도적인뒷받침, 상시적으로위해요소에대한적극적인관리, 부작용에대한환자교육을통하여좀더부작용관리체계를적극적으로개선할필요가있다. 또한부작용의표준치료지침의지속적인갱신과더불어약사의중재활동이좀더광범위하고적극적인방향으로선회해야할필요성을제시하고있다 26). 나아가복약상담과정에서암환자의주요부작용에대한예방약복용의중요성과발생시대처법을적극적으로교육한다면, 환자들의불안감감소및삶의질향상에크게기여할수있을것으로생각된다. Table 7. Improvement rates of common ADRs by pharmacist s intervention Hiccup Constipation Myalgia Anorexia Nausea Neuropathy Stomatitis ADR Patient number 10 67 50 56 92 78 47 Improved Patient no. 8 22 16 11 15 6 3 Improvement rate (%) 80.0 32.8 32.0 19.6 16.3 7.7 6.4-158 -
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