TPN Pharmacy Newsletter August 2010 = 목차 = Ÿ TPN 제제 Ÿ Journal Review Ÿ 의약품안전성정보 Ÿ 의약품변경안내 TPN 이란일반적으로장관또는경구로섭취할수없거나섭취해서는안되는환자에게필요한영양소를소화관을거치지않고말초또는중심정맥을통해공급하는것으로아미노산, 포도당, 지방, 전해질등이함께혼합된수액을이용합니다. Ⅰ. TPN 의투여경로 Central TPN Peripheral TPN 투여기간 장기간 (1 주이상 ) 단기간 (1~2 주 ) 시작속도 2~3 일에걸쳐서서히증가시킴 원하는최대속도로시작 중단속도 1 일에걸쳐서서히감소후중단 Tapering 없이중단가능 Osmolarity 제한없음 < 900 mosm 장점 단점 필요한영양분을적은양의수액으로장기간공급가능 감염, 카테터에의한외상 투여가간편, 안전함 필요한영양분투여시많은양의수액필요, 2 주이내사용, 정맥염발생가능 Ⅱ. Osmolarity Nutrient Osmolarity (mosm / g) Nutrient Osmolarity (mosm / meq) 410-769 경기도고양시일산동구정발산로 111 번지국립암센터약제과 Tel. (031) 920-0217 Fax.(031) 920-0219 E-mail : nccph@ hanmail.net http://www.ncc.re.kr Amino acid 10 Sodium 2 Dextrose 5 Potassium 2 20% Lipid emulsion 0.71 (product dependent) Magnesium sulfate 1 - - Calcium gluconate 1.4 Pharmacy Newsletter Vol. 9. No. 8. 1 / 7
Ⅲ. Fluid 요구량 ⑴ Maintenance fluid = [ (body weight 20kg) x20 ] +1500 ml / day ⑵ Maintenance fluid 간단계산식 : 30-40 ml / kg / day Fluid 요구량을늘려야할때 Fever, Fistula, Diarrhea, NG suction Fluid 요구량을줄여야할때 Renal failure, Congestive heart failure, Cirrhotic ascites, Pulmonary disease Ⅳ. Monitoring ( 성인기준 ) Parameter Critically ill patients Stable patients Chemistry screen (Ca, Mg, LFTs, P) Electrolytes, BUN, creatinine 주 2-3 회 매일 주 1 회 주 1-2 회 Serum triglycerides 주 1 회주 1 회 CBC with differential 주 1 회주 1 회 PT, PTT 주 1 회주 1 회 Capillary glucose 일 3 회 (until consistently <200 mg/dl) 일 3 회 (until consistently <200 mg/dl) Weight 매일주 2-3 회 Intake and output 매일매일 Nitrogen balance 필요시필요시 Indirect calorimetry 필요시필요시 (BUN, blood urea nitrogen; CBC, complete blood count; LFT = liver function test; PT, prothrombin time; PTT, partial thromboplastin time) Pharmacy Newsletter Vol. 9. No. 8. 2 / 7
Ⅴ. 원내 TPN 제제 1. 아미노산제제 효능말초정맥용중심정맥용간장애용신장애용 - - 상품명 peri 40 peri 21 MCT peri Combi 48 70 Hepatamine 8% Nephramine 5.4% Cletamin 10.4% Cafsol 10% peri34 central 약품코드 NTR40 CMB21 NTRL60 CMBL34 CMBL40 NTR48 NTRL70 CMB50 CMBL58 HPT NPM PAME5 PAME25 volume 1000ml 1100ml 1875ml 1440ml 1000ml 1000ml 1250ml 1000ml 1450ml 500ml 250ml 500ml 250ml 가격 ( 원 ) 26,351 14,400 34,026 38,615 28,803 29,220 37,172 22,723 39,427 17,686 8,279 9,124 7,447 Na+(meq) 27 37.5 75 32 28.0 37.2 67 52.5 42 5 1.25 2.5 K+(meq) 15 25.0 45 24 24.0 25.0 47 25 36 - - - Mg2+(meq) 8.0 5.0 4.5 4 4.0 11.4 5.3 7.5 6 - - - Ca2+(meq) 5.0 4.5 4.5 2 3.6 7.2 5.3 6.8 5.4 - - - Cl-(mmol) 31.6 43.5 72 47 32.0 35.5 60 1.5 0.75 - Acetate(mmol) 19.5 47.0 60 39 60.0 22.9 60 31 11 30 Phosphate(mmol) 5.7 7.5 11.25 11 12.0 20.0 20 15 18 5 - - Zinc(mmol) - - 0.045 - - - 0.04 0.15 - - Sulfate(mmol) - - - 4 - - - 0.15 - - Glucose(g, 무수물 ) 80 120 120 97 160 300 180 250 232 - - - Total AA(g) 40 20.7 60 34 40 48 71.8 50 58 40 13.4 51.8 25 Total lipid(g) 75 51 40 50 58 mosmol/l 900 878 750 1470 2300 1545 Total calories 460 547 1433 1433 1200 1317 1475 1169 1740 160 54 208 Pharmacy Newsletter Vol. 9. No. 8. 3 / 7
상품명 peri 40 Branched amino acid ( 함유량 g) peri 21 MCT peri Combi peri34 central 48 70 Hepatamine 8% Nephramine 5.4% Cletamin L-isoleucine 2.34 1.48 3.51 1.73 2.40 2.82 4.11 2.8 3.48 4.4 1.4 2.8 1.73 L-leucine 3.13 1.93 4.69 2.30 2.92 3.76 5.48 6.25 4.23 5.5 2.2 6.25 2.28 L-valine 2.60 1.4 3.9 2.16 2.32 3.12 4.51 2.25 3.36 4.2 1.6 2.25 1.65 Aromatic amino acid ( 함유량 g) L-lysine 2.27 1.55 3.38 2.74 2.32 2.72 3.98 6.2 3.36 3.1 1.6 4.4 2.55 L-methionine 1.96 1.13 2.94 1.73 1.60 2.35 3.42 1.75 2.32 0.5 2.2 1.75 1.33 L-phenylalanine 3.51 1.2 5.27 2.30 2.24 4.21 6.15 4.68 3.25 0.5 2.2 4.675 1.4 L-threonine 1.82 0.85 2.74 1.73 1.68 2.18 3.18 3.25 2.44 2.25 1 3.25 1 L-tryptophan 0.57 0.33 0.86 0.58 0.72 0.68 1.00 0.65 1.04 0.33 0.5 0.65 0.38 L-histidine 1.25 0.60 1.88 2.02 1.92 1.50 2.19 3.0 2.78 1.2 0.625 3.0 0.7 L-arginine 2.70 2.03 4.05 3.46 4.60 3.24 4.73 3.95 6.67 3.0-3.95 2.38 L-alanine 4.85 1.5 7.28-8.28 5.82 8.49 3.1 12.0 3.85-3.125 1.78 L-proline 3.40 2.38 5.1 2.02 2.72 4.08 5.95 1.65 3.94 4.0-1.65 2.8 L-serine 3.00 1.25 4.5 1.35 2.0 3.6 5.25 1.1 2.9 2.5-1.1 1.48 Glycine 1.65-2.48 2.30-1.98 2.89 5.35 5.97 4.5-5.35 3.5 L-cysteine - 0.05 - - - - - 0.5 0.1 0.05 0.5 0.06 L-tyrosine - - - 0.07 0.16 - - 0.18 0.23 - - 0.175 L-aspartate 1.50-2.25 1.02-1.80 2.63 1.9 - - 1.9 L-glutamate 3.5-5.25 1.73-4.21 6.14 3.25 - - 3.25 비고 CMB21 NTR40 보다 AA 비해 고함량 고열량 에 CMBL34 보다 AA 고함량 Ca2+ 고함량 CMBL40 보다 AA 고함량 10.4% Cafsol 10% Pharmacy Newsletter Vol. 9. No. 8. 4 / 7
2. Lipid 제제 TPN 상품명 SMOFlipid 20% 250ml Intralipos 20% 250ml/ 10% 500ml 약품코드 ILF22 IL22 IL5 성분및함량 Purified soybean oil ( 정제대두유 ) 15g MCT (medium chain triglyceride) 15g Purified Olive oil ( 정제올리브유 ) 12.5g Purified Fish oil ( 정제어유 ) 7.5g 총 50g Purified soybean oil ( 정제대두유 ) 50g 열량 500 kcal 500 kcal ω-6:ω-3 ratio α-tocopherol 함량 2.5:1 7:1 Ideal for critically ill pts, intensive care pts, septic pts (4~2 : 1) (Not ideal for all pts) * ω-6 : 기인한 metabolit 가혈관수축, 혈전응고및전반적염증반응의증가에관련한면역반응을약화시킴 * ω-3 : 미세혈류를증진시키고세포면역반응의증강과염증반응을감소시킴 50mg 3.75mg 7.5mg Vit. E 는지방유제의과산화를방지하고환자의산화적스트레스를경감시키는기능을담당 (Vit.E 경정맥일일요구량 : 10~15mg/day) vitamin K 37.5~125 mcg 150 mcg 300mcg 가격 18,486 원 12,454 원 12,092 원 비고 소아에대한안전성 / 유효성없음당뇨, 신부전환자에대한임상자료부족 NCC : 열량보충을위해서는주로 20% 250ml 격일투여를추천하고있음 3.Vitamin 제제 4. Trace elements 제제 : Furtman 2ml /vial ( 상용량 : 0.5~1ml/day) 상품명 엠브이에취주 타미풀주 판비콤프주 원내코드 MVH TMPI BI Ascorbic acid 500 mg 100 mg Vitamin A 10,000 IU 3300 IU Vitamin D 1,000 IU 200 IU Vitamin E 5 IU 10 IU Thiamin (B1) 50 mg 3.81 mg 10 mg Riboflavin (B2) 12.7 mg 3.6 mg 5.53 mg Pyridoxine (B6) 15 mg 4.86 mg 4 mg Cyanocobalamin (B12) Pantothenate (Dexpanthenol) - 5 mcg 8 mcg 25 mg 15 mg 5.17 mg Biotin - 60 mcg 500 mcg Folic acid - 400 mcg Nicotinamide(B3) 100 mg 40 mg 40 mg 가격 ( 원 ) 1,422 2,160 171 비고엽산제추가삐콤헥사대체 [Reference] 추천용량 ( 성인기준 ) (mg/day) 함량 (mg/ml) Zn 2.5-5 5 부족시나타날수있는증상 Anorexia, immune deficiency, diarrhea Cu 0.3-0.5 1 Anemia, osteoporosis Mn 0.06-0.1 0.5 Growth delay Cr 0.01-0.015 0.01 1. 임상영양학제 2 판 2. Pharmacotherapy 4 th Glucose intolence, peripheral neuritis 3. ASPEN Nutrition Support Practice Manual 2nd Edition 4. 제품설명서 < 임상약무계정은경약사 > Pharmacy Newsletter Vol. 9. No. 8. 5 / 7
Journal Review Oral Bisphosphonate Use & Breast cancer incidence in postmenopausal women 폐경후여성에서 oral bisphosponate 와 invasive breast ca 의 incidence 를보려고한연구로그결과평균 7.8 년의 follow up 기간을통해 alendronate 등의 bisphosphonate 제제을복용한군에서 [HR], 0.68; 95% CI, 0.52 to 0.88; P <.01 로 invasive breast ca 발생율을유의하게낮추었다. Purpose Emerging clinical evidence suggests intravenous bisphosphonates may inhibit breast cancer while oral bisphosphonates have received limited evaluation regarding breast cancer influence. Patients & Methods The association between oral bisphosphonate use and invasive breast cancer was examined in postmenopausal women enrolled onto the Women's Health Initiative (WHI). We compared a published hip fracture prediction model, which did not incorporate bone mineral density (BMD), with total hip BMD in 10,418 WHI participants who had both determinations. To adjust for potential BMD difference based on bisphosphonate use, the hip fracture prediction score was included in multivariant analyses as a BMD surrogate. Results Of the 154,768 participants, 2,816 were oral bisphosphonate users at entry (90% alendronate, 10% etidronate). As calculated hip fracture risk score was significantly associated with both BMD (regression line = 0.79 to 0.0478 log predicted fracture; P <.001; r = 0.43) and breast cancer incidence (P =.03), this variable was incorporated into regression analyses to adjust for BMD difference between users and nonusers of bisphopshonate. After 7.8 mean years of follow-up (standard deviation, 1.7), invasive breast cancer incidence was lower in bisphosphonate users (hazard ratio [HR], 0.68; 95% CI, 0.52 to 0.88; P <.01) as was incidence of estrogen receptor (ER) positive invasive cancers (HR, 0.70; 95% CI, 0.52 to 0.94, P =.02). A similar but not significant trend was seen for ER-negative invasive cancers. The incidence of ductal carcinoma in situ was higher in bisphosphonate users (HR, 1.58; 95% CI, 1.08 to 2.31; P =.02). Conclusions Oral bisphosphonate use was associated with significantly lower invasive breast cancer incidence, suggesting bisphosphonates may have inhibiting effects on breast cancer. JCO 2010;28(22):3582-3590 Hepatitis B virus infection and risk of non-hodgkin lymphoma in South korea : a cohort study B 형간염감염과 NHL 의 risk 를확인하는한국에서진행된 cohort study 로 HBsAg(+) 군이 HBsAg(-) 에비해높은 NHL 발생율을보였다 (incidence 19.4 vs 12.3per 100,000 person.years;hr=1.74 95%Cl 1.45~2.09);P=.051), NHLd 의 subtype 중에서도 foliicular,t-cell NHL 과는연관이없고 DLBL 등의 risk 를증가시켰다. Background Hepatitis B virus (HBV) infection is common throughout Asia and Africa. Whether chronic HBV infection increases risk of non- Hodgkin lymphoma (NHL) is unclear. We aimed to assess the association between chronic HBV infection and subsequent development of NHL in a South Korean cohort. Methods The Korean Cancer Prevention Study is a cohort study of South Korean workers and their dependants enrolled during 1992 95. From this cohort, we excluded individuals who died before Jan 1, 1993, who had cancer at or before the initial visit, who had missing information about weight, height, alanine aminotransferase or aspartate aminotransferase concentrations, or alcohol use, or who had evidence of HIV or HCV infection. Of 1 284 586 eligible participants, 603 585 had baseline data for serum hepatitis B surface antigen (HBsAg) status and were included in our study. We regarded HBsAg positivity at baseline as evidence of chronic HBV infection. Participants were followed up from baseline until Dec 31, 2006. We used national databases of inpatient and outpatient diagnoses and mortality records to ascertain occurrence of haematological malignancies. We assessed incidence of NHL overall and of NHL subtypes, malignant immunoproliferation, Hodgkin's lymphoma, multiple myeloma, and various leukaemias. We used Cox regression to evaluate associations with HBsAg status, adjusting for sex, age, and enrolment year. Findings 53 045 (9%) of 603 585 participants tested positive for HBsAg at baseline. Subsequently, 133 HBsAg-positive and 905 HBsAg-negative individuals developed NHL. HBsAg-positive participants had an increased risk of NHL overall compared with those who were HBsAg-negative (incidence 19 4 vs 12 3 per 100 000 person-years; hazard ratio [HR] 1 74, 95% CI 1 45 2 09, adjusted for sex, age at baseline, and enrolment year). Among NHL subtypes, HBsAg positivity was associated with increased risk of diffuse large B-cell lymphoma (n=325, incidence 6 86 vs 3 79 per 100 000 person-years; adjusted HR 2 01, 1 48 2 75) and other or unknown subtypes (n=591, incidence 10 5 vs 7 07 per 100 000 personyears; adjusted HR 1 65, 1 29 2 11), compared with HBsAg negativity. Increased risk was also recorded for malignant immunoproliferation (n=14, incidence 0 44 vs 0 15 per 100 000 person-years; adjusted HR 3 79, 1 05 13 7). Risk of these malignancies was consistently raised in HBsAg-positive participants throughout 14 years of follow-up. HBsAg positivity was not associated with follicular or T-cell NHL, Hodgkin's lymphoma, multiple myeloma, or various leukaemias. The Lancet oncology vol11 issue8 august 2010. Pharmacy Newsletter Vol. 9. No. 8. 6 / 7
의약품안전성정보 Estradiol 외용제제 미국 FDA 에서는안면홍조등폐경에따르는에스트로겐결핍증상에사용되는에스트라디올 (estradiol) 함유국소외용제에대한검토를진행중이라고발표하면서, 어린이가 에스트라디올성분에노출되지않도록의약품이도포된피부부위에어린이가접촉하지 않도록할것 과접촉이불가피한경우라면의약품을도포한부위를가릴수있는옷을 입도록할것 을권고함에따라식약청에서안전성서한을발표하였습니다. 의약품관리과 - 5732 < 의료전문가를위한정보사항 > 어린이의의도치않은에스트로겐노출은여아의조발사춘기와유방발달및남아의여성형유방의증상및징후를야기할수있음에주의할것. Lamotrigine 정제 미국 FDA 에서는간질치료제인라모트리진제제에대하여, 드물게 무균수막염 과연관이있을수있다고결론내리고제품라벨의경고및주의항에동사항을반영하여개정중임을알려온바식약청에서도해당제품의라벨개정조치등의안전성서한을발표하였습니다. 의약품관리과 - 6062 < 의료전문가를위한정보사항 > 만약환자에게수막염이의심되면다른수막염의원인이있는지도평가하고필요에따라치료해야하고다른분명한수막염의원인이확인되지않는다면라모트리진치료를중단할것 의약품변경안내 성분 ( 함량 ) 효능 내용 Avandaryl (4/4mg tab) 혈당강하제 원내사용량부진으로코드종료, 원외만처방가능 Kanamycin (1g) inj & oral 항생제 제조사원료수입중단으로장기간품절예정 60 1875mL TPN 제제 Copy 품인 MCT peri 1875mL( 중외제약 ) 로변경 Anastrozole korea (1mg/tab) 항암호르몬제 보령제약아나스토도입 ( 원내외처방가능 ) Docetaxel korea (20,80mg/vial) 항암제동아제약모노탁셀도입 Letrozole korea (10mg/tab) 항암호르몬제신풍제약브레트라도입 ( 원내외처방가능 ) 오리지날약제코드별도운영 Adefovir korea (10mg/tab) 항바이러스제부광약품아데포비어도입 ( 원내외처방가능 ) 발행인 : 김영주편집인 : 정혜진, 김지회, 정은경, 김주영, 김혜원, 최예지발행일 : 2010 년 8 월 19 일 Pharmacy Newsletter Vol. 9. No. 8. 7 / 7