목적 : 지방공사 강남병원 순환기 내과에서 추적 검사 받는 고지혈중 환자 107명을 대상으로 아토바스타틴 저용량인 5mg과 10mg 사용시의 콜레스테롤 저하 효과, 부작용 등을 조사하였다. 방법 : NCEP guideline에 따라 약물 치료가 필요한 환자등 LDL-C 농도가 130mg/dL이상이면서 TG농도가 400mg/dL이하인 고콜레스테롤혈증 환자를 대상으로 5mg, 10mg 투여군으로 나누어 6개월 후의 지질 농도를 측정, 비교 분석하였다. 부작용 발생 여부에 대하여 매월 정기적 검진, 혈액 검사 등을 시행하였다. 2001년 3월부터 2003년 1월까지의 114 명중 107명이 최종적으로 연구대상에 포함되었다. 결과 : 남녀 비는 29:78이었고 전체 대상군중 16%에서 관상동맥 질환이, 고혈압이 84%에서, 당뇨병이 22%에서 있었다. 46명이 아토바스타틴 5mg, 61명이 10mg을 투여하였다. 각 그룹모두 6개월 후의 지질치는 HDL-C을 제외하고는 기저치에 비하여 감소하였다(p<0.05). 용량간의 지질치에 대한 비교는 차이가 없었다. 각 용량의 동등한 지질 감소 효과를 고려하면 NCEP guideline 목표 달성 정도는 비슷하다고 할 수 있겠다. 부작용은 모두 4명에게서 관찰되었는데 그 중 1예는 근육통이 심해 약물 투여를 중단하였다. 나머지 3예는 부작용이 경미해 약물 투여를 계속하였다. 5mg용량이 안전성에 대하여 우수하였다(p=0.04). 결론 : 아토바스타틴 5mg, 10mg 모두 LDL-C을 저하시켜 관상동맥 질환을 예방하는데 효과적이었다. 관상동맥 질환에 대한 NCEP 10-year risk가 10% 미만인 군에서는, 부작용과 지질 저하에 관한 동등한 효과를 고려할 때 5mg이 초기 용량으로 추천될 수 있겠고 10%이상인 군에서는 20mg이상을 아토바스타틴의 초기 용량으로 추천할 수 있겠다.

Background : Cefepime is a broad spectrum cephalosporin that is used for various pathogens including Pseudomonas aeruginosa. Its dosing regimen in Korea has been confined to 2 g q 12 h due to the reimbursement guidelines set for budget containment. To find out scientific guideline for cefepime dosage in Korean patients, knowledge on its population pharmacokinetics is a useful reference. Methods : We recruited 51 febrile neutropenic patients with hematologic malignancy. For the control of their infections, cefepime was given together with other antibiotics. Peak (1-3 h after dosing) and trough (around 6 h after dosing) blood samples per patients were taken for the mixed effect modeling analysis using NONMEM Ver. V. Simulation based upon the population parameters was performed and 500 patients data made up thereafter were tested for the time over MIC (TOM) 2, 4, 8 mg/L. Results : CL was proportional to CLcr, but Vd was not explained by any of the covariates. At the MIC of 2 mg/L, TOM was greater than 40% of dosing interval in all simulated patients. At the MIC of 4 and 8 mg/L, 92% and 67% of the simulated patients had TOM greater than 40% of dosing interval respectively. Discussion : The present study is the first report of population pharmacokinetics of cefepime in febrile neutropenic patients. We expect that this result will be used as a fundamental data for the rational pharmacotherapy of high-cost antibiotics in Korea.

Background : Rosiglitazone is a novel thiazolinedione anti-diabetic drug and metabolized by cytochrome P450 2C8. A number of studies have evaluated the pharmacokinetic profiles of rosiglitazone in different ethnic groups but there is no available data for Korean subjects. Methods : Nine healthy Korean male subjects were treated 8 mg rosiglitazone orally. Plasma rosiglitazone concentrations were measured using high performance liquid chromatography and pharmacokinetic analysis was done using non-compartmental method. Results : Pharmacokinetic variables of rosiglitazone in Koreans healthy subjects are as follows: ${C_{max},\;535.6\;{\pm}\;123.9 \;ng/mL;}$ elimination half life, ${3.9\;{\pm}\;0.3h;\;AUC_{0-inf},\;2886.2 \;{\pm}\;471.8\;ng{\cdot}h/mL,}$ oral clearance, $2.8\;{\pm}\;0.5 L/h$. The variation of pharmacokinetic variables was less than 20% except $C_{max}\;and\;T_{max}$. Conclusion: This study showed that Korean showed similar pharmacokinetic characteristics to Caucasians.

항암화학요법을 시행받는 고형암 환자에서 류코그린$^{\circledR}$은 기존에 임상에서 사용되고 있는 대조약과 비교하여 호중구감소증의 예방률, 기간, 최저치 면에서 효능이 다르지 않았으며 시험약과 관련된 이상반응은 대조약과 비슷하고 심각하지 않았다.

Background : Candesartan is a long-acting. selective angiotensin II type 1 receptor blocker. It is administered orally as the inactive prodrug candesartan cilexetil (CC) which is rapidly and completely converted to candesartan during gastrointestinal absorption. The objective of this study was to confirm antihypertensive efficacy and safety of CC through comparing with enalapril maleate (EM) in mild to moderate essential hypertensive patients. Methods : This study was an two centers, randomized, rouble-blind, non-inferiority study of once-daily 8mg CC versus 10mng EM, including 78 (age, 32 to 72 years) mild to moderate essential hypertensives (mean sitting diastolic blood pressure (MSiDBP), $95{\sim}114mmHg$) for 8weeks. After 4 weeks study period, drugs were eventually increased to 16mg and 20mg in non-responders who were defined as MSiDBP was equal to or greater than 90mmHg. The reduction of trough MSiDBP, side effects and laboratory findings were compared between CC and EM at the end of this study. Results : In the 66 patients evaluable for intention to treat analysis, at the end of 8 weeks of treatment, reduction of MSiDBP were similar in both drugs ($14.4{\pm}7.7mmHg$ for CC, $10.2{\pm}9.8mmHg$ for EM, p=0.059). There was no significant difference between the two drugs in the systolic blood pressure reduction, blood pressure normalizing rate, number of rose escalation patients. Cough significantly less occurred in CC group but other safety profiles were comparable in both groups. Conclusion: The antihypertensive efficacy, safety and tolerability of once-daily administration of CC are not inferior to those of EM in essential hypertensive patients.