• 한국임상약학회지
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• 제22권4호
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• pp.316-323
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• 2012

미숙아는 단백질 대사 속도가 빠르기 때문에 성장이 충분히 이루어질 수 있도록 ASPEN 가이드라인에서는 아미노산 초기용량을 1-2 g/kg/day로 투여하도록 권장하고 있다. 또한 최근 여러 연구에서 출생초기 고용량 (1.5-4 g/kg/day) 아미노산 투여에 대해 보고하고 있다. 이를 근거로 하여 삼성서울병원 신생아 중환자실에서도 2009년 6월부터 아미노산 초기용량을 0.5 g/kg/day에서 1.5~2 g/kg/day으로 증량하여 투여하고 있다. 본 연구에서는 신생아 중환자실에서 정맥영양요법을 받은 미숙아를 대상으로 고용량 아미노산 공급 효과를 평가하고자 하였다. 2009년 6월 기준으로 출생 후 48시간 이내에 0.5 g/kg/day로 아미노산을 투여 받은 저용량 환아군(38명: 대조군)과 1.5~2 g/kg/day로 투여 받은 고용량 환아군(38명: 시험군)의 전자의무기록을 후향적으로 검토하였다. 고용량 아미노산 공급 효과를 체중증가량 및 총 정맥영양기간, 경구 및 경장 영양 시작 시기, 재원기간으로 평가하였고, 안전성 평가를 위해 혈액화학검사 및 합병증을 조사하였다. 또한 두 군의 인구학적 및 주산기 인자, 영양 공급량 등에 대해 조사하였다. 두 군의 인구학적 및 주산기 인자는 재태기간에서만 차이를 보였으며, 시험군에서 재태기간이 길었다(p < 0.05). 초기 아미노산 용량만이 생후 28일간 일평균 체중증가량에 영향을 미치는 인자였으며 시험군의 일평균 체중증가량이 대조군보다 유의하게 큰 것으로 나타났다($12.6{\pm}4.5$ g/day vs $9.8{\pm}4.5$ g/day, p < 0.05). 목표 체중증가량에 도달한 비율도 시험군이 높았다(65.8% vs 47.4%). 총 공급열량, 총 정맥영양 공급 기간과 경구 및 경장 영양 시작 시기는 두 군간 차이가 없었으나 시험군에서 목표열량 도달시간, 신생아 중환자실 재원기간이 단축되었다(p < 0.05). 혈액화학검사 결과 및 대사성 산증, 호흡곤란증후군, 괴사성장염 발생은 두 군간 차이가 없었으며 고혈당 및 감염, 기관지폐이형증, 뇌실내출혈 발생률은 대조군에서 유의하게 높았다(p < 0.05). 연구 결과, 미숙아에서 출생 초기 고용량 아미노산 공급은 혈액화학검사 이상이나 합병증 없이 체중증가와 재원기간 감소에 효과가 있음을 확인하였다. 따라서 미숙아에 대한 출생초기 영양지원으로 1.5~2 g/kg/day 아미노산 공급은 안전하고 효과적이라고 사료된다.

• 한국임상약학회지
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• 제22권3호
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• pp.251-259
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• 2012

Ulcerative colitis (UC) is characterized by a life-long chronic course with remissions and exacerbations. Use of biological therapies may reduce or delay the surgical procedures in patients with UC. The aim of this study was to determine the impact of infliximab (IFX) use on the rate of remission, surgical interventions, and the effect on quality of life in patients with moderate to severe UC. Literature was searched for studies that investigated the efficacy of IFX on the rate of remission, colectomy and quality of life (QoL) between January 1990 and June 2012 at MEDLINE, January 1988 and June 2012 at EMbase and others. Eleven trials were included in the meta-analysis; divided into placebo controlled 8 trials and intravenous corticosteroid controlled group 3 trials. In comparison to placebo control groups, patients who received IFX had an odds ratio (OR) of 3.712 (95% CI: 2.714, 5.079) for the short-term clinical remission, and 3.053 (95% CI: 2.044, 4.559) for the rate of long-term remission. In colectomy rate and quality of life (QoL), odds ratio were 0.566(95% CI: 0.387, 0.827) and 0.658 (0.505, 0.811) respectively. Any adverse reactions including infections, infusion reaction, rash and arthralgia were equivalent in both groups. Compared with intravenous corticosteroid controlled group, patients who received IFX had lower remission rate with short-term odds ratio 0.227 (95% CI: 0.033, 1.556) and long-term odds ratio 1.054 (95% CI: 0.317, 3.502) respectively. However, statistical significance was not showed with both two analyses. The higher adverse drug reaction (ADR) rates were occurred in the corticosteroid controlled groups. 73.3% of patients treated corticosteroid reported Cushing-like syndrome with moon face. In conclusion, IFX does increase remission rate and decrease the rate of colectomy in patients with UC without elevating any adverse reactions significantly. IFX also improves QoL in moderate to severe UC patients. It would not exceed the efficacy of intravenous corticosteroid, whereas intravenous corticosteroid also reported high rate of adverse reactions.

• 한국임상약학회지
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• 제22권3호
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• pp.239-250
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• 2012

In recent years, national health insurance(NHI) coverage had been expanded gradually for cancer as a severe disease requiring high level of medical expenditure, to reduce patient's financial burden. But, subjective burdens level for out-of-pocket(OOP) money expense are still considerable owing to high medical cost and decent numbers of services not covered by benefit plan. This study aimed to investigate OOP medical expenditures and identify factors influencing subjective financial burden in cancer patients. A 28-items questionnaire for self-reporting by responders was designed to satisfy study goal and finalized following by one pilot study and experts' verification process. Subjects were enrolled during July to October 2010 through regular meetings organized by five patient or patient-advocacy groups had acknowledged the study purpose. Subjects who aged 20 or more, have histories of cancer diagnosis and anticancer drug use, and voluntarily agreed to participate in this study were recruited. Total 107 subjects included in the analysis have cancer lesions in breast, colon, kidney, liver or stomach at the stages from I to IV. Approximately 73% of them has passed less than 5 years since cancer diagnosis. For the OOP medical expenditure regarding cancer, less 6 million won was in 31%, 6-15 million won in 35% and more than 15 million won in 28% of responders, and more than half responders(58%) felt financial burden subjectively. 63% of responders had subscribed commercial insurances, resulting in money receipts of more than 10 million won since cancer diagnoses in 76% of responders. Logistic regression results showed significant differences in subjective OOP financial burden level depending on gender, household income level, benefit type, commercial insurance money receipt degree, year cancer diagnosed, cancer lesion, therapy type, duration of anticancer drug use, drug listing in national formulary, total OOP medical expenditure and total OOP anticancer drug expense. They had mixed feelings both wishes to expand NHI coverage to reduce financial burden(70%) and no willingness to increase premium(59%). This result suggested that NHI might direct future strategies to reduce absolute total OOP medical cost and expand benefit plan coverage in higher burden groups in particular.

• 한국임상약학회지
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• 제22권3호
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• pp.220-227
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• 2012

Kidney and liver are the major organs of metabolism and excretion of drugs. Renal and Hepatic impairment may affect the pharmacokinetics/pharmacodynamics and the safety of drugs. Adjusting the dosage based on organ function is the essential role of pharmacists. However, differences have been noted on the recommended dosage among the literatures. We compared and analyzed the recommendations of 4 literature sources which are commonly used for dosage adjustment. From April, 2011 to August, 2011, we selected data on recommendations for dosage adjustment for impaired renal and hepatic function of 100 drugs through a protocol. We analyzed the definition terms of renal and hepatic impairment, recommendations for dosage adjustment, evidenced references in four literature sources: Korean National Formulary (KNF), American Hospital Formulary System Drug Information (AHFS), Micromedex (MM) and Drug Prescribing of Renal Failure (DPRF). We further examined the data homogeneity by comparing how drugs that required no adjustment according to one source were categorized by the other. Sources use different definition terms among themselves except DRPF. Presence or absence of evidenced references about renal/hepatic functional states are KNF (0%/0%), AHFS (78%/62.6%), MM (87.5%/65.6%) and DPRF (93.2%/no recommendation) respectively. Recommendations of specific dosage and dosing interval are KNF (24%/13%), AHFS (39.6%/12.1%), MM (50%/17.7%), and DPRF (55.4%/no recommendation) respectively. Regarding the data homogeneity, the differences were remarkable. Drugs with no adjustment according to AHFS were categorized to be adjusted/ contraindicated by KNF, MM, DPRF and the values were (44%/5.6%), (22%/0%), and (36%/0%) in renal function, (39%/6.5%), (19%/3.2%), and (no recommendation/no recommendation) in hepatic function respectively. Our study shows remarkable definite variation in definitions and recommendations about definition terms, information of dosage and interval, presence or absence of evidenced references. Especially for KNF, quantitative recommendations on dosages and dosing intervals should be made in the near future. To maximize the drug effect and safety and to minimize the heterogeneity of the literature sources, reviewing at least two sources are suggested when recommending the proper dosage adjustment based on organ function.

• 한국임상약학회지
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• 제22권4호
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• pp.330-339
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• 2012

Background : Hypertension is treated with both lifestyle modification and pharmacotherapy. The Seventh Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7), published in 2003, provides a streamlined management approach to hypertension for the primary care physician. The JNC-7 is the gold standard also in Korea. According to the JNC-7, special therapeutic considerations are recommended for high-risk individuals with compelling indications. The presence of compelling indications in any given patient should be considered when selecting specific pharmacotherapy to treat hypertension. However, in patients with compelling indications, it is unknown that hepatotoxicity is caused by Calcium Channel Blocker (CCB), one of 1st anti-hypertensive drugs. Now, the CCB is the most used 1st anti-hypertensive drug in Korea Therefore, we evaluated the changes in blood liver function parameters (ALT, AST, Total bilirubin, serum albumin) for the study group. Methods : We randomly collected and retrospectively analyzed Electronic Medical Record data (n=28,788) of patients, and who took calcium channel blockers(non-dihydropyridines; diltiazem, verapamil, dihydropyridines; amlodipine, barnidipine, benidipine, clinidipine, efonidipine, felodipine, isradipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine), with having liver function tests (LFTs) from July 1st 2009 to June 30th 2010 at the Seoul National University Hospital in Korea. Control groups are two antihypertensive agents: RAS blockade (ARB; candesartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, ACE-I; cilazapril, enalapril, fosinopril, imidapril, perindopril, ramipril) and, Diuretics (loop; furosemide, torsemide, thiazide; hydrochlorothiazide[HCTZ], indapamide). Patients not having LFT results at these three standard points of time(baseline, during, medication, and after finishing medication) were excluded. The collected data were analyzed by using the SPSS (Version12.0) and Microsoft Excel (Version2007). Results : 711 patients who were treated CCB (297), RAS blockade (232) or Diuretics (182) monotherapy were selected for the study. In selected patients, liver damage degree(changes of each LFTs value) was higher in diuretics group than other groups, followed by RAS blockade and CCB. In diuretics group's was loop-diuretics group was higher than thiazide-diuretics group. In CCB group, Nondihydropyridine-CCB's damage degree was higher than Dihydropyrine-CCB's that. Conclusions : Despite the limitations due to the retrospective study, among patients with abnormal LFTs, the use of CCBs led to a less liver damage than other 1st anti-hypertensive agents. It can be recommended CCBs as one of the initial treatments of hypertension in patients with liver disease.

• 한국임상약학회지
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• 제22권4호
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• pp.340-346
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• 2012

Background: Amphotericin B is a mainstay in the treatment of many systemic fungal infections due to its wide antifungal spectrum and low incidence of resistance. However, the use of amphotericin B is limited by its nephrotoxicity. Objectives: The objective of this study was to evaluate the incidence and risk factors of renal adverse drug reactions (ADRs) of conventional amphotericin B (Fungizone$^{(R)}$). In addition, we compared the changes of serum creatinine (SCr) between patients who remained conventional amphotericin B and patients who were switched to liposomal amphotericin B after occurrence of renal adverse reactions. Methods: Adult hospitalized patients who reported renal adverse reactions caused by conventional amphotericin B from January 2011 to July 2012 at pharmacovigilance center in Yonsei University Healthcare System included in this study. ADRs scored as 'doubtful' in Naranjo probability ADR scale were excluded. We retrospectively analyzed patients' basic clinical characteristics, concurrent diseases or nephrotoxic drugs in order to find variables that can correlate with occurrence of renal ADRs. Changes in SCr were compared between conventional amphotericin B group and liposomal amphotericin B group. Results: A total of 231 ADRs after administration of conventional amphotericin B in 75 patients were reported to pharmacovigilance center and assessed their severities as 'possible', 'probable', or 'definite'. Renal adverse reaction was the most common ADR with incidence rate of 42% (96 of 231 ADRs). Mean change in SCr from baseline was 0.26 mg/dL (change % 37.8) and statistically significant (p=0.000). Simple correlations analysis revealed that the number of concurrent diseases and number of nephrotoxic drugs were positively correlated with changes in SCr, but these results were not statistically significant. Among 43 patients who remained amphotericin B after occurrence of renal ADRs, 27 patients was administered conventional amphotericin B and 16 patients changed to liposomal amphotericin B. Mean change in SCr in amphotericin B group was 0.23 mg/dL (32.75%), whereas mean change in SCr in liposomal amphotericin B group were -0.28 mg/dL (19.38%) and difference between two groups was statistically significant (p=0.003). The numbers of patient with SCr elevation more than 30% were 9 (33.3%) in amphotericin B group and 2 (12.5%) in liposomal amphotericin B group (Odd Ratio=3.50, 95% Confidence Interval 0.65-18.85; p=0.130). Conclusion: An analysis of ADRs due to amphotericin B administration revealed significant mean changes in SCr from baseline. Switching to liposomal amphotericin B showed significant decrease in SCr compared with conventional amphotericin B.

• 한국임상약학회지
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• 제22권4호
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• pp.304-315
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• 2012

Today, suicide by self-poisoning of prescribed or non-prescribed drugs on purpose has been increasing and is a major cause of mortality. It is very important to treat promptly and properly for saving the lives from those suicides. There is neither an organization such as poison control center nor measurement in S. Korea, though. The object of this study was to evaluate information of frequently used substances for suicide attempt in S. Korea. Our results also can provide healthcare provider including pharmacists and doctors, etc and contribute to increasing health and welfare for Korean. From June $1^{st}$ 2006 to April $30^{th}$ 2012, we retrospectively studied patients visiting emergency room due to suicide attempt. We collected information of underlying disease, history of past medical condition and suicide attempt, ingredient and getting route of ingesting substances, emergency treatment, and outcome by reviewing electronic medical record. We also evaluated actual treatment of self-poisoning and made guide information about antidote medication for S. Korean healthcare provider. Among total 242 cases of suicidal attempts, cases ingesting substances including prescription, non-prescription drugs and agricultural chemicals were 86.4%. The most frequently used drugs for suicide attempt were sedatives-hypnotics (53.6%), followed by analgesics (16.7%) and antidepressants (12.4%). Analgesics including acetaminophen and aspirin were most in teenagers but sedatives-hypnotics including benzodiazepines, non-benzodiazepine (zolpidem) and antihistamine were most in other ages including elderly people. Most frequently used antidote was activated charcoal (62.7%) and specific antidotes for some substances (acetaminophen, aspirin, agricultural chemicals) were also treated properly, accompanying with medication for supportive care. In conclusion, the most used substances for suicide attempt were sedatives-hypnotics and treatments for self-poisoning in emergency room were appropriate based on existing references. Therefore, information of frequently used substances and antidote reflecting these results will be useful for South Korean healthcare provider.

• 한국임상약학회지
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• 제26권3호
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• pp.213-219
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• 2016

Objective: Although guideline recommends beta blockers (BBs) as first line antianginal agent and calcium channel blockers (CCBs) as alternatives after percutaneous coronary intervention (PCI), the prescription patterns in real practice are not in accordance with the guideline. We aimed to investigate the prescribing patterns of primary antianginal drug and relating factors in patients who underwent PCI. Methods: Patients who have undergone PCI without myocardial infarction (MI) from November 2012 to June 2014 and followed up at least one year in a tertiary teaching hospital were included. Prescribing patterns of primary antianginal drug before, at the time of, and one year after PCI were described. Factors affecting drug selection, and their relationship with incidence of clinical outcomes defined as MI and repeated PCI, unscheduled admission or visit related with heart problem were analyzed with multivariate logistic regression. Results: A total of 506 patients were included and as primary antianginal drugs, BB, CCB, and both were prescribed in 32.2%, 24.5%, and 17.8% of patients, respectively. Also, neither BB nor CCB was prescribed at the time of PCI in 25.5% of patients. Compared with BB, CCBs were more likely prescribed in patients who had hypertension (Odds Ratio, OR 2.18, 95% confidence interval, CI 1.16-4.07), use of same class before PCI (OR 7.18, 3.37-15.2) and concomitant angiotensin receptor blocker (ARB) use (OR, 1.92, 95% CI 1.10-3.33). Incidence of clinical outcomes were not significantly greater in patients who prescribed CCB compared with BB at the time of PCI (aOR 1.32, CI 0.65-2.68). Conclusion: This study demonstrated that half of the patients who underwent PCI were prescribed BB. CCB were favored in patients with hypertension, use of same class before PCI, and concomitant ARB use. Significant difference in clinical outcome was not observed between BB and CCB selection as primary antianginal drug.

• 한국임상약학회지
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• 제26권3호
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• pp.201-206
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• 2016

Objective: Direct current cardioversion for atrial fibrillation could be associated with the risk of thromboembolic events. Anticoagulation therapy with warfarin (INR 2.0-3.0) is recommended 3 weeks before and 4 weeks after cardioversion to reduce the risk of thromboembolism. This study evaluated warfarin therapy in pharmacist-managed anticoagulant services (ACS). Methods: This retrospective study was performed in 106 patients with atrial fibrillation from 2012 to 2013. The primary efficacy endpoint was the composite of stroke, transient ischemic attack, myocardial infarction, and cardiovascular death. The primary safety measure was major bleeding. To evaluate the peri-procedural effects of warfarin treatment, we studied whether target INR was maintained, as well as the maintenance period of the therapeutic range. Quality of treatment was measured by time in therapeutic range (TTR) by using the Rosendaal method. Results: There were no thromboembolic events, but TEE examination at time of cardioversion showed a left atrial thrombus in three patients (2.8%). Bleeding complications after cardioversion occurred in 2 patients (1.9%). The average INR value at the time of cardioversion was $2.59{\pm}0.8$, and was within the therapeutic range in 83 patients (78%). Analysis of the patients in whom the value was within the therapeutic range twice consecutively showed that the ratio of TTR was 80% and the therapeutic range was maintained in 67 patients (63%) for an average of 4.90 weeks prior to cardioversion. Similarly, 76 patients (72%) had a stable INR within the therapeutic range for an average of 5.70 weeks and a mean TTR of 83%. Conclusion: Pharmacists significantly contributed to appropriate warfarin treatment with close monitoring during cardioversion. Likewise, active pharmacist monitoring and systemic management should be considered to reduce thromboembolism and bleeding complications in the peri-cardioversion period.

• 한국임상약학회지
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• 제27권3호
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• pp.119-126
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• 2017

Background: As the demands of pharmacist's role and quality performance have increased, the verification of pharmacist's ability has been required. In this study, we aimed to select appropriate items for assessment of pharmacist's knowledge, attitude and performance. Methods: Based on the pharmacist job analysis, we selected duties and tasks in consideration of applying pharmacy practical examination through brainstorming of internal researchers and group discussion with experts. Survey was conducted to evaluate the tasks according to the criteria detailed below: Realistic, Understandable, Measurable, Behavioral and Achievable (RUMBA). The subjects included professors at colleges of pharmacy and instructors of institutional or community pharmacy settings. Results: Nine duties including 41 tasks were drawn for the survey through primary internal researchers. Of the 90 respondents, 95.6% were professors or preceptors who was engaged in practical training, and 62.2% had more than five years of practical experience. As a result of survey and discussion with expert panel, selected seven duties were selected as followings: 'Patient (customer) reception', 'Drug preparation and distribution', 'Patient care', 'Administration', 'Patient counseling', 'Non-prescription medication counseling', and 'Provision of drug information'. The final 20 tasks from seven duties were chosen to assess skills that a pharmacist should be able to perform. Conclusion: This is the first study to select the items that can be included in pharmacist practical examination in the future, based on the RUMBA criteria. As a next step, it is necessary to study how to implement these items.