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Community acquired pneumonia (CAP) remains a prevalent and potentially life threatening illness. American Thoracic Society and Infectious Disease Society America recommend combination therapies with plus a macrolide or a fluoroquinolone monotherapy for the empirical treatment of CAP. The aim of this study was to compare moxifloxacin monotherapy with cephalosporin plus azithromycin combination therapies. From January 2004 to March 2005, 18 patients in the moxifloxacin group(MG) and 21 patients in the cefuroxime or ceftriaxone plus azithromycin group(CAG) with CAP were retrospectively reviewed with regard to clinical, laboratory and microbiological data. Each patient was stratified into mild (risk class I-II), moderate (risk class III) and severe (risk class VI, V) group according to and PSI (Pneumonia Severity Index) score. Each group was compared for microbiological eradication, clinical assessment, the length of hospital stay. As results, Total 39 patients with CAP were reviewed. The appropriateness of admission was 83.3% in MC vs. 76.2% in CAC. The mean length of the hospital day was for 8.31 days vs. 7.39 days, days switching parenteral to oral antibiotics in 5.19 days vs. 5.28 days, clinical improvement in 2.43 days vs. 2.61 days in MG vs. CAC. Radiological improvement required 3.75 days vs 3.63 days in MG vs. CAG and bacteriological eradication rate at discharge was the same in the both groups. Mortality rate was 11.1% (2 of 18) vs 14.3% (3 of 21) in MG vs. CAG (p=0.77). Drug cost of the mean 5 hospital days requiring parenteral antibiotics was the most inexpensive in moxifloxacin group for the 147,045 won, and ceftriaxone 1g-azithromycin group for the 170,285 won, cefuroxime bid-azithromycin group for the 207,800 won, ceftriaxone 2g-azithromycin group far the 220,570 won, cefuroxime tid-azithromycin group for the 251,700 won. There was no significant statistical difference in clinical, bacterial, radiological cure and hospital days, and switch to oral days. In conclusion, that i.v. moxifloxacin monotherapy was as effective as azithromycin plus cefuroxime or ceftriaxone combination therapies fur the treatment of CAP. In drug cost analysis, moxifloxacin is less expensive than CAG.

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

This study was aimed to determine influenza vaccination coverage in 2004 in Koreans and investigate the factors associated with vaccination. Documentation of vaccination status and baseline data was conducted by a survey using questionnaire sheets. Baseline data and vaccination status were documented on 1465 people out of whom 60.1% received the influenza vaccine. Forty-seven percent of the responders were male; 4% were aged 1-12, 32% were aged 13-39, 32% were aged 40-64 and 32% were aged 65 or older. Twenty-three percent reported a chronic illness, increasing their risk for complications from influenza. Predictors of influenza vaccination were: older age (OR=11.7, 95% CI 5.1-26.8), the presence of chronic illness (OR=2.3, 95% CI 1.1-4.7), previous vaccination (OR=1.8, 95% CI 1.1-2.8), belief that influenza vaccine is effective in preventing influenza (OR=2.5, 95% CI 1.1-5.7) and education level (OR=1.7, 95% CI 1.0-2.7). Immunization rates were much higher in those who will take immunization again (OR=10.4, 95% CI 5.5-19.6). Factors affecting the decision on immunization were self-determination (43.6%), public relations (24.1%), recommendation from family members or friends (22.4%) and consulting with health professionals (5.8%). The main reason not to take influenza vaccine was the thought that they are healthy (50.1%). Overall, influenza vaccine coverage was high in those aged 65 or older. Immunization against influenza was influenced more by existing medical problem and belief about the vaccine's effectiveness, rather than sex or residence.

The aim of this study was to evaluate the safety and efficacy of treatment of mesoglycan. This study was conducted between September 2003 and May 2004. A total of 292 patients with vascular disorders including cerebral infarction were enrolled. The patients were administered with 50-100mg of mesoglycan by an oral route everyday for eight weeks. Subjective physicians' assessments of efficacy had ratings of 'improvement', 'invariability', 'exacerbation' and 'not being able to assess'. An improvement was observed in 241 patients out of 274; 18 patients were rules out. The efficacy rate was influenced statistically significantly by the duration of therapy (p=0.0392) and daily mean drug dose (p<0.0001). The adverse events were reported in 8 patients (9 cases) out of 292 patients: skin/appendages disorders (0.7%), liver/biliary system disorders (0.7%), cardiovascular system disorders (0.7%), neurologic disorders (0.3%). respiratory disorders (0.3%) and gastrointestinal system disorders (0.3%). There showed no serious adverse events. These results indicate that mesoglycan was well tolerated and effective for the prevention of vascular disorders.

건강한지원자에서 세프라딘 250 mg 캡슐을 오전 09:00시와 오후22:00시에 경구투여하여 세프라딘의 약물동태학적 주기변화 (생체리듬)를 검토하였다. 혈장중 세프라딘의 농도는 두 투여시간에서 유의성 있는 차이를 보여주었다. 혈장농도곡선하면적 (AUC)은 오후 때 보다 오전 투여시에 유의성 있게 증가되었으며, 생물학적반감기는 오후 때 보다 오전 투여시에 더 연장되었다. 전신청소를 은 오후 때 보다 오전 투여시 유의성 있게 감소되었다.

Following intracoronary stenting, antiplatelet therapy lead to greater protection from thrombotic complication. A few data are available about the effect of clopidogrel versus cilostazol, an antiplatelet commonly used after intracoronary stenting. To evaluate the efficacy and safety of clopidogrel plus aspirin compared with those of cilostazol plus aspirin in coronary stenting and to evaluate the efficacy of clopidogrel loading dose prior to coronary stealing in clopidogrel group. Data were retrospectively collected from medical charts of patients who had undergone coronary stenting and received either clopidogrel with or without loading 300 mg followed by 75 mg/d (n=58), or 200 mg/d cilostazol(n=72) for 1 year, between January 2000 and May 2002. All patients in both groups received aspirin 200 mg/d throughout the study. The primary endpoints at 7, 30, 180 and 365 days after stealing were the composite of death, Myocardial Infarction, stroke, angina, and revascularization in the intent to treat population and restenosis at follow up angiography. The secondary endpoints were the incidence of bleeding complications at 7, 30, and 365 days, and durg adverse effects at 365 days after stenting. At 180 and 365 days after stenting, the combined primary endpoints were significantly reduced in clopidogrel plus aspirin group (relative risk 0.39; 95% CI 0.17 to 0.92; p=0.021, RR 0.43; 95% CI 0.22 to 0.84; p=0.0085, respectively). However, the combined primary endpoints were not significantly different between the two groups at 7 and 30 days (p:1.00, p=0.79, respectively). Angiographic restenosis rate was 14.3% in clopidogrel plus aspirin uoup and 32.1% in cilostazol plus aspirin group (p=0.19). 300mg of clopidogrel loading dose did not significantly reduce the combined primary endpoints at 30 days after stenting (RR 0.14; 95% CI 0.01 to 2.65; p=0.23). The rate of bleeding complications and drug adverse effects were not different between the two groups. In patients undergoing intracoronary stenting, clopidogrel plus aspirin therapy is more beneficial than cilostazol plus aspirin in reducing major adverse cardiac events with similar rate of bleeding complication. A loading dose of clopidogrel did not lead to a statistically significant reduction in major adverse cardiac events.

In our study, osteoporosis was induced by ovariectomized in female Sprague-Daweley (SD) rats, and the prevention and treatment efficacy of the climacteric disease the ostmenopausal type I pattern was examined by using the experimental substance soybeans and arowroot. No clinical signs and mortality after continuous oral administration of experimental substances for 14 weeks were not observed, however, the weight of experimental animals underwent ovariectomized was increased significantly in comparison with control group (p<0.01). The atrophy of the uterus due to T3 group was 23.64% after 7 weeks, 24.44% after 14 weeks (in comparison with N.C. group), and it was statistically significantly increased. In regard to the change of blood cells, it was observed that platelets were statistically significantly reduced in the ovariectomized group, and administered orally experimental substances continuously for 7 weeks, in all groups administered experimental substances, it was found that platelets had the tendency to be increased more than N. C. group. In regard to He change of blood biochemistry, removed the ovary, the concentration of ALP showed the tendency to be increased than control group, and particularly in T3 group, it was increased significantly. In regard to the concentration of cholesterol, in comparison with negative control group, it was reduced 68% at 7 weeks and 35% at 14 weeks. After ovariectomized, the amount of estrogen was found to be reduced by 21.37% in comparison with control group, it showed the tendency to be increased by 4.49% in T1 group and 7.62% in T2 group, the concentration of estrogen in each group showed the tendency to be increased than negative control group, and in T3 group, it was increased to 100.46% and 117.65% in T4 group, and it was increased more than control group. Based on the above experimental results, in the experimental animals female rats, because of the hormonal imbalance induced by ovariectomized, a large mount of fat is accumulated in the body and due to it osteoporosis, obesity, hypertension, hyperlipidemia, fat of the liver, arteriosclerosis, diabetes, and other metabolic diseases were developed. Hence, when the experimental substance Extraction of ferment arrowroot was orally administered continuously for 14 weeks, it was thought that a certain proportion of the hormonal balance was maintained that functioned as a substance interfering the accumulation of fat, and it was considered to be of help in the treatment of not only osteoporosis Type I, but also for the prevention and treatment of various endocrinal diseases.

This is to examine the OTC regulatory system of Korea in comparison with those of Japan, UK and US, and suggest the possible regulatory actions to harmonize it to international standards. Individual countries have their own regulatory requirements and processes far OTC application based on established drug monographs and safety profiles from clinical experiences. Categories of OTC drug monographs are being expanded with transparent establishment procedure according to detailed guidelines, and public opinions as well as professional experts for assessing appropriateness of wide usage without physician's prescription. In line with trend of self-medication worldwide, the number of OTC drugs is increasing and more efficient and professional drug review is underway in the separate OTC division in regulatory agency. For improving OTC regulatory system in Korea, settlement of optimal drug classification policy and management for encouraging OTC drug use, development of more detailed and specific guidelines for OTC drug application, expansion of OTC drug monographs, transparent process for OTC monographs establishment, and establishment of OTC division in health authority, are suggested.

Appropriate drug classification is important fur rational drug consumption. This study was conducted to evaluate the appropriateness of current drug classification system and suggest possible ways for improving the system. Nonprescription drug market has been decreased. Since total 27,962 products had been classified (prescription 17,187 vs. nonprescription 10,775 products, 61.5% vs. 38.5%) in July 2000 for implementing separation of drug prescribing and dispensing system, there are no classification changes. Reclassification is not motivated by product holder and regulatory system did not lead classification change either. Consumers' ease access to some nonprescription drugs is demanded. But point of public awareness and cultural and health environmental views, saff drug use rather than advantages from broad supply of nonprescription drugs is more critical. We concluded that current 2-categorized (prescription and nonprescription) drug classification system is appropriate, and addition of general sale category should be approached carefully with long term Preparations such as establishment of better nonprescription drug consuming infrastructure by public information provision and education for improving public medicinal knowledge and strengthening self medication guidance, and review of current classification status of marketed drugs and switching possibilities. For systemizing and encouraging reclassification, introduction of regulatory renewal system as a continuous reevaluation program which is the best way to review appropriateness of drug classification as well as provision of detailed guidance for industry including policy, requirement and process fer reclassification application, are necessary.

Purpose: To determine the extent and rate of prescription drug therapy, especially polypharmacy and the prevalence of potentially inappropriate medication use in Korean elderly ambulatory patients based on an explicit criterion. Methods: Performed a retrospective study of 65 years or older ambulatory patients visiting a university hospital based clinic from January 2002 to April 2004. Study determined the patterns of drug prescription per Anatomical Therapeutic Chemical Classification and the potentially inappropriate medication usage based on explicit Beers criteria. Results: Of the 4,042 elderly patients the mean number of prescription was , which was similar between genders and all age groups within the elderly. 10.7% of patients were prescribed with more than 5 medications concurrently. The most frequently prescribed medication was the drugs used for treating nervous system diseases (44.3%), followed by alimentary tract/metabolism disorders (27.6%), cardiovascular disease (10.7%), blood/blood forming disorders (4.3%), respiratory disorders (6.5%), and musculoskeletal diseases (3.2%). A total of 511 elderly (13%) was prescribed with medication that met the criteria for=1 potentially inappropriate drugs for the elderly. This proportion was similar between genders and all age groups within the elderly. Among these 511 elderly patients the mean number of potentially inappropriate drugs prescribed was drugs. Potentially inappropriately prescribed drugs included amitriptyline (76 cases), diazepam (69 cases), ketorolac (57 cases), short acting nifedipine (44 cases), triazolam (38 cases), and hydroxyzine (38 cases). Conclusion: Potentially inappropriate drug prescribing in Korean ambulatory elderly patients are common. Education programs and interventions aimed at optimizing the prescribing and dispensing of the most appropriate drugs are needed.

수마트립탄은 뇌혈관에 분포되어 있는 5-HT1B/1D수용체에 특이적이고 선택적으로 작용하여 뇌혈관 수축 작용을 나타내어 편두통의 치료에 널리 쓰이는 약물이다. 본 연구는 수마트립탄 제제인 이미그란(50 mg tablet, GSK사)을 대조약으로 하여 시험약인 명인 제약의 수마트란 50mg정의 생물학적 동등성 평가를 하기 위해 22명의 건강한 지원자를 모집하였다. 지원자를 두 군으로 나누어 1정씩 투여하였고 교차시험을 실시하였다. 수마트립탄의 혈장 중의 농도를 정량하기 위하여 발리데이션된 HPLC/FD를 사용하였다. 채혈 시간은 투약 전 및 투약 후 0.5, 1, 1.5, 2, 2.5, 3,4, 5, 7, 9, 12시간에 걸쳐 총 12시점에 걸쳐 시행하였다. 생물학적 동등성을 판정하기 위한 파라미터로 12시간까지의 혈장 중 농도 곡선 하 면적 최고 혈중 농도를 사용하였다. 의 평균은 (시험약)과 (대조약)으로 나타났다. 의 경우 각 각 29.30 ng/ml(시험약)과 29.25ng/m1(대조약)으로 관찰되었다. 의 경우 로그변환 한 평균치 차의 90% 신뢰구간이 log0.95-log1.24이었고, 의 경우 log0.90-log1.149로 계산되 어 두 항목 모두 log0.8-log1.25이어야 한다는 식품의 약품 안전청 과 FDA의 기준을 모두 만족시켰다. 이상의 결과를 종합하면 시험약 수마트란 정 50 mg은 대조약 이미그란 정 50 mg에 대하여 생물학적으로 동등한 것으로 판정되었다.

엑세나타이드는 2005년 4월에 미국 FDA로부터 허가된 새로운 계열의 당뇨병치료제로서 적응증은 멧포르민이나 설포닐유레아계열의 당뇨병치료제로서 치료를 받고 있음에도 불구하고 혈당이 목표치로 저하되지 않는 제2형 당뇨병환자에게 기존의 치료법에 부가적으로 사용하는 것으로 제한되어 있다. 엑세나타이드는 39개의 아미노산으로 구성되어 있으며 미국 캘리포니아주에 자생하는 도마뱀의 타액에서 유래된 물질과 조성과 기능이 유사하도록 합성된 펩타이드 약물이다. 이 약물은 혈중포도당의 농도에 의존적으로 인슐린분비를 촉진하며, 비정상적으로 높은 혈중 글루카곤농도를 저하시키며, 음식물의 위통과시간을 연장하며, 식욕을 저하시키는 등의 여러 가지 기전을 통하여 혈당을 조절하는 것으로 알려져 있다. 멧포르민으로 1일 1500 mg을 사용하고 있는데도 불구하고 당화혈색소가 7%를 초과하는 제2형 당뇨병환자 336명을 대상으로 부가적으로 30주간 엑세나타이드 또는 을 1일 2회 피하주사 한 임상시험결과에 의하면, 당화혈색소가 7% 미만인 환자의 비율은 intent-to-treat 로서 각각 27%와 40%로 나타났다. 이는 기존의 치료법과 위약으로 치료받은 군에서의 13%에 비하여 통계적으로 매우 유의성 있는 결과인 것으로 분석되었다(p<0.01). 또 다른 임상시험에서는 상기 임상시험과 유사한 임상시험계획을 바탕으로 하여 설포닐유레아로 치료받고 있었지만 당화혈색소가 7%를 초과하는 제2형 당뇨병환자를 대상으로 임상시험을 실시하였으며, 그 결과에 의하면 엑세나타이드와 설포닐유레아의 병용치료 시 혈당조절에 매우 유리한 것으로 나타났다. 멧포르민과 설포닐유레아의 병용요법으로 치료받고 있던 당뇨병환자를 대상으로 실시한 임상시험에서도 동일한 결과가 나타났다. 이 약의 부작용은 치료개시 후 나타나는 메스꺼움이 문제로 지적되었으며 저 혈당현상은 큰 문제가 되지 않는 것으로 나타났다. 이 약은 인슐린 대용약물이 될 수 없으며 당뇨병성 케토산증의 치료에 사용할 수 없다. 또한 이 약물은 심한 신부전이 있거나 말기신장질환 환자에게 사용해서는 안 된다.