Earticle

Community acquired pneumonia(CAP) is the most prevalent disease among pneumonia patients and progressed to severe pneumonia. A retrospective study was performed to evaluate antibiotic regimens according to guidelines of Infectious Disease Society of America. From January to October 2005, chart review of 50 patients with CAP was peformed in terms of microbiology and laboratory data of each regimen. Temperature, WBC count, ALT, AST and alkaline phosphatase of each patient were examined for liver toxicity. In three patients received levofloxacin appeared to have normalized temperature and improved cough. The patients who received cefmetazole -aminoglycoside appeared to have worsen LFT(Liver function test). Many patients in flomoxef-aminoglycoside group received mechanical ventilation because of the basis diseases like tuberculosis, diabetes mellitus and hypertension. In conclusion, antibiotic therapy for the treatment of CAP should be selected according to tolerance, bacteria and severity of disease.

스타틴이 골형성을 자극하며 골밀도를 개선한다는 다수의 동물실험과 임상보고에 의해, 스타틴을 폐경기 이후 노령의 여성 고지혈증 환자에게 골다공증의 예방 혹은 치료적 용도로 사용할 수 있는가에 대한 관심이 고조되어 왔다. 하지만, 보고된 문헌들이 예방 혹은 치료효과를 제시하거나 해석됨에는 아직도 실험결과가 상이하거나 의견이 상충되고 있다. 본 연구는 폐경기 이후의 고지혈증을 지닌 골다공증 환자에게 처방된 스타틴이 실질적으로 골다공증 혹은 골절위험을 경감시키는 예방적 또는 치료적 효과를 지니는지 규명하고자, 1990년부터 2005년 사이에 MEDLINE에 등재된 데이터베이스 중에서 6개의 키워드를 사용하여 인체대상 연구보고서를 cross-sectional study, prospective cohort study 및 case-control study의 연구유형별로 수집, 분류하여 각각의 결과를 비교, 평가하였다. 각 연구결과들은 골다공증 평가에 이용하는 다수의 측정지표들에 대하여 공히 인정될 만한 수준의 유의성 여부를 제공하기에는 곤란했는데, 이는 연구디자인이 부적절했거나 실험대상 환자들이 보유한 각종 질병요소들과 치료상황이 복잡한 상호관계를 지녔기 때문이다. 따라서 대규모의 잘 계획된 이중맹검형 다국가 임상시험을 통해서 임상적 효과 유무가 입증되기 전에는 스타틴을 고지혈증을 보유한 폐경기 이후 노령 여성의 골다공증의 예방 혹은 치료적 용도로 사용하는 것은 아직 시기상조로 사료된다.

There are 3 different hypotheses on how statins may affect bones, through promoting bone formation, inhibiting bone resorption or through anti-inflammatory effect. In the 3 cross-sectional studies above, one showed increase BMD at hip and spine, one showed increase BMD only at mid-forearm and one showed that the risk reduction in fractures is not explained by the changes in BMD however, all 3 studies showed a decrease in risk of fracture associated with statins. In the 2 prospective cohort studies, one showed the use of statins was not associated with BMD at any skeletal site or decreasing the risk of fracture, and the other showed statins except pravastatin decreased in risk of vertebrate fracture but not affecting lumbar spine BMD. All of case-control studies indicated reduction in fracture risk but did not provide any data regarding BMD. 2 of the randomized, controlled studies showed no significant reduction in fracture risk as well as statins' effects on BMD. Finally, one longitudinal study showed statin use reduced fracture risk and increased BMD. Among the conflicting results shown above, even when statin use was shown to increase BMD, it does not seem to account for the reduction in fracture risk. There may be different ways that statins affect bone other than those hypotheses proposed above. Many studies seem to agree that pravastatin does not have any effect on bone. Some studies suggested that the reason statins did not achieve clinically significant increases in BMD in some studies, is due to the low affinity of statins on bone; statins are designed to act in the liver therefore their effective concentration in extrahepatic tissue is low. The limitations to those studies discussed above. Many studies did not account for the change of lifestyle while subjects' were on statins. Increases in weight bearing exercise and changes in diet might affect BMD and thus reduce risk of fractures. Mental alertness and vision acuity might prevent falls from occurring; many statin-users in the studies were young so the risk of fractures from falls would be decreased. Almost all of the studies failed exclude patients with neurological problems. During study periods, many subjects may have been started on drugs for diseases that usually occur with aging which could cause drowsiness and lead to falls. The sample sizes used in some of the trials were small and the duration of treatment and follow up might not have been long enough to see clinically relevant results.

Medication counseling improves patients' compliance, which enhances the effectiveness of treatment and reduces the medical cost consequently. Since separation of dispensary from medical practice took place, most patients have had to go to pharmacy after receiving prescription from hospital. The importance of medication counseling in pharmacy thus has been emphasized. To study the present conditions of medication counseling from the pharmacists and the patients satisfaction with them, we conducted a survey with questionnaires. The subjects were 146 outpatients and 55 pharmacies located in Yeongdeungpo-gu. The research showed that 69.9% of the outpatients had received medication counseling and only 35.5% of them were satisfied with it. The main reason for their unsatisfaction was insufficiency of explanation. A number of patients(75.3%) were thinking that medication counseling from the pharmacists is necessary for appropriate administration and optimal efficacy of the medicine. Among 55 pharmacies involved in the research, 17 of them(30.9%) answered that they have been giving patients medication counseling, which were mostly verbally done. Only 8 of them(l4.5%) were providing medication information sheets for some specific drugs. The pharmacists referred to a few problems disturbing optimal medication counseling like these: 1) Lack of time, 2) insufficient information, 3) inappropriate counseling skills. To improve these problems, they hope to get more information about prescription and specific medicines from pharmacy in hospital. If hospital decides to hold the lectures on medication counseling, about 80% of the pharmacists tend to take part in them.

Korea Food and Drug Administration (KFDA) has been expediting the Biological Equivalence Examination (BEE) project to encourage generic substitution without expense of inappropriate therapeutic outcome. However, little is known about which considerations are most important in making the decision to prescribe a drug among many generic drugs. The purpose of this survey was to identify how strongly the KFDA certification of BEE influenced doctors when they make a choice between brand and generics of glimepiride preparations. Telephone survey was performed towards doctors working at local clinics by using a questionnaire. Most influential factor to doctors' decision was drug cost followed by pharmaceutical representatives, therapeutic efficacy, and review guideline for reimbursement. Advertisement of the drug was the least influential followed by KFDA certification of BEE. The meaning of BEE was best understood by relatively young doctors with specialty in surgical parts. This survey result further indicated that the doctors considered the therapeutic equivalence examination a preferred measure to expedite generic substitution.

The aim of the present study was to evaluate the bioequivalence of two talniflumate preparations. We used Somalgen tablet (Kun Wha Pharmaceutical Co., Korea.) as a reference drug for bioequivalence of Crimain tablet (Samjini Pharmaceutical Ind. Co., Korea), and performed this whole study according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male volunteers, years in age and in body weight, were divided into two groups and a randomized cross-over study was employed. After one tablet containing 370 mg of talniflumate was orally administered, blood was taken at predetermined time intervals and the concentrations of talniflumate in plasma were determined using HPLC method with UV-detector. The analysis system was validated in specificity, accuracy, precision and linearity. These items of the analysis condition in this study conform to the guideline of KFDA. The pharmacokinetic parameters such as were calculated using the analysis condition we established and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed and Cmax. of reference drug and test drug in value were and respectively. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log (1.25) for , respectively. These results indicate that Samjin talniflumate tablet is bioequivalent to reference drug, Somalgen tablet.

This study was aimed to investigate the current status and expectations of orphan drugs in Korea. The Korea Orphan Drug Center was established to supply many medicines for the patients with rare diseases. Among the medicines supplied by the Center, the number designated as the orphan drugs by the KFDA is quite few. However, a few of medicines are not under circulation even if the items are designated as the orphan drugs. Neoplasm-related medicines, infectious and parasitic disease-related medicines, endocrine, nutritional and metabolic disease-related medicines are the ones circulated most. There are several unapproved drugs among the medicines supplied by the Center. It's because the director of the Center can import the goods without a process to getting an approval from the KFDA. The Korea Orphan Drug Center has contributed to the selection of the medicines for treating the rare disease. On the contrary, some problems remain in the supply process. The safety and effectiveness of the medicines supplied by the Center are not guaranteed. So far, rare diseases have no specific legal definition, and therefore are only referred to in terms of the population of patients, which prevent from establishing the range of medicines. The introduction of Special Access Program or Access to Unapproved Therapeutic Goods will be the solution of these problems. In addition, it is another solution to keep intimate relations with the Rare and Intractable Disease Center and the Medicine Safety Information Center which will be open soon.

Purpose: A retrospective study was performed to assess the efficacy and tolerance of administration in patients with heart failure and diabetes. Method: Records of 164 patients who were treated for the heart failure condition more than a year were studied retrospectively. Patients were divided into 4 groups based on their diabetes(DM) status and the administration of ( group: 14, DM w/o : 19, No DM + : 62, No DM + no : 69). All patients had been receiving conventional therapy such as digoxin, ACE-I, ARB, diuretics, nitrates, aspirin, anticoagulants or lipid-lowering agents. The primary endpoints (death and hospital admission) were recorded during 1 year period and hemodynamic factors (HR, LVEF, SBP, DBP) were obtained from all patient groups before and after 12 months of treatment. To evaluate toxicity of , SCr, BUN, AST, ALT and Alkaline phosphatase were obtained. Result: There were less death and hospital admission in DM + group than in DM without group (p=0.014). Relative risk of hospital admission for group over no DM group was 1.17. Long term administration was associated with an improvement of heart rate in patients with DM (P< 0.02) with no significant improvement of LVEF, SBP, DBP. in DM patient. In patient without DM, was associated with improvement in LVEF, HR and DBP (P<0.01, P<0.03), but not in SBP. The incidence of toxicity was similar between the four group with no significant difference. Conculsion: Treatment of heart failure patients with appears to be beneficial in terms of hospital admission event and several hemodynamic factors. The toxicities of treatment were not significant and the treatment is generally well-tolerated in most of the heart failure patients.

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

Heptaplatin, a new platinum derivative, has several contradicting reports on the nephrotoxicity. Therefore, the aim of this study is to compare the toxicities of heptaplatin-containing regimens in the chemotherapy. This study was performed retrospectively on seventy-seven patients with advanced gastric cancer who did not receive chemotherapy within the last 1 months before taking of heptaplatin- or cisplatin-containing chemotherapy. The 38 patients among total patients was received heptaplatin-containing regimens (26 with SEF regimens: heptaplatin/epirubicin/5-FU, 12 with SF regimens: heptaplatin/5-FU) and the rest 39 patients was received cisplatin-containg regimens (11 with CEF regimens: cisplatin/epirubicin/5-FU, 28 with ELF regimens: epirubicin/leucovorin/5-FU). Before and after the chemotherapy serum creatinine (Scr) and proteinuria were measured by urine stick test in all patient groups. Also Scr was measured a day before the second cycle and did not vary significantly between groups. However Scr on cycle 3 were significantly higher in SEF and SF groups. In case of proteinuria, it was more frequent on cycle 1 in heptaplatin/5-FU group. Proteinuria before and after on cycle 2 was not different between the two cisplatin -containing groups, but was more frequent in heptaplatin-containing groups. The reason why the Scr measured was not so different could be because we excluded the patients who received only one cycle of heptaplatin and changed the regimen due to signs of nephrotoxcity. As the results nephrotoxicity such as protienuria was appeared to be more frequent with heptaplatin-treated patients. It suggests that the clinical consequences of the toxicity need to further evaluation and also the modalities to prevent or minimize nephrotoxicity of heptaplatin should be studied for future utilization of the drug.

Objectives: Bio-equivalence(BE) test is important not only to ensure the quality of generic drugs, but also to promote drug substitution under the separation of prescribing and dispensing practice(SPD). This study was intended to investigate the perception of consumers, doctors, and pharmacists on the confidence of bio-equivalence(BE) assured drugs. Methods: Nation-wide telephone interview survey was conducted for 1,018 consumers, 800 doctors, and 806 pharmacists from September to October in 2003. Descriptive analysis and analysis were conducted. Results: Even though people showed higher confidence level for the Bioequivalent drugs compared with Bio-inequivalent drugs, the confidence was generally low. Among those asked about the therapeutic substitutability of original drugs by BE versions, 95.78% of pharmacists responded "positive", while only 39.33% of consumers and 31.13% of doctors said so. The elderly, the less educated, who takes chronic disease medicine, pays high cost of prescription drugs, and are in the low income responded less aware of that. Also most consumers got information such as effect of drugs from either media or doctors. Conclusions: In order for people to believe that BE drugs and original drugs are equivalent, we need to strengthen health education, and to clarify any misunderstanding. It is also necessary for the national policy to provide accurate information about drugs to the public.

Drugs are often taken together with meals and there are numerous opportunity for food-drug interaction to occure. Food-drug interactions and their clinical consequences are very complex indeed. The composition of the meal, and the volume of fluid that is ingested often are decisive factors in food-drug interactions. Various formulations of a specific drug may behave differently. Solutions and suspensions seem to be less susceptible and enteric-coated preparations are more susceptible, to food interactions than are other dosage forms but exceptions to this rule do exist. Furthermore, generic and environmental factors, disease and other drugs cause considerable inter- and intraindividual variation in food-drug interactions. Also, eating habits are dissimilar in different parts of the world, and diets often vary greatly from day to day. The taking of drugs together with meals offers some obvious benefits. It may help to reduce gastrointestinal irritation and compliance is improved. On the other hand, in some cases food interferes seriously with drug absorption. The purpose of this review is to clarify the complexity of food-drug interactions, and to discuss interactions that may be of clinical importance.

Great inter-variability in drug response and adverse drug reactions is related to inter-variability of drug bioavailability, drug interaction and patient's disease and physyological state that cause change in absorption, distribution, metabolism and excretion of drugs. However, these alone do not sufficiently predict and explain inter-variability in drug response. In recent studies, it is reported that inter-variability in drug response and adverse drug reactions may largely resulted from genetically determined differences in drug absoption, distribution, metabolism and drug target proteins. Especially, the major human drug-metabolizing enzymes such as CYP450, N-acetyl tranferase, thiopurine S-methyl transferase, glutathione S-transferase are identified as the major gene variants that cause inter-individual variability in drug's response and adverse drug reactions. These variations may have most significant implications for those drugs that have narrow therapeutic index and serious adverse drug reactions. Therefore, the genetic variation such as polymorphisms in drug metabolizing enzymes can affect the response of individuals to drugs that are used in the treatment of depression, psychosis, cancer, cardiovascular disorders, ulcer and gastrointestinal disorders, pain and epilepsy, among others. This review describes the pharmacogenomics of the drug metabolizing enzymes associated with the drug response and its clinical applications.