• The Korean Journal of Pain
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• v.30 no.2
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• pp.86-92
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• 2017

Osteoblasts, originating from mesenchymal cells, make the receptor activator of the nuclear factor kappa B ligand (RANKL) and osteoprotegerin (OPG) in order to control differentiation of activated osteoclasts, originating from hematopoietic stem cells. When the RANKL binds to the RANK of the pre-osteoclasts or mature osteoclasts, bone resorption increases. On the contrary, when OPG binds to the RANK, bone resorption decreases. Denosumab (AMG 162), like OPG (a decoy receptor), binds to the RANKL, and reduces binding between the RANK and the RANKL resulting in inhibition of osteoclastogenesis and reduction of bone resorption. Bisphosphonates (BPs), which bind to the bone mineral and occupy the site of resorption performed by activated osteoclasts, are still the drugs of choice to prevent and treat osteoporosis. The merits of denosumab are reversibility targeting the RANKL, lack of adverse gastrointestinal events, improved adherence due to convenient biannual subcutaneous administration, and potential use with impaired renal function. The known adverse reactions are musculoskeletal pain, increased infections with adverse dermatologic reactions, osteonecrosis of the jaw, hypersensitivity reaction, and hypocalcemia. Treatment with 60 mg of denosumab reduces the bone resorption marker, serum type 1 C-telopeptide, by 3 days, with maximum reduction occurring by 1 month. The mean time to maximum denosumab concentration is 10 days with a mean half-life of 25.4 days. In conclusion, the convenient biannual subcutaneous administration of 60 mg of denosumab can be considered as a first-line treatment for osteoporosis in cases of low compliance with BPs due to gastrointestinal trouble and impaired renal function.

• YAKHAK HOEJI
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• v.52 no.5
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• pp.331-344
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• 2008

Recently, the FDA (Food and Drug Administration) of the United States and many advanced countries remark biomarkers and surrogate endpoints as a critical path tool on model based drug development. Economic, technical and social profit on model based drug development like a reduction of the length of research and development have been achieved. Therefore we summarize previous studies about biomarkers and surrogate endpoints and suggest a development direction of therapeutic agents. In diabetes mellitus (DM) and osteoporosis, there are remarkable increases in number of patients and most of patients take medicine during their whole lifetime. For this reason, many patients with DM and osteoporosis have a tolerance on their medicine. We expect that research and development on biomarkers and surrogate endpoints will contribute to new drug development on DM and osteoporosis. Biomarkers for DM are blood levels of glucose, insulin, ${HbA}_{1c}$, CRP, alpha-glucosidase, adiponectin and DPP-4. Among these, validated surrogate endpoints for DM are blood levels of glucose, insulin and ${HbA}_{1c}$ Biomarkers for osteoporosis are BMD, BMC, trabecular volume, ICTP, DPD, osteocalcin, the activity of osteoclast and production of osteoblast. The validated surrogate endpoints for osteoporosis are BMD only. This review summarizes all suggested biomarkers and surrogate endpoints in DM and osteoporosis. The biomarkers are classified by drugs, and the method of validation for surrogate endpoints is suggested. This information would contribute to suggest a direction of DM and osteoporosis therapeutic agent development.

• Environmental Analysis Health and Toxicology
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• v.31
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• pp.16.1-16.9
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• 2016

Objectives Banha-sasim-tang (BST), which consists of seven different herbs, is one of the most popular herbal formulae for treating gastrointestinal disorders in Eastern Asia. The commonly used herbal medicine is often co-administered with other therapeutic drugs, which raises the possibility of herb-drug interactions and may modify the clinical safety profile of therapeutic drugs. Methods We investigated the potential herb-drug interactions between BST extract and midazolam (MDZ) in mice. The area under the plasma concentration-time curve (AUC) of MDZ and 1'-hydroxymidazolam (1'-OH-MDZ) was evaluated for both oral and intraperitoneal administration of MDZ, following oral administration of BST (0.5 and 1 g/kg). Results It was found that the AUC of MDZ and 1'-OH-MDZ was lower in case of oral administration of MDZ. Administration of BST extract was not associated with hepatic cytochrome P450 activity. BST extract induced a strong reduction in pH and it has been reported that oral mucosal absorption of MDZ is lower at low pH. The decreased absorption rate of MDZ might be caused by the ingredients of BST and may not be related to other factors such as increased excretion of MDZ by P-glycoprotein. Conclusions The altered pharmacokinetics of midazolam caused by co-administration with BST in vivo could be attributed to a decrease in pH and subsequent reduction of MDZ absorption rate.

• Tuberculosis and Respiratory Diseases
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• v.80 no.2
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• pp.143-152
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• 2017

Background: Fluoroquinolones are considered important substitutes for the treatment of tuberculosis. This study investigates the current status of fluoroquinolone for the treatment of tuberculosis. Methods: In 2009, a retrospective analysis was performed at one tertiary referral center for 953 patients diagnosed with tuberculosis. Results: A total of 226 patients (23.6%), who received fluoroquinolone at any time during treatment for tuberculosis, were enrolled in this study. The most common reasons for fluoroquinolone use were adverse events due to other anti-tuberculosis drugs (52.7%), drug resistance (23.5%), and underlying diseases (16.8%). Moxifloxacin (54.0%, 122/226) was the most commonly administered fluoroquinolone, followed by levofloxacin (36.3%, 82/226) and ofloxacin (9.7%, 22/226). The frequency of total adverse events from fluoroquinolone-containing anti-tuberculosis medication was 22.6%, whereas fluoroquinolone-related adverse events were estimated to be 2.2% (5/226). The most common fluoroquinolone-related adverse events were gastrointestinal problems (3.5%, 8/226). There were no significant differences in the treatment success rate between the fluoroquinolone and fluoroquinolone-$na{\ddot{i}}ve$ groups (78.3% vs. 78.4%, respectively). Conclusion: At our institution, fluoroquinolones are commonly used for the treatment of both multidrug-resistant tuberculosis and susceptible tuberculosis, especially as a substitute for adverse event-related drugs. Considering the low adverse event rates and the comparable treatment success rates, fluoroquinolones seem to be an invaluable drug for the treatment of tuberculosis.

• Korean Journal of Clinical Pharmacy
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• v.13 no.2
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• pp.72-81
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• 2003

Adverse drug reaction (ADR) may increase hospital admission, morbidity and mortality and adding extra cost to healthcare expenditures. AIMS: This study was performed to identify the types of ADR being reported in a tertiary hospital, and to find out the ways to improve current ADR monitoring system. To investigate the attitudes of hospital pharmacists towards, and their understanding of ADR reporting. METHODS: Of 117 reports submitted to the pharmacy department during 3 months survey period, A questionnaire survey of 75 randomly selected hospital pharmacists was conducted. RESULT: Of the report was from patients aged between 60 and 70. The medical department with the high frequency in ADR reporting was Internal Medicines $(60\%)$. The most common ADR manifestations were gastrointestinal complaints $(47.8\%)\;and\;80\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $38.4\%.\;55.5\%$ of respondent were aware of the need to education and information about ADR monitoring. The important reasons for unreporting ADR were unknown of how to report ADRs $(94.6\%)$. CONCLUSIONS: An ADR reporting system based on reporting by staff pharmacists has been effective increasing the number of reported reactions and pharmacist involvement in monitoring patients for ADRs. Pharmacists have the knowledge and responsibility to contribute to ADR reporting program. A great opportunity exists for pharmacists to contribute in this area of patient care.

• Journal of Haehwa Medicine
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• v.18 no.2
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• pp.1-12
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• 2009

Most of the cholesterol is synthesized by liver in the body while about one of third is taken via dietary. The main functions of cholesterol is to protect membranes in cell surface, avoid the arterial bleeding by hypertension, and prolong the life of erythrocytes, and so on. However, overload of cholesterol leads to arteriosclerosis associated with leading death cause. Lack of physical activity, emotional and environmental stress, and low intake of protein or vitamin E induce the unbalance between HDL- and LDL-cholesterol so become a basis of ischemic disorders in heart, brain and elsewhere in the body. So far, four major classes of medications for hyperlipidemia are HMG-CoA reductase inhibitors (statins), bile acid sequestrants, nicotinic acid, and fibric acids. The statins can lower LDL and levels triglyceride, but may induce myopathy and an elevation of liver enzyme levels. The bile acid sequestrants lower LDL levels and raise HDL levels with no effect on triglyceride levels but side effects of gastrointestinal (GI) distress, constipation, and a decrease in the absorption of other drugs. Nicotinic acid and fibric acids lower LDL and triglyceride levels with showing flushing, hyperglycemia, hyperuricemia, GI distress, and hepatotoxicity dyspepsia, gallstones, myopathy, and unexplained noncardiac death as adverse effects. Above western drugs lower cholesterol by 15 to 30% while all have notable adverse effects. In traditional medicine, hyperlipidemia is regarded as retention of phlegm and fluid disease. Etiology and pathogenesis of hyperlipidemia is basically based on Spleen-Deficiency and Phlegm-Stagnation, accumulation and stasis of -heat, and Qi & blood stagnation induced by Phlegm-damp, water-dampness, and blood stasis. Thereby, strengthening Spleen and dissolving Phlegm, clearing away heat and diuresis, and supplementing Qi and activating blood circulation are commonly used therapeutic methods for hyperlipidemia. The traditional herbal medicine, have been used for patients with CVA, hypertension or hyperlipidemia in Oriental hospital or Oriental clinic. The lock and key theory is used to develop most of western medicine, however many diseases are caused by mixed factors in body-complex system. We expect that Oriental pharmacological theory could be newborn as a novel drug showing high advantage of blood levels of lipidsand QOL of performance without side effects.

• The Journal of Internal Korean Medicine
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• v.28 no.4
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• pp.956-962
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• 2007

In cancer patients showing nausea and vomiting, a number of factors can be considered as the cause including brain tumor, electrolyte imbalance, gastrointestinal diseases or types of chemotherapy agents and dose of the drugs. Though nausea and vomiting can be minimized through the use of various anti-emetic drugs, many people still suffer from severe nausea and vomiting with poor quality of life compared with patients who do not show significant nausea and vomiting. In this report, we introduce a case of a cancer patient who suffered from severe nausea and vomiting. The patient was female and 59 years old with NSCLC (non small cell lung cancer) with metastatic brain tumor. Though western conventional medical treatment was used to reduce the symptoms, persistent nausea and vomiting were noted during the admission period. Herbal decoction Gamibokryungbanha-tang was used for nausea and vomiting which were uncontrolled under conventional western medicine; the patient showed remarkable improvement in terms of frequency and severity of nausea and vomiting. Further study will be needed in order to determine the long-term effectiveness of oriental medical treatment on cancer patient with nausea and vomiting.

• Journal of The Korean Society of Clinical Toxicology
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• v.10 no.2
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• pp.111-117
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• 2012

Purpose: In Korea, few studies have examined the acute toxicity of anti-obesity drugs. The purpose of this study is to analyze the general characteristics and clinical aspect of acute anti-obesity drug intoxication. Methods: We retrospectively investigated patients admitted to the emergency department after anti-obesity drug intoxication between March, 2004 and February, 2012. The medical records of these patients were reviewed for demographic data, toxicologic history, time elapsed to presentation, clinical symptoms and signs, treatment, and outcome. Results: There were a total of 18 anti-obesity intoxication cases during the study period; of 16 which were included in our study. The purchasing route of the anti-obesity drug was mainly through a doctor's prescription (68.8%), however, some were obtained through the internet and the pharmacies. The mean time to The most commonly ingested antiobesity drug was sibutramine (31.3%) and many of the cases (62.5%) were multi-drug ingestions. The most common clinical manifestations were gastrointestinal symptoms (94%), but, CNS symptoms (75%) and cardiovascular symptoms (75%) were almost equally present. 13 patients (81%) were discharged after clearance of toxic symptoms and signs with a mean observational period of 7.0 hours. 3 patients were admitted for observation and treatment; of which 1 patient died due to fatal complications. Conclusion: Most anti-obesity intoxications show mild toxicity and a nonfatal clinical course. However, the recent trend toward prescribing psychostimulant anti-obesity medication, which can be fatal after an acute overdose, calls physicians' attention to treating of anti-obesity intoxications.

• Korean Journal of Pharmacognosy
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• v.11 no.2
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• pp.85-94
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• 1980

In this paper, we studied what the drug name of Sang-Baik-Pi(桑白皮) Mori Cortex Radicis) is, how to collect it; and how the chief symptoms had changed in the chinese medical references and herbological literatures and formularies. Also we bibliographically analyzed in the herbological way the drugs combinated with Sang-Baik-Pi and their active principles among the prescriptions in the famous medical book; 'Dong-Ui-Bo-Gam', (東醫寶鑑) of our country. Finally, we concluded as foolow. Numerous names of botainical origin were described, but it was not recorded that San-Keun-Baik-Pi(桑根白皮) in old days is different from root bark of Morus sp. in this times. Sang-Baik-Pi has been a common designation since Ming dynasty (AD 1500). Collections of it were independent of seasons, it could effect perfectly over 10 years old. And its cork layer should be removed after collections, it was especially emphacised that root bark on ground was poisonous. The chiefly cured symptoms with Sang-Baik-Pi were constantly not different from the contents of 'Shin-Nong-Bon-Chau-Kyung'(神農本草經) in ancient times, but it has been developed since Ming dynasty. Its uses are widely extended to a surgical and dermatologic desease; rheumatis, beriberi and diabetes in this times. and its efficacies depend upon curing. Prescriptions on Sang-Baik-Pi that were prescribed in 'Dong-Ui-Bo-Gam' are there, 177 drugs combinated with it. Glycyrrhizae Radix is most frequently combinated with Sang-Baik-Pi(frequently 68%). It is proved that Armeniacae Semen, Platycodi Radix etc, in the order take strong effects on anti-tussive, anti-phlogistic, diuretic, anti-pyretic etc. It is expressed 34 times, frequently, that a dose is 3.75g, and it shows that a usual doses is 2-4g. As the above prescriptions are classified, the results is as follows, respiratory tract desease is most frequently in 69 prescriptions, the next gastrointestinal tract 13 times, diuretic 12 times, and antipyretic 11 times. Therefore, Sang-Baik-Pi contains a good remedial value chiefly of the effects upon the respiratory diseases.

• The Korean Journal of Food And Nutrition
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• v.10 no.2
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• pp.186-192
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• 1997

Endoscopic diagnosis and medical management from K43 and C45 patients, whose sex, occupation, character and life patterns are quite different each other, were discussed. The K43 was patient with erosive gastritis, which may caused by maldietary habits and life stresses. Although the effective drugs such as H2-receptor antagonists with atacids, H+/K+-pump inhibitors, prokinetics, colloidal bismuth, and sucralfates, were administrated for long time, symptomatic relief of abdominal pain was not improved. The tests of clinical phathology and abdominal sonogram were normal, visceral hypersensitivity was appeared from barostat test of stomach. However C45 had taken headache during every day life, and endoscopically confirmed as a gastric·duodenal ulcer patiant, which may caused by chronic use of NSAIDs. The her ulceric symptoms were suppressed from active stage to healing stage by using combination therapy for H. pylori with traditional antipeptic ulcer drugs, where as amitriptyline was administrated to the K43 but not effective. Nonulcer dyspepsia and irritable bowel syndrome is pooly defined, and affect about 15% of the population annually in U. S. A. but don't seek medical care. Author would like to point out that statistics for visceral pains are absent in Korea.