• Korean Journal of Clinical Pharmacy
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• v.32 no.1
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• pp.1-7
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• 2022

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

• Genomics & Informatics
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• v.21 no.3
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• pp.31.1-31.8
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• 2023

Multiple myeloma (MM) is a hematological malignancy. It is widely believed that genetic factors play a significant role in the development of MM, as investigated in numerous studies. However, the application of genomic information for clinical purposes, including diagnostic and prognostic biomarkers, remains largely confined to research. In this study, we utilized genetic information from the Genomic-Driven Clinical Implementation for Multiple Myeloma database, which is dedicated to clinical trial studies on MM. This genetic information was sourced from the genome-wide association studies catalog database. We prioritized genes with the potential to cause MM based on established annotations, as well as biological risk genes for MM, as potential drug target candidates. The DrugBank database was employed to identify drug candidates targeting these genes. Our research led to the discovery of 14 MM biological risk genes and the identification of 10 drugs that target three of these genes. Notably, only one of these 10 drugs, panobinostat, has been approved for use in MM. The two most promising genes, calcium signal-modulating cyclophilin ligand (CAMLG) and histone deacetylase 2 (HDAC2), were targeted by four drugs (cyclosporine, belinostat, vorinostat, and romidepsin), all of which have clinical evidence supporting their use in the treatment of MM. Interestingly, five of the 10 drugs have been approved for other indications than MM, but they may also be effective in treating MM. Therefore, this study aimed to clarify the genomic variants involved in the pathogenesis of MM and highlight the potential benefits of these genomic variants in drug discovery.

• Quality Improvement in Health Care
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• v.7 no.2
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• pp.168-179
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• 2000

Background : Economic evaluation of clinical pharmacokinetic consultation services for theophylline, which is being widely used recently, is considered in patients for both proper care and cost efficiency. Mathods : This is a cost-benefit analysis of clinical pharmacokinetic consultation service for theophylline. Trial groups were chosen from 2 general hospitals which was performing clinical pharmacokinetic consultation- services in 1998. Control group was chosen from another one general hospital. The analysis includes 25 patients (sample patients) for trial group and 17 patients for control group. Results : On the basis of incremental analysis, it is estimated that the total (direct and indirect) annual costs of the clinical, pharmacokinetic services of theophylline for the patients in the trial group was about \65 million, whereas total annual benefits from those services was estimated to be about \551 million. The net benefits incurred to the sample patients, thus calculated, was about \485 million per year. In the analysis, we assumed that indirect benefits accruing to those services were non-existent. If that amount was included, the estimated net benefits would be much greater than the calculated one. Conclusion : We found that clinical pharmacokinetic consultation services for theophylline could produce more marginal benefits than marginal costs by those services from the social point of view. More controlled prospective trial in the future would be helpful for affirmation of the results of this study.

• Journal of Acupuncture Research
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• v.28 no.5
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• pp.87-96
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• 2011

Objectives : The aim of this study is to review clinical trials using moxibustion on hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of moxibustion were performed in nine electronic databases (four international databases and five Korean databases) and handsearch. English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of twelve studies met the inclusion criteria. Seven randomized controlled trial, three non-randomized trials and two before-after studies were included. Seven studies used direct moxibustion(two are scarring one) and five used indirect one. Five of twelve studies used moxibustion treatment just one time, except for that most frequency was once daily or 2-3 times per week for 1-2 months. Of ten randomized or non-randomized studies, three used antihypertension drug control and another three used waiting list control. Compare to baseline, change of blood pressure after moxibustion treatment was significant in all studies. However, the results of effect in blood pressure between moxibustion and controlled were not consistent. Methodological quality of clinical trials included in this review was low and has risk of bias, especially in blinding of parcitipant. Conclusions : There are little high-quality clinical trials of moxibustion for hypertension. To evaluate the effect of moxibustion, more rigorous trials are warranted. Also, methodology of clinical trials have to be descripted in detail.

• The Journal of Internal Korean Medicine
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• v.40 no.1
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• pp.89-116
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• 2019

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

• Journal of Ginseng Research
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• v.46 no.4
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• pp.585-591
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• 2022

Background: Korean Red Ginseng (KRG) extract has been shown to have beneficial effects in patients with atherosclerosis, suggesting that KRG extract may be effective in preventing subsequent ischemic stroke in patients with severe atherosclerosis. Methods: This double-blind, placebo-controlled trial randomized patients with severe atherosclerosis in major intracranial arteries or extracranial carotid artery, to ginseng group and placebo group. They were given two 500-mg KRG tablets or identical placebo tablets twice daily for 12 months according to randomization. The primary endpoint was the composite of cerebral ischemic stroke and transient ischemic attack during 12 months after randomization. The secondary endpoints were change in volumetric blood flow of the intracranial vessels and the incidence of newly developed asymptomatic ischemic lesions. Any adverse events were monitored. Results: Fifty-eight patients were randomized from June 2016 to June 2017, 29 to ginseng and 29 to placebo, and 52 (28 and 24, respectively) completed the study. One patient in the placebo group, but none in the ginseng group, experienced ischemic symptoms (p = 0.46). Changes in volumetric blood flow and the presence of ischemic brain lesions did not differ significantly in the two groups, and none of these patients experienced adverse drug reactions. Conclusion: Ginseng was well tolerated by patients with severe atherosclerosis, with these patients showing good compliance with ginseng dosing. Ginseng did not show significant effects compared with placebo, although none of the ginseng-treated patients experienced ischemic events. Long-term studies in larger patient populations are required to test the effect of ginseng.

• Journal of Ginseng Research
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• v.46 no.4
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• pp.543-549
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• 2022

Background: In physical activity or labor, the human body is in a state of high intensity stress, and all parts or physiological functions of the body respond positively to maintain or balance the need for movement. The human body has many physiological changes in the process of movement, and fatigue is the external manifestation of various complex changes inside the human body. Fatigue is also a physiological mechanism of self-protection after the body reaches a certain level of activity, which can prevent the occurrence of life-threatening excessive functional failure. The generation of fatigue is a very complex process, and its mechanism has not been concluded yet. Therefore, it is an important work to search and screen the effective components of natural plants that have anti-fatigue effect and to explore their mechanism. Methods: This was a 8-week, randomized, double-blind, placebo-controlled clinical trial. A total of 110 subjects who passed physical examination were included according to the scheme design, and randomly divided into a test group which was given KRG and a placebo control group. The calculation is carried out according to the standard of sub-high-intensity exercise test. Results: There was no adverse effect on safety index of subjects after taking red ginseng capsule. After KRG treatment, subjective strength grade is significant lower than placebo treatment. Blood lactic acid content is significantly get lower after trial in KRG group, and significant lower than placebo group. Creatine phosphokinase(CK) content is significantly get lower after trial in KRG group, and significant lower than placebo group. Conclusion: According to the criterion in the test scheme, the result shows that KRG is helpful on relieving physical fatigue.

• Tuberculosis and Respiratory Diseases
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• v.67 no.5
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• pp.422-429
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• 2009

Background: The discomfort caused by chronic cough, that is persistent for more than 3 weeks, causes a number of patients to seek medical attention. However, the underlying disorder often remains undetermined despite thorough examinations, and is considered to be idiopathic. This study compared the efficacy of inhaled corticosteroid with conventional cough suppressants on chronic idiopathic cough. Methods: Eligible patients with chronic idiopathic cough were randomly assigned to either the inhaled fluticasone group or the codeine plus levodropropizine oral administration group. The subjects in each group took their planned medication for 2 weeks. After the trial, comparative analyses of outcomes were performed in terms of the remnant cough (%) at the end of treatment, drug compliance, and adverse drug events. Results: Seventy-seven patients were enrolled in this randomized trial; 38 to the inhaled fluticasone group and 39 to the codeine plus levodropropizine group. The remnant cough was 41.0${\pm}$35.8% in the inhaled fluticasone group, and 32.4${\pm}$32.0% in the codeine+levodropropizine group (p=0.288). Drug compliance was 95.4${\pm}$7.4% and 81.8${\pm}$18.6% in the inhaled fluticasone and the codeine+levodropropizine group, respectively (p<0.001). Nine patients had adverse drug events in the codeine+levodropropizine group compared to one in the inhaled fluticasone group (p<0.001). Conclusion: Short-term inhaled corticosteroid is not inferior to conventional antitussive agents in controlling chronic idiopathic cough without significant adverse events.

• Journal of Pharmaceutical Investigation
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• v.35 no.3
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• pp.179-185
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• 2005

Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug Surfolase, were -1.64, -3.33 and -0.92% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.

• The Journal of Korean Medicine
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• v.31 no.1
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• pp.47-56
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• 2010

Objective: Many drug or non-drug therapies are reported to be effective in reducing the severity of attention deficit/hyperactivity disorder (ADHD). The aim of this study was to assess the effect of color and pattern on the severity of ADHD in young ADHD patients. Method: We randomly assigned 30 children into two groups and had them participate in 15-minute block play sessions once in a week. The experimental group used blocks with green (3G, Munsell color system) circle patterns on them, while the control group played with plain white blocks. We also provided a set of playing cards with the corresponding patterns. This trial continued for 4 weeks and 29 children (96.7%) completed. The primary outcome measurement was the ADHD rating scale-IV and was evaluated on every visit. Results: After the trial, ADHD score decreased in both groups but not significantly ($34.4{\pm}8.0$ to $30.0{\pm}4.3$; $34.0{\pm}6.0$ to $30.3{\pm}3.2$). However, there were significant differences in 4 items of ADHD rating scale between the two groups. These consisted of 3 inattention (Q3, Q7, Q15) and 1 hyperactivity-impulsivity (Q12) items and the reduction between the first and final visits was significant (p=0.0240, p=0.0498, p=0.0237 and p=0.0012 respectively). Conclusion: Repeated exposure to a green circle pattern might not influence the total score of ADHD rating scale but reduced 3 inattention items and 1 hyperactivity-impulsivity significantly in children with ADHD. Proper visual stimuli are partially helpful for pediatric ADHD.