• 한방비만학회지
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• 제7권2호
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• pp.27-37
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• 2007

Background Clinical practice guidelines (CPG) are systematically developed statements to assist practitioners and patients on healthcare decisions. They provide recommendations for the average patient, which should take into account individual clinical judgment and the patient's values and expectations. Ephedra has sympathomimetic effect and has been used for weight loss worldwide. However, its safety is controversial especially in autonomic and cardiovascular systems. Therefore, the need of appropriate CPG for ephedra prescription in obesity was advocated in Korean Traditional Medicine. Methods The committee comprised of specialists of obesity, oriental herbology, oriental cardiology, constitutional medicine. The committee collected all relevant references about adverse effect and safety of ephedra in the forms of meta-analysis, systematic review, randomized controlled trial, case-control study and observational study from international and domestic databases and paper journals. 11 English- and 5 Korean-language references were gathered and categorized by PICO (Patient, Intervention, Comparison, Outcome) method. We could not complete strength of recommendation which should be clarified according to the evidence grade estimation. Result The first version of CPG for ephedra prescription in obesity was issued by Korean Oriental Association for Study of Obesity. It includes topics of introduction, pharmacokinetics, side effects and adverse events, constitutional aspect and recommendations for dose, indication and contraindication. Conclusion There should be periodic upgrade of this CPG from now on. Although there are some drawbacks in this version of CPG, it has significance as the first CPG in Korean Traditional Medicine.

• Journal of Pharmaceutical Investigation
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• 제35권3호
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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.

• 대한한의학회지
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• 제44권2호
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• pp.70-105
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• 2023

This study was conducted to examine the current status of traditional korean medicine studies on gastroesophageal reflux disease in Korea, identify deficiencies, and suggest the direction of future medicine research methods to lay the foundation for traditional korean medicine treatment. All domestic papers on the korean traditional treatment of gastroesophageal reflux disease were selected among the literature published until August 2022 in six domestic databases. A total of 52 selected research data were classified into experimental research papers, clinical research papers, and review papers. In experimental papers, to evaluate the effectiveness of treatment, improvement of esophageal mucosal lesions, anti-inflammatory mechanisms, antioxidant mechanisms, esophageal mucosal protection mechanisms, gastric peristalsis control, and gastric acid secretion inhibition mechanisms were used as evaluation measures. In the clinical research paper, the basis for diagnosis of cases was clinical symptoms through medical history listening and diagnosis through visits to hospitals in the past. The average treatment period was 40.7 days, and the duration of treatment was not significantly affected by the duration of the disease. The most widely used Korean medicine treatment intervention was herbal medicine. There were 3 literature review studies, 3 systematic literature review and meta-analysis studies, 1 comparative review study for clinical trial guideline development, all using Chinese papers. This study included all domestic papers on gastroesophageal reflux disease to identify the research trend of the Korean oriental medicine community, and based on this, it is meaningful to confirm areas that need to be supplemented in future research plans.

• Journal of Pharmaceutical Investigation
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• 제35권3호
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• pp.193-199
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• 2005

Gabapentin is an antiepileptic drug that is structurally similar to ${\gamma}-aminobutyric$ acid (GABA), but does not interact with the GABA receptor. It does not bind significantly to plasma proteins, and is excreted to unchanged form in the urine. The purpose of the present study was to evaluate the bioequivalence of two gabapentin capsules, $Neurontin^{TM}$ capsule 300 mg (Pfizer Pharm. Co., Ltd.) and Kuhnil $Gabapentin^{TM}$ capsule 300 mg (Kuhnil Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin 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 six healthy male subjects, $22.46{\pm}1.86$ years in age and $67.64{\pm}7.24$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 300 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. 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, $Neurontin^{TM}$ capsule 300 mg, were -2.03, -0.43 and 4.29% 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 $(e.g.,\;log\;0.89{\sim}log\;1.09\;and\;log\;0.91{\sim}log\;1.09$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil $Gabapentin^{TM}$ capsule 300 mg was bioequivalent to $Neurontin^{TM}$ capsule 300 mg.

• Journal of Pharmaceutical Investigation
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• 제35권4호
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• pp.295-301
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• 2005

Famciclovir is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, $Famvir^{TM}$ tablet 250 mg (Novartis Korea Ltd.) and Famcivir (Hanmi Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $24.19{\pm}2.08$ years in age and $71.55{\pm}6.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 250 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at water. 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, $Famvir^{TM}$ tablet 250 mg, were -2.93, -8.02 and 10.47% 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 log0.8 to log1.25 (e.g., $log0.92{\sim}log1.01$ and $log0.85{\sim}log1.00$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir was bioequivalent to $Famvir^{TM}$ tablet 250 mg.

• Journal of Ginseng Research
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• 제46권1호
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• pp.71-78
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• 2022

Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

• 동의생리병리학회지
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• 제31권5호
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• pp.284-293
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• 2017

Thread embedding therapy is used increasingly for various disease including neck pain. However, the evidence of thread embedding therapy on neck pain and the assessment of their methodology are still limited. This study aimed to investigate the clinical research methodology using thread embedding therapy on neck pain. Thread embedding therapy is used increasingly for various disease including neck pain. However, the evidence of thread embedding therapy on neck pain and the assessment of their methodology are still limited. This study aimed to investigate the clinical research methodology using thread embedding therapy on neck pain. Total 31 studies were included in analysis. Thread embedding therapy usually was used once a week(32.3%), once per 10days(29.0%), once per two weeks (25.8%). The most common concurrent treatment used with thread embedding therapy was Chinese medicine. Among acupuncture points, EX-B2 (61.3%) was most commonly used, followed by GV14(45.2%), GB20(29.0%), GB21(22.6%). For control group, acupuncture were most commonly used(58.1%). All studies reported that the effect of thread embedding therapy was more effective compared to control group. and 11 studies reported side effects. Only 13 studies(41.9%) reported the appropriate randomization method, and the mean Jadad score of included studies was 1.52. Previous clinical trials included in this study showed the effect of thread embedding therapy for neck pain. However, the quality of the studies was not high. Further rigorous clinical trials are need to assess the effect of thread embedding therapy.

• 식품과학과 산업
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• 제51권1호
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• pp.37-44
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• 2018

The prevalence of obesity is continually increasing in South Korea; about 1/3 of adults are diagnosed with obesity and 1/2 of adults are overweight in 2016. Abnormal body fat mass increased the risk factors of metabolic syndrome (including hypertension, type II diabetes, dyslipidemia), chronic kidney failure, osteoarthritis, and cardiovascular disease. Ministry of Food and Drug Safety (MFDS) in Korea established the validation and approval system for "functional food" based on related laws and regulations. According to the guideline of MFDS, the biomarkers for obesity study in vitro, in vivo, and clinical trial are well summarized. The analysis of physical phenotypes is necessary condition to study further molecular phenotypes and pathway analysis in vivo study. Thus, we will review currently available physical phenotype analysis; dual energy X-ray absorptiometry (DEXA) and Oxylet gas analysis will be examined in-depth.

• 응용통계연구
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• 제23권6호
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• pp.1067-1080
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• 2010

임상시험을 위한 표본 수 산정방법에 대해 지금까지 많은 방법이 개발되었고 현재 국내외 임상시험 기관에서 이 방법들을 토대로 표본 수를 산정하고 있다. 하지만 마이크로어레이칩 을 이용한 실험에 필요한 표본 수 산정에 대한 연구는 아직 미비하여 제대로 이용되지 않고 있다. 본 연구의 목적은 마이크로어레이 실험에 필요한 표본 수를 산정하는 데 있어 실제 마이크로어레이 자료의 재현성에 대한 정보를 이용하여 그 지침을 제공하는데 있다. 재현성 비교에서는 5가지 검정방법 즉, Fold change, Two-sample t-test, Wilcoxon rank-sum test, SAM, LPE 방법 별로 재현성을 측정하였다. 발현 값의 표준화 방법에 있어서는 MAS5, RMA 두 가지로 세분화 하였으며 반복수에 따라 상위 20개 또는 100개 유전자에 대한 일치성도 측정하였다. 또한, 표본수를 산정하는데 있어 기존에 제시한 방법에 현실적인 정보를 이용하여 좀 더 세분화하여 실험에 필요한 표본수를 산정해 보았다.

• Journal of Acupuncture Research
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• 제26권3호
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• pp.115-131
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• 2009

Objectives: This survey was done in order to find out how Korean medical doctors derive pattern identification for acupuncture prescriptions in treating low back pain in real clinical practice. Methods : The survey questionnaire was developed by the committee of experts who major in acupuncture & moxibustion or statistics for acupuncture clinical trial protocol development. The questionnaires were distributed via e-mail to 75 members of Korean Acupuncture & moxibustion society from March 26th to April 14th in 2009. 57 members completed answers, and the computerized data were analyzed by SPSS 17.0 statistical program. Results : 1.57 Korean medical doctors selected meridian pattern identification based on the course of the meridians(44.6%), visceral pattern identification(32.1%), pattern identification based on cause of disease(14.3%) as the most commonly used pattern identification methods for acupuncture prescription when treating low back pain patients in real clinical practice. 2. In meridian pattern identification based on the course of the meridians, gallbladder meridian of hypochondriac region(13.0%), bladder meridian of lateral low back region(11.2%), governer vessel of central low back region(11.7%) were selected 3. In visceral pattern identification, yang deficiency of kidney(20.2%), deficiency of kidney(19.3%), liver(16.7%), yin deficiency of kidney(14.0%), violence qi of kidney(8.8%), small intestine(7.9%) were selected. Conclusions : In our e-mail survey, Korean medical doctors answered that Meridian Pattern Identification based on the course of the meridians is the most often used diagnosis method. Visceral pattern identification, pattern identification based on cause of disease, meridian pattern identification based on symptom and pattern identification based on qi-blood-yin-yang theory in order of frequency used, were selected for low back pain diagnosis in real clinical practice.