위식도역류질환 한약제제 임상시험 가이드라인 개발을 위한 관련 국내 가이드라인 분석 및 기존 한약임상시험과의 비교

한가진,임정태,김진성,이준희,Han, Ga-jin,Leem, Jung-tae,Kim, Jin-sung,Lee, Jun-hee 대한한방내과학회 2016 大韓韓方內科學會誌 Vol.37 No.1

Objectives: This study aimed to learn what should be considered in the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) by analyzing the existing guidelines and clinical trials.Methods: The development committee searched the existing guidelines for herbal medicinal products or GERD. Then, clinical trials related to GERD using herbal medicine were selected. The chosen trials were analyzed in terms of their inclusion and exclusion of participants, intervention, comparators, outcome, and trial design. Then, we compared the results of the analysis according to the regulations and guidelines of the Ministry of Food and Drug Safety to suggest the issues that we will have to consider when developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).Results: As a result, few guidelines for GERD and clinical trials with herbal medicinal products were located in the national institution homepage. In addition, 8 articles were found using the following combination of search terms: “Gastroesophageal reflux disease”, “GERD”, “herbal medicine”, “herbal therapy”, “Korean Medicine”, “Traditional Chinese Medicine”, and “TCM”. Even though all trials had their own unique research questions, all studies were performed using a randomization method. Most trials included participants with reflux esophagitis, but two trials targeted proton pump inhibitor-refractory GERD. The type of intervention varied, such as decoction, granules, and capsules. Additionally, individualized herbal medicines were used in two studies. Comparators were diverse, such as placebo, Western medicine, and electro-acupuncture. The most frequently used outcome for efficacy was the effectiveness rate. In addition, the outcome for evaluating quality of life, esophageal mucosa and pressure, esophageal acid reflux, and recurrence rates were used. Safety was investigated by recording adverse events and carrying out laboratory tests.Conclusions: We identified some issues by reviewing the existing guidelines and comparing them with clinical trials for GERD and herbal medicinal products. These results will be utilized for developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).

기능성 소화불량 환자의 한방치료 전후의 주관적 평가지표와 Electrogastrography Parameters를 이용한 객관적 지표의 변화 관찰

한가진,김진성,류봉하,Han, Ga-Jin,Kim, Jin-Sung,Ryu, Bong-Ha 대한한방내과학회 2011 大韓韓方內科學會誌 Vol.32 No.4

Objectives : Functional dyspepsia is a type of disease characterized by bothersome postprandial fullness, early satiation, epigastric pain and burning without structural gastrointestinal disease. The aim of this study was to analyze the characteristics of functional dyspepsia patients and evaluate changes in symptoms, quality of life, and electrogastrography parameters before and after oriental medical interventions. Methods : We recruited forty-six functional dyspepsia patients who visited gastroenterology clinic in the oriental medicine hospital of Kyung Hee University between November 2009 and February 2011. Patients were assessed for their frequency of dyspepsia (based on short form-Leeds Dyspepsia Questionnaire: SF-LDQ), quality of life (based on functional dyspepsia-related quality of life questionnaire: FD-QoL), gastric motility (based on electrogastrography: EGG) on the first visit. Then, the effect of oriental medical interventions was evaluated using EGG on the second visit. Results : The majority of patients had symptoms of nausea and indigestion. The largest decrease in EGG parameters was found in the indigestion group. The frequency of regurgitation and postprandial EGG power % bradygastria showed a significant correlation. Also, significant correlations were found between some items of FD-QoL and some EGG parameters. Compared to the EGG parameters before oriental medical interventions, some parameters after treatment had positive results, implying the improvement of gastric motility disorder. We also found improvement of EGG parameters in both digestant medicinal group and digestant combined with qi-tonifying medicinal group. Conclusions : The results of this study suggest that clinical application of EGG can be an objective diagnostic tool in functional dyspepsia patients visiting oriental medical hospital.

구취환자의 구강건조감과 스트레스, 기울의 상관성 분석

한가진,김진성,선종기,손지희,오승환,박영선,정용재,정의민,박재우,류봉하,Han, Ga-Jin,Kim, Jin-Sung,Seon, Jong-Ki,Son, Ji-Hee,Oh, Seung-Wha,Park, Young-Sun,Jung, Yong-Jae,Jerng, Ui-Min,Park, Jae-Woo,Ryu, Bong-Ha 대한한방내과학회 2010 大韓韓方內科學會誌 Vol.31 No.3

Objective : This study was designed to investigate the correlation between Qi movement stagnation condition, stress level and xerostomia in halitosis patients. Methods : Ninety-nine halitosis patients visiting the Halitosis Clinic in the hospital of Oriental medicine, Kyung Hee University from January, 2010 to May, 2010 were recruited. The subjects were assessed on their stress levels(based on the Stress Response Inventory), xerostomia symptoms(based on the 8-item Visual Analogue Scale xerostomia questionnaire), and Qi movement stagnation(氣鬱) condition(one of the subcategories in the Qi, blood and water pattern identification(氣血水辨證)). Salivary functions were evaluated using the unstimulated whole salivary flow rate measurements. Results : Compared to the non-Qi movement stagnation group(Qi movement stagnation pattern identification score < 30), the confirmed Qi movement stagnation group(Qi movement stagnation pattern identification score $\geqq$ 30) showed higher levels of xerostomia and stress. In the regression analysis, the Qi movement stagnation condition and stress levels showed a significant correlation. Furthermore, the Qi movement stagnation condition and stress levels each displayed significant correlations with xerostomia. Conclusions : The results of this study suggest that stress and Qi movement stagnation condition contribute to xerostomia symptoms in halitosis patients. Considering the correlation found between the Qi movement stagnation and stress, this study suggests a novel methodology in treating xerostomia, halitosis, and other stress-related disorders through the Qi movement stagnation-related approach.

유방암에 대한 한양방 병용 치료 증례 보고 1례

한가진,이아람,정준석,성신,김성수,Han, Ga-jin,Lee, A-ram,Jung, Jun-suk,Seong, Sin,Kim, Sung-su 대한한방내과학회 2017 大韓韓方內科學會誌 Vol.38 No.5

The prevalence of breast cancer is very high in Korea. Although the patients receive standard treatments, such as surgery, chemotherapy, or radiotherapy, they frequently experience recurrence or metastasis of their tumors. In addition, many patients with breast cancer also suffer from side effect symptoms induced by these standard treatments. Therefore, increasing numbers of patients now want to undergo treatment with traditional Korean medicine (TKM) in addition to conventional treatment. We present a case of 46-year-old female with recurred breast cancer. She first received two kinds of chemotherapy and then underwent surgery. She then also received 4 cycles of adjuvant chemotherapy. At a follow-up examination, she was informed of recurrent lesions on the right anterior chest wall. She started to receive TKM treatments together with a new chemotherapy. After about one month, the size of the recurred tumor in right chest wall had decreased. Her symptoms, such as shoulder pain, chest pain, and nausea induced by conventional therapy, were also improved. We suggest that a combination of TKM and chemotherapy is a promising treatment for breast cancer.

진행성 유방암에 대한 한양방 병용 치료 치험 1례

한가진,이아람,성신,김성수,Han, Ga-jin,Lee, A-ram,Seong, Sin,Kim, Sung-su 대한한방내과학회 2018 大韓韓方內科學會誌 Vol.39 No.2

Although patients with breast cancer receive standard treatments, they often experience recurrence or metastasis of tumors. Therefore, patients seeking treatment with traditional Korean medicine (TKM) in addition to conventional treatment have increased. We present a case of 46-year-old female with recurring breast cancer. She underwent surgeries and various hormone therapies since being diagnosed in 2007. Upon follow-up examination, she had metastatic lesions on the lung and multiple bones in 2015 and 2016. She received TKM treatments from May 2017 with Aromasin and Afinitor. However, hepatic metastasis was found after two months, so she started Capecitabine with TKM. After about two months, the liver nodules disappeared and a seeding nodule in the right paracolic gutter was decreased. After two months, the tumor response was stable disease. Back pain due to bone metastasis was improved. We suggest that combination treatment of TKM and chemotherapy is a promising method for treating breast cancer.

위식도역류질환 변증도구 개발 연구

한가진,임정태,이나라,김진성,박재우,이준희,Han, Ga-jin,Leem, Jung-tae,Lee, Na-la,Kim, Jin-sung,Park, Jae-woo,Lee, Jun-hee 대한한방내과학회 2015 大韓韓方內科學會誌 Vol.36 No.2

Objectives: This study was designed to develop a standard tool for pattern identification of gastroesophageal reflux disease (GERD) patients. Methods: Korean and Chinese literature was selected that mentioned pattern identification of GERD. We gathered the pattern identification and their symptoms and a Chinese medical doctor proficient in Korean translated the Chinese characters into Korean. A Korean linguist then confirmed the translation results to develop a draft of the standard tool for pattern identification of gastroesophageal reflux disease (PIGERD). The final PIGERD was developed after assessment by an expert committee composed of professors from the Korean Medicine University, using the following items: inclusion of the pattern identification and its symptoms, importance of items, and validity of translation. Results: Six pattern identifications and 94 symptoms were selected from 45 references and translated into Korean. Four pattern identifications [pattern/syndrome of liver qi invading the stomach (肝胃不和), spleen-stomach weakness (脾胃虛弱), spleen-stomach dampness-heat (脾胃濕熱), and stomach yin deficiency (胃陰不足)] and 49 symptoms were then selected through the Delphi method by the expert committee. The final standard PIGERD tool was completed after the assessment of translation validity and reflection of individual opinions by the expert committee. This tool consists of 40 items including tongue and pulse diagnosis. The weighted value was also computed from assessment of the importance of items. Conclusions: We developed a standard tool for pattern identification of gastroesophageal reflux disease (PIGERD) to clarify the pattern identification of patients with gastroesophageal reflux disease for standardized diagnosis.

가미도홍사물탕 약욕요법 이후 호전된 항암화학요법 유발 수족증후군 1례

한가진,장명웅,성신,김성수,Han, Ga-jin,Jang, Myeong-woong,Seong, Sin,Kim, Sung-su 대한한방내과학회 2018 大韓韓方內科學會誌 Vol.39 No.2

Hand-foot syndrome (HFS) frequently occurs after receiving chemotherapy, such as sorafenib, in patients with hepatocellular carcinoma (HCC), and this impairs quality of life (QOL). The prevalence of HFS due to sorafenib is 10-28%. The effective methods to treat HFS are not established aside from temporary discontinuation of chemotherapy agents and drug dosage adjustment because the mechanism of HFS has not been elucidated. According to a previous study, modified Dohongsamul-tang was effective in the treatment of patients with HFS and improved patients' QOL. Based on these results, we administered the soaking method with modified Dohongsamul-tang to a 50-year-old male patient with HCC complaining of HFS due to sorafenib. After two weeks, the symptoms of HFS were improved despite taking sorafenib. We suggest that modified Dohongsamul-tang is a novel method for treating HFS.

구강작열감증후군 환자의 임상적 특징 및 음허증 평가

선종기,김진성,한가진,오승환,손지희,강경,김주연,류봉하,Seon, Jong-Ki,Kim, Jin-Sung,Han, Ga-Jin,Oh, Seung-Whan,Son, Ji-Hee,Kang, Kyung,Kim, Ju-Yeon,Ryu, Bong-Ha 대한한방내과학회 2011 大韓韓方內科學會誌 Vol.32 No.4

Objectives : This study was designed to investigate the clinical characteristics and usefulness of comprehensive diagnosis of Yin-deficiency and heart rate variability in patients with burning mouth syndrome (BMS). Methods : We surveyed 30 burning mouth syndrome patients visiting the Oral Diseases Clinic of Kyung Hee University Oriental Medicine Hospital from April to September of 2011. The subjects were evaluated on self-assessed severity of burning mouth syndrome and xerostomia using visual analogue scale (VAS) score and Yin-deficiency condition (based on the 10-item Yin-deficiency questionnaire). Salivary function was measured by the unstimulated salivary flow rate (USFR), and heart rate variability (HRV) parameters were recorded by SA-2000E (Medicore Co., Ltd., Korea). Results : There were substantial significant positive correlations between burning sensation VAS scores in mouth and Yin-deficiency scores. There was significant negative correlation between xerostomia VAS score and USFR. Compared to the normal range of total power (TP) in HRV parameters, the burning mouth syndrome patients showed significant lower values of TP. Conclusions : The results of this study suggest that comprehensive diagnosis of Yin-deficiecny and HRV parameters are useful in diagnosing of burning mouth syndrome patients. Therefore, we assume that improvement of Yin-deficiency condition can be a potentially effective way to treat burning mouth syndrome.

임상연구의 효과적인 대상자 모집 전략 - 기능성 소화불량증 임상시험 자료에 대한 분석 -

정의민,고석재,한가진,오승환,김진성,류봉하,박재우,Jerng, Ui-Min,Ko, Seok-Jae,Han, Ga-Jin,Oh, Seung-Hwan,Kim, Jin-Sung,Ryu, Bong-Ha,Park, Jae-Woo 대한한방내과학회 2010 大韓韓方內科學會誌 Vol.31 No.4

Objectives : While the proportion of clinical trials is increasing in oriental medical research, no studies in recruitment strategies exist. This study was conducted to investigate which recruitment strategy was efficient to increase the number of potential subject and to reduce cost. Methods : Data from 179 callers in a single-center between June 22 and August 12, 2010 were analyzed. Results : We found that daily newspaper and free newspaper advertisement collected maximal participants. Advertisements in the hospital and on the Internet were considered as the most cost-effective methods. Conclusions : Intensive multiple overlapping recruitment strategies might be effective in success of participant registration in a clinical trial.

디지털 설진기를 이용한 구취군과 비구취군 간의 설태 평가

정용재(Yong-Jae Jung),김진성(Jin-Sung Kim),오승환(Sung-Hwan Oh),한가진(Ga-Jin Han),김유승(Yoo-Seung Kim),홍인아(In-A Hong),박영선(Young-Sun Park),박재우(Jae-Woo Park),박경모(Kyung-Mo Park),류봉하(Bong-Ha Ryu) 대한한의학회 2010 대한한의학회지 Vol.31 No.1