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).

폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰

한가진,조민지,박은주,성신,김성수,김관일,정희재,이범준,임정태 대한한의학회 2019 대한한의학회지 Vol.40 No.1

Objectives: This study aimed to ascertain what should be considered in the “Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer” by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the “Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer”. Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: ‘lung neoplasm', 'herbal medicine’, 'Medicine, Korean traditional', ‘Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of “Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer”.

간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰

한가진,김동훈,박은주,성신,김성수,임정태 대한한방내과학회 2019 大韓韓方內科學會誌 Vol.40 No.1

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.”

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.

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.

유방암에 대한 국내 한의학 연구 동향 고찰- 국내 한의학 논문을 중심으로 -

한가진,손지영,성신,김성수 대한한방내과학회 2018 大韓韓方內科學會誌 Vol.39 No.1

Objective: This study aimed to investigate the trend in the research on breast cancer using traditional Korean medicine (TKM) and establish the direction for further study. Methods: Breast cancer studies using Korean medicine were searched using the Oriental Medicine Advanced Searching Integrated System (OASIS). The search term was ‘breast’ and there was no restriction in year. The searched studies were analyzed according to the type of research. Results: 1. 83 studies were searched. The types and numbers of study were as follows: 42 were in vitro studies, 5 were in vivo studies, 12 were studies for review, and 27 were clinical research including case reports. 2. Various cell lines such as MCF-7, MDA-MB-231, SKBR3, and MCF-10A were used for in vitro studies. The studies reported a decrease in cell viability, induction of apoptosis, and change of expression in cancer-related genes. In vivo studies also reported induction of apoptosis, and anti-proliferative activity of herbal medicine against the cancer cells. 3. Among the clinical research, 8 were cross-sectional studies, 3 were controlled-trial, and 15 were case reports. The baseline characteristics of breast cancer patients were analyzed in the cross-sectional studies. Interventions such as pharmacopuncture, herbal medicine, massage, Qi gong, acupuncture, electroacupuncture and moxibustion were used in clinical research. 4. Research on the review of breast cancer covered various subjects as follows: herbal medicine, acupuncture, pattern identification of breast cancer in traditional Korean medicine, analysis of previous experimental studies, and clinical trials. Conclusion: We have found the applicability of TKM for treatment of breast cancer through this review. It is necessary to conduct further studies, such as well-designed clinical trials based on the results from experimental research.

췌장암에 대한 국내 한의학 연구 동향 고찰 - 국내 한의학 논문을 중심으로 -

한가진,정하영,박은주,이아름,이준명,성신,김성수 대한한방내과학회 2019 大韓韓方內科學會誌 Vol.40 No.1

Objective: This study investigated the trends in pancreatic cancer research on Korean medicine in order to establish a direction for further study. Methods: Pancreatic cancer research on Korean medicine was reviewed using databases such as OASIS, KoreanTK, KISS, RISS, KISTI, and NDSL. The search terms were “pancreatic cancer” “Korean medicine,” and “herbal medicine.” There was no restriction on publication dates, and the reviewed studies were analyzed according to the type of research. Results: Nineteen studies were reviewed. The numbers and types of research were as follows: 9 clinical studies including case reports, 2 review studies, and 8 in vitro studies; there was no in vivo study. Among the clinical research were 3 descriptive studies and 6 case reports. The baseline characteristics and quality of life of pancreatic cancer patients were analyzed in the descriptive studies. In the case reports, interventions such as herbal medicine, pharmacopuncture, and acupuncture were used. Research articles on the review of pancreatic cancer were titled “Preliminary Study for Development of Korean Medicine Clinical Practice Guideline for Pancreatic Cancer” and “Systemic Review on the Tumor Dormancy Therapy.” Cell lines such as PANC-1, MIA PaCa-2, and AsPC-1 were used for in vitro studies. These studies have reported decreased cell viability, induced apoptosis, and changes in cancer-related gene expression. Conclusion: Through this review, we found that using Korean medicine for treating pancreatic cancer is applicable. However, due to overall limited the number of study, the benefit of Korean medicine for pancreatic cancer may be substantiated to a limited degree. Better methodological quality and large controlled trials are expected to further quantify the therapeutic effect of Korean medicine.

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.

어둠속에있는그대에게

한가진 중앙대학교 예술대학 문예창작학과 1984 창작문화 Vol.1 No.-

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.