• 동의생리병리학회지
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• 제20권6호
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• pp.1678-1727
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• 2006

This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

• 동의생리병리학회지
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• 제31권2호
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• pp.126-137
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• 2017

This study was aimed to develop the instrument of Korean medical pattern Identification and Functional Evaluation for Five Organ. This study followed seven steps, consisted of first composition of research members, second set-up of the aim, third review for advanced research, fourth finding an important index, fifth puting on the weight for index, sixth advice from linguist and last development of draft of questionnaire. Twenty two in and out researchers joined and put the weight on each question. We developed a draft version of questionnaire of Korean medical pattern identification and functional evaluation for five organ. Most questions between pattern identification and functional evaluation of five organ have similar weight, but several ones have difference in order. Generally, specific symptom represented specific location or related with pain have relatively higher weight on pattern identification, and weakness question gained weight on functional evaluation. We develop the questionnaire of Korean medical pattern identification and functional evaluation for five organ. Following study, which will evaluate the reliability and validity, is needed.

• 동의생리병리학회지
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• 제30권2호
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• pp.124-130
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• 2016

The aim of this study was to suggest the future direction of diagnostic and evaluative pattern identification questionnaire (PIQ) by reviewing the state of development and utilization of PIQ according to Korean classification of disease-U (KCD-U). We surveyed the database of OASIS, NDSL, KISS, DBPIA, and Pub-med to know the kinds of developed and developing PIQ of Korean medicine. We used 'Pattern Identification' and 'Questionnaire' to find suitable papers. The inclusion criteria met 47 cases. The number of PIQ before 2000yrs, between 2001 to 2005, 2006-2010, 2011-2015 were 2, 5, 18, 22cases. The number of PIQ belonged to the disease of Korean medicine, the pathological symptom of korean medicine, the Sasang constitutional pattern identification and etc according to KCD-U were 20(42.6%), 8(17%), 9(19.1%) and 10(21.3%). Twenties among forty seven PIQ were validated, and the rest of them were not validated. The distribution of the numbers of PIQ were significantly different according to KCD-U (p=0.003). The direction of Utilization of PIQ was 36 questionnaires in diagnosing PI, 14 cases in evaluating health state, 4cases in evaluating effects of a treatment and 8 ones in diagnosing Sasang constitutional types. This study reveals the status on validated and non-validated PIQ of Korean medicine and suggests the basic information for the direction of developing PIQ in the future.

• 동의생리병리학회지
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• 제25권6호
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• pp.1113-1118
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• 2011

In this paper, when a physician make a diagnosis of the pattern identification (PI) in Korean stroke patients, the development methods of the PI classification function is considered by diagnostic questionnaire of the PI for stroke patients. Clinical data collected from 1,502 stroke patients who was identically diagnosed for the PI subtypes diagnosed by two physicians with more than 3 years experiences in 13 oriental medical hospitals. In order to develop the classification function into PI using Korean Stroke Syndrome Differentiation Standard was consist of the 44 items (Fire heat(19), Qi deficiency(11), Yin deficiency(7), Dampness-phlegm(7)). Using the 44 items, we took diagnostic and prediction accuracy rate through of discriminant model. The overall diagnostic and prediction accuracy rate of the PI subtypes for discriminant model was 74.37%, 70.88% respectively.

• 동의생리병리학회지
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• 제32권3호
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• pp.165-170
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• 2018

The aim of this study was to investigate the predictive validity of the five organ pattern identification questionnaire(FOPIQ). Data collection was conducted from 190 people who were randomly selected from the general population living in D city from October 2016 to June 2017, and the collected data were analyzed by SPSS 23.0 Statistics Program. Pearson correlation coefficient was used to know the relation between the expert's score and FOPIQ's one. The cut-off value, sensitivity and specificity were analyzed through ROC-curve. Significant p was <.05. The pearson correlation coefficient was .735, .756, .762, .736, and .513 between individual score of FOPIQ and that of the experts in liver, heart, spleen, lung, and kidney, respectively. The cut-off value of the FOPIQ was 46.209, 47.276, 45.336, 48.823, and 42.508 in liver, heart, spleen, lung, and kidney respectively. The AUC derived from the cut-off value of the FOPIQ was .907, .854, .888, .902, and .781 respectively. This study suggests that the FOPIQ could be valid to apply for general population in clinics as well as health checkups.

• 대한한의학회지
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• 제28권3호통권71호
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• pp.23-36
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• 2007

Objective : To poll oriental medical doctors on their opinions about the necessity of standard medical charts and of detailed items in their development. Currently, oriental medical institutions use their own medical charts, but a standard medical chart is necessary for medical information sharing. Methods : Report by 912 of the 10,490 oriental medical doctors surveyed on their general aspects, actual conditions, and requirements. Results : The oriental medical doctors surveyed who worked in oriental medicine clinics, oriental medicine hospitals, and public health centers said medical examination programs should consist of chief complaints (said by 814 respondents or 89.25%), history (792 or 86.84%), ordinal symptoms (753 or 82.57%), diet (727 or 79.71%), emotions and overstrain (654 or 71.71%), side effects and allergies (622 or 68.20%), improvement of symptoms (605 or 66.34%), a questionnaire on particular diseases (558 or 61.18%), social aspects (523 or 57.35%), a physical examination (520 or 57.02%), a questionnaire on syndrome differentiation (514 or 56.36%), diagnosis using medical devices and laboratory tests (471 or 51.64%), and Sasang constitution (357 or 39.14%). Ninety-one percent of the respondents said they intended to use a standard chart, and 82.19% agreed to share patient information with medical institutions. Conclusions : Over 90 percent of the oriental medical doctors surveyed said they need a standard medical examination program. Oriental medical examination items that correspond with the opinions of the oriental medical doctors surveyed and of experts will thus be developed, and the draft chart will be distributed to oriental medical institutions with the developed medical forms and electronic medical chart.

• Journal of Acupuncture Research
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• 제21권3호
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• pp.215-229
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• 2004

Objective : We had a clinical report in headache but didn't in migraine. We have planned this study in order to get the basic data of migraine in oriental medicine. Methods : The patient of 36 in migraine checked sex, age, onset, family history, severity of pain, influences of life, induced cause, clinical pain characteristics, associated symptom, treatment style, and prescription, frequency, using period of analgesics by a questionnaire and differentiated syndromes in migraine and evaluated autonomic bioelectric response recorder(ABR-2000). Results : There are 23.4% in prevalence rate of migraine. The ratio of sex is M:F=1:17. The age of an attack is the highest in thirties. The patient are the most in forties. The mean duration of illness is $12.0{\pm}9.9$ years. 83.4% had a family history. 61.1% had a moderate grade in severity of pain. 77.8% selected fatigue in induced cause of migraine. 69.4% had tingling sense, nausea and vomiting in the associated symptoms. 91.7% used analgesics for treatment and 51.5% of them used analgesics voluntarily. 61.9% of them take analgesics less than once in a week. 33.6% had the phlegm syncope headache in differentiation of syndrome. In ABR-2000 results, item of graph showed low tendency mostly. Conclusions : We expected that this report of clinical progress, differentiation of syndromes and ABR-2000 results in migraine would be used basic data by oriental medicine to treat migraine.

• 대한한의학회지
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• 제42권1호
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• pp.1-11
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• 2021

Objectives: This pilot study aimed to evaluate the agreement between traditional face-to-face Korean medicine (KM) pattern identification and non-face-to-face KM pattern identification using the data from related questionnaires, tongue image, and pulse features in patients with cancer. Methods: From January to June 2020, 16 participants with a cancer diagnosis were recruited at the one Korean medicine hospital. Three experienced Korean medicine doctors independently diagnosed the participants whether they belong to the cold pattern or not, heat pattern or not, deficiency pattern or not, and excess pattern or not. Another researcher collected KM pattern related data using questionnaires including Cold-Heat Pattern Identification (CHPI), tongue image analysis system, and pulse analyzer. Collected KM pattern related data without participants' identifier was provided for the three Korean medicine doctors in random order, and non-face-to-face KM pattern identification was carried out. The kappa value between face-to-face and non-face-to-face pattern identification was calculated. Results: From the face-to-face pattern identification, there were 13/3 cold/non-cold pattern, 4/12 heat/non-heat pattern, 14/2 deficiency/non-deficiency pattern, and 0/16 excess/non-excess pattern participants. In cold/non-cold pattern, kappa value was 0.455 (sensitivity: 0.85, specificity: 0.67, accuracy: 0.81). In heat/non-heat pattern, the kappa value was 0.429 (sensitivity: 0.75, specificity: 0.72, accuracy: 0.75). The kappa value of deficiency/non-deficiency and excess/non-excess pattern was not calculated because of the few participants of non-deficiency, and excess pattern. Conclusions: The agreement between traditional face-to-face pattern identification and non-face-to-face pattern identification seems to be moderate. The non-face-to-face pattern identification using questionnaires, tongue, and pulse features may feasible for the large clinical study.

• 대한중풍순환신경학회지
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• 제8권1호
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• pp.17-21
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• 2007

Objectives : This study was done to investigate the relationship of drinking and Dampness-Phlegm pattern in acute stroke patients. Methods : In the time of period Mar. 2007 to Jun. 2007, 103 patients with stroke admitted in the department of Internal Medicine of Kyungwon University Seoul Oriental Medical Hospital, Kyungwon University Incheon Oriental Medical Hospital, Kyunghee University Oriental Medical Hospital, Dongguk Il-san Oriental Medical Hospital were included. Patients were hospitalized within a month after the onset of stroke. Stroke patients were interviewed by residents who studied standard operation procedures in Fundamental Study for Standardization and Objectification of Differentiation and Pattern Identification of Syndrome of Oriental Medicine for Stroke. A questionnaire was completed by a question-and-answer form between patients and residents after explanation details to patients and the agreement of patients. Results : Drinking subjects have tendency of Dampness-Phlegm Pattern(p=0.096), but don't have statistical significance(p<0.05). Conclusions : In this study, we found the relationship of drinking and Dampness-Phlegm Pattern. To acquire more concrete conclusion on this theme, we need more research.

• 대한중풍순환신경학회지
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• 제7권1호
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• pp.46-53
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• 2006

Objectives : The purposes of this study were to investigate that a blepharospasm means the presymptom of stroke based on the traditional hypothesis in the oriental medicine and to compare a blepharospasm with warning signs of stroke in the western medicine. Methods : In the time period Oct. 2005 to Oct. 2006, 409 patients with a first-ever stroke admitted in the department of Internal Medicine of Kyungwon University In-cheon Oriental Medical Hospital, Kyunghee University Oriental Medical Hospital, Dongguk Il-san Oriental Medical Hospital were included. Patients were hospitalized within 14 days after the onset of stroke. Stroke patients were interviewed by residents who studied standard operation procedures in Fundamental Study for Standardization and Objectification of Differentiation and Pattern Identification of Syndrome of Oriental Medicine for Stroke. A questionnaire was completed by a question-and-answer form between patients and residents after explanation details to patients and the agreement of patients. Results : Age, care of patients or grandson, diabetes mellitus, and smoking were higher among cerebral infarction group, while smoking was higher among hemorrhage group. Female, young age, hyperlipidemia, hypertension in the family history and fat body in waist-hip ratio were higher among patients undergoing the blepharospasm before stroke onset. And the incidence of blepharospasm was lower in patients who dislike the fast food. Finally, when we compared a blepharospasm with warning signs of stroke in the western medicine, the incidence of blepharospasm in this study were the most frequent. Conclusion : In this study, the incidence of blepharospasm in patients before stroke onset was more frequent than that of warning signs in the western medicine. But more data from prospective cohort studies should be collected to be accepted that the blepharospasm is the presymptom of stroke as like warning signs in the western medicine.