• 제목/요약/키워드: Medical Act

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A Study on How Governance of Genetic Scissors CRISPR-Cas9 for Research on Embryos Can Encourage a Researcher to Have a Sense of Responsibility - Focus on the Bioethics and Safety Act Article 47 - (유전자가위 CRISPR-Cas9을 이용한 인간 배아 연구에 있어서 연구자의 책임의식 고양을 위한 거버넌스 -개정 생명윤리 및 안전에 관한 법률 제47조를 중심으로-)

  • Kim, Minsung
    • The Korean Society of Law and Medicine
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    • v.23 no.1
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    • pp.121-148
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    • 2022
  • CRISPR-Cas9 is one of the gene-editing technologies that infinite potential. It may provide human beings with many benefits or cause unanticipated challenges. The governance as standards setting or regulation of gene-editing technologies can contribute to keeping a balance between scientific value and ethical commitments. Guaranteeing public participation provides an additional opportunity to think about ethical and moral considerations: For whose benefit the internationally discussed governance of gene-editing technologies is directed at? There is a doubt regarding whether the governance justifies scientific researchers' gene-editing research. Suppose that governance promotes the advancement of CRISPR-Cas9, it should also encourage greater research responsibility. If not, there may be tragedies brought about by the misconduct of researchers. Thus, the essential matter on the governance for the research of CRISPR-Cas9 is the researchers' responsibility.

Current Status of Informed Consent Form for Acupotomy in Korean Medicine Hospitals and Development of a Standard Informed Consent Form Using Delphi Method (한방병원의 침도 시술 동의서의 현황 조사와 델파이 기법을 활용한 표준 시술 동의서 개발)

  • Jihun Kim;Bonhyuk Goo;Hyongjun Kim;Kyoungsuk Seo;Myungjin Oh;Myungseok Ryu;Sang-Hoon Yoon;Kwang Ho Lee;Hyun-Jong Lee;Jungtae Leem;Hyungsun Jun;Jeong Ihn Sook;Sung Woon Choi;Tae Wook Lee;Yeonhak Kim;Yoona Oh;Kunhyung Kim;Gi Young Yang;Eunseok Kim
    • The Journal of Korean Medicine
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    • v.45 no.1
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    • pp.182-201
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    • 2024
  • Objectives: This study was conducted to develop a standard acupotomy consent form that takes into account the unique characteristics of Korean Medicine. The study was motivated by the increasing importance of patient autonomy and the growing number of legal disputes related to medical malpractice in the clinical field of Korean Medicine. Methods: The analysis phase of the study involved a survey of the current status of acupotomy consent forms in Korean Medicine hospitals nationwide. The items of each form were analyzed based on the contents of the Medical law and the standard contract for medical procedures of the Fair Trade Commission (FTC). In the development and evaluation phase, the items and contents of the acupotomy consent form were evaluated using a 5-point Likert scale and content validity was assessed through two rounds of Delphi surveys. In the improvement phase, the contents of the consent form were revised based on the results of a survey of inpatient and outpatient patients in the Department of Acupuncture and Moxibustion at Pusan National University Korean Medicine Hospital, and real-time online meeting. The final version of the standard acupotomy consent form was completed after undergoing proofreading and corrections by a linguistics expert. Results: Only 30% of Korean Medicine hospitals have implemented acupotomy consent forms. The items of the consent forms did not fully include the items presented in the Medical act and the standard contract for medical procedures of the FTC. To address this issue, two rounds of Delphi surveys and a real-time discussion were conducted with a panel of 12 experts on 27 preliminary items of consent forms. The items and contents that met the criteria for content validity ratio, convergence, and consensus were derived. Based on the derived items and content, a standard acupotomy consent form was developed. Conclusions: The standard consent form for acupotomy is anticipated to ensure patient autonomy and enhance transparency and liability in acupotomy. Furthermore, it is expected to serve as evidence in case of medical disputes related to acupotomy and contribute as a reference document for the development of standard consents forms for various procedures of Korean Medicine. However, the limitations of the study include that the survey of consent forms was limited to only training hospitals of Korean Medicine, and the standard consent form is only applicable to adults in Korea. Future studies are needed to address these limitations.

Review of 2015 Major Medical Decisions (2015년 주요 의료판결 분석)

  • Yoo, Hyun Jung;Lee, Dong Pil;Lee, Jung Sun;Jeong, Hye Seung;Park, Tae Shin
    • The Korean Society of Law and Medicine
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    • v.17 no.1
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    • pp.299-346
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    • 2016
  • There were also various decisions made in medical area in 2015. In the case that an inmate in a sanatorium was injured due to the reason which can be attributable to the sanatorium and the social welfare foundation that operates the sanatorium request treatment of the patient, the court set the standard of fixation of a party in medical contract. In the case that the family of the patient who was declared brain dead required withdrawal of meaningless life sustaining treatment but the hospital rejected and continued the treatment, the court made a decision regarding chargeable fee for such treatment. When it comes to the eye brightening operation which received measure of suspension from the Ministry of Health and Welfare for the first time in February, 2011, because of uncertainty of its safety, the court did not accept the illegality of such operation itself, however, ordered compensation of the whole damage based on the violation of liability for explanation, which is the omission of explanation about the fact that the cost-effectiveness is not sure as it is still in clinical test stage. There were numerous cases that courts actively acknowledged malpractices; in the cases of paresis syndrome after back surgery, quite a few malpractices during the surgery were acknowledged by the court and in the case of nosocomial infection, hospital's negligence to cause such nosocomial infection was acknowledged by the court. There was a decision which acknowledged malpractice by distinguishing the duty of installation of emergency equipment according to the Emergency Medical Service Act and duty of emergency measure in emergency situations, and a decision which acknowledged negligence of a hospital if the hospital did not take appropriate measures, although it was a very rare disease. In connection with the scope of compensation for damage, there were decisions which comply with substantive truth such as; a court applied different labor ability loss rate as the labor ability loss rate decreased after result of reappraisal of physical ability in appeal compared to the one in the first trial, and a court acknowledged lower labor ability loss rate than the result of appraisal of physical ability considering the condition of a patient, etc. In the event of any damage caused by malpractice, in regard to whether there is a limitation on liability in fee charge after such medical malpractice, the court rejected the hospital's claim for setoff saying that if the hospital only continued treatments to cure the patient or prevent aggravation of disease, the hospital cannot charge Medical bills to the patient. In regard to the provision of the Medical Law that prohibit medical advertisement which was not reviewed preliminarily and punish the violation of such, a decision of unconstitutionality was made as it is a precensorship by an administrative agency as the deliberative bodies such as Korean Medical Association, etc. cannot be denied to be considered as administrative bodies. When it comes to the issue whether PRP treatment, which is commonly performed clinically, should be considered as legally determined uninsured treatment, the court made it clear that legally determined uninsured treatment should not be decided by theoretical possibility or actual implementation but should be acknowledged its medical safety and effectiveness and included in medical care or legally determined uninsured treatment. Moreover, court acknowledged the illegality of investigation method or process in the administrative litigation regarding evaluation of suitability of sanatorium, however, denied the compensation liability or restitution of unjust enrichment of the Health Insurance Review & Assessment Service and the National Health Insurance Corporation as the evaluation agents did not cause such violation intentionally or negligently. We hope there will be more decisions which are closer to substantive truth through clear legal principles in respect of variously arisen issues in the future.

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A Study of CVA patients에 Experience of the Illness (뇌졸중 환자의 질병경험에 관한 연구)

  • 남선영
    • Journal of Korean Academy of Nursing
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    • v.28 no.2
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    • pp.479-489
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    • 1998
  • This work was done for 9 patients having experience of a herb medical treatment after being diagnosed as CVA during a year from January, 1996 to December, 1996 by using an ethnographic research method. The summarized results of this research are following. Ⅰ. THE EXPERIENCE OF THE ILLNESS First, the falling-ill phase is the time that they have the first stroke of paralysis and the decision pattern of medical institution' comes out. The emotional experience in the period is something like 'flustration', 'anxiety', 'despair', and 'expectation'. Second, the active-treatment phase is the time that the patients as well as their family or care giver not only show the positive attitude and actively participate in the illness treatment but also show a lot of interest in medical institutions and activities of health recovery. There is a primary factor of the continuation of treatment as an experience of treatment and being crushed and sensitivity as an experience of the illness. Third, the rehabilitation phase is the time that the patients or their family become tired and insensitive to the treatment and recuperation, and then reduce the treatment activity. There is a primary influence factor of the discontinuance of treatment as an experience of treatment and physical experience and emotional experience as an experience of the illness. The physical experience is divided into 'personal-hygiene care', and 'the sphere of activity' The emotional experiences are 'blaming someone', 'contempt' and 'despair' as a negative experience and 'hope' as a positive experience. Ⅱ. COPING STRATEGY There are a physical coping, an emotional and mental coping, a social coping, and a spiritual coping as a coping strategy used for the patients to overcome their illness and adjust themselves to their altered life. First, the physical coping comes out as 8 categories, 'using an auxiliary tool', 'doing exercise', 'protecting', 'improving their diet', 'taking care of something', 'using subsidiary medicines', 'trying a folk remedy', and 'having interest in their health'. Second, for the emotional and mental coping, there are 'accepting' and 'trying' as a positive coping and a failure of control as a negative coping. Third, the social coping is appeared as 'being supported'. Fourth, the spiritual coping is recognized as' recourse to God' and 'preparation of death'. After all, the elderly CVA patients in an agricultural area choose the act of treatment based on the traditional belief and the relationship with a caretaker. A personal health can be maintained by taking care of themselves and controling their mind, and the overcome of the illness is decided on the basis of traditional concepts and cultural principles in which the patients as well as the family, neigbors and take carers should work out together and cooperate with each other in order to achieve that.

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Correlation between EGFR Gene Mutations and Lung Cancer: a Hospital-Based Study

  • Kavitha, Matam;Iravathy, Goud;Adi Maha, Lakshmi M;Ravi, V;Sridhar, K;Vijayanand, Reddy P;Chakravarthy, Srinivas;Prasad, SVSS;Tabassum, Shaik Nazia;Shaik, Noor Ahmad;Syed, Rabbani;Alharbi, Khalid Khalaf;Khan, Imran Ali
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.16
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    • pp.7071-7076
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    • 2015
  • Epidermal growth factor receptor (EGFR) is one of the targeted molecular markers in many cancers including lung malignancies. Gefitinib and erlotinib are two available therapeutics that act as specific inhibitors of tyrosine kinase (TK) domains. We performed a case-control study with formalin-fixed paraffin-embedded tissue blocks (FFPE) from tissue biopsies of 167 non-small cell lung carcinoma (NSCLC) patients and 167 healthy controls. The tissue biopsies were studied for mutations in exons 18-21 of the EGFR gene. This study was performed using PCR followed by DNA sequencing. We identified 63 mutations in 33 men and 30 women. Mutations were detected in exon 19 (delE746-A750, delE746-T751, delL747-E749, delL747-P753, delL747-T751) in 32 patients, exon 20 (S786I, T790M) in 16, and exon 21 (L858R) in 15. No mutations were observed in exon 18. The 63 patients with EFGR mutations were considered for upfront therapy with oral tyrosine kinase inhibitor (TKI) drugs and have responded well to therapy over the last 15 months. The control patients had no mutations in any of the exons studied. The advent of EGFR TKI therapy has provided a powerful new treatment modality for patients diagnosed with NSCLC. The study emphasizes the frequency of EGFR mutations in NSCLC patients and its role as an important predictive marker for response to oral TKI in the south Indian population.

The Analysis of radioactivity Concentration in drainage when using a radioactive Iodine (방사성옥소 사용 시 배수 중 방사능농도 분석)

  • Lee, Kyung-Jae;Sul, Jin-Hyung;Park, Young-Jae;Lee, In-Won
    • The Korean Journal of Nuclear Medicine Technology
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    • v.22 no.1
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    • pp.28-34
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    • 2018
  • Purpose With regard to the use of radioiodine in domestic medical institution, the case of exceeding the allowance of nuclear safety Act about radioactive concentration in drainage was found. Through understanding the cause of exceeding case and analyzing radioactive concentration in drainage, evaluating the relationship of the public waters in surroundings and usefulness. Materials and Methods From November 1, 2014 to April 30th, 2015, the research is aiming at domestic twenty hospitals for six months. By using a HPGe gamma-ray spectrometer(Canberra DSA-1000) and GENIE-2000 Analysis software for comparative analysis, measuring a radioactive concentration of radioiodine in drainage. Consequently, we confirm the excess of radioactive concentration of radioiodine in seven medical institutions. Results Conducting a survey of twenty hospitals and average radioactive concentration of radioiodine in drainage appears $42,100Bq/m^3$. The features of domestic hospitals where show a high radioactive concentration are a number of medical treatment patient when using radioactive iodine and the absence of private rest room. During I-131 whole body scan, the pretreatment procedure of urinating is considered emission of residual Iodine. In public waters, the cause of exceeding detect on radioactive concentration in drainage suppose a diagnostic radioactive iodine. Conclusion We confirm the importance of enhanced education, providing a safety control instructions and installing a private rest rooms for patients who injected a low capacity radioiodine. Also, constructing institutional and legal management system is considered about the Emission management standard in drainage.

A 6 Year Experience with the St. Jude Medical Cardiac Valve Prosthesis (St. Jude Medical 판을 이용한 심판막 치환술의 성적)

  • 조광현
    • Journal of Chest Surgery
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    • v.25 no.3
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    • pp.296-306
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    • 1992
  • A 6 year experience with the bileaflet St. Jude Medical valve is reported. Between Feb. 1986 and Dec. 1992, 68 patients received 87 such valves[36 mitral, 13 aortic, and 19 double mitral-aortic valve replacements]. The results are summarized as follows 1. There were 35 male and 33 female patients ranging in age from 17 to 55 years the mean age of 35.3 $\pm$ 9.7 years. 2. The mean aortic clamp time[ACT] of the MVR, AVR and DVR groups were 91.5$\pm$16.4, 117.2$\pm$28.7 and 165.5$\pm$24.1 minutes. The mean total bypass time [TBT] of the MVR, AVR and DVR groups were 112.8$\pm$19.5, 134.7$\pm$31.4 and 192.2$\pm$28.5 minutes. 3. Eighty seven valves were used [55 mitral site, 32 aortic site]. 31mm[20], 33mm[15], 29mm[15], 27mm[2], 25mm[2] and 35mm[1] were used in mitral site and 23mm[13], 21mm[8], 19mm[7] and 25mm[4] were used in the aortic site. In the DVR, there were valve combinations such as 4 cases of M[29mm]-A[19mm], 4 of M[31mm]-A[23mm], 3 of M[33mm]-A[23mm] and others. 4. Preoperative NYHA functional classes were II [3 cases], III [46 cases], IV[19 cases] and improved to I [52 cases] and Il [13 cases] postoperatively. 5 Early postoperative complications were occurred in 15 cases[2Z.l%] and there were LOS in 5 cases[7.4%], arrythmia [3 cases], wound infection [2 cases], hepatitis [2 cases], sudden cardiac arrest [2 cases] and postoperative bleeding [1 case]. The early hospital death was occurred in 3 cases[4.4%] with LOS [1 case] and sudden cardiac arrest [2 cases]. 6. Mean follow-up time of survival cases[65 cases] was 31.3$\pm$21.9 months and the total follow-up time was 169.8 patient-years. Late postoperative complications were occurred in 4 cases[2 thromboembolism, 1 paravalvular leak, 1 thromboembolism br paravalvular leak, 1 valve endocarditis] with the occurrence rate as 2.35% per patient-years. Reoperation was performed in 2 cases [1 paravalvular leak, 1 left atrial thrombus] and there was one [1.5%] late valve related death. Therefore the 6 year complication free rate was 90.6% and 6 year actuarial survival rate was 98.3$\pm$1.7%. On the basis of this experience and the results, SJMvalve appears to be one of the best performing mechanical prosthesis currently available, in terms of both hemodynamics and lower complications with warfarin antioagulation.

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Cost-Benefit Analysis of Back School Program for Occupational Low Back Pain Patients (직업성 요통환자에서 재활 프로그램(Back School Program) 도입의 비용-편익분석)

  • Ju, Yeong-Su;Ha, Mi-Na;Han, Sang-Hwan;Kwon, Ho-Jang;Cho, Soo-Hun;Kim, Chang-Yup;Kim, Sun-Min
    • Journal of Preventive Medicine and Public Health
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    • v.29 no.2 s.53
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    • pp.347-357
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    • 1996
  • Although occupational low back pain accounts for $20\sim40%$ of all occupational illness and injury, there are limited numbers of studies regarding the effectiveness of back school program. The objective of this study was to evaluate the economic benefit of back school program for early return to work of occupational low back pain patients in the current occupational injury compensation and management system. The cost-benefit analysis in this study was conducted to evaluate the relative magnitude of benefit to cost. The total cost was estimated by calculating the value of components in back school program according to governmental budget protocol. The back school program was consisted of three major approaches, pain center, work-hardening program and funcional restoration program and each of components had various facilities and experts. The total amount of cost was estimated as 250,866,220 won per year. The most promising type of back school program were quite intensive (a 3 to 5-week stay in a specialized center), therefore, if we adopted the 5-week stay course, 10 courses could be held in a year. Following to the medical act, 20 patients per doctor could participate in a each course, ie, total 200 patients in a year. As a result, we could estimate the cost of 1,254,331 won a patient. We estimated the benefit by using data of a few local labor offices about average medical treatment beneficiary and off-duty beneficiary of 46 occupational low back pain patients in 1994. Ullman and Larsson (1977) mentioned that the group of chronic low back pain patients who participated in back school program needed less time to recover by 48.4% of beneficiary duration. And in the trying to estimate the benefit, we asked 10 rehabilitation board certificate doctors about reduction proportion of treatment cost by introducing back school program. The answered reduction proportions were in the range of $30\sim45%$, average 39%. As a final result, we could see that the introduction of back school program in treatment of chronic occupational low back pain patients could produce the benefit to cost ratio as 3.90 and 6.28. And we could conclude that the introduction of back school program was beneficial to current occupational injury compensation and management system.

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Development of Enzyme Immuno Assay for Analysis of Free Prostate Specific Antigen in Serum (혈청 유리형 전립선항원 (free PSA) 측정을 위한 효소면역측정법의 개발)

  • Kyung-Ok Lee;Kyung-In Kim;Kyu-Pum Lee
    • Biomedical Science Letters
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    • v.3 no.2
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    • pp.107-114
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    • 1997
  • Recent reports indicate that the clinical usefulness of prostate specific antigen (PSA), particulary in the differentiation of benign prostate hyperplasia from prostate cancer, can be improved by measuring the amount of free PSA in serum. Measuring free PSA is especially useful in attempts to improve diagnositc performance of PSA in the diagnostic gray zone of total PSA. The objective of this study was to develop free PSA assay kit using sandwich microplate enzyme immunoassay format. We chose a test format with polyclonal anti-PSA antibodies coated on the wells and monoclonal anti-free PSA antibodies for quantification to gain higher test sensitivity. We adpoted 10 uL of specimen and 2 hours of first incubation time with detecting antibody for free PSA EIA format using microplate. The within-day and between-day precision (%CV) in the high and low concentration ranges were below 4%. The correlation coefficient between in-house free PSA assay and commercial assay kit was r=0.9965 (slope=0.0984, y intercept=0.0173, N=27). No hook effect was found by 40 ng/mL and correlation coefficient (r) value of the fitted linear regression was over 0.995. The recovery tests were in the range of 98.9∼104.1% for free PSA. In conclusion, in-house free PSA enzyme immune assay is cost effective, simple and rapid and could be useful for the prognosis after theraphy as well as for the differential diagnosis between prostate cancer and benign prostate hyperplasia.

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${\ll}$황제내경소문(黃帝內經素問).사기조신대논(四氣調神大論)${\gg}$ 주석서(注釋書)의 비교분석연구(比較分析硏究)

  • Lee Yong-Beom;Kim Seong-Hwan
    • Journal of Korean Medical classics
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    • v.13 no.1
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    • pp.184-232
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    • 2000
  • The trend of the concept for modern medicine is gradually forwarding to preventive medicine from therapeutic medical science. One of the most remarkable characteristics of oriental medicine is that it attaches greater importance to preventive medicine scientifically. The basic theory of oriental medicine principally takes roots in Huang Di Nei Jing and it is Si Qi Tian Shen Da Lun that is deep-rooted in the principle of "growing life" grounded in theory of unity of heaven and man of oriental medicine. Therefore having translated annotation of 〈Si Qi Tian Shen Da Lun·Huang Di Nei Jing Su Wen〉 which is quoted frequently and using it for appendix and comparing each views of annotators, I would like to state the results of dissertation as below. 1. Si Qi Tian Shen of title of the paper means that it keeps our health and prevent diseases in advance to control our mind and rhythm of life to the change of Yin and Yang - that is, the grower Yin, the looser Yang - following four seasons of nature environment. 2. The summary of this dissertation is that spring means things newly sprout from old ones, things become profuse, beautiful and brilliant in the summer. Autumn stands for things is harvested and allocated evenly and finally things is closed and stored. That is, in the spring and summer. If one break this principle of growth, diseases are followed after this. Therefore an excellent physician should handle diseases before they are attacked not remedy them after outbreak of diseases. It is said that a sage governs the nation before it is put into confusion. 3. These four terms standing for each season describe definitely and realistically rural life in the agricultural environment, in other words, spouting in spring, growing in summer, harvesting in autumn, storing in winter. Going with the current of the times, they have developed to theoretical concept of getting, growth, harvest, store so that implied the principle of growth for four seasons. 4. It means in a concrete way "Yang would grow in the spring and summer and Yin would grow in autumn and winter" as follow. That is, when the day is long, things act energetically and emit the warmth of life and expand the vigor of growth. On the other hand, when the night is long, things lessen their activity to protect the warmth of life and to preserve the sprit of growth. In addition, we should be concerned about the work outward and try to concretely fulfill plan of business in spring and summer. It is in autumn and winter when we should grow Yin. It does not mean that we simply grow cold yin in our body to build Yin. But according to annotators, for example, Wang Bing stated that we need to make things be cool in spring and summer, and be warm in autumn and winter for improvement. Zhang Jie Bin noted that things should not be cold in spring and summer and not be too hot to improve in autumn and winter. Those principles theorized to unify physiological status into the principle of changing of Yang and Yin in the nature and enriched the contents. In these principles, no problems are not found logically somewhat.

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