Objective: To investigate and understand the causes of partial disorder in health care market of traditional Chinese medicine in recent years and put forward relevant countermeasures and suggestions. Methods: A multi-stage stratified random sampling method was used to investigate 410 medical staff and 535 patients in 10 traditional Chinese medicine medical institutions in Beijing. Self-filling questionnaires were used to obtain relevant data on their views on partial disorder of health care services in traditional Chinese medicine. Statistical software SPSS22.0 was used to analyze the data. Results: Firstly, both doctors and patients believed that "unclear functions of supervision department" was the main cause of some disorder in health care industry of TCM. Secondly, medical staff were more inclined than patients to think that the main causes were "lack of access threshold for institutions and personnel", "unclear functions of supervision department"and "lack of basis for law enforcement". Thirdly, 63.0％ of medical staff said that the legal system most needed to promote the healthy development of health care industry in traditional Chinese medicine was "industry standard system". Conclusion: According to the results of the survey, this paper holds that the healthy development of health care services in traditional Chinese medicine should be ensured by standardizing the supervision system of health care in traditional Chinese medicine, strengthening the construction of industry standards, establishing the self-regulatory mechanism of the industry, standardizing the media propaganda of health care in traditional Chinese medicine, and strengthening the ethical constraints of practitioners.

Based on the questionnaire survey among 10 Traditional Chinese Medicine medical institutions in Beijing , this paper found that 65 . 2％ of the medical staffs and 82 . 0％ of the patients agreed to include the medical expertise into Traditional Chinese Medicine service system;37 . 3％ of the medical staffs believed that there was a certain risk of relaxing access of Traditional Chinese Medicine clinics, and 38. 4％ of the patients showed that they would choose private clinics to see a doctor. Most medical staffs considered that the current risks of Traditional Chinese Medicine diagnosis and treatment focused on standardized use of toxic decoction pieces and overdose of drugs. Medical staffs were most concerned about the risk of"diagnosis and treatment" on the Internet, were least worried about the risk of "distribution". The clinic registration system of the Law of the People ' s Republic of China on TCM, the registration system of the processed concocted decoction pieces, and the unclear scope of diagnosis and treatment technology posed challenges to future risk management, and it need to adopt the following countermeasures to respond:establishing a new multiple and multi-level risk management mechanism, exploring differentiated supervision, perfecting the technical norms and application scope of Traditional Chinese Medicine diagnosis and treatment, establishing a special system for regulating Traditional Chinese Medicine health care services, and establishing and improving a flexible supervision and law enforcement model to protect the legitimate rights and interests of relatives.

Different from Western medicine theory, Traditional Chinese Medicine knowledge is tacit knowledge, and the Traditional Chinese Medicine knowledge system also is a complete system independent from the Western medicine system. But the protection for Traditional Chinese Medicine knowledge nowadays still mainly stems from the Western intellectual property system. The current intellectual property system is in a dilemma in the protection of Traditional Chinese Medicine due to its limitations, and it urgently needs to build a special knowledge protection system that is specially applicable to traditional knowledge;while using genetic resources protection system and benefit sharing system of traditional knowledge from Convention on Biological Diversity to protect Traditional Chinese Medicine has its advanced nature and rationality. In the premise of clarifying the definition of "intellectual property right of Traditional Chinese Medicine", this paper proposed 5 countermeasures and suggestions, including establishing the legal content of Traditional Chinese Medicine intellectual property, promoting the legislative coordination of existing intellectual property law and the Law of the People' s Republic of China on TCM, strengthening the institutional coordination of the Law of the People' s Republic of China on TCM, the Law of Intangible Cultural Heritage and the Law of the People' s Republic of China on Drug Administration, promoting the institutional innovation at the local legislation level, and building a benefit sharing mechanism for the holders of Traditional Chinese Medicine knowledge.

The incidence of each of the rare disease is very low. The complexity and diagnosis difficulty of the rare disease lead to the difficulties in the clinical research and development (R&D) of drugs for rare diseases. There is an urgent clinical need for the drug development of rare diseases in China. Encouraging R&D of new drugs, particularly the innovative drugs with China's own independent intellectural property is the basis for solving the predicament in drug shortage in China.. In order to further improve the efficiency of clinical R&D of drugs for rare diseases, the National Medical Products Administration (NMPA), Center for Drug Evaluation (CDE) issued Technical Guidance for Clinical Research and Development of Drugs for Rare Diseases. This is the first guidance for rare diseases in China that is drafted from the standpoint of the clinical technology research and development.The guidance is the scientifitc thinking and framework for the drug developing enterprises to research and develop drugs for rare disease efficiently and appropriately by following drug developing protocols and relating to the special features of rare disease.This paper presents the concepts and rationale in the guidance for the appraisal of rare disease drug research and development.

BACKGROUND: The effect of arteriosclerotic intracranial arterial vessel wall enhancement (IAVWE) on downstream collateral flow found in vessel wall imaging (VWI) is not clear. Regardless of the mechanism underlying IAVWE on VWI, damage to the patient's nervous system caused by IAVWE is likely achieved by affecting downstream cerebral blood flow. The present study aimed to investigate the effect of arteriosclerotic IAVWE on downstream collateral flow. METHODS: The present study recruited 63 consecutive patients at the Second Hospital of Hebei Medical University from January 2021 to November 2021 with underlying atherosclerotic diseases and unilateral middle cerebral artery (MCA) M1-segment stenosis who underwent an magnetic resonance scan within 3 days of symptom onset. The patients were divided into 4 groups according to IAVWE and the stenosis ratio (Group 1, n = 17; Group 2, n = 19; Group 3, n = 13; Group 4, n = 14), and downstream collateral flow was analyzed using three-dimensional pseudocontinuous arterial spin labeling (3D-pCASL) and RAPID software. The National Institutes of Health Stroke Scale (NIHSS) scores of the patients were also recorded. Two-factor multivariate analysis of variance using Pillai's trace was used as the main statistical method. RESULTS: No statistically significant difference was found in baseline demographic characteristics among the groups. IAVWE, but not the stenosis ratio, had a statistically significant significance on the late-arriving retrograde flow proportion (LARFP), hypoperfusion intensity ratio (HIR), and NIHSS scores ( F = 20.941, P <0.001, Pillai's trace statistic = 0.567). The between-subject effects test showed that IAVWE had a significant effect on the three dependent variables: LARFP ( R2 = 0.088, F = 10.899, P = 0.002), HIR ( R2 = 0.234, F = 29.354, P <0.001), and NIHSS ( R2 = 114.339, F = 33.338, P <0.001). CONCLUSIONS: Arteriosclerotic IAVWE significantly reduced downstream collateral flow and affected relevant neurological deficits. It was an independent factor affecting downstream collateral flow and NIHSS scores, which should be a focus of future studies. TRIAL REGISTRATION ChiCTR.org.cn, ChiCTR2100053661.
Humans ; Constriction, Pathologic/pathology* ; Magnetic Resonance Imaging/methods* ; Middle Cerebral Artery/pathology* ; Tomography, X-Ray Computed