Current status of public health system in Guangdong-Hong Kong-Macao Greater Bay Area and improvement suggestion / 中华流行病学杂志

Guangdong-Hong Kong-Macao Greater Bay Area (GBA) has three public health systems under different systems, which plays an important role in the construction of the public health system in China. Further strengthening the construction of the public health system in the GBA will play an important reference role in the optimization and upgrade of China's public health system in the future. Based on the key consulting project of "research on the strategy of the modern public health system and capacity building in China" by Chinese Academy of Engineering, this paper deeply analyzes the current status and existing problems of public health system construction in GBA and suggests to improve and innovate the mechanisms of collaborative prevention and control of public health risks, resource coordination and joint research and result sharing, information sharing and exchange, personnel training and team building in order to comprehensively improve the capacity of public health system in GBA, and promote the construction of Healthy China.

Analysis on the Quality Status of in Vitro Diagnostic Reagents for National Medical Device Supervision and Inspection in 2020 / 中国医疗器械杂志

OBJECTIVE@#This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.@*METHODS@#This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.@*RESULTS@#The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.@*CONCLUSIONS@#It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.

Analysis on the Characteristics of Quality Variation of National Medical Device Supervision and Inspection in 2020 / 中国医疗器械杂志

This study is based on the summary of the characteristics of quality variation of national medical device supervision and inspection in 2020. According to the results of the national medical device supervision and inspection through comparative analysis, this study puts forward suggestions on the medical device production and supervision measures for the post-marketing products, so as to further improve the level of the medical device and ensure the safety use of medical device.

Analysis and Suggestions on National Drug Quality Disclosure System / 中国药房

OBJECTIVE：To provide reference for further improving the national drug quality disclosure system. METHODS ： The national drug quality disclosure system was analyzed in respects of general information ，implementation procedure ， implementation situation and effects ，and existing problems. The improvement suggestions were put forward. RESULTS & CONCLUSIONS：The national drug quality disclosure system had gone through the bulletin stage ，notice stage and announcement stage. At present ，it had become drug regulatory measure with timely release ，rigorous procedures and sanctions. The process of national drug quality disclosure included five steps ，ie. informing the sampling enterprises of the fact that the drugs were unqualified，controlling the risk of unqualified drugs ，providing legal relief to the notified units ，preparing the contents of the national drug quality notice ，and releasing the national drug quality notice to the public. In recent years ，National Medical Products Administration had made greater efforts to release the national drug quality notice. The release of the national drug quality notice has played an important role on forcing drug manufacturers to improve drug quality and enhance the credibility of drug regulatory departments. However ，there are also some problems ，such as the non-conforming report is not delivered in time ，the tracing time for suspected counterfeit TCM pieces is too long ，and the provincial drug regulatory bureau does not strictly control the first trial of complaints. It is suggested that National Medical Products Administration strengthen the training ，review and punishment of provincial drug regulatory departments ；at the same time ，provincial drug regulatory departments also need to strengthen responsibility and business capacity-building ，pay attention to relevant work and strengthen daily supervision.

Analysis of Quality Status of National Medical Device Supervision and Inspection in 2019 / 中国医疗器械杂志

Summarize the quality status and variety quality change characteristics of the sampling products through the Summary and analysis, according to the results of the national medical device supervision and inspection in 2019. Put forward suggestions on the development of the medical device industry and supervisory measures. Thereby, further improve the level of the medical device and ensure the safety use of medical device.

Discussion on the Quality Risk Reminder Mechanism of Drug Sampling and Testing in China / 中国药房

OBJECTIVE：To provide a reference for further improvi ng the quality risk reminder mechanism of the drug sampling and testing （called“the Reminder ”as for short ）in China ，and strengthening the drug quality management. METHODS ： The quality risk management situation of the drug sampling and testing were summarized ，and the legal nature ，main content and working procedures of the Reminder were analyzed. The latest data of the Reminder in 2020 were taken as an example to analyze the role of the Reminder in the investigation of potential drug quality risks ，and made the suggestions for existing problems. RESULTS & CONCLUSIONS ：Based on legal standards ，China’s drug regulatory departments had carried out exploratory research on drugs that may have quality and safety risks due to drug quality control blind spots or deviations of manufacturing enterprises ， and divided them into serious risks and general risks according to the severity of the problems found ，and implemented hierarchical management. The Reminder was an administrative measure for general drug quality risks based on the principle of persuasion first ， and did not have sanctions. Its main content covered all the information required for risk investigation and rectification （basic drug information， suggested risk information ， contact information ， risk discovery methods ， troubleshooting and rectification requirements，and responsibilities of local provincial drug regulatory departments ）. It involved five responsible parties ，ie. the inspection institution ，China Institute for Food and Drug Control ，National Medical Products Administration ，the provincial food and drug administration of the relevant manufacturing enterprises and the relevant manufacturing enterprises. Through the mode of closed-loop management ，the benign interaction between regulatory authorities and manufacturing enterprises could been realized. In 2020，National Medical Products Administration issued 312 reminders to 286 manufacturers，with an accuracy of 87.91％，which was scientific and targeted. The manufacturer had carried out a series of rectification measures for the contents of the Reminder ， including carrying out process verification ，revising internal control standards and strengthening production process control. However， there were also some problems ， such as the rationality of the prompt contents being questioned by the manufacturer and the i nsufficient investigation of the manufacturer. It is suggested that the manufacturers correctly understand the nature and value of the Reminder. The inspection agency should further improve the scientific pertinence of the problems found ，while the drug regulatory department should focus on the troubleshooting of the problems found ，so as to jointly promote the improvement of drug quality.

Current Status Analysis and Suggestions on the Results Disclosure of Drug Sampling and Testing in China / 中国药学杂志

OBJECTIVEP: To provide a reference to improve the information disclosure of drug sampling and testing. METHODS: Through literature and information disclosure measures research, combined with examples, the historical evolution, disclosure form, disclosure status, and significance of the drug sampling and testing results disclosure in China was analyzed, suggestions was made. RESULTS: AND CONCLUSION: The disclosure of drug sampling and testing results are helpful to improve the government's credibility, protect the public's right to know, deter illegal enterprises and promote the improvement of drug quality. It is suggested that the drug regulatory department learn from the FDA's experience to improve the legal status of information disclosure, strengthen timeliness, transform results, monitor public opinion and remove the enterprise information from public environment after credit repair,and all circles of society correctly understand and rationally treat the information disclosure content, in order to improve the information disclosure of drug sampling and testing and promote the social co-construction and co-governance of drug quality and safety.

Comparative Analysis of Test and Retest Contents between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing / 中国药房

OBJECTIVE：To provide re ference for the relevant personnel of drug quality sampling and testing to understand and implement the new requirements in the Management of Drug Quality Sampling and Testing . METHODS ：The test and retest requirements were compared between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing. The revised and newly added contents were analyzed ，and the recommendations for implementation were put forward. RESULTS & CONCLUSIONS ：Referring to drug regulation need ，related requirements of test and retest in the Management of Drug Quality Sampling and Testing were modified and supplemented on the basis of the Regulation of Drug Quality Sampling and Testing . In the requirements for test ，the requirements for test items were revised ，the requirements for test time limit were confirmed ，the requirements for test report ，original record and quality management system ，the definition of “serious risk ” and its reporting requirements were added newly. The requirements for exploratory research were put forward for test institutions， as well as new requirements for test institutions and inspectors ’behaviors. In the requirements for retest ，the materials to be submitted for retest were revised ，and the identity certificate of the manager and time limit certificate were added ；the situation of no-retest were revised ，and the treatment method were added when obviously visible foreign matters were detected ；transfer requirements for retest report were added newly. It is suggested that the relevant personnel should pay more attention to the above changes，strengthen the construction of test capacity a nd the management of tes t time and quality ，attach importance to serious quality risks ，actively carry out exploratory research ，and mind their own test behaviors ；strictly review retest materials ， pay attention to the newly revised no-test and comprehensively transfer the retest report according to the requir ements and actual situation ，conduct and implement the Management of Drug Quality Sampling and Testing actively.

Analysis of Variety Selection for Medical Device Supervision and Inspection / 中国医疗器械杂志

This article introduces the process and principles of variety selection for medical device supervision and inspection, and it analyzes the reason and consideration of the variety selection data of national medical device supervision and inspection from 2017 to 2019, it also put forward a collection of selected varieties for reference in the future by sorting out the classified catalogue of medical devices and diagnostic reagents.

Risk Point Analysis of Product Quality and Safety in Sample Inspection of National Medical Device Supervision / 中国医疗器械杂志

This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.

Establishment of Sampling Inspection Scheme Paradigm for Medical Device Sampling Inspection / 中国医疗器械杂志

This paper introduces the sampling scheme and the inspection scheme paradigm followed in organizing the sampling inspection of medical devices. The sampling scheme paradigm includes the definition and operation guidelines for sampling products, the regulations for individual sampling batches and related model specifications, accessory data, validity period, storage conditions, etc., the requirements for sampling areas, places and quantities, and the requirements for samples to be sent to inspection institutions. The inspection scheme paradigm includes the provisions for inspection basis, inspection items and determination principles.

Application of intestinal CT texture analysis and nonlinear discriminant analysis in differential diagnosis of colorectal cancer and ulcerative colitis / 上海交通大学学报（医学版）

Objective·To evaluate the value of texture analysis in the discrimination of colorectal cancer (CRC) and ulcerative colitis (UC). Methods?·?The CT images of 61 CRC patients, 62 UC patients and 42 control objects were retrospectively analyzed. All the patients were pathologically proved and performed triphasic contrast-enhanced CT scan: non-enhanced phase (NP), the arterial phase (AP) and the enteric phase (EP). The region of interest was drawn along the abnormal bowel wall’s edge in each scan phase and texture features were generated by MaZda software. Based on 3 texture feature selection methods, the optimal subsets were generated and analyzed by 6 texture feature classification methods. The results were shown by misclassification rate (MCR). To compare the performance of texture-based classification and human visual classification, two radiologists with more than 10 years of gastrointestinal disease diagnostic experience analyzed the data. Results?·?The texture analysis based average MCR of differentiation between CRC and UC was (28.42±6.89)%, (28.19±4.07)%, (19.10±3.58)% in NP, AP, EP respectively. Compared with other texture feature classification methods, nonlinear discriminant analysis (NDA) was more accurate. In EP, NDA achieved an excellent classification result (MCR=12.61%). The average MCR between CRC and normally dilated bowel wall (NOR) was (13.33±7.21)%, (15.49±5.47)%, (6.74±3.02)%, while the average MCR between UC and NOR was (19.26±4.68)%, (20.04±6.63)%, (16.74±6.36)% in NP, AP and EP respectively. For visual classification between CRC and UC, the average MCR was (40.48±3.21)%, (35.71±1.60)%, (26.43±1.15)% in NP, AP, EP respectively. But the MCR of texture classification was lower than that of human vision classification, and computer texture classification had higher differential diagnosis rate. Conclusion?·?The CT-based texture analysis could be a feasible supplementary method to differentiate CRC from UC. NDA is more accurate than other classification methods, especially in EP.

Analysis of Changing the Original Test Result after Retesting in National Medical Device Sampling and Testing from 2013 to 2016 / 中国医疗器械杂志

The types and the reasons of changing the original test result after retesting in national medical device sampling and testing from 2013 to 2016, are summarized and analyzed. Firstly, collecting data of "standards not complied" and retesting. Then, giving specific examples when summarizing five types of changing the original test result after retesting. Meanwhile, analyzing the relevant reasons, discovering the deep problems. Finally, giving suggestions for the above problems.

Observation of the effect of bismuth pectin combined with aluminium phosphate gel in the treatment of chronic atrophic gastritis / 中国基层医药

Objective To observe the clinical efficacy of bismuth pectin combined with aluminium phosphate gel in the treatment of chronic atrophic gastritis.Methods 110 patients with chronic atrophic gastritis were randomly divided into observation group(n =55) and control group(n =55).The observation group received bismuth pectin combined with aluminium phosphate gel treatment,the control group received bismuth pectin and amoxicillin treatment.The occurrence of pathological changes of integral clinical efficacy and adverse reaction were compared between the two groups.Results The total effective rate of the observation group was 87.27％,which was significantly higher than 74.55％ of the control group (x2 =5.238,P ＜ 0.05).The atrophy,intestinal metaplasia,dysplasia,chronic inflammation,activity of pathological scores in the observation group were (2.36 ± 0.79) points,(1.11 ± 0.18) points,(2.19 ± 0.54) points,(1.35 ± 0.27) points,(0.43 ± 0.16) points,respectively,which were significantly lower than (1.44 ± 0.57) points,(0.48 ± 0.29) points,(1.38 ± 0.52) points,(0.69 ± 0.22) points,(0.21 ± 0.09) points in the control group (t =7.004,13.688,8.013,7.240,8.888,all P ＜ 0.05).The incidence rate of adverse reactions of the observation group was 5.45％,which was significantly lower than 18.18％ of the control group (x2 =7.777,P ＜ 0.05).Conclusion Bismuth pectin combined with aluminium phosphate gel in the treatment of chronic atrophic gastritis can significantly reduce the clinical symptoms,and has better clinical curative effect,low incidence of adverse reactions,it is safe,reliable and worthy of promotion in clinical.

Research progress on acupuncture therapy forxerophthalmia / 国际中医中药杂志

The clinical and experimental publish literatures of the traditional acupuncture treatment for xerophthalmia were review and selected, and the acupoints and outcomes index were analyzed. The clinical studies demonstrated that acupoints around eyes, head and face were mainly coordinated with Zangfu organs and meridians; and the experimental studies showed the effect of acupuncture work through stimulation of the lacrimal gland secretion, repairing lacrimal gland structure, inhibition of apoptosis to increase the flow of tears, extending the breakup time of lacrimal film, and relieving eye related symptoms.

Clinical efficacy on xerosis conjunctivitis of liver and kidney yin deficiency treated with SHI's acupuncture manipulation / 中国针灸

<p><b>OBJECTIVE</b>To compare the efficacy of the patients of xerosis conjunctivitis with liver and kidney yin deficiency among the combined therapy of acupuncture and Shi's manipulation, common acupuncture and artificial tears therapy.</p><p><b>METHODS</b>One hundred and eight patients were randomized into an acupuncture group, a SHI's manipulation group and an artificial tears group, 36 cases in each group. A total of 15 cases dropped out before the end of the study, including 4 cases in the acupuncture group, 6 cases in the SHI's manipulation group, and 5 cases in the artificial tears group. In the acupuncture group, acupuncture was applied to Jingming (BL 1) and Qiuhou (EX-HN 7) on the affected side, and the bilateral Sanyinjiao (SP 6) and Taixi (KI 3). The needles were retained for 20 min. In the SHI's manipulation group, on the basis of the treatment as the acupuncture group, Shuigou (GV26) was added and stimulated with SHI's acupuncture manipulation. In these two groups, acupuncture was given 3 times a week totally for 3 weeks. In the artificial tears group, sodium hyaluronate eye drops were used, 5 times a day, for 3 weeks totally. Separately, before treatment, at the moment after the 1st treatment and 3 weeks after treatment, the subjective symptom score, Schirmer I test, breakup time (BUT) of tear film were observed in each group.</p><p><b>RESULTS</b>(1) Subjective symptom score: at the moment after the 1st treatment and 3 weeks after treatment, the scores in each group were all reduced significantly as compared with those before treatment (all P < 0.05). At the moment after the 1st treatment, the score in the SHI's manipulation group and the artificial tears group was reduced apparently as compared with that in the acupuncture group (both P < 0.05). In 3 weeks of treatment, the score in the SHI's manipulation group was reduced apparently as compared with the acupuncture group and the artificial tears group (both P < 0.05). (2) For Schirmer I test, at the moment of the 1st treatment, the result in the SHI's manipulation group and the artificial tears group was improved significantly as compared with that before treatment (both P < 0.05). In 3 weeks of treatment, the result in the acupuncture group and the SHI's manipulation group group was improved significantly as compared with that before treatment (both P < 0.05). At the moment of the 1st treatment, the result in the artificial tears group was improved significantly as compared with the acupuncture group and the SHI's manipulation group (both P < 0.05). In 3 weeks of treatment, the result in the acupuncture group and the SHI's manipulation group was better than that in the artifi-cial tears group separately (both P < 0.05). (3) For BUT, the result in the acupuncture group and the SHI's manipulation group was prolonged significantly as compared with that before treatment and was prolonged apparently as compared with that in the artificial tears group (both P < 0.05) in 3 weeks of treatment.</p><p><b>CONCLUSION</b>The intervention of SHI's acupuncture manipulation relieves the subjective symptoms of xerosis conjunctivitis of liver and kidney yin deficiency and achieves the same efficacy as the common acupuncture and artificial tears treatment. It does not present the apparent advantages as the common acupuncture in the short term for promoting the tear secretion and tears film repair.</p>

Primary exploration of the product quality supervision on medical devices in use / 中国医疗器械杂志

This paper focuses on issues needed to be clear towards the product quality supervision of medical devices in use. The life circle of medical devices, the supervision regarding its boundary, target, emphasis, basis and standards have been analyzed in turn. A clear and creative idea is also provided for theoretical exploration of the supervision on medical devices in use.

Analysis of the status and countermeasures of sales supervision on medical devices / 中国医疗器械杂志

This article analyzes the status quo of sales supervision on medical devices through some aspects, including the relevant regulation system, the standards of sales admittance, the supervision team and the approval of business license. According to the exiting problems, some improving countermeasures are proposed for reference.

Discussion on the revision of National Administrative Provisions for the Sampling and Testing of Quality Supervision on Medical Devices / 中国医疗器械杂志

This paper focused on the revision of national administrative provisions for the sampling and testing of quality supervision on medical devices, according to the practice, it introduced the scope of application, Chinese system of sampling and testing on medical devices, the methods of sampling, inspection standards, re-inspection institutes and the other issues should be taken into consider and discussed The current situation of these issues, main idea of the revision and influences of the provisions were also analyzed to provide theoretical exploration for the revision.

Reform on diversified teaching of medical imaging / 中华医学教育探索杂志

Discipline of medical imaging has developed very quickly,which play an increasingly important role in the diagnosis and treatment of clinical disease.According to the characteristics of medical imaging disciplines,we launched reform on teaching management,teaching methods,course content,teacher training and modes of teaching,examing and researching in an aim to improve medical imaging education standards.