The blood transfusion service blue book is released, the future development trend of blood products!

Medical Network September 7th, September 6th, the "Blue Book of Blood Transfusion Service: China Blood Transfusion Industry Development Report (2018)" was held in Shanghai by the Editorial Committee of Blood Transfusion Service Blue Book and Social Science Literature Publishing House. .

The Blue Book of Blood Transfusion Service was written by many professionals in the field of transfusion medicine in China. It discussed the development of the blood supply and blood transfusion service industry in 2017, including blood supply and blood supply equipment, information construction, blood quality management, clinical blood transfusion technology, and blood transfusion research. Construction, business leadership training and the development of blood supply and blood supply at some provincial and prefecture levels, etc., put forward a lot of new ideas and reflections, informative and wide-ranging, showing the independent views, ideas and research contents of the industry and experts. .

Since the "People's Republic of China Blood Donation Law", "Blood Station Management Measures", "Blood Station Quality Management Regulations", "Blood Station Laboratory Quality Management Regulations" and other series of regulations have been promulgated and implemented successively, China's blood supply and blood supply industry has developed rapidly under the guidance of laws and regulations. At the same time that the blood collection volume is increasing year by year, all kinds of modern equipment are used throughout the blood supply chain. It has become a necessary condition for normal blood bank operation, efficient operation and blood safety, such as blood testing from manual methods to fully automatic testing equipment. It not only makes blood testing safe, accurate, timely and effective, but also realizes the traceability of the detection process. The preparation of blood components from manual separation to automation, information transformation, standardization and standardization of blood component preparation. For the purpose of profit, it is a public welfare health institution that collects and provides clinical blood. The resource allocation of the blood station should be borne by the government. However, due to the different levels of economic development, the equipment configuration of the blood station may also vary greatly. Clear the allocation of equipment on the blood supply chain in the blood stations in different regions of the country to better formulate China's "one Blood Device Configuration Requirements "standard, Chinese Society of Blood Transfusion equipment Professional Committee in 2017 8 to 12 months organized a national blood bank equipment section configuration research.

The survey involved 115 blood stations in 25 provinces, autonomous regions and municipalities directly under the Central Government, but not in Inner Mongolia, Anhui, Hainan, Yunnan, Shaanxi and other provinces. There are only 4 central blood stations and 3 blood centers in North China, and 5 in the southwest. One central blood station and two blood centers have fewer blood stations and less effective data, so they may not reflect the real situation in these two areas.

Since the promulgation and implementation of the 'One Law and Two Regulations', the blood station has gone through more than 10 years of development. With the modernization of the blood station and the construction of information, many of the equipment purchased by the blood station in the same year are aging to be updated. Some of the devices that need to be configured are updated, backed up and expanded, such as the relatively early implementation of automated blood serological testing equipment; the other part is the need to gradually realize automation, information equipment, such as Automatic blood component separation instrument, automatic blood type analyzer, second generation ID card reader, residual white blood cell counter, etc. From the research status quo, the current blood station and blood supply industry equipment configuration mainly has the following problems.

(1) The configuration of the blood station equipment is related to the regional economic development status and the financial investment of the local government.

According to this survey, the average number of blood components, blood tests, and other devices in the southwestern region are ranked at the end. The northeast region is even ahead of other regions in some low-value equipment, such as hemoglobin. Test strip, application of hand-held heat sealing machine, but high value large equipment The penetration rate and average number are not high, such as aseptic bonding machine, blood irradiator, blood component separation automatic equipment, enzyme-free detection and nucleic acid detection equipment, etc. Assuming that all equipment has a weighting factor of 1, all equipment is popularized. The rate is added by region, and the average number of devices is added by region. The equipment configuration is ranked as: North China>Central South>East China>Southwest>Northeast>Northwest. Although the economy is developed in East China, However, in terms of blood station equipment configuration, it is not as good as North China and Central South. It can be seen that in addition to relying on local economic conditions, blood station equipment configuration must rely on the local government's attention to the blood supply industry and its financial input.

If each item is compared with the central blood station and the blood center, the latter is superior to the former. The reason is that the blood center is generally located in the municipality, the provincial capital city, and its economic development is higher than the city where the surrounding central blood station is located. However, from the whole country Inside, it is not excluded that the central blood station in economically developed areas and the blood center in economically underdeveloped areas are inverted. Similarly, even in the same area, the gap between the central blood stations still exists. For example, Guangdong, Jiangsu.

Since blood testing is the earliest department in the blood station to achieve automation and informationization, and the preparation of components, the quality sampling department has always relied more on manual work. Therefore, except for the detection facilities of central blood stations in some areas, the configuration is poor. The blood test equipment performance of blood stations in some areas is not much different, but there is only a difference in quantity. In recent years, the preparation of ingredients has only begun to implement automation, informationization, and automation equipment for quality sampling, so the blood station equipment is configured in these two. The department gap is more obvious.

According to the daily processing capacity of various equipment: North China>Central South>Southwest>East China>Northeast>Northwest. Composition preparation in North China, blood testing equipment load is large, but it may also be due to blood in the statistical area The proportion of the center is significantly higher than other regions. Northeast, northwestern region has less equipment load, which is related to local blood collection.

(5) In blood stations in economically underdeveloped areas, there is a general problem of equipment aging

For example, in many central blood stations in Shaanxi Province, most of the large-scale key equipment has been used for more than ten years. The equipment is outdated and the degree of automation is low. It has become a major hidden danger affecting blood quality and safety. Most of the central blood stations in Yunnan Province use equipment ( Including the blood donation vehicle) Most of the 2002 national debt project configuration, with the increasing supply of blood supply, the equipment failures occur frequently, the damage aging situation is highlighted, the blood safety has a hidden danger. The use of equipment in Guangdong Province for 5 to 10 years accounted for 33.07%, equipment used for more than 10 years accounted for 20.04%, especially the equipment in Yuedong, Yuexi, and Yuebei blood stations is more prominent. Liu Jiaxin is the editor of China Blood Transfusion Industry Development Report (2017), Social Science Literature Publishing House. , 2017; Zhu Yongming, Editor-in-Chief of China Blood Transfusion Industry Development Report (2016), Social Science Literature Publishing House, 2016.

(vi) does not conform to the method specified in the Blood Station Technical Operation Regulations (2015)

The survey found that some blood stations use a blood cell counter to perform quality sampling of white blood cell residues, which is inconsistent with the method specified in the Blood Station Technical Operation Regulations (2015). The sensitivity of the blood cell counter to detect white blood cells does not reach the white blood cell filtration. After the detection of leukocyte residuals, it is not appropriate to use this method.

Blood products belong to the category of biological products, and are a special kind drug Mainly based on healthy human plasma, it is a biologically active product prepared by separation, purification technology or bioengineering technology and multi-step blood-borne virus inactivation method. The blue book describes the development history of domestic blood products industry, comparing The development differences between the domestic and international blood products industry, through the objective and detailed data analysis of the domestic raw material plasma collection and blood supply status, evaluation of the new policy related to blood products and its implementation, predicting the future of domestic blood products in the following five Aspect development trend.

(1) Increase market input and strengthen clinical medicine promotion

Due to the recent series of policies such as 'pharmaceutical ratio' and 'two-vote system', the number of imported blood products has increased year by year and the annual average amount of raw material plasma collected has double-digit growth. The contradiction between supply and demand in the market is changing. The healthy and sustainable development of the blood products industry should actively integrate domestic blood product manufacturers, research institutes, and clinical hospital And the superior resources such as inspection agencies, further education, guidance and cultivation of the blood products market, academic food and medical promotion, guiding the clinical departments to rationally use drugs, mining clinical indications for blood products, doing everything possible to enlarge the Chinese blood products market cake, and promote China's blood products industry is bigger and stronger.

(2) Establishing a long-term mechanism for industry supervision and improving management level

For the current domestic blood products industry Regulation Lag, the standard of plasma collection station is seriously missing, the level of information management is low, and it is impossible to guarantee the effective monitoring of the whole process. The relevant laws and regulations should be established and improved as soon as possible, and modern information technology and biometric identification methods should be used to establish a national single. The plasma station and plasma donors information network and unqualified blood donor database, etc., to implement effective supervision of the industry, to promote the healthy and sustainable development of China's blood products industry.

(3) Integrating resources to promote the speed of mergers and acquisitions in the industry

Due to the limited plasma source, the number of pulp stations is large, the amount of pulp is large, and the comprehensive utilization rate of plasma is high. enterprise It has obvious competitive advantages and obvious economies of scale. At present, the concentration of blood products industry in China is still obviously low. The annual annual pulping volume of large domestic blood products enterprises is generally 300~500 tons, which is quite different from the volume of foreign blood products giants. There is still a lot of room for mergers and acquisitions between enterprises. With the continuous introduction of national guiding policies and the development of the industry itself, in recent years, the mergers and acquisitions among blood products enterprises in China have gradually increased, and the industry concentration will be further improved.

(4) Improve the comprehensive utilization rate of plasma and develop new products

In order to make full and reasonable use of valuable plasma resources, all manufacturers should upgrade production equipment and improve the technical level of production technology. Actively adopt new protein separation and purification technologies and methods to improve product yield and purity, and promote original products and production. At the same time, we will actively carry out the comprehensive utilization of plasma proteins, vigorously research and develop new products, and adjust the product structure according to market needs. In addition, we encourage and guide the application of genetic engineering technology in the production of blood products, and focus on recombinant plasma proteins. Development work.

(5) Actively carry out exchanges and cooperation at home and abroad, and introduce advanced technology and management

Create conditions and opportunities to participate in international exchanges, and carry out targeted technology introductions. To establish information networks and databases, there is a comprehensive data, data and information collection system for international and domestic blood product production capacity, level, development direction and route. Investing in funds and formulating policies for development, promoting the introduction, use and upgrading of new technologies. It is particularly important to select appropriate chromatographic methods for the extraction and purification of some coagulation factor products and trace protein components.

The Blue Book is based on 12 blood collection and supply institutions in Hebei Province. It uses questionnaires, data collection and data analysis methods to construct the infrastructure for blood collection and supply in 2017, blood collection, blood supply, and blood supply. Review the blood test and the development of special work, describe the development status and main work achievements of blood collection and blood supply in Hebei Province, analyze the existing problems, and propose constructive measures such as establishing a working mechanism, clarifying departmental responsibilities, creating a social atmosphere, and improving emergency response capabilities. With suggestions.

According to the survey, in 2017, the gender ratio of unpaid blood donors in Hebei Province constituted: 513,305 males in the unpaid blood donation population, accounting for 67.22%; 250326 females, accounting for 32.78%.

Regarding the age distribution of unpaid blood donors in Hebei Province, in 2017, the total number of unpaid blood donations in Hebei Province was 763,631, of which 145,902 were 18 to 25 years old, accounting for 19.11%; 215,140 were 26 to 35 years old, accounting for 28.17%. 36 to 45 years old, a total of 211,292 person-times, accounting for 27.67%; 46 to 55 years old, 18,064 person-times, accounting for 23.58%; 56 to 60 years old, 11,233 person-times, accounting for 1.47%.

The occupational distribution of unpaid blood donors in the province in 2017 cannot explain the proportion of blood donation in a certain group. There are two reasons for this: First, the occupational classification is not accurate enough. With the continuous refinement of social division of labor, occupational classifications are diversified. The occupational classification of the Institute does not fully reflect the occupations of blood donors. At the same time, some blood donors are often reluctant to fill out the secrets of their occupations. Second, the occupational distribution of the province is not clear. But from the collection Statistical data is not difficult to see, workers, farmers, students are the main body of blood donation, these three groups accounted for 52.18% of the total blood donation.

Over the past 100 years, through the constant exploration of human beings, blood transfusion medicine has made a leap-forward development. The blood transfusion business has been included in the track of regularization and legalization. Blood transfusion technology is also constantly developing, improving and perfecting. Science, rationality, safety Effective blood transfusion has become the focus of the whole society. China's blood transfusion business is facing both challenges and opportunities.

First, the safety of blood transfusion will be further improved. In the future, through continuous innovation research, the sensitivity of virus detection methods in blood products will be improved, the window period will be shortened, and the inactivation of pathogens will be developed to ensure the safety of blood products.

Second, blood transfusion services will be more perfect. In the past, blood transfusions in patients with autoimmune hemolytic anemia, RhD-negative pregnant women, and emergency blood transfusions in pre-hospital emergency patients have been controversial, and in recent years, more and more Concerned about the problem of difficult blood transfusion, discussion and research, gradually standardization to establish a coordinated blood transfusion, emergency blood transfusion process, to provide more timely, high-quality services for clinical blood transfusion.

Third, the electronic information management of blood transfusion. Blood transfusion-related data usually requires preservation for ten years. In the future, with the continuous improvement of information management, these large and complicated data will be quickly classified and managed, and integrated analysis will greatly Improve clinical blood transfusion efficiency and quality of service.

Fourth, new blood transfusion technologies, including blood transfusion testing technology, blood product testing technology, blood preparation technology, and application research of a new generation of blood component products will become the most potential development direction of future blood transfusion medicine.

Fifth, as the most complex biological therapy at present, there are still many technical difficulties in cell therapy, and the exact mechanism of action is still unclear. Cell therapy ethics, cell product quality control, tumor CAR T and CAR NK cell therapy, tumor Immunological checkpoint therapy, T cell adoptive immunotherapy, stem cell transplantation therapy, combination of gene editing technology and stem cells, genetically modified cell therapy, microencapsulated cell transplantation therapy, application of 3D printing in tissue engineering, and clinical The effectiveness and security of the application is the focus of current attention and debate.

Sixth, clinical blood transfusion is aimed at paying attention to patient outcomes, saving human scarce resources, ensuring clinical safety and effective blood transfusion as the principle, making full use of various mature blood protection technologies, multidisciplinary collaboration with blood management. Patient blood management is The development direction of clinical blood management, under the premise of paying attention to the patient's outcome, pursue the maximization of patient treatment benefits.

Seventh, we will continue to strengthen the training of clinical blood transfusion personnel. The development of disciplinary technology is inseparable from talents. The cultivation of talents is inseparable from education. Therefore, cultivating echelon of blood transfusion technology-related talents is of great significance in promoting the development of blood transfusion technology.

The Blue Book analysis pointed out that through the efforts and practice of clinical and scientific researchers all over the world, blood transfusion technology will have more development and innovation, and clinical blood transfusion management will be more scientific and efficient, thus providing safer, more timely and effective clinical. Blood transfusion treatment.