Investigation On The Present Situation Of Adverse Transfusion Reaction In China And Research On The Prevention Strategy And Control Measures

Background:Since the blood group ABO was discovered in early 20 th century, blood transfusion has been widely employed in clinic. Nowadays, blood is intensively needed anytime in the world to cope with various kinds of treatments such as surgery, trauma, anemia and so on. In America, about 4.5 million patients need blood transfusion every year, so blood has played an indispensable role in today’s health care. However, blood transfusion is a double-edged sword. Owing to the complexity and diversity of blood, there are such serious risks existing in blood transfusion as the spread of infectious adverse transfusion reaction and non infections adverse transfusion reaction. Blood transfusion adverse reactions also called the transfusion transmitted diseases, infectious disease caused by transfusion transmitted diseases, such as hepatitis, syphilis and other diseases after blood transfusion, AIDS. Non infected blood transfusion adverse reaction is the recipient in the process of transfusion and transfusion after a period of time, a group of new cannot explain the symptoms and signs of the disease, such as acute hemolytic transfusion reactions, febrile non hemolytic transfusion reaction, allergic transfusion reaction, transfusion related acute lung injury and so on.According to the statistical results of the National Ministry of Health, the hepatitis incidence rate is 2.4%-27.6% after blood transfusion, positively related to blood transfusion amount and the number of transfusions, and an increasing incidence rate is also shown in blood transfusion infection(such as AIDS, syphilis). Therefore, blood security has been listed as a priority of the global health work by WHO. Since WHO’s QMP(Quality Management Project) launched in 2000, the transfusion infection rate has obviously decreased with the recruitment of low risk blood donors, the strict blood screening and continuous improvement of blood detection quality. The risk of transfusion transmitted virus in developed countries and regions has been lower than or similar to the probability of major natural calamities and man-made misfortunes in daily life or the medical work of important medical accident probability, in American the probability of transfusion transmitted virus is only 1:63000~ 1:64100. With the declining risk of transfusion-transmitted infectious disease, noninfectious adverse transfusion reaction have emerged as the leading complication of transfusion. Currently, a patient is up to 1000-fold more likely to experience a noninfectious adverse reaction than an infectious complication of transfusion. The Food and Drug Administration(FDA) reported death rates due to hemolytic transfusion reactions are more than twice that due to all infectious hazards combined. Therefore, Prevention and control of noninfectious blood transfusion reactions has become a hot issue in current research of transfusion medicine. This paper refers to the adverse reactions were noninfectious blood transfusion reactions.As early as 90 s of 20 th Century, some European scholars, blood transfusion scientists and clinicians recognized the serious lack of transfusion safety information, as well as the epidemiological and statistical data support to important policies and clinical guidelines. Promote Haemovigilance System covering the whole process built in Europe, the system can collect the clinical treatment of all kinds of adverse reactions and assessment of early warning, prevention and control guidance of adverse transfusion reaction.At present there are 57 nations which have established blood warning system nationwide. This system has definitely decreased the incidence rate of adverse reactions in these nations, with an unprecedented promotion in public confidence to the blood security.Compared with foreign countries, there is a significant lag in the prevention and control of adverse transfusion reaction between the domestic and abroad.At present there has no national monitoring system of adverse transfusion reaction in our nation, and the systematic baseline epidemiological data is insufficient. The lack of integrity, systematicness and accuracy of literature and reporting has a significant influence on the formulation and implementation of policies and measures related to the adverse reaction. At the same time, there are other important restricting factors: the lack of complete policies and regulations of adverse transfusion reaction and standard and unified reporting system contribute to insufficient legal binding force to the adverse reaction monitoring, prevention and control, unstandardized data with little availability. The medical staff’s insufficient awareness and attention lead to inefficient identification of adverse transfusion reaction and inaccurate reporting. Some medical personnel and unwilling to report any adverse reaction owing to the worries of medical disputes and the unit’s reputation. The master degree and the attention of the knowledge of blood transfusion adverse reactions of clinical medical staff are the key factors to impact the recognition of adverse transfusion reactions as well as accurate reporting.Therefor, in the first part of this study the author adoptedthe method of system evaluation to get hold of the baseline data and characteristics of the domestic adverse transfusion reaction, find out the key links which impact the management and monitoring of adverse transfusion reaction and restricting factors of transfusion adverse reporting, providing the direction for the follow-up survey. In the second part, combing with previous system evaluation, the author found the direct relation between clinical medical personnel and their implementation and treatment of blood transfusion, which was an important factor to adverse transfusion reaction. So a questionnaire survey is conducted to inquire the knowledge of adverse transfusion reactionof the clinical medical staff and the demand of continuing education. Based on the study of previous two parts, the author probed into the prevention and control of adverse transfusion reaction in the third part with the reference of national conditions of our country and literature research. Some concrete strategies and measures were put forward to reduce the risk of adverse reactions and normalize the corresponding report system, thus security of blood use can be guaranteed.Part I Incidence Rate of Adverse Transfusion Reaction in Grade Thee Class-A Hospitals in China: A Meta-analysis of Single rateObjective: Using the Meta analysis method to evaluate the characteristics of adverse transfusion reaction, thus to provide scientific evidence for its prevention and control. Methods: With Pub Med, The Cochrane Library retrieval system(2014 11th), EMbase, VIP, CNKI, CBM and Wan Fang database, supplemented by hand searching and reference literature tracing method, retrieval time for building time has occurred, the study found out the domestic research literature about adverse transfusion reaction with the retrieval time as early as databases’ founding. In strict accordance with the inclusion and exclusion criteria of the literature screening, data extraction and assessment of methodological quality, this process is conducted by 2 reviewers independently. Meta analysis was carried out with R 3.1.1 software. Results: There were 72 articles, a total of 1660472 cases of blood transfusion involved in this study. The Meta analysis results showed that:Much heterogeneity is shown in the reference literature,and the total adverse transfusion reaction incidence was 0.58%(95%CI=0.48%~0.69%). Further subgroup analysis revealed that:Differences in the incidence rate of adverse transfusion reaction in western, central, eastern region had statistical significance(P<0.05), which are 0.56%(95%CI=0.43%~0.70%),0.55%(95%CI=0.41%~0.70%) and 0.42%(95%CI=0.31%~0.55%) respectively. The incidence rate of adverse reactions of different kinds of blood products were 1% in platelet(95%CI=0.73% ~ 1.30%), 0.41% in red blood cells(95%CI=0.32% ~ 0.50%), 0.57% in plasma(95%CI=0.43% ~ 0.72%),among which the rate of red cells and plasma was significantly lower than that of platelet( P < 0.05).Conclusion: This research has found the large differences of various reporting and the need for further regulate the report and system to obtain baseline data. System evaluation and meta analysis indicated, China reported adverse reaction rate of literature great heterogeneity, There exists significant difference with foreign report type, difficult to response the real situation, to further standardize the report and conduct surveys in order to get accurate baseline data specification system, there exists significant difference with foreign report type, difficult to response the real situation, to further standardize the report and conduct surveys in order to get accurate baseline data specification system.Part II Investigation on clinical medical staff’s core knowledge awareness of adverse transfusion reaction and demand surveyObjective: The medical staff is the key link which will directly lead the adverse transfusion reaction, therefore it is necessary to understand medical staff core knowledge awareness and demand of adverse transfusion reaction, so as to put forward the concrete measures of prevention and control in this filed in the future. Methods: The medical staff of main blood use department in 3 Class A Grade 3 hospitals are involved in the questionnaire survey, inquired about the core knowledge awareness and demand. The results were analyzed with SPSS 19.0 statistical analysis software. Results: In this survey, there are a total of 1903 health care workers, including 773 doctors, 1130 nurses, with the doctor-nurse proportion of 0.68:1 and the title distribution proportion of 44.3:3.7:1(senior to primary). The investigation revealed that, clinical medical staff’s master level is generally low in terms of related knowledge of adverse transfusion reaction, the final scores of different degree(J the scores of college students, bachelor, master and doctor are 15.98±3.79,16.41±3.95,15.72±4.19and16.82±3.98 respectively), different professional title(the scores of junior title, middle title and senior title are 16.06±3.96,16.87±3.95 and 16.99±3.73 respectively), different working years(15.82±3.93 for working years﹤5years, 16.62±4.04 for 6-10 years and 16.92±3.69﹥10 years) and training times(16.26±3.72 for null, 16.30±3.79 for 1-3 times, and 16.71±3.65 for over 4 times) were statistically significant(P < 0.05), but no statistical significance between different hospitals or different posts(P>0.05). Vital signs monitoring of patients before transfusion(accuracy8.40%),attention matters of transfusion(accuracy28.5%) and the identification of bacteria pollution response(accuracy16.18%)are among the worst comprehensible knowledge. And 96.42% of the medical staff agree that it is necessary to carry out relevant training to improve the knowledge of adverse transfusion reactions. Conclusion: Clinical medical staff generally lack the knowledge of adverse transfusion reactions, therefore, it is necessary to promote professional training to improve the knowledge level, reduce the incidence rate of adverse transfusion reaction, and to guarantee the safety in blood use.Part III Research on the prevention strategy and control measures of adverse transfusion reaction in China’s hospitalsBased on abundant study of literature survey and present situation investigation, and with foreign experience and domestic experience of prevention and control of infectious diseases surveillance system, we put forward some suggestions of adverse transfusion reaction prevention and control for further reference.On the one hand, we should set up a national adverse transfusion reaction prevention and control system: the establishment of the mechanism covering the National Sanitation Planning Commission, local medical affair offices, the blood collection agencies and medical institutions at the local hospital, the completion of legal system management of the state, department and industry, the founding of relevant system files and processes of adverse transfusion reaction prevention and control system, and a national information network of mandatory reporting.On the other hand, some measures should be adopted to manage the quality control links of the terminal medical institutions which directly affect the reporting quantity and quality of adverse transfusion reaction: to strengthen the supervision of the relevant medical reports of adverse transfusion reaction, implement the responsibilities of corresponding departments, strengthen the hardware and software, talent construction and the training of medical personnel of blood transfusion department,thus to improve the reporting quality of adverse transfusion reaction.