ABSTRACT
OBJECTIVE: To provide a reference to the use of quality standards in national drug sampling and testing, and establish the implementation plan. METHODS: By carding the approval process and usage flow of drug standards, analyzing approval form, authorized department, revise and numbering methods of the standard, composition and influencing factors of standard serviceability were studied. RESULTS AND CONCLUSION: The correctness and accuracy of the quality standards have a tremendous impact on national drug sampling and testing which is a significant measure of post-marketing surveillance. The article focuses on three aspects including the correctness, accuracy and orderliness, and then some solutions are proposed such as establishing the implementation plan and multi sector coordination, which can solve the problem of using standards in national drug sampling and testing.
ABSTRACT
OBJECTIVE: To enhance the level of drug emergency inspection managements, and provide new ideas to deal with the drug incidents. METHODS: Firstly, the management courses of our drug emergency inspection were sorted out. Secondly, the solution ideas to the typical drug emergency incidents were analyzed. Thirdly, the relational experiences of developed countries were researched. RESULTS: The emergency management of our country had experienced from zero to full, and the responsible institution experienced from the point to surface. Although the emergency network had been basically established, each component was insufficient. We formulated a series of measures to strengthen the management with the analysis results on typical cases and the experiences of developed countries. CONCLUSION: A special solution idea and four innovative measures were made by a combination of theory and practice. The firstly, a whole system management plan was drawn up which could form a system cohesion and reverse the individual combat. The secondly, the technical plan was proposed which could provide the reasonable path to find reason. The thirdly, three effective measures were designed which could provide supplementary resources for management plan and technical plan. The fourthly, the government and enterprises strategies were suggested which could prevent from the source. In brief, our emergency management ability would be significantly enhanced by implementing the mentioned measures.
ABSTRACT
<p><b>OBJECTIVE</b>To explore the conversion rule of serological blood group and blood group substance after successful allogeneic hematopoietic stem cell transplantation, and to provide theory for clinical special blood type identification and blood transfusion.</p><p><b>METHODS</b>The growth cycle of recipient WBC and RBC, RBC chimera, blood group antibody production and remaining in full transition were observed. Conversion rule of blood group substance, contradiction between cells typing and sera typing were detected by saline medium tube method and microcolumn gel method after stem cells transplantation.</p><p><b>RESULTS</b>The average time of engraftment in 21 recipients was about 18.6 days, RBC growth cycle in 8 major blood type incompatibility was 56.6 days, 25.9 days in 9 minor blood type incompatibility, 67 days in 4 bidirectional blood type incompatibility (P < 0.01). The ratio of RBC chimeric growth was 1:9, gradually converse to donor's blood group. Residue of recipient anti-A(B) was left after conditioning regimen, disappeared after full transformation, and recipient anti-A(B) was converse to donor's blood type in major blood type incompatibility. 5 A blood type recipient donated by O blood type blood generated anti-B instead of anti-A, 3 B blood type recipient generated only anti-A instead of B in minor blood type incompatibility, and 1 AB blood type recipient donated by A did not generate anti-B. Among 4 bidirectional blood type incompatibility, 2 B blood type recipient donated by A blood type blood did not generate anti-B, 2 A recipient by B could not produce anti-A. Recipient blood group substance helped original ABO blood type substance remain unchanged.</p><p><b>CONCLUSION</b>Among patient with allogeneic hematopoietic stem cell transplantation, recipient's ABO and RBC blood type can be converse to donor's, but there is significant difference between patients of serological blood group and of normal people (P < 0.01). Recipient blood group substance helps original ABO blood type substance remain unchanged (P > 0.01).</p>