PubMed · 5193168
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J C Potier. 1969. [Lymphocytes].. https://pubmed.ncbi.nlm.nih.gov/5193168/
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The studies of the late effects of atomic-bomb (A-bomb) radiation on the immune system were started about 20 years after the bombings in 1945. The most remarkable late effects of radiation are the functional and quantitative abnormalities of T and B cells in survivors exposed to high doses (> or = 1.0 Gy). Abnormalities of T-cell immunity include (1) a decreased proportion of CD3+ T cells in peripheral blood lymphocytes, particularly the proportion of CD4+ CD45RA+ naive T cells (study period 1987-91); (2) an increased frequency of CD4- and CD8- (double negative) alpha beta + T cells (1987-91); and (3) functional defects in T-cell responses to mitogens and alloantigens (1974-85). B-cell abnormalities include: (1) a significant increase in the proportion of B cells among peripheral lymphocytes (1987-91); (2) an increase in serum immunoglobulin A levels in females and immunoglobulin M and the incidence of rheumatoid factor in both sexes (1987-89); and (3) an increased level of anti-Epstein-Barr virus antibody titer (1987-90). In contrast, suggestive (0.05 < p < 0.1) or not significant (p > 0.1) dose effects were observed for the number and function of natural killer cells (1983-91), and benign monoclonal gammopathy (1979-87). In addition, studies initiated sooner after the bombing such as the incidence of autoimmune diseases (1958-87), systemic bacterial infections (1954-67), and granulocyte functions (1947-79) also show little dose-effects. Thus, A-bomb radiation induced the alteration of the balance/interaction between the T- and B-cell subsets--specifically, a decrease in the T-cell population and an increase in the B-cell population in the periphery.
The basic statistical issue in pharmacovigilance is to claim, with reasonable certainty, that the incidence of an event of interest in a population of subjects is less than a certain value. How many subjects and events must be observed before such a claim can be made? A first situation of practical importance is when a product has been on the market for some period of time, and the safety of this product regarding some outcome of interest is questioned (for instance, the viral safety of blood products). Having observed a few occurrences of the event of interest, how confident can we be that the product is responsible for an elevation of the incidence of this event compared with the baseline incidence in a reference population? This issue will increasingly need to be addressed prospectively: how many subjects need to be treated and how many events observed, to be reasonably certain that a product is safe? Multi-stage designs are appropriate to address this question, yet they do not seem popular in pharmacovigilance. Such approaches could complement the standard recommendations to assess the safety of blood products, which are adequate as a first screen against major safety problems, but wholly inadequate for the long-term surveillance of subjects at risk of rare events. It will be argued that, from a regulatory perspective, the implementation of prospective protocols for pharmacovigilance, using appropriate statistical tools, would permit a tight control of the safety of new products, while making these products available as early as possible to the patients who need them.
Essential to a neonate's survival is an ability to respond effectively to hostile environmental forces. The developing neonate's immune system has functional, albeit limited, defensive, homeostatic and surveillance capabilities. The development of the cellular components of the neonatal immune system and their physiologic interrelationships and limitations are discussed.