134 research outputs found
El diseño experimental y los métodos de Taguchi: Conceptos y aplicaciones en la industria farmacéutica
Los orĂgenes del diseño experimental se remontan a las primeras dĂ©cadas del siglo XX, cuando Ronald Fisher introdujo el concepto de aleatorizaciĂłn y el anĂĄlisis de varianza. En estos Ășltimos años, la teorĂa y aplicaciones del diseño de experimentos se consolidaron y expandieron y, en varias industrias, las contribuciones de Gen'ichi Taguchi, abrieron el camino de aplicaciones rutinarias. En este documento de trabajoi se presentan ejemplos hipotĂ©ticos del empleo de estas tĂ©cnicas en la industria farmacĂ©utica, tanto en situaciones de diseño como de manufactura y de servicios. El objetivo es motivar y consolidar el interĂ©s de los profesionales por estos temas, asĂ como difundir las ideas de Taguchi sobre el diseño robusto y la funciĂłn de pĂ©rdida cuadrĂĄtica. El trabajo estĂĄ organizado del siguiente modo. La secciĂłn I destaca el papel del diseño experimental en la mejora de los procesos y la importancia bĂĄsica del anĂĄlisis de varianza. La secciĂłn II es una revisiĂłn del anĂĄlisis de varianza que, a travĂ©s de ejemplos numĂ©ricos, procura dar una perspectiva intuitiva de los conceptos. La secciĂłn III introduce los experimentos factoriales, con aplicaciones farmacĂ©uticas de diseño y de servicio. El enfoque de Taguchi se esboza en la secciĂłn IV y se lo compara con los mĂ©todos tradicionales. La secciĂłn V brinda breves recomendaciones para el uso de estos mĂ©todos.
Transfusion Related Acute Lung Injury (TRALI) Caused by Red Blood Cell Transfusion Involving Residual Plasma Anti-HLA Antibodies: A report on two Cases and General Considerations
TRALI is considered a serious hazard among immune complications
of blood transfusion and its occurrence is admitted to be globally underestimated.
Each type of blood product is likely to cause TRALI. We report here on two
consecutive observations of TRALI caused by red blood cell concentrates, in
which anti-HLA class I and class II antibodies resulting from post-gravitational
allo-immunization were evidenced in donors. HLA class I and II antigenic
community between recipients and donors' husbands were found and strong
reacting IgG antibodies directed at several of those common antigens were
detected in the donors' serum. Both donors had more than 3 pregnancies, raising
the issue of
blood donor selection or of plasma reduction for cellular products
Use of B-natriuretic peptide as a diagnostic marker in the differential diagnosis of transfusion-associated circulatory overload
Transfusion-associated circulatory overload (TACO) occurs when the transfusion rate or volume exceeds the capacity of a compromised cardiovascular system. Characteristic symptoms and signs associated with TACO are neither sensitive nor specific. B-natriuretic peptide (BNP) is a 32-amino-acid polypeptide secreted from the cardiac ventricles in response to ventricular volume expansion and pressure overload. This study was performed to explore the usage of BNP in the differential diagnosis of TACO. STUDY DESIGN AND METHODS: Pre- and posttransfusion BNP levels were determined in 21 patients with suspected TACO and 19 control patients. The BNP was considered significant if the posttransfusion-to-pretransfusion ratio was at least 1.5 and the posttransfusion BNP level was at least 100âpg per mL. RESULTS: The BNP test has a sensitivity and specificity of 81 and 89âpercent, respectively, in diagnosis of TACO. It has a positive predictive value of 89âpercent, a negative predictive value of 81âpercent, and an accuracy of 87âpercent. In logistic regression analysis, BNP was found to have significant predictive power independent of other clinical variables in models predicting which patients had TACO. CONCLUSIONS: Our study suggests that in patients who present symptoms suggestive of TACO, BNP can be a useful adjunct marker in confirming volume overload as the cause of acute dyspnea and symptoms related to cardiovascular compromise.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/75697/1/j.1537-2995.2005.04326.x.pd
Entomologic and Serologic Evidence of Zoonotic Transmission of Babesia microti, Eastern Switzerland
We evaluated human risk for infection with Babesia microti at a site in eastern Switzerland where several B. microtiâinfected nymphal Ixodes ricinus ticks had been found. DNA from pooled nymphal ticks amplified by polymerase chain reaction was highly homologous to published B. microti sequences. More ticks carried babesial infection in the lower portion of the rectangular 0.7-ha grid than in the upper (11% vs. 0.8%). In addition, we measured seroprevalence of immunoglobulin (Ig) G antibodies against B. microti antigen in nearby residents. Serum from 1.5% of the 396 human residents of the region reacted to B. microti antigen (>1:64), as determined by indirect immunofluorescence assay (IgG). These observations constitute the first report demonstrating B. microti in a human-biting vector, associated with evidence of human exposure to this agent in a European site
Activated prothrombin complex concentrate factor VIII inhibitor bypassing activity (FEIBA) for the reversal of warfarin-induced coagulopathy
Human genetics in troubled times and places
Abstract The development of human genetics world-wide during the twentieth century, especially across Europe, has occurred against a background of repeated catastrophes, including two world wars and the ideological problems and repression posed by Nazism and Communism. The published scientific literature gives few hints of these problems and there is a danger that they will be forgotten. The First World War was largely indiscriminate in its carnage, but World War 2 and the preceding years of fascism were associated with widespread migration, especially of Jewish workers expelled from Germany, and of their children, a number of whom would become major contributors to the post-war generation of human and medical geneticists in Britain and America. In Germany itself, eminent geneticists were also involved in the abuses carried out in the name of âeugenicsâ and ârace biologyâ. However, geneticists in America, Britain and the rest of Europe were largely responsible for the ideological foundations of these abuses. In the Soviet Union, geneticists and genetics itself became the object of persecution from the 1930s till as late as the mid 1960s, with an almost complete destruction of the field during this time; this extended also to Eastern Europe and China as part of the influence of Russian communism. Most recently, at the end of the twentieth century, China saw a renewal of government sponsored eugenics programmes, now mostly discarded. During the post-world war 2 decades, human genetics research benefited greatly from recognition of the genetic dangers posed by exposure to radiation, following the atomic bomb explosions in Japan, atmospheric testing and successive accidental nuclear disasters in Russia. Documenting and remembering these traumatic events, now largely forgotten among younger workers, is essential if we are to fully understand the history of human genetics and avoid the repetition of similar disasters in the future. The power of modern human genetic and genomic techniques now gives a greater potential for abuse as well as for beneficial use than has ever been seen in the past
Intravenous Immunoglobulin Prevents Murine Antibody-Mediated Acute Lung Injury at the Level of Neutrophil Reactive Oxygen Species (ROS) Production
Transfusion-related acute lung injury (TRALI) is a leading cause of transfusion-associated mortality that can occur with any type of transfusion and is thought to be primarily due to donor antibodies activating pulmonary neutrophils in recipients. Recently, a large prospective case controlled clinical study of cardiac surgery patients demonstrated that despite implementation of male donors, a high incidence of TRALI still occurred and suggested a need for additional interventions in susceptible patient populations. To examine if intravenous immunoglobulin (IVIg) may be effective, a murine model of antibody-mediated acute lung injury that approximates human TRALI was examined. When BALB/c mice were injected with the anti-major histocompatibility complex class I antibody 34-1-2s, mild shock (reduced rectal temperature) and respiratory distress (dyspnea) were observed and pre-treatment of the mice with 2 g/kg IVIg completely prevented these symptoms. To determine IVIg's usefulness to affect severe lung damage, SCID mice, previously shown to be hypersensitive to 34-1-2s were used. SCID mice treated with 34-1-2s underwent severe shock, lung damage (increased wet/dry ratios) and 40% mortality within 2 hours. Treatment with 2 g/kg IVIg 18 hours before 34-1-2s administration completely protected the mice from all adverse events. Treatment with IVIg after symptoms began also reduced lung damage and mortality. While the prophylactic IVIg administration did not affect 34-1-2s-induced pulmonary neutrophil accumulation, bone marrow-derived neutrophils from the IVIg-treated mice displayed no spontaneous ROS production nor could they be stimulated in vitro with fMLP or 34-1-2s. These results suggest that IVIg prevents murine antibody-mediated acute lung injury at the level of neutrophil ROS production and thus, alleviating tissue damage
MHC class Iâspecific antibody binding to nonhematopoietic cells drives complement activation to induce transfusion-related acute lung injury in mice
In a manner partially independent of activating FcÎł receptors, antibody-mediated production of complement component C5a and recruitment of macrophages elicit transfusion-related acute lung injury in mice
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