Logistic model for determining factors associated with HIV infection among blood donor candidates at the Fundação HEMOPE

OBJECTIVE: To determine factors associated with HIV infection in blood donor candidates in Recife, Brazil. METHODS:A transversal study was performed of 106,203 blood donor candidates found eligible by the routine clinical screening process in the blood bank in Recife of the Fundação de Hematologia e Hemoterapia de Pernambuco (HEMOPE) in the period from January 1998 to November 2003. Additional indirect immune and western blot confirmation tests for HIV infection were performed and the candidates were classified as HIV positive or negative. The Chi-squared test and stepwise multiple logistic regression were conducted to examine any association between HIV infection and age, gender, place of residence, schooling, number of donations and serological tests for core hepatitis B antigen virus (anti-HBc), the hepatitis C antivirus (anti-HCV), human T-type antivirus lymph cells (anti-HTLV 1 and 2), serological tests for syphilis (VDRL) and the hepatitis B virus surface antigen (HBsAg). RESULTS: In the observed sample, 0.204% of blood donor candidates were found to be HIV positive. Among the studied variables, the age, education level, residency, donation type, and serologic status for anti-HBc and VDRL tests were found to be associated with HIV infection. CONCLUSION: The younger, spontaneous donor candidates living in the Recife metropolitan area with a low level of education and positive for anti-HBc and VDRL have an higher risk of HIV infection than the other candidates. Data such as these are useful to understand the dynamics of infection and to guide healthcare policies.

A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation

Highly purified intravenous immunoglobulin G concentrate (IV IgG) was produced with the use of polyethylene glycol associated to a single-stage precipitation by ethanol, instead of the classic Cohn-Oncley process, which employs cold alcohol as the precipitating agent, in a three-stage process. Precipitation of crude fraction containing more than 95% of immunoglobulin G was performed by liquid chromatography with a cation exchanger, CM-Sepharose, as a stationary phase. During the process, the product was subjected to two-stage viral inactivation. The first stage was performed by the action of sodium caprylate, 30 mM at pH 5.1+/- 0.1, and the second stage was performed by the action of a solvent-detergent mixture. The finished product was formulated at 5% with 10% sucralose as the stabilizing agent. The process yields 3.3g of IgG/liter of plasma. The finished product analysis showed an anti-complementary activity lower than 1CH50. Polymer and aggregate percent levels were lower than 3% in the five batches studied. The analysis of neutralizing capacity showed the presence of antibacterial and antiviral antibodies in at least three times higher concentrations than the levels found in source plasma. The finished product fulfilled all purity requirements stated in the 4th edition of the European pharmacopeia.

Obteve-se concentrado de imunoglobulina G intravenosa IgGIV, altamente purificado, utilizando-se polietilenoglicol associado a uma única etapa de precipitação por etanol, em substituição ao tradicional método descrito por Cohn-Oncley, que emprega, em três etapas, o mesmo álcool resfriado, como agente precipitante. A purificação da fração bruta contendo mais de 95% de imunoglobulina G foi realizada utilizando-se cromatografia líquida com um trocador de cátion, a CM-Sepharose, como fase estacionária. Durante o processamento o produto foi submetido a dupla inativação viral sendo a primeira pela ação do caprilato de sódio, 30 mM a pH 5,1+/- 0,1 e a segunda por ação de mistura de solvente/detergente. O produto acabado foi formulado a 5% utilizando-se sucralose 10% como estabilizante. O rendimento da metodologia foi de 3,3g de IgG/litro de plasma. A análise do produto acabado demonstrou atividade anti-complementar inferior a 1CH50. O valor percentual de polímeros e agregados em cinco lotes realizados foi inferior a 3%. O estudo da capacidade de neutralização demonstrou a presença de anticorpos anti-bacterianos e anti-virais em concentração pelo menos três vezes maior que o plasma de origem. O produto acabado apresentou conformidade com todos os requisitos de pureza dispostos na farmacopéia européia IV edição.

Weekly monitoring of the effects of conventional external beam radiation therapy on patients with head and neck, chest, and pelvis cancer by means of blood cells count / Avaliação semanal dos efeitos da radioterapia externa convencional pela contagem dos leucócitos e plaquetas de pacientes portadores de câncer nas áreas de cabeça e pescoço, tórax e pelve

OBJETIVO: Avaliar a necessidade de monitoração semanal, pela contagem de leucócitos e plaquetas, dos pacientes portadores de câncer das áreas de cabeça e pescoço, tórax e pelve submetidos a radioterapia externa convencional. MATERIAIS E MÉTODOS: Cento e um adultos, portadores de câncer das áreas de cabeça e pescoço (11 pacientes), tórax (35 pacientes) e pelve (55 pacientes), submetidos a radioterapia, avaliados semanalmente com leucograma e contagem de plaquetas, comparando-se as contagens das células antes do início do tratamento com as obtidas nas semanas ao longo do tratamento, área tratada, sexo e faixa etária. RESULTADOS: A maior queda dos leucócitos e plaquetas ocorreu na quarta semana, quando linfócitos, leucócitos totais, neutrófilos, monócitos e plaquetas apresentaram diminuição de 53,5 por cento, 26,8 por cento, 19,4 por cento, 22,2 por cento e 14,6 por cento, respectivamente, ao serem comparados aos valores do início do tratamento. Durante o tratamento, as médias geométricas da pelve foram estatisticamente menores do que as de tórax e cabeça e pescoço. Os linfócitos foram os mais sensíveis à irradiação. Não houve alteração da contagem de leucócitos e plaquetas relacionadas ao sexo ou à faixa etária. CONCLUSÃO: A partir dos resultados obtidos não parece ser necessária a contagem semanal de leucócitos e plaquetas para pacientes submetidos a radioterapia externa convencional em campos localizados.

OBJECTIVE: To evaluate the necessity of weekly monitoring by means of leukocyte and platelet counts of patients with head and neck, chest, and pelvis cancer submitted to conventional radiotherapy. MATERIALS AND METHODS: A hundred and one adult patients with cancer of head and neck (n = 11), chest (n = 35) and pelvis (n = 55), submitted to radiotherapy were assessed by means of leukocyte and platelet counts on a weekly basis, with a comparison between the results before and during the treatment and in correlation with the area treated, patient's sex and age group. RESULTS: The most significant decrease in leukocytes was observed in the fourth week, when lymphocytes, total leukocytes, neutrophils, monocytes and platelets presented a decrease of 53.5 percent, 26.8 percent, 19.4 percent, 22.2 percent and 14.6 percent, respectively, in comparison with the values found before the beginning of the therapy. Geometric means for pelvis during the treatment were lower than those for chest, and head and neck. Lymphocytes demonstrated to be more sensitive to radiation therapy. No alteration was found in leukocyte or platelet counts in correlation with patients' sex or age. CONCLUSION: Based on the results of the present study, weekly leukocyte and platelet counts do not seem to be useful in the assessment patients submitted to conventional radiotherapy for localized cancer.