Stromal Cell Signature Associated with Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer.

Breast cancer stromal compartment, may influence responsiveness to chemotherapy. Our aim was to detect a stromal cell signature (using a direct approach of microdissected stromal cells) associated with response to neoadjuvant chemotherapy (neoCT) in locally advanced breast cancer (LABC). The tumor samples were collected from 44 patients with LABC (29 estrogen receptor (ER) positive and 15 ER negative) before the start of any treatment. Neoadjuvant chemotherapy consisted of doxorubicin and cyclophosphamide, followed by paclitaxel. Response was defined as downstaging to maximum ypT1a-b/ypN0. The stromal cells, mainly composed of fibroblast and immune cells, were microdissected from fresh frozen tumor samples and gene expression profile was determined using Agilent SurePrint G3 Human Gene Expression microarrays. Expression levels were compared using MeV (MultiExperiment Viewer) software, applying SAM (significance analysis of microarrays). To classify samples according to tumor response, the order of median based on confidence statements (MedOr) was used, and to identify gene sets correlated with the phenotype downstaging, gene set enrichment analysis (GSEA). Nine patients presented disease downstaging. Eleven sequences (FDR 17) were differentially expressed, all of which (except H2AFJ) more expressed in responsive tumors, including PTCHD1 and genes involved in abnormal cytotoxic T cell physiology, TOX, LY75, and SH2D1A. The following four pairs of markers could correctly classify all tumor samples according to response: PTCHD1/PDXDC2P, LOC100506731/NEURL4, SH2D1A/ENST00000478672, and TOX/H2AFJ. Gene sets correlated with tumor downstaging (FDR < 0.01) were mainly involved in immune response or lymphocyte activation, including CD47, LCK, NCK1, CD24, CD3E, ZAP70, FOXP3, and CD74, among others. In locally advanced breast cancer, stromal cells may present specific features of immune response that may be associated with chemotherapy response.

Prevalence of low back pain in the elderly population: a systematic review

The aim of this study was to estimate the prevalence of low-back pain (LBP) and to identify the level of functional disability in elderly individuals in different populations. From January 1985 to October 2018, a search was performed using the following databases: Embase, LILACS, SciELO, Scopus, Medline, and the Web of Science. The descriptors were low-back pain, back pain, lower-back pain, prevalence, and elderly in Portuguese and English. Two independent reviewers conducted a search for studies and evaluated their methodological quality. The search strategy returned 2186 titles, and 35 were included in this review. The studies evaluated 135,059 elderly individuals aged between 60 and 102 years, and the prevalence of LBP ranged from 21% to 75%. The levels of functional disability, as well as functional difficulties, activities of daily living, and physical capacity, were identified in 60% of the studies. This review indicated a high prevalence of LBP in elderly individuals and functional disability that affects factors important for independence. However, the studies used different methodologies, suggesting that more studies be conducted with scientific accuracy, methodological quality, and low risk of bias to contribute to the proposal of preventive actions for elderly populations.

A comment on "Writing Good English: Is scientific English a Latin Language in Disguise?"

Dear Editor I have read an article recently published in "Medical Express", "Writing Good English: Is scientific English a Latin Language in Disguise?" With respect to the statistical analyses, I have some comments. I would like to point out that ANOVA, the statistical treatment used to compare the incidence of Latin/Greek words in English against Portuguese texts, is not appropriate for the data analyzed. The reason is very simple: the sample space of a normal distribution is the whole real set of numbers extending from −∞ to +∞. In contrast, the sample space of a proportion π extends from zero to one. Another point is that the beta distribution is symmetric only when (π = ½ - beta). The beta distribution, considered here, is one of the adequate distributions to analyze proportions. Asymmetry grows as π moves away from ½. The author kindly provided me with the raw data allowing me to reanalyze the results within his focus. I came up with the results shown in Figure 3A which may be advantageously compared with Figure 3 of the article. Adding another technical argument and having adopted the beta distribution, I found that the log-odds, ln (π / 1 - π ),are normally distributed allowing us to apply standard statistical methods. My decision was to use confidence intervals to clearly illustrate the differences between English and Portuguese on the use of Latin/Greek words. I call the attention to the fact that the intervals for Portuguese are more asymmetric than the ones for English which are close to ½. To obtain the intervals for proportions the inverse transformations were taken from log-odds to proportions. These transformations through the log-odds made the distribution of the proportions be described as Logistic-Normal, as painstakingly discussed in: Aitchison J. (2003), The Statistical Analysis of Compositional Data, Blackburn Press.

The SURMetaGIT study: Design and rationale for a prospective pan-omics examination of the gastrointestinal response to Roux-en-Y gastric bypass surgery.

Objective To describe the protocol of the SURgically induced Metabolic effects on the Human GastroIntestinal Tract (SURMetaGIT) study, a clinical pan-omics study exploring the gastrointestinal tract as a central organ driving remission of type 2 diabetes mellitus (T2DM) after Roux-en-Y gastric bypass (RYGB). The main points considered in the study's design and challenges faced in its application are detailed. Methods This observational, longitudinal, prospective study involved collection of gastrointestinal biopsy specimens, faeces, urine, and blood from 25 obese women with T2DM who were candidates for RYGB (20 patients for omics assessment and 5 for omics validation). These collections were performed preoperatively and 3 and 24 months postoperatively. Gastrointestinal transcriptomics; faecal metagenomics and metabolomics; plasma proteomics, lipidomics, and metabolomics; and biochemical, nutritional, and metabolic data were assessed to identify their short- and long-term correlations with T2DM remission. Results Data were collected from 20 patients before and 3 months after RYGB. These patients have nearly completed the 2-year follow-up assessments. The five additional patients are currently being selected for omics data validation. Conclusion The multi-integrated pan-omics approach of the SURMetaGIT study enables integrated analysis of data that will contribute to the understanding of molecular mechanisms involved in T2DM remission after RYGB.

MicroRNAs discriminate familial from sporadic non-BRCA1/2 breast carcinoma arising in patients ≤35 years.

The influence of genetic factors may contribute to the poor prognosis of breast cancer (BC) at a very young age. However BRCA1/2 mutations could not explain the majority of cases arising in these patients. MicroRNAs (miRs) have been implicated in biological processes associated with BC. Therefore, we investigated differences in miRs expression between tumors from young patients (≤35 years) with sporadic or familial history and non-carriers of BRCA1/2 mutations. Thirty-six young Brazilian patients were divided into 2 groups: sporadic (NF-BC) or familial breast cancer (F-BC). Most of the samples were classified as luminal A and B and the frequency of subtypes did not differ between familial or sporadic cases. Using real time qPCR and discriminant function analysis, we identified 9 miRs whose expression levels rather than miR identity can discriminate between both patient groups. Candidate predicted targets were determined by combining results from miRWalk algorithms with mRNA expression profiles (n = 91 differently expressed genes). MiR/mRNA integrated analysis identified 91 candidate genes showing positive or negative correlation to at least 1 of the 9 miRs. Co-expression analysis of these genes with 9 miRs indicated that 49 differentially co-expressed miR-gene interactions changes in F-BC tumors as compared to those of NF-BC tumors. Out of 49, 17 (34.6%) of predicted miR-gene interactions showed an inverse correlation suggesting that miRs act as post-transcriptional regulators, whereas 14 (28.6%) miR-gene pairs tended to be co-expressed in the same direction indicating that the effects exerted by these miRs pointed to a complex level of target regulation. The remaining 18 pairs were not predicted by our criteria suggesting involvement of other regulators. MiR-mRNA co-expression analysis allowed us to identify changes in the miR-mRNA regulation that were able to distinguish tumors from familial and sporadic young BC patients non-carriers of BRCA mutations.

Helicobacter pylori and iron-deficiency anemia in adolescents in Brazil.

AIM: The aim of the study was to evaluate the association between Helicobacter pylori infection and iron deficiency (ID) in adolescents attending a public school. PATIENTS AND METHODS: From March to June 2001, a cross-sectional study was conducted among adolescents (10-16 years) enrolled in a single public school in São Paulo, Brazil. Of 400 eligible students, 195 agreed to participate, but 1 was excluded due to sickle cell disease. A blood sample was collected from each subject to measure hemoglobin and ferritin. H pylori status was investigated with the C-urea breath test. All of the subjects with either anemia or ID were given iron therapy. RESULTS: H pylori prevalence was 40.7% (79/194), being higher in male subjects (45/90 vs 34/104, P = 0.014). There was no relation between infection and nutritional status. Abnormally low serum ferritin was observed in 12 subjects, half of whom were positive for H pylori (odds ratio [OR] 1.49, 95% confidence interval [CI] 0.38-5.81). The median serum ferritin was 33.6 ng/mL (interquartile range 23.9-50.9) in infected subjects and 35.1 ng/mL (interquartile range 23.7-53.9) in uninfected subjects. Anemia was detected in 2% (4/194) of the students, half of whom were infected (OR 1.47, 95% CI 0.1-20.6). The mean hemoglobin value in infected subjects was 13.83 g/dL ± 1.02 versus 14 g/dL ± 1.06 in uninfected subjects. CONCLUSIONS: The study was not able to find a relation between H pylori infection and ID or anemia.

Stretching and joint mobilization exercises reduce call-center operators' musculoskeletal discomfort and fatigue

AIM: We sought to evaluate musculoskeletal discomfort and mental and physical fatigue in the call-center workers of an airline company before and after a supervised exercise program compared with rest breaks during the work shift. INTRODUCTION: This was a longitudinal pilot study conducted in a flight-booking call-center for an airline in São Paulo, Brazil. Occupational health activities are recommended to decrease the negative effects of the call-center working conditions. In practice, exercise programs are commonly recommended for computer workers, but their effects have not been studied in call-center operators. METHODS: Sixty-four call-center operators participated in this study. Thirty-two subjects were placed into the experimental group and attended a 10-min daily exercise session for 2 months. Conversely, 32 participants were placed into the control group and took a 10-min daily rest break during the same period. Each subject was evaluated once a week by means of the Corlett-Bishop body map with a visual analog discomfort scale and the Chalder fatigue questionnaire. RESULTS: Musculoskeletal discomfort decreased in both groups, but the reduction was only statistically significant for the spine and buttocks (p=0.04) and the sum of the segments (p=0.01) in the experimental group. In addition, the experimental group showed significant differences in the level of mental fatigue, especially in questions related to memory Rienzo, #181ff and tiredness (p=0.001). CONCLUSIONS: Our preliminary results demonstrate that appropriately designed and supervised exercise programs may be more efficient than rest breaks in decreasing discomfort and fatigue levels in call-center operators.

Association study between the -62A/T NFKBIL1 polymorphism and obsessive-compulsive disorder.

OBJECTIVE: Evidence from family and molecular genetic studies support the hypothesis of involvement of immunologic mechanisms in the pathophysiology of obsessive-compulsive disorder. The nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor-like 1 (NFKBIL1) has been suggested as a modulator of the immunological system. Given the importance of NFKBIL1 in the immunological response, the present study investigated the -62A/T polymorphism (rs2071592), located in the promoter region of its gene (NFKBIL1), as a genetic risk factor for the development of obsessive-compulsive disorder. METHOD: The -62A/T NFKBIL1 polymorphism was investigated in a sample of 111 patients who met DSM-IV criteria for obsessive-compulsive disorder and 272 healthy age- and gender-matched controls. RESULTS: There were no differences in genotypic distributions between patients and controls (chi2 = 0.98; 2 d.f.; p = 0.61). DISCUSSION: Despite these negative findings, more comprehensive polymorphism coverage within the NFKBIL1 is warranted in larger samples. Populations with different ethnic backgrounds should also be studied. CONCLUSION: The results of the present investigation do not provide evidence for the association between the -62A/T NFKBIL1 polymorphism and obsessive-compulsive disorder in this Brazilian sample.

Association study between the -62A/T NFKBIL1 polymorphism and obsessive-compulsive disorder / Estudo de associação entre o polimorfismo -62A/T NFKBIL1 e o transtorno obsessivo-compulsivo

OBJECTIVE: Evidence from family and molecular genetic studies support the hypothesis of involvement of immunologic mechanisms in the pathophysiology of obsessive-compulsive disorder. The nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor-like 1 (NFKBIL1) has been suggested as a modulator of the immunological system. Given the importance of NFKBIL1 in the immunological response, the present study investigated the -62A/T polymorphism (rs2071592), located in the promoter region of its gene (NFKBIL1), as a genetic risk factor for the development of obsessive-compulsive disorder. METHOD: The -62A/T NFKBIL1 polymorphism was investigated in a sample of 111 patients who met DSM-IV criteria for obsessive-compulsive disorder and 272 healthy age- and gender-matched controls. RESULTS: There were no differences in genotypic distributions between patients and controls (χ2 = 0.98; 2 d.f.; p = 0.61). DISCUSSION: Despite these negative findings, more comprehensive polymorphism coverage within the NFKBIL1 is warranted in larger samples. Populations with different ethnic backgrounds should also be studied. CONCLUSION: The results of the present investigation do not provide evidence for the association between the -62A/T NFKBIL1 polymorphism and obsessive-compulsive disorder in this Brazilian sample.

OBJETIVO: Evidências advindas de estudos de família e de genética molecular têm dado suporte à hipótese do envolvimento de mecanismos imunológicos na fisiopatologia do transtorno obsessivo-compulsivo. Tem sido sugerido que o potencializador do fator nuclear do polipeptídeo kappa light em células-B inibidoras-like 1 (NFKBIL1) é um modulador do sistema imunológico. Dada a importância do NFKBIL1 na resposta imunológica, o presente estudo investigou o polimorfismo -62A/T (rs2071592), localizado na região promotora de seu gene, como fator de risco genético para o desenvolvimento do transtorno obsessivo-compulsivo. MÉTODO: O polimorfismo -62A/T do gene do NFKBIL1 foi investigado em uma amostra de 111 pacientes com o diagnóstico de transtorno obsessivo-compulsivo, de acordo com os critérios do DSM-IV, e 272 controles saudáveis emparelhados por idade e gênero. RESULTADOS: Não houve diferenças na distribuição genotípica entre pacientes e controles (χ2 = 0,98; 2 d.f.; p = 0,61). DISCUSSÃO: Apesar dos resultados negativos, estudos compreendendo mais polimorfismos no gene do NFKBIL, em amostras maiores, são necessários. Populações com diferentes origens étnicas também precisam ser avaliadas. CONCLUSÃO: Os resultados da presente investigação não evidenciam associação entre o polimorfismo -62A/T do gene do NFKBIL1 e o transtorno obsessivo-compulsivo nesta amostra brasileira.

Sequential allocation to balance prognostic factors in a psychiatric clinical trial

OBJECTIVE: This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients. METHOD: Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one. RESULTS: We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment. CONCLUSION: Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov NCT00466609 and NCT00680602.

Weight of evidence / A importância da evidência

Evidence-based Medicine (EBM) has become a major source of medical knowledge. It handles complexities of virtually every method or technique used in research. The knowledge on how the EBM researcher retrieves information, judges for relevance and analyzes derived data is invaluable for the skillful reader of medical scientific reports.

Prevalência de indivíduos cor-deficientesentre alunos de odontologia / Prevalence of color vision-deficient individuals among dental students

O objetivo deste estudo foi identificar indivíduos deficientespara visão de cores, testando a acuidade visualdentre um grupo de estudantes de Odontologia, e compararo resultado obtido com os resultados encontradosna literatura, considerando o prejuízo das discromatopsiascongênitas para a Odontologia, especialmente naescolha da cor dental. Foram escolhidas seis cartas determinadasdentre as cartas da seqüência do Teste de Ishiharae essas foram apresentadas como seis ôslidesõ para 308indivíduos, alunos de Odontologia. Durante a apresentação,o indivíduo preenchia um formulário com suasinformações pessoais e a leitura da carta que estava vendo.O Teste de Ishihara é um teste de leitura de placas pseudo-isocromáticas usado para identificar indivíduos comdiscromatopsias congênitas; e é o mais usado dos testespara esse fim. Trezentos e oito indivíduos foram avaliados.Desses, 121 (39,3 por cento) eram homens e 187 (60,7 por cento) erammulheres, com idades entre 19 e 37 anos. Do total, 13(4,2 por cento) foram considerados indivíduos cor-deficientes: 8(6,6 por cento) homens e 5 (2,6 por cento) mulheres. Após a análise estatística,pudemos afirmar que, com 95 por cento de probabilidade,a proporção real de homens cor-deficientes está nointervalo de 3,14 por cento a 12,16 por cento; e a proporção real de mulherescor-deficientes está no intervalo de 0,96 por cento a 5,68 por centoRejeitamos a hipótese de que a população feminina desteestudo está de acordo com a encontrada na literatura.Por outro lado, a população masculina deste estudo pareceestar de acordo com os achados da literatura.

Relação entre a dureza e o manchamento das resinas compostas / The influence of staining on hardness of composite resins

O objetivo deste estudo in vitro foi analisar a influência de dois líquidos corantes (café e vinho tinto) na estabilidade de cor de nove marcas comerciais de resinas compostas (Z250, Filtek Flow, Tetric Ceram, Herculite, Point 4, Admira, Durafil, Solitaire e Charisma) e relacionar o manchamento com a microdureza. Para cada marca de resina composta foram confeccionados nove corpos de prova, na cor A2, submetidos durante 30 dias aos líquidos corantes. A análise estatística da dependência entre dureza e manchamento indicou a existência de uma associação positiva entre as duas características. A associação foi maior quando houve exposição ao café. Com relação à exposição ao vinho, embora com menos significância, a análise indicou também haver associação entre dureza e manchamento. Na exposição à água, não foi observada associação significativa entre alteração de cor e de dureza. Finalmente, foram observadas diferenças significantes entre os corantes. Com relação à variação de cor, a ordem da menor para a maior foi água, vinho, café. Quanto à variação de dureza, a relação foi água=vinho/café.

Detection of determinant genes and diagnostic via Item Response Theory

This work presents a method to analyze characteristics of a set of genes that can have an influence in a certain anomaly, such as a particular type of cancer. A measure is proposed with the objective of diagnosing individuals regarding the anomaly under study and some characteristcs of the genes analyzed. Maximum likelihood equations for general and particular cases are presented.

Assessment of anxiety and quality of life in fibromyalgia patients

CONTEXTO: Fibromialgia é uma síndrome reumática caracterizada por dores músculo-esqueléticas difusas e crônicas e sítios dolorosos específicos à palpação, chamados de tender points, freqüentemente associados a fadiga, distúrbios do sono, rigidez matinal e, em alguns casos, dispnéia e ansiedade. Devido ao seu caráter crônico, a síndrome geralmente causa impacto negativo na qualidade de vida dos fibromiálgicos. OBJETIVO: Comparar a eficácia de instrumentos que avaliam a qualidade de vida de fibromiálgicos mensurada pelo Fibromyalgia Impact Questionnaire(FIQ) e pelo Medical Outcomes Study 36-item Short-Form Healthy Survey (SF-36), e a ansiedade avaliada pelo Inventário de Ansiedade Traço-estado (IDATE). TIPO DE ESTUDO: Transversal. LOCAL: Ambulatório de Reumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP). MÉTODOS: Participaram do estudo 80 sujeitos: 40 com fibromialgia (grupo teste) e 40 saudáveis (grupo controle). Três questionários (dois para avaliação de qualidade de vida - FIQ e SF-36 û; e um para ansiedade - IDATE) foram aplicados aos indivíduos dos dois grupos em uma única entrevista. Toda a análise estatística foi realizada utilizando-se o Teste "t" Student e o teste de Correlação de Pearson (r), com significância p < 0,05. Além disso, o teste estatístico Qui-quadrado de Pearson, para homogeneidade, foi usado para comparar o grau de escolaridade entre os grupos teste e controle. RESULTADOS: Os resultados obtidos mostram que houve diferença estatisticamente significante entre os grupos (p = 0,00), indicando que os fibromiálgicos têm pior qualidade de vida e níveis mais altos de ansiedade. A correlação entre os três questionários foi alta (r = 0,90). DISCUSSAO: O impacto negativo na qualidade de vida decorrente da Fibromialgia tem sido relatado em muitos estudos, nos quais os protocolos de avaliação são os principais istrumentos de medida. O FIQ é um instrumento utilizado em vários estudos clínicos para avaliar a função física. Este estudo comprovou a eficiência do FIQ para avaliar o impacto da fibromialgia sobre a qualidade de vida. O SF-36 é menos específico que o FIQ, mas também se mostrou eficiente para a avaliação da qualidade de vida de fibromiálgicos, uma vez que os discrimina dos indivíduos saudáveis. A ansiedade é considerada um ...

Assessment of anxiety and quality of life in fibromyalgia patients.

CONTEXT: Fibromyalgia is a syndrome characterized by chronic, diffuse musculoskeletal pain, and by a low pain threshold at specific anatomical points. The syndrome is associated with other symptoms such as fatigue, sleep disturbance, morning stiffness and anxiety. Because of its chronic nature, it often has a negative impact on patients' quality of life. OBJECTIVE: To assess the quality of life and anxiety level of patients with fibromyalgia. TYPE OF STUDY: Cross-sectional. SETTING: Rheumatology outpatient service of Hospital das Clínicas (Medical School, Universidade de São Paulo). METHODS: This study evaluated 80 individuals, divided between test and control groups. The test group included 40 women with a confirmed diagnosis of fibromyalgia. The control group was composed of 40 healthy women. Three questionnaires were used: two to assess quality of life (FIQ and SF-36) and one to assess anxiety (STAI). They were applied to the individuals in both groups in a single face-to-face interview. The statistical analysis used Student's t test and Pearson's correlation test (r), with a significance level of 95%. Also, the Pearson chi-squared statistics test for homogeneity, with Yates correction, was used for comparing schooling between test and control groups. RESULTS: There was a statistically significant difference between the groups (p = 0.000), thus indicating that fibromyalgia patients have a worse quality of life and higher levels of anxiety. The correlations between the three questionnaires were high (r = 0.9). DISCUSSION: This study has confirmed the efficacy of FIQ for evaluating the impact of fibromyalgia on the quality of life. SF-36 is less specific than FIQ, although statistically significant values were obtained when analyzed separately, STAI showed lower efficacy for discriminating the test group from the control group. The test group showed worse quality of life than did the control group, which was demonstrated by both FIQ and SF-36. Even though STAI was a less efficient instrument, it presented significant results, showing that fibromyalgia patients presented higher levels of anxiety, both on the state and trait scales. Thus, patients with fibromyalgia had higher levels of tension, nervousness, preoccupation and apprehension, and higher propensity towards anxiety. CONCLUSION: The three instruments utilized showed efficiency in evaluating fibromyalgia patients. FIQ was found to be the most efficient instrument for discriminating and assessing the impact of fibromyalgia on their quality of life. It can be concluded that such patients have a worse quality of life and higher levels of anxiety.

Medicina e estatistica / Medicine and statistics

O medico-pesquisador habitualmente emprega testes de hipotese, intervalos de confianca ou ambas as tecnicas estatisticas na analise dos resultados de suas pesquisas. Se por um lado essa tarefa simplificou-se com o uso de programas estatisticos em microcomputadores, contribui tambem para afastar o medico do convivio com o estatistico e com os conceitos da Estatistica. Mostra-se nesta rota que a colaboracao do estatistico melhora a qualidade da pesquisa medica, tomando-se como exemplo as afirmacoes probalisticas sob o enfoque classico em comparacao com o enfoque bayesiano. Evidentemente, nem mesmo a simples consideracao da analise bayesiana ocorreria sem a cooperacao do estatistico. Ademais, nota-se que esta analise fornece informacoes probabilisticas direta e clara, em contraste com o palavreado tortuoso e indireto que e tipico de teoria classica...

Fotossensibilidade e termoestabilidade de vacinas contra o sarampo (CEPA BIKEN CAM-70) liofilizadas e/ou reconstituídas para administraçäo / Photosensitivity and stability of freeze-dried and reconstituted measles vaccines (Biken CAM-70 strain)

Três lotes de vacinas contra o sarampo, produzidos com a cepa de vírus Biken CAM-70, sob as formas liofilizada e reconstituída, pertencentes ao estoque da rede de vacinaçäo da Secretaria de Estado da Saúde de Säo Paulo, Brasil, foram submetidos a testes de sensibilidade a luz, a temperatura de 2 a 8§C, e de termoestabilidade (protegidos da luz) as temperaturas de 28, 36,5 e 45§C, objetivando verificar por quanto tempo retinham sua potência, isto é, a concentraçäo ideal recomendada para a cepa de vírus presente. A análise de retas de regressäo ajustadas demonstrou que, de modo geral, tanto os lotes de vacinas liofilizados como de potência no decorrer do experimento, a qual foi mais acentuada para vacinas expostas a luz. Reconstituídos e mantidos a 2 a 8§C, os lotes näo apresentaram homogeneidade no referente a sensibilidade a luz. Quando a fotossensibilidade de lotes de vacinas liofilizadas foi testada a 2 a 8§C eles mostraram-se mais sensíveis a degradaçäo térmica quando expostos a luz do que quando protegidos dela. Entretanto, expostos ou protegidos, a potência foi inferior a mínima aceita para a cepa Bikien CAM-70. As demais temperaturas, mesmo ao abrigo da luz, os dois lotes näo retiveram potência mínima. Quanto as vacinas do lote 3, conservadas a 2 a 8§C, mantiveram-se de acordo com os requerimentos mínimos de potência durante 60 dias quando protegidas da luz, e durante 40 dias quando expostas a ela. A degradaçäo térmica as demais temperaturas foi mais acentuada (28§C: 5 dias...