Objetivos: Avaliar o impacto das intervenções espirituais/religiosas sobre a saúde de indivíduos, descrever os protocolos utilizados e analisar a qualidade metodológica dos artigos. Métodos: Revisão sistemática e meta-análise realizada nos seguintes bancos de dados: PubMed, Scopus, Web of Science, PsycINFO, The Cochrane Collaboration, Embase e Scielo. Através de expressão booleana foram incluídos artigos que: (i) investigaram os desfechos na saúde; (ii) realizaram ensaios clínicos randomizados, e (iii) foram redigidos em inglês, espanhol ou português. Foram excluídos protocolos sobre prece intercessória ou cura à distância. O estudo foi realizado em duas fases: (1) a leitura de título e resumo, (2) leitura completa dos artigos e avaliação de sua qualidade metodológica. Resultados: Através da revisão sistemática, 4751 estudos foram obtidos, dos quais 4367 foram excluídos por não se encaixarem nos critérios de inclusão ou por serem repetidos (fase 1). Dos restantes 162 artigos, 123 foram excluídos por não serem intervenções espirituais/religiosas ou por apresentarem randomização inadequada, permanecendo assim 39 artigos (fase 2). Em geral, os estudos têm mostrado que as intervenções espirituais/religiosas diminuíram os sintomas de depressão, ansiedade, consumo de álcool, excesso de peso e estresse, e melhoraram qualidade de vida em diferentes doenças. A meta-análise mostrou efeitos significativos sobre a ansiedade (p < 0.0001), mas não sobre a depressão (p=0.41) ou qualidade de vida (p=0.56). Conclusão: Os estudos sobre intervenções espirituais/religiosas mostraram benefícios em sintomas clínicos (principalmente ansiedade e estresse), maior adesão a tratamento médico e satisfação com o procedimento. A diversidade de população e protocolos apontam para a necessidade de mais estudos envolvendo E/R como tratamento complementar na saúde / Objectives: To evaluate the impact of spiritual/religious interventions on the health of individuals, describe the protocols utilized and analyze the methodological quality of papers. Methods: A systematic review and meta-analysis conducted in the following databases: PubMed, Scopus, Web of Science, PsycINFO, The Cochrane Collaboration, Embase and Scielo. Through a Boolean expression, were included papers that: (i) investigated health outcomes; (ii) conducted randomized clinical trials, and (iii) were written in English, Spanish or Portuguese. Protocols of intercessory prayer or distance healing were excluded. The study was conducted in two phases: (1) reading the title and abstract, (2) reading full articles and assessing their methodological quality. Results: The systematic review obtained 4751 studies, of which 4367 were excluded because did not fit in eligibility criteria or were repeated (phase 1). Of the remaining 162 articles, 123 were excluded for not fit into spiritual/religious interventions definition or for inadequate randomization, remaining 39 articles (phase 2). In general, studies have shown that spiritual/religious interventions improved clinical symptoms in different diseases, as depression, anxiety, alcohol consumption, overweight and stress, and quality of life. The meta-analysis showed significant effects on anxiety (p < 0.0001), but not on depression (p=0.41) or quality of life (p=0.56). Conclusion: Studies on spiritual/religious interventions showed benefits such as reduction of clinical symptoms (especially anxiety and stress), greater adherence to medical treatment and satisfaction with the procedure. The diversity of population and protocols and indicate the need for further studies evaluating E/R as a complementary treatment in health

Introdução: A episiotomia é uma ampliação cirúrgica do períneo amplamente utilizada na assistência ao parto, embora seu emprego rotineiro não seja justificado pelas evidências científicas. Está associada à dor e ao desconforto no período pós-parto. O Laser em Baixa Intensidade (LBI) vem se destacando na literatura como uma tecnologia promissora em relação ao tratamento de feridas. Apresenta efeitos de redução da dor, inflamação e estímulo à cicatrização. Objetivo: Avaliar os efeitos do laser em baixa intensidade na cicatrização da região perineal, na frequência e magnitude da dor perineal, após a episiotomia médio-lateral direita. Método: Ensaio clínico aleatorizado, paralelo e triplo cego, com uma amostra de 54 puérperas, divididas em grupo experimental (recebeu irradiação de laser) e controle (recebeu simulação de irradiação). As puérperas foram incluídas no estudo entre 6 e 10 horas após o parto no Alojamento Conjunto do Hospital Universitário da Universidade de São Paulo. Os critérios de inclusão foram: idade 18 anos, idade gestacional 37 e <42 semanas; sem parto vaginal anterior; parto espontâneo de feto único, vivo e em apresentação cefálica, com episiotomia médio-lateral direita; ausência de processo infeccioso, hemorroidas, hematomas ou varizes na região vulvoperineal; não ter realizado preparo da região perineal na gravidez; não ter feito uso de drogas fotossensibilizantes e sem intercorrências clínicas ou obstétricas. Foram excluídas do estudo mulheres que utilizaram qualquer produto diferente de água e sabão na região vulvoperineal. A intervenção com o laser consistiu em três irradiações (primeira: de 6 a 10 horas após o parto, segunda: 20 a 24 horas e terceira: 40 a 48 horas após a primeira aplicação), com laser diodo infravermelho, meio ativo semicondutor Gallium-Aluminum-Arsenide (GaAIAs), tamanho do spot de 0,04 cm2, densidade de energia de 5J/cm2, potência de 20 mW, duração da irradiação de 10 segundos por ponto. Em cada sessão, a episiotomia foi irradiada em nove pontos diferentes, com 0,2J por ponto e energia total de 1,8J por sessão. Na simulação da irradiação, a ponteira que emite o laser vermelho foi modificada pelo próprio fabricante, que substituiu o laser por uma luz guia. Em ambos os grupos, a cicatrização perineal foi avaliada em quatro momentos: antes das três irradiações e 7 a 10 dias após a alta hospitalar, por meio da escala Redness Edema Echymosis Discharge Aproximation (REEDA). A avaliação da dor perineal foi feita em sete ocasiões: antes e após as três irradiações e 7 a 10 dias, após a alta hospitalar pelo questionamento de presença ou ausência de dor e pela escala numérica de 0 a 10. A coleta de dados foi realizada entre junho e outubro de 2011. Resultados: Foram randomizadas 54 mulheres (29 no grupo experimental e 25 no grupo controle). Houve perda de seguimento de 11 mulheres na última avaliação (7 a 10 dias). Os grupos foram semelhantes quanto às variáveis: idade materna em anos completos; Índice de Massa Corporal; idade gestacional; peso do recém-nascido em gramas; Apgar de 1º, 5º e 10º minutos; perímetro cefálico em centímetros; extensão da episiotomia em centímetros; número de gestações, partos e abortos; cor; escolaridade; profissão; estado marital; presença de acompanhante; número de doses analgésicas e intervalo entre a ingestão do analgésico e a avaliação. A anestesia raquidiana foi usada com maior frequência no grupo controle (p=0,043). Quanto à cicatrização, os grupos não diferiram na escala REEDA em nenhuma das avaliações. Quanto às médias de dor perineal, os grupos diferiram nas seguintes ocasiões: o experimental apresentou maiores médias de dor na avaliação antes (grupo experimental 4,5; grupo controle 2,0; p=0,002), após a primeira irradiação (grupo experimental 4,1; grupo controle 2,0; p=0,008), e após a terceira irradiação (grupo experimental 1,5; grupo controle 0,6; p=0,019). Quanto à presença de dor, não houve diferença estatisticamente significante entre os grupos nos distintos momentos de avaliação. Não houve diferenças estatisticamente significantes entre os dois grupos entre a redução média de dor antes e após a irradiação laser, tanto em porcentagem quanto em relação a uma melhora <30% e 30%, nos três momentos em que a intervenção foi realizada. O procedimento foi considerado muito bom por 44,4% das mulheres, bom por 53,4% delas e ruim por 2,2% delas; 95,6% delas referiram o fariam novamente. Conclusão: O uso de LBI não teve efeito na cicatrização ou na frequência e na magnitude da dor perineal em mulheres com episiotomia, após o parto vaginal espontâneo. / Introduction: An episiotomy is a surgical widening of the perineum largely used in the childbirth, despite the fact that its routine use has not been justified by scientific evidence. It is associated with pain and discomfort in the postpartum period. The Low-Level Laser Therapy (LLLT) has been pointed out in the literature as a promising technology for the treatment of wounds. It has the effects of reducing pain and inflammation and healing stimulation. Objective: Evaluate the effects of low intensity laser therapy in the healing of the perineal region and in the frequency and magnitude of perineal pain, after right mediolateral episiotomy. Method: Parallel, triple blind randomized clinical trial, with a sample of 54 mothers who were divided into experimental (received laser irradiation) and control group (received simulated radiation). Postpartum women were included in the study from 6 to 10 hours after birth in the Rooming-in Unit of the Hospital of the University of São Paulo. Inclusion criteria were: age 18 years, gestational age 37 and <42 weeks, no previous vaginal delivery, to have a spontaneous delivery of a singleton fetus in cephalic presentation with right mediolateral episiotomy, absence of infection, hemorrhoids, bruises or varicose veins in the vulvoperineal region; no perineum preparation during pregnancy, no use of photosensitizing drugs and no clinical or obstetric complications. We excluded women who had used any product other than soap and water in the vulvoperineal region. The LLLT intervention consisted of three irradiations (first: from 6 to 10 hours after birth, second: from 20 to 24 hours after birth and third one from 40 to 48 hours after the first application), using infrared diode laser, with a semiconductor active medium Aluminum-Gallium-arsenide (GaAlAs), a size spot of 0.04 cm, 2 5J/cm2 energy density, power of 20 mW, and length of irradiation of 10 seconds per point. In each session, the episiotomy was irradiated in nine different points, with a total of 0.2 J per point and a total energy of 1.8 J per session. To simulate the irradiation, the tip that emits the red laser was modified by the manufacturer, who replaced the infrared laser by a guiding light in the same pen that emits the laser. In both groups, the perineal wound healing was assessed at four time moments: before the three irradiations and from 7 to 10 days after hospital discharge, through the scale Echymosis Discharge Aproximation Redness Edema (REEDA). The perineal pain was assessed in seven occasions: before and after the three sessions of irradiation and in one occasion from 7-10 days after birth, using numerical scale from 0 to 10 and questioning the woman on the presence or absence of pain. Data collection was carried out between June and October 2011. Results: We randomized 54 women (29 in the experimental group and 25 in the control group). Eleven women were lost in the follow-up, in the last evaluation (7-10 days). Both groups were similar with regard to the variables: maternal age in years, body mass index, gestational age, weight of the newborn in grams; Apgar score at 1, 5 and 10 minutes and head circumference in centimeters; episiotomy length in centimeters, number of pregnancies, births and miscarriages, skin color, education, profession, marital status, presence of caregiver, the number of analgesic doses and interval between the intake of analgesics and evaluation. The spinal anesthesia was more frequently used in the control group (p = 0.043). Regarding the healing, the groups did not differ in any assessments of the REEDA scale. Regarding the means of perineal pain, the groups differed on the following occasions: the experimental group had higher means of pain scores in the evaluation before (experimental group 4.5, control group 2.0, p = 0.002), and after the first irradiation (experimental group 4.1, control group 2.0, p = 0.008), and after the third irradiation (experimental group 1.5, control group 0.6, p = 0.019). Regarding the presence of pain, there was no statistically significant difference between groups in different stages of evaluation. There was no statistically significant differences between the two groups, both regarding the mean reduction of pain before and after laser irradiation in percentage and regarding an improvement <30% and 30% in the three moments when the intervention was performed. The procedure was evaluated as very good by 44.4% of women, as good by 53.4% and as bad by 2.2% of them; 95.6% of women who had the procedure reported that would have it again. Conclusion: The use of LLLT had no effect on wound healing or in the frequency and magnitude of perineal pain in women with episiotomies after spontaneous vaginal delivery, with the dosage and number of sessions used in this study.

This master thesis is a description of the clinical trial, which is part of medical law un- der the law aspects. This thesis is split to topic, whose a brief outline is in the introduction. Process of the clinical trial and their institutions are discussed under the law and medical aspects. Resources of this thesis are a professional literature, knowledge of experts from pharmaceutical company and my own experience from part-time job in this type of com- panies. Aim of the thesis is to bring more resources and information about that topic to experts and other people who are interested in. This thesis is devided into five chapters. First chapter is speaking about a general insti- tute in the clinical trial. There are listed sources of the law. In the next chapter I deal with the process of the clinical trial from the begining i.e. from the development of a new sub- stance through the clinical trial to the final registration. The chapter about the european law regulation is following. In the fourth chapter I deal with the ethical aspects, which are conected with clinical trial. In that part I emphasised the influence of the international ethical documents. The last chapter is conclusion, where I describe the goal of this master thesis and also I am linking to the opinions of authorities regarding the...

The immunotherapeutic drug DCVAC/OvCa is being tested in the treatment of ovarian cancer patients within the SOV02 clinical trial (Eudra CT number: 2013-001323-38). Ovarian cancer belongs to gynaecological malignancies with the highest mortality rate. Around 60% of patients are diagnosed at advanced stages. Despite the initial successful treatment, relapses occur in most cases, and the disease often becomes resistant to chemotherapy. Effective therapy for relapsed or metastatic patients is still missing. The solution could be immunotherapeutic treatment. DCVAC is an active cellular immunotherapy based on autologous dendritic cells. The aim of this diploma thesis was monitoring of immune parameters in samples from clinical trial SOV02 patients during the time period defined in the study protocol. We have monitored the presence of antigen specific T lymphocytes, tumor specific antibodies, immunosuppressive populations of regulatory T cells and MDSC cells, and also the expression of inhibitory molecules on the surface of T lymphocytes. We observed higher levels of Her-2, Muc-1 and MAGE-A1 antibodies in the DCVAC/OvCa treated group of patients versus the control group. Significant differences in the other monitored parameters were not observed. However, a large amount of data have been obtained that...

The present study investigated the efficacies of Individual CBT (ICBT), Parent Relationship Skill Training (RLST, which targets increasing parental acceptance of youth and increasing autonomy granting) and Parent Reinforcement Skills Training (RLST, which targets increasing parental positive reinforcement and decreasing negative reinforcement). The specific aims were to examine treatment specificity and mediation effects of parenting variables. ICBT was used as a baseline comparison condition. The sample consisted of 253 youth (ages 5-16 years; M = 9.38; SD = 2.42) and their parents. To examine treatment outcome and specificity, the data were analyzed using analysis of variance within a structural equation modeling framework. Mediation was analyzed via structural equation modeling using MPlus. Results indicated that ICBT, RLST, and RFST produced positive treatment outcomes across all indices of change (i.e., clinically significant improvement, anxiety symptom reduction) and across all informants (i.e., youths and parents). RLST was associated with incremental reduction in youth anxiety symptoms beyond ICBT, as per youth report. Treatment specificity effects were found for participants in RFST in terms of parental reinforcement, as per parent report only. Treatment mediation was not found for any of the hypothesized parenting variables (i.e., parental acceptance, parental autonomy granting, parental reinforcement). The results support the use of CBT involving only the youth and the parent and youth together for treating youth anxiety. The findings’ implications are further discussed in terms of the need to conduct further meditational treatment outcome designs in order to continue to advance theory and research in youth anxiety treatment.

Fear of cancer recurrence (FCR) is defined as “fear, worry, or concern relating to the possibility that cancer will come back or progress (Lebel et al., 2016, p. 3266). FCR is the most frequently reported concern identified among cancer survivors (Baker, Denniston, Smith, & West, 2005; Lebel, Rosberger, Edgar, & Devins, 2007). Although approximately 50% of cancer survivors experience moderate-to-high levels of FCR (Simard et al., 2013), few psychosocial interventions exist that directly target this construct. The overarching study objectives were: (a) to adapt a manualized, 6-week, cognitive-existential group therapy intervention for FCR to an individual format; (b) to pilot-test the feasibility, acceptability, and satisfaction of this individual intervention on n=3 participants; and (c) to further pilot-test the efficacy of the individual intervention on n=25 participants, via a randomized controlled trial (RCT). In study 1, n=3 cancer survivors (1 male, 2 females) completed the one-on-one therapy intervention for the psychological treatment of FCR. Sessions were 60-90 minutes long, and included cognitive restructuring exercises, behavioural experiments, relaxation techniques, existential processing of the here-and-now, and finding meaning in life post-diagnosis. Participants completed questionnaire packages throughout the intervention and an exit interview to determine their overall feedback on the intervention. Quantitative analyses revealed downwards trends in fear of cancer recurrence and cancer-specific distress across participants. Qualitative analyses of the exit interviews revealed that all participants found the intervention useful, and that the sessions had favourable pacing and length. In study 2, the FCR intervention was further pilot-tested via an RCT. Twenty-five female cancer survivors were randomized to an experimental group or a wait-list control group. Sessions included cognitive restructuring techniques, behavioural experiments, confronting existential distress, and relaxation exercises. Nineteen women (n=9 intervention, n=10 control) completed the 6-week therapy intervention, and completed questionnaire packages at pre-, post- and 3-month follow-up. Between-within ANOVAs revealed significant interactions in the primary outcome measure of FCR, and secondary outcome measures of cancer-specific distress and uncertainty in illness for participants in the experimental group. Repeated measures ANOVAs revealed reductions in FCR, cancer-specific distress, uncertainty in illness, reassurance-seeking, cognitive avoidance, and intolerance of uncertainty, and revealed improvements in positive reinterpretation and growth, use of emotional support and mental health (improved quality of life) for participants in the experimental group, as compared to the wait-list control group. The variables that changed either maintained or improved at follow-up. Results from this study demonstrate promising results in addressing FCR in cancer survivors via a cognitive-existential intervention. Future research should continue investigating the specific therapeutic ingredients that are most effective for the psychological treatment of FCR.

Nowell (1976) first proposed that unless cytotoxic cancer therapy eradicates all tumor cells, genetic or heritable variation within heterogeneous tumors will inevitably lead to the evolution of chemotherapeutic resistance through clonal selection. This evolutionary hypothesis was formalized by Goldie and Coldman (1979), who developed one of the earliest mathematical kinetic models of resistance evolution in neoplasms. Their model predicted that the likelihood of response and cure would be increased in combination vs single agent cytotoxic therapies. In a later study, Gardner (2002) developed a computational kinetic model to predict chemotherapeutic combinations, doses, and schedules most likely to result in patient response and prolonged life. This model predicts that combination therapy involving both cytotoxic and cytostatic drugs will be more effective than combination therapy involving only cytotoxic drugs. Thus far, no systematic evaluation of the Goldie and Coldman and Gardner hypotheses have been conducted in the metastatic clinical trial setting. Here I test these hypotheses using the results of over 700 phase II, III and II/III clinical trials. I show that, as predicted by Goldie and Coldman, both overall response rate and overall survival were greater in combination arms. Moreover, median duration of response – the key indicator of the rate of resistance evolution - was also greater in combination vs single agent arms. These results suggest that generally combination chemotherapy is more effective than single agent therapy for advanced solid tumors as predicted by Goldie and Coldman (1979) hypothesis and that, at least in the metastatic setting, the potential disadvantages of combination therapy with respect to accelerated resistance evolution are outweighed by the greater waiting times for resistance mutations to arise. By contrast, although combination cytotoxic and cytostatic therapy is associated with a greater average overall response rate than multi agent cytotoxic therapy, this is not the case for both median duration of response and overall survival. Hence, there is no evidence that, in contrast to the predictions of the Gardner (2002) model, combination cytotoxic and cytostatic therapy decreases the rate of resistance evolution relative to that obtaining under combination cytotoxic therapy.

Background: Angiogenesis is the process by which new blood vessels develop from existing vasculature and is a critical step in all tumours to facilitate growth beyond a few millimetres. As this process is largely inactive in physiological circumstances in adults, it represents an attractive therapeutic target in oncology. Drugs that target the angiogenic process are classified as anti-angiogenic agents. The first anti-angiogenic drug to be approved by the FDA was bevacizumab; a recombinant humanized monoclonal antibody against VEGF. Randomised studies in colorectal cancer (and other solid malignancies) have reported prolonged progression free survival and overall survival for bevacizumab. However, standard radiological criteria, Response Evaluation Criteria In Solid Tumours (RECIST), although widely employed to assess response to therapy in clinical trials, are generally insensitive to the predominantly cytostatic effects of anti-angiogenic and other targeted therapies. Alternative methods of predicting or assessing early response to such agents are needed, particularly given the cost and toxicity implications of such treatments. However, biomarkers to aid selection of patients for anti-angiogenic therapies, including bevacizumab, remain elusive. Purpose: To investigate Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted Imaging (DWI) and circulating angiocytokines, measured using an ELISA multiplex, as prognostic markers in patients with metastatic colorectal cancer treated with bevacizumab and chemotherapy. Results: Seventy patients were treated. DCE-MRI and DWI parameters showed good reproducibility with coefficient of variation between 3.7 to 23% for parameters. The median progression free survival, the primary end point of the trial, was 9.3 months. The overall response rate was 44%. The clinical variables which were significant for progression free survival on univariate analysis were: performance status (p=0.005), CEA (p=0.04) and serum LDH (p=0.005). Biomarkers which were significant for progression free survival on univariate analysis were serum VEGF-A (p=0.02), serum HGF (p=0.005), sVEGFR-2 (p=0.02). In each case, low values of the biomarker were associated with improved outcome. Multivariate analysis identified Ktrans (p=0.015), performance status (p=0.008) and serum HGF (p=0.003) as the most significant predictors of progression free survival. A prolonged progression free survival was associated with a good ECOG performance status, high Ktrans and low serum HGF.Conclusions: Whilst these results are encouraging, future work is required to establish whether HGF and Ktrans are prognostic markers for metastatic colorectal cancer and their precise role in the prediction of patients likely to benefit from treatment with bevacizumab.

Introdução: Freqüentemente a progressão da doença coronariana aterosclerótica é observada por angiogramas seqüenciais e atribuída ao aumento da incidência de eventos coronarianos.O significado prognóstico desta progressão em pacientes randomizados e submetidos a diferentes formas terapêuticas ainda é pouco conhecido. Este estudo compara a progressão da aterosclerose nas artérias coronárias nativas de pacientes submetidos a tratamento clinico, cirúrgico ou através da angioplastia. Métodos: 611 pacientes portadores de DAC multiarterial estável com função ventricular preservada, foram estudados e submetidos de maneira randomizada, a três formas terapêuticas habituais. Após cinco anos de evolução, 392 pacientes (64%) foram submetidos à cinecoronariografia. A progressão da doença foi definida como surgimento de estenose de, pelo menos, 20% de obstrução em um segmento arterial, admitido previamente como normal. A progressão foi avaliada nas artérias nativas que correspondem a DA, CX, CD dos três grupos terapêuticos. Resultados: 392 pacientes estudados, 136 eram do grupo Cirúrgico, 146 do grupo Angioplastia e 110 do grupo Clínico. Os grupos eram homogêneos em relação às características basais. A análise de progressão entre os grupos terapêuticos mostrou maior progressão da doença na artéria DA do grupo angioplastia. Entre os fatores relacionados à progressão da doença a presença de HAS influenciou significativamente (p= 0,048). Em relação à oclusão total, houve maior incidência no sexo masculino (p= 0,0078) e novo IAM (p= 0,0006). Não se observou relação estatística entre eventos coronarianos e progressão da doença na amostra estudada. Conclusão: Nessa amostra observou-se a progressão da aterosclerose independente da opção terapêutica. Todavia, encontrou-se menor progressão da doença nos pacientes do grupo cirúrgico. Exceto pela presença de hipertensão, nenhum outro fator de risco parece ter influenciado nesta condição. / Introduction: The progression of atherosclerotic in the coronary artery disease (CAD) is observed through consecutive angiograms. The prognosis of this progression randomized patients is not clear. This study compared the progression of native coronary arteries and bypass graft in patients undergoing to surgery (CABG), angioplasty (PCI), or medical strategy (MT). Methods: Six hundred eleven patients with stable multivessel CAD and preserved ventricular function were randomly assigned to the 3 therapeutic options: MT, PCI, or CABG. After a 5-year of follow-up, 392 patients (64%) underwent routine coronary angiogram. Progression was defined as stenosis of at least 20% in an artery segment previously considered normal. Progression was assessed in the native arteries irrigating the three territories, left anterior descending (LAD), left circumflex (LCX) and right coronary artery (RCA). Uni and multivariate analysis were performed in all therapeutic groups. Results: Of the 392 patients, 136 were to CABG, 146 PCI, and 110 MT. Baseline characteristics of three treatment were homogeneous. Analysis of progression within the three groups showed a more significant progression of atherosclerosis in the LAD territories of the PCI group. Among the factors related to the progression, there was a significant influence by hypertension (p = 0.048). Males presented a higher incidence of occlusion (p= 0.0078) and new Myocardial Infarction. (p= 0.0006). There was no statistical difference between coronary events and the development of progression in the sample studied. Conclusion: In this study, we have observed the occurrence of atherosclerosis progression, regardless the treatment option. However, we?ve found less progression of disease in patients from the surgery group. Except for hypertension, any other risk factor seems to have no influence on the increase of this condition.

Das Ziel der vorliegenden randomisierten, klinisch kontrollierten, prospektiven Studie war es, die Leistungsfähigkeit des Universaladhäsivs 3M™ Scotchbond™ Universal (SBU) bei dessen Anwendung an nicht kariösen Zahnhalsläsionen (NCCL) klinisch und mit optischer Kohärenztomografie (OCT) zu bewerten. An 55 Patienten wurde das Universaladhäsiv in den Konditionierungsmodi self-etch (SE, n = 55), selective-enamel-etch (SEE, n = 55) und etch-and-rinse (ER, n = 55) in Kombination mit dem Komposit Filtek™ Supreme XTE angewendet. Das etablierte Etch-and-rinse-Adhäsiv OptiBond™ FL (OFL) diente als Referenzsystem (n = 55). Die Restaurationen wurden nach 14 Tagen (Baseline), sechs und 12 Monaten klinisch untersucht (FDI-Kriterien). Parallel dazu erfolgte die quantitative Bewertung der interfazialen Spaltformationen am Schmelz und Dentin/Zement mit OCT, welche erstmals bereits direkt nach Füllungslegung vorgenommen wurde. Die kumulativen Fehlerraten (CFR), die klinischen Parameter Randverfärbung, Randadaptation und Frakturen/Retention, sowie die gemittelten adhäsiven Defekte pro Gruppe wurden statistisch ausgewertet. Nach 12 Monaten ergaben sich in allen Gruppen mit SBU signifikant geringere kumulative Fehlerraten als in der Kontrollgruppe OFL. Unmittelbar nach Füllungslegung sowie nach sechs und 12 Monaten konnten an der Schmelz-Komposit-Interface in der Gruppe SBU/SE mehr adhäsive Defekte als in den Gruppen SBU/SEE und OFL nachgewiesen werden. An der dominierenden Dentin/Zement-Komposit-Interface zeigte sich hingegen in der Gruppe OFL generell ein signifikant höheres Verbundversagen. Sowohl die klinische als auch die tomografische Bewertung ergaben ein geringeres Verbundversagen in den Gruppen mit SBU im Vergleich zu OFL. Dabei resultierte auch aus der unbeabsichtigten Phosphorsäureätzung am Dentin bei selektiver Schmelzätzung kein Nachteil. Mit OCT konnten signifikante Gruppenunterschiede früher als mit der klinischen Bewertung, nämlich bereits unmittelbar nach Füllungslegung, dargestellt und reproduziert werden. Das verdeutlicht die hohe Sensitivität und Reliabilität der Methode zur Bewertung des Zahn-Komposit-Verbundes und lässt sehr viel frühere Aussagen zur klinischen Bewährung von Systemen zur Restauration mit Kompositen zu.