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1.
Sci Rep ; 10(1): 19934, 2020 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-33203934

RESUMO

REBa2Cu3O7-δ (REBCO, RE: rare earth, such as Y and Gd) compounds have been extensively studied as a superconducting layer in coated conductors. Although ErBCO potentially has better superconducting properties than YBCO and GdBCO, little research has been made on it, especially in chemical solution deposition (CSD). In this work, ErBCO films were deposited on IBAD (ion-beam-assisted-deposition) substrates by CSD with low-fluorine solutions. The crystallization process was optimized to achieve the highest self-field critical current density (Jc) at 77 K. Commonly, for the investigation of a CSD process involving numerous process factors, one factor is changed keeping the others constant, requiring much time and cost. For more efficient investigation, this study adopted a novel design-of-experiment technique, definitive screening design (DSD), for the first time in CSD process. Two different types of solutions containing Er-propionate or Er-acetate were used to make two types of samples, Er-P and Er-A, respectively. Within the investigated range, we found that crystallization temperature, dew point, and oxygen partial pressure play a key role in Er-P, while the former two factors are significant for Er-A. DSD revealed these significant factors among six process factors with only 14 trials. Moreover, the DSD approach allowed us to create models that predict Jc accurately. These models revealed the optimum conditions giving the highest Jc values of 3.6 MA/cm2 for Er-P and 3.0 MA/cm2 for Er-A. These results indicate that DSD is an attractive approach to optimize CSD process.

2.
ACS Appl Mater Interfaces ; 11(34): 31434-31440, 2019 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-31180638

RESUMO

Usually hydroxyl groups present on top of oxidized silicon served as binding centers for a silanization reaction toward surface functionalization. In this study, we developed a novel surface functionalization strategy where hydroxyl functionalization on nonoxidized silicon surfaces are obtained. These surfaces were stable for several weeks even in ambient air at room temperature. This high stability indicates a strong spatial isolation of the hydroxyl groups because they keenly tend to undergo a condensation reaction, forming silicon oxide. To prove the applicability of the obtained hydroxylated silicon surface, we further modified the hydroxyl groups with a commonly used silane molecule, (3-aminopropyl)triethoxysilane (APTES). The functional amino groups of the APTES layer bonded to the surface were subsequently altered by N-maleoyl-ß-alanin to generate a surface highly specific for the immobilization of thiol-containing biomolecules (like thiolated single-stranded DNA or cysteine-tagged proteins). All modification steps have been investigated by IR spectroscopic ellipsometry measurements.


Assuntos
Técnicas Biossensoriais , Dióxido de Silício/química , Silício/química , Propilaminas/química , Silanos/química , Espectroscopia de Infravermelho com Transformada de Fourier , Propriedades de Superfície
3.
Rev Sci Instrum ; 90(1): 015106, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30709201

RESUMO

A new state-of-the-art electrical transport measurement system was developed for the characterization of industrially produced coated conductors (CCs). The current leads are rated to a conduct current of up to 1000 A, which opens up the possibility of measuring the critical current Ic of tapes at a wide range of temperatures. The setup operates in a He-gas flow cryostat that provides stable temperatures between 1.8 and 200 K. The setup is equipped with a split-coil magnet that can apply fields of up to 6 T. A continuous rotation of the sample with respect to the magnetic field with an angular resolution of 0.5° enables characterization of anisotropic Ic of different tapes. In the measured voltage-current curves, weak sample heating mostly occurs from the dissipation in the tape during the Ic transition. It is demonstrated that the system can provide reliable data on the properties of CCs at temperatures lower than 77 K for a magnet design and other applications. The results allow the study of vortex pinning for further prospects of engineering the microstructure of the superconducting layer as well as to assess the performance of various tapes with different architectures to achieve optimum performance at different operating temperatures and magnetic fields.

4.
J Sci Med Sport ; 21(12): 1215-1220, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29843960

RESUMO

OBJECTIVES: To determine injury risk-workload associations in collegiate American Football. DESIGN: Retrospective analysis. METHODS: Workload and injury data was recorded from 52 players during a full NCAA football season. Acute, chronic, and a range of acute:chronic workload ratios (ACWR: 7:14, 7:21 and 7:28 day) calculated using rolling and exponentially weighted moving averages (EWMA) were plotted against non-contact injuries (regardless of time lost or not) sustained within 3- and 7-days. Injury risks were also determined relative to position and experience. RESULTS: 105 non-contact injuries (18 game- and 87 training-related) were observed with almost 40% sustained during the pre-season. 7-21 day EWMA ACWR's with a 3-day injury lag were most closely associated with injury (R2=0.54). Relative injury risks were >3× greater with high compared to moderate and low ratios and magnified when combined with low 21-day chronic workloads (injury probability=92.1%). Injury risks were similar across positions. 'Juniors' presented likely and possibly increased overall injury risk compared to 'Freshman' (RR: 1.94, CI 1.07-3.52) and 'Seniors' (RR: 1.7, CI 0.92-3.14), yet no specific ACWR - experience or - position interactions were identified. CONCLUSIONS: High injury rates during college football pre-season training may be associated with high acute loads. In-season injury risks were greatest with high ACWR and evident even when including (more common and less serious) non-time loss injuries. Substantially increased injury risks when low 21-day chronic workloads and concurrently high EWMA ACWR highlights the importance of load management for individuals with chronic game- (non-involved on game day) and or training (following injury) absences.


Assuntos
Traumatismos em Atletas/epidemiologia , Futebol Americano/lesões , Carga de Trabalho , Humanos , Masculino , Fatores de Risco , Estados Unidos , Universidades
5.
Nanoscale ; 10(17): 8187-8195, 2018 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-29676427

RESUMO

An outstanding current carrying performance (namely critical current density, Jc) over a broad temperature range of 10-77 K for magnetic fields up to 12 T is reported for films of YBa2Cu3O7-x with Ba2Y(Nb,Ta)O6 inclusion pinning centres (YBCO-BYNTO) and thicknesses in the range of 220-500 nm. Jc values of 10 MA cm-2 were measured at 30 K - 5 T and 10 K - 9 T with a corresponding maximum of the pinning force density at 10 K close to 1 TN m-3. The system is very flexible regarding properties and microstructure tuning, and the growth window for achieving a particular microstructure is wide, which is very important for industrial processing. Hence, the dependence of Jc on the magnetic field angle was readily controlled by fine tuning the pinning microstructure. Transmission electron microscopy (TEM) analysis highlighted that higher growth rates induce more splayed and denser BYNTO nanocolumns with a matching field as high as 5.2 T. Correspondingly, a strong peak at the B||c-axis is noticed when the density of vortices is lower than the nanocolumn density. YBCO-BYNTO is a very robust and reproducible composite system for high-current coated conductors over an extended range of magnetic fields and temperatures.

6.
Sci Rep ; 7(1): 4589, 2017 07 04.
Artigo em Inglês | MEDLINE | ID: mdl-28676703

RESUMO

A quantum critical point (QCP) is currently being conjectured for the BaFe2(As1-x P x )2 system at the critical value x c ≈ 0.3. In the proximity of a QCP, all thermodynamic and transport properties are expected to scale with a single characteristic energy, given by the quantum fluctuations. Such a universal behavior has not, however, been found in the superconducting upper critical field H c2. Here we report H c2 data for epitaxial thin films extracted from the electrical resistance measured in very high magnetic fields up to 67 Tesla. Using a multi-band analysis we find that H c2 is sensitive to the QCP, implying a significant charge carrier effective mass enhancement at the doping-induced QCP that is essentially band-dependent. Our results point to two qualitatively different groups of electrons in BaFe2(As1-x P x )2. The first one (possibly associated to hot spots or whole Fermi sheets) has a strong mass enhancement at the QCP, and the second one is insensitive to the QCP. The observed duality could also be present in many other quantum critical systems.

7.
Sci Rep ; 6: 36047, 2016 10 26.
Artigo em Inglês | MEDLINE | ID: mdl-27782196

RESUMO

Fe-based superconductors (FBS) present a large variety of compounds whose properties are affected to different extents by their crystal structures. Amongst them, the REFeAs(O,F) (RE1111, RE being a rare-earth element) is the family with the highest critical temperature Tc but also with a large anisotropy and Josephson vortices as demonstrated in the flux-flow regime in Sm1111 (Tc ∼ 55 K). Here we focus on the pinning properties of the lower-Tc Nd1111 in the flux-creep regime. We demonstrate that for H//c critical current density Jc at high temperatures is dominated by point-defect pinning centres, whereas at low temperatures surface pinning by planar defects parallel to the c-axis and vortex shearing prevail. When the field approaches the ab-planes, two different regimes are observed at low temperatures as a consequence of the transition between 3D Abrikosov and 2D Josephson vortices: one is determined by the formation of a vortex-staircase structure and one by lock-in of vortices parallel to the layers. This is the first study on FBS showing this behaviour in the full temperature, field, and angular range and demonstrating that, despite the lower Tc and anisotropy of Nd1111 with respect to Sm1111, this compound is substantially affected by intrinsic pinning generating a strong ab-peak in Jc.

8.
Nat Commun ; 4: 2877, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24309386

RESUMO

The discovery of superconductivity with a transition temperature, Tc, up to 65 K in single-layer FeSe (bulk Tc=8 K) films grown on SrTiO3 substrates has attracted special attention to Fe-based thin films. The high Tc is a consequence of the combined effect of electron transfer from the oxygen-vacant substrate to the FeSe thin film and lattice tensile strain. Here we demonstrate the realization of superconductivity in the parent compound BaFe2As2 (no bulk Tc) just by tensile lattice strain without charge doping. We investigate the interplay between strain and superconductivity in epitaxial BaFe2As2 thin films on Fe-buffered MgAl2O4 single crystalline substrates. The strong interfacial bonding between Fe and the FeAs sublattice increases the Fe-Fe distance due to the lattice misfit, which leads to a suppression of the antiferromagnetic spin density wave and induces superconductivity with bulk Tc≈10 K. These results highlight the role of structural changes in controlling the phase diagram of Fe-based superconductors.

9.
Int J Clin Pract ; 67(11): 1138-43, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24165427

RESUMO

AIMS: To compare the efficacy and tolerability of a muscarinic receptor antagonist, darifenacin, in the treatment of overactive bladder (OAB) patients with concomitant diabetes as compared with those without comorbidities. METHODS: Post hoc exploratory analysis of a published, large, non-interventional study in OAB patients treated with darifenacin including 532 diabetics and 1315 controls. Associations of diabetes with treatment responses were evaluated by multiple regression models. RESULTS: Diabetics (largely type 2 patients) and controls differed in baseline age, body weight, duration of OAB symptoms and presence of co-medications. However, they exhibited similar OAB symptom episode frequency and problem rating and received similar starting doses of darifenacin. Presence of diabetes was associated with a significantly smaller reduction of OAB symptoms, but the effect attributable to diabetes was small relative to the overall treatment response. The presence of diabetes was not associated with differences in tolerability. DISCUSSION AND CONCLUSIONS: We conclude that a muscarinic receptor antagonist has comparable efficacy and tolerability in the treatment of OAB patients with and without concomitant diabetes.


Assuntos
Benzofuranos/uso terapêutico , Complicações do Diabetes/complicações , Antagonistas Muscarínicos/uso terapêutico , Pirrolidinas/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noctúria/etiologia , Análise de Regressão , Resultado do Tratamento , Doenças da Bexiga Urinária/etiologia , Bexiga Urinária Hiperativa/complicações , Incontinência Urinária/etiologia
10.
Phys Rev Lett ; 106(13): 137001, 2011 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-21517413

RESUMO

Having succeeded in the fabrication of epitaxial superconducting LaFeAsO(1-x)F(x) thin films we performed an extensive study of electrical transport properties. In the face of multiband superconductivity we can demonstrate that an anisotropic Ginzburg-Landau scaling of the angular dependent critical current densities can be adopted, although being originally developed for single band superconductors. In contrast with single band superconductors the mass anisotropy of LaFeAsO(1-x)F(x) is temperature dependent. A very steep increase of the upper critical field and the irreversibility field can be observed at temperatures below 6 K, indicating that the band with the smaller gap is in the dirty limit. This temperature dependence can be theoretically described by two dominating bands responsible for superconductivity. A pinning force scaling provides insight into the prevalent pinning mechanism and can be specified in terms of the Kramer model.

11.
Nanotechnology ; 21(41): 415303, 2010 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-20834121

RESUMO

Rutile single crystals treated with ion-beam preferential etching (IBPE) are investigated with electrical transport and transmission electron microscopy. The initially insulating single crystals show the formation of an oxygen vacancy-rich, highly ordered, thin conducting layer, below a crystalline rutile TiO(2) surface layer. Carrier concentrations of 10(19) cm(-3) and very high mobilities of the order of 300 cm(2) V(-1) s(-1) are observed in the nanolayers. The observations indicate that rutile single crystals can be effectively transformed into controlled conducting material using IBPE for creating a new breakthrough in transparent conducting media.

12.
Int J Clin Pract ; 64(9): 1287-93, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20500534

RESUMO

AIMS: Gender, age, obesity, smoking and alcohol or caffeine intake have been shown or proposed to be risk factors for the prevalence and/or severity of the overactive bladder symptom complex (OAB) or related parameters. We have explored whether any of these factors affect the therapeutic response to a muscarinic receptor antagonist during routine clinical use. METHODS: Data were analysed from 3766 OAB patients (77.1% woman, age 62.6 +/- 12.8 years) participating in an observational, open-label postmarketing surveillance study of the safety and efficacy of darifenacin. Multiple logistic regression models were applied to explore the effect of potential OAB risk factors on the darifenacin treatment-associated improvement of OAB symptoms, patient's subjective rating of bladder problems and global efficacy and tolerability. RESULTS: Age and (less consistently) gender were statistically significantly correlated with efficacy parameters, but the extent of their impact was judged to be too small to be clinically relevant. Except for a very small effect of body mass index on urgency episode improvement, none of the lifestyle-associated factors had significant effects on the efficacy of darifenacin. Except for a very small age effect, none of the potential risk factors had significant effects on global tolerability. DISCUSSION AND CONCLUSIONS: We conclude that the efficacy and tolerability of a muscarinic receptor antagonist, such as darifenacin is largely independent of potential OAB risk factors, such as gender, age, obesity, smoking and alcohol or caffeine intake.


Assuntos
Antagonistas Muscarínicos/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Fatores Etários , Idoso , Consumo de Bebidas Alcoólicas/efeitos adversos , Café/efeitos adversos , Feminino , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Fatores de Risco , Fatores Sexuais , Fumar/efeitos adversos , Resultado do Tratamento , Bexiga Urinária Hiperativa/etiologia , Incontinência Urinária/tratamento farmacológico , Incontinência Urinária/etiologia
13.
Phys Rev Lett ; 104(7): 077001, 2010 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-20366908

RESUMO

Superconducting LaFeAsO1-xFx thin films were grown on single crystalline LaAlO3 substrates with critical temperatures (onset) up to 28 K. Resistive measurements in high magnetic fields up to 40 T reveal a paramagnetically limited upper critical field mu{0}H{c2}(0) around 77 T and a remarkable steep slope of -6.2 T K-1 near T{c}. From transport measurements we observed weak-link behavior in low magnetic fields and evidence for a broad reversible regime.

14.
Int J Impot Res ; 22(1): 61-7, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-19907425

RESUMO

Cardiovascular and metabolic conditions are risk factors for ED and are common among men with ED. The purpose of this study was to assess the safety and effectiveness of, and notably patient satisfaction with, vardenafil treatment in a general population of men with ED, including those with underlying conditions, over a period of 3-12 months. A prospective, multicenter, noninterventional study was carried out in Germany between July 2005 and January 2007. Men aged > or =18 years (n=7088) who were prescribed vardenafil for ED, irrespective of previous ED treatment or underlying conditions, were eligible for inclusion. Safety, effectiveness and patient satisfaction data were collected by physician case report forms (CRFs) after 3 months, with optional self-completed patient questionnaires at baseline, 3, 6, 9 and 12 months. The intent-to-treat population included 6474 patients, and 1331 patients returned at least one questionnaire. No serious adverse events were related to vardenafil use. CRF data showed that 93.0% of patients reported improved erections after 3 months, with similar rates of improvement among men with underlying conditions. High levels of patient satisfaction with vardenafil regarding effectiveness of treatment, time to onset and duration of action were sustained throughout the study.


Assuntos
Disfunção Erétil/tratamento farmacológico , Disfunção Erétil/psicologia , Imidazóis/uso terapêutico , Aceitação pelo Paciente de Cuidados de Saúde , Inibidores de Fosfodiesterase/uso terapêutico , Piperazinas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Alemanha , Humanos , Imidazóis/efeitos adversos , Masculino , Pessoa de Meia-Idade , Inibidores de Fosfodiesterase/efeitos adversos , Piperazinas/efeitos adversos , Estudos Prospectivos , Sulfonas/efeitos adversos , Sulfonas/uso terapêutico , Inquéritos e Questionários , Resultado do Tratamento , Triazinas/efeitos adversos , Triazinas/uso terapêutico , Dicloridrato de Vardenafila
15.
Phys Rev Lett ; 101(14): 145501, 2008 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-18851539

RESUMO

We report a new type of carbon material-porous colossal carbon tubes. Compared with carbon nanotubes, colossal carbon tubes have a much bigger size, with a diameter of between 40 and 100 mum and a length in the range of centimeters. Significantly, the walls of the colossal tubes are composed of macroscopic rectangular columnar pores and exhibit an ultralow density comparable to that of carbon nanofoams. The porous walls of colossal tubes also show a highly ordered lamellar structure similar to that of graphite. Furthermore, colossal tubes possess excellent mechanical and electrical properties.

16.
J Microsc ; 231(3): 506-17, 2008 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-18755006

RESUMO

Filopodia are rod-shaped cell surface protrusions composed of a parallel bundle of actin filaments. Since filopodia frequently emanate from lamellipodia, it has been proposed that they form exclusively by the convergence and elongation of actin filaments generated in lamellipodia networks. However, filopodia form without Arp2/3-complex, which is essential for lamellipodia formation, indicating that actin filaments in filopodia may be generated by other nucleators. Here we analyzed the effects of ectopic expression of GFP-tagged full length or a constitutively active variant of the human formin mDia2/Drf3. By contrast to the full-length molecule, which did not affect cell behaviour and was entirely cytosolic, active Drf3 lacking the C-terminal regulatory region (Drf3DeltaDAD) induced the formation of filopodia and accumulated at their tips. Low expression of Drf3DeltaDAD induced rod-shaped or tapered filopodia, whereas over-expression resulted in multiple, club-shaped filopodia. The clubs were filled with densely bundled actin filaments, whose number but not packing density decreased further away from the tip. Interestingly, clubs frequently increased in width after protrusion beyond the cell periphery, which correlated with increased amounts of Drf3DeltaDAD at their tips. These data suggest Drf3-induced filopodia form and extend by de novo nucleation of actin filaments instead of convergent elongation. Finally, Drf3DeltaDAD also induced the formation of unusual, lamellipodia-like structures, which contained both lamellipodial markers and the prominent filopodial protein fascin. Microarray analyses revealed highly variable Drf3 expression levels in different commonly used cell lines, reflecting the need for more detailed analyses of the functions of distinct formins in actin cytoskeleton turnover and different cell types.


Assuntos
Proteínas de Transporte/metabolismo , Pseudópodes/ultraestrutura , Citoesqueleto de Actina/metabolismo , Animais , Fusão Gênica Artificial , Proteínas de Transporte/genética , Linhagem Celular , Células Cultivadas , Forminas , Perfilação da Expressão Gênica , Proteínas de Fluorescência Verde/genética , Proteínas de Fluorescência Verde/metabolismo , Humanos , Camundongos , Proteínas dos Microfilamentos/metabolismo , Análise de Sequência com Séries de Oligonucleotídeos , Pseudópodes/química , Proteínas Recombinantes de Fusão/genética , Proteínas Recombinantes de Fusão/metabolismo , Deleção de Sequência
17.
Exp Clin Endocrinol Diabetes ; 116(1): 18-25, 2008 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17926235

RESUMO

AIMS: Primary care physicians are gatekeepers of the healthcare system and thus responsible for screening, prevention and treatment of diabetes. Little is known about the prevalence of diabetes, impaired fasting glucose and factors that are associated with the risk of future development of diabetes and subsequent cardiovascular disease in unselected patients presenting to general practitioners. RESEARCH DESIGN AND METHODS: A nationwide sample of 35,869 primary care patients screened in 2005 was used to estimate the prevalence of detected and undetected diabetes as well as of impaired fasting glucose. Logistic regressions were used to assess the prevalence, cardiovascular morbidity and the factors associated with undetected diabetes and impaired fasting glucose. RESULTS: 1) Using a blood glucose screening algorithm the prevalence of known type 1 and type 2 diabetes mellitus was found to be 0.6 and 12.2%, respectively. Another 2.9% (23% of the diagnosed) had either undiagnosed diabetes (0.9%) or impaired fasting glucose (2.0%). 2) Undiagnosed patients had a more unfavourable cardiovascular risk profile compared to non-diabetic patients. 3) Moreover, higher age, male gender, low HDL-cholesterol and elevated triglycerides as well as a family history of diabetes were associated with unknown diabetes or impaired fasting glucose. CONCLUSIONS: Approximately 15.7% of individuals in Germany consulting a primary care physician are affected from either diabetes (known and unknown) or impaired fasting glucose and face a substantially elevated cardiovascular risk score. This study demonstrated that using a simplified blood glucose screening algorithm considering risk markers like higher age, male gender, low HDL-cholesterol, high triglycerides and a family history of diabetes may well serve as a suitable screening approach for undiagnosed diabetes and impaired fasting glucose in primary care practice.


Assuntos
Glicemia/análise , Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/epidemiologia , Jejum , Atenção Primária à Saúde , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Diabetes Mellitus Tipo 2/diagnóstico , Feminino , Alemanha/epidemiologia , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Fatores de Risco
18.
Z Gastroenterol ; 45(10): 1041-8, 2007 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-17924300

RESUMO

AIM: The objective of this study was to assess the efficacy and safety of the phytopharmacon STW 5 versus metoclopramide in functional dyspepsia. METHODS: A retrolective, epidemiological cohort study with parallel groups in 23 randomised centres where both drugs were used routinely was performed. The main outcome variable was improvement of 10 dyspepsia-specific symptoms of a valid gastrointestinal symptom score (GIS) during therapy. For inclusion, patients had to suffer from at least three of these symptoms before therapy. Secondary outcome variables were change of single symptoms, time till complete symptom relief, investigators' judgement of efficacy and tolerability, duration of inability to work and occurrence of adverse events. RESULTS: The per protocol collective comprised 490 STW 5 and 471 MCP patients. Anamnestic data were comparable. 439 of patients had taken MCP as drops. There was no relevant difference in median treatment duration. Significantly more patients were symptom-free after STW 5 treatment (71.6 vs. 62.8% p = 0,012). Additionally, the extent of symptom improvement (excluding nausea and vomiting) and median duration of inability to work (1 vs. 3 days) were significantly different in favour of STW 5. More physicians assessed STW 5 as effective (71.6 vs. 63.1% p<0.01) and very well tolerated (90 vs. 70.6% p<0.001). Adverse drug reactions were documented only under MCP. CONCLUSION: The present study illustrates a comparable to higher efficacy of STW 5 vs. MCP with better tolerability in treating functional dyspepsia under practice conditions, especially regarding complete symptom improvement, symptom duration and quality of life. The study confirms the results of prospective trials for STW 5 as being an appropriate alternative to the frequently administered antacids and prokinetics.


Assuntos
Dispepsia/tratamento farmacológico , Dispepsia/epidemiologia , Metoclopramida/uso terapêutico , Extratos Vegetais/uso terapêutico , Medição de Risco/métodos , Antieméticos/uso terapêutico , Estudos de Coortes , Humanos , Internacionalidade , Prevalência , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
19.
Forsch Komplementarmed Klass Naturheilkd ; 11 Suppl 1: 23-9, 2004 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-15353899

RESUMO

UNLABELLED: The randomized controlled clinical trial (RCT) is accepted as the "golden standard" for the evaluation of efficacy and safety of new drugs. In contrast, to demonstrate efficacy and safety of drugs with "well-established use" that have been on the European Community market for long time, observational comparative epidemiological studies can be used according to the European drug regulation directive. However, because comparative epidemiological cohort studies can share some risk of bias with other nonrandomized observational study designs, there is a need for an approach that could effectively reduce the bias risk in this type of studies. STUDY OBJECTIVES: The purpose of the study was to evaluate the therapeutic efficacy and safety of a long-term complementary therapy of primary, non-metastatic breast carcinoma patients treated with standardized European mistletoe extract Iscador("mistletoe") in addition to the conventional adjuvant oncologic therapy, and compared to the control group treated with the conventional therapy alone. METHODS: The multicenter, comparative, retrolective, pharmaco-epidemiological cohort study with parallel groups design and randomly selected centers that routinely used both treatments was carried out according to Good Epidemiological Practice rules under a standard operating procedure control. The test group patients received the mistletoe extract treatment subcutaneously for at least 3 months, while the control group patients of the same cohort was exclusively treated with the conventional therapy. The patients were followed up for at least 3 years or until death. The primary endpoint of efficacy was the incidence of adverse reactions to the conventional oncologic therapy. Secondary endpoints were change from baseline of the symptoms associated with the disease and treatment as well as overall survival. All endpoints were adjusted to baseline imbalance and confounders. Safety was assessed descriptively by the number of patients with adverse drug reactions (ADRs) attributed to the test treatment. RESULTS: 1442 patients (710 tests and 732 controls) were eligible for the "per protocol" analysis of efficacy and safety. At baseline, the test group had a more advanced disease and worse prognostic factors profile. After a median follow-up of 66 vs. 60 months, and a median mistletoe therapy duration of 52 months, significantly fewer test group patients (16.2%) than control patients (54.0%) developed ADRs attributed to the conventional therapy [adjusted odds ratio, OR (95% confidence interval, CI), OR = 0.47 (0.32-0.67), p < 0.001]. In the test group, the majority of the symptoms disappeared more frequently, and overall mortality hazard was significantly lower [adjusted hazard ratio, HR (95% CI), HR = 0.46 (0.22-0.96), p = 0.038] than in the control group. Systemic ADRs attributed to the test treatment developed in 0.8%, and local ADRs in 17.3% of the patients. ADR severity was mild to intermediate. Tumor enhancement was not observed. CONCLUSIONS: Complementary therapy of patients with primary, non-metastatic breast carcinoma with the mistletoe extract Iscador was safe and in comparison to the control group within the same study cohort showed considerably fewer ADRs attributed to concurrent conventional therapy, reduced disease symptoms, and suggested a significant improvement of survival. Despite some methodical limitations that require careful study planning and conduction as well as critical interpretation, the applied study design seems suitable to evaluate the efficacy and safety of drugs with "well-established use", particularly in oncology.


Assuntos
Antineoplásicos Fitogênicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Erva-de-Passarinho , Fitoterapia , Extratos Vegetais/uso terapêutico , Projetos de Pesquisa , Antineoplásicos Fitogênicos/efeitos adversos , Estudos de Coortes , Determinação de Ponto Final , Estudos Epidemiológicos , Feminino , Humanos , Pessoa de Meia-Idade , Extratos Vegetais/efeitos adversos , Segurança , Análise de Sobrevida , Resultado do Tratamento
20.
Anticancer Res ; 23(6D): 5081-7, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-14981970

RESUMO

This epidemiological study was performed to evaluate the influence of postoperative complementary treatment with lectin-standardized mistletoe extract (sME) on breast cancer patients. The design (retrolective cohort analysis with parallel groups) and conduct of the study were in agreement with current standards for prospectively randomized clinical trials. A cohort of 1,248 breast cancer patients on postoperative chemo-, radio-, hormone-therapy were studied in 27 randomized centers. Patients with complementary medications other than sME were excluded from the evaluation and the final analysis was performed on data of 689 patients. From this cohort 219 patients received a complementary treatment exclusively with sME (therapy group), while 470 patients were without complementary treatment (control group). The median follow-up time was 284 days (therapy group) and 285 days (control group). The primary end-point of the study was to determine the impact of complementary sME treatment on disease- or therapy-induced adverse reactions in breast cancer patients. Imbalances for causal effects (covariates) were adjusted by propensity scores. Final evaluation was performed by estimating the linear regression between change in symptom score and propensity score with all data and using the regression line to calculate the change in symptom score expected for each patient. Tumor-associated events were evaluated by number and time until event. The safety of sME treatment was analysed in terms of number, severity, duration and outcome of adverse reactions. As compared to breast cancer patients without complementary treatment (control group), the administration of sME (therapy group) resulted in a significant reduction of adverse reactions induced by the tumor-destructive therapies (e.g. nausea, gastro-intestinal tract symptoms, depression, fatigue, mental symptoms) and prolonged relapse-free intervals, most pronounced for UICC stages IIa and IIb. The rate of sME-associated adverse reactions was 12.8%. All side-effects were mild to moderate, predominantly local skin reactions and self-limiting without therapeutic intervention. Complementary treatment of breast cancer patients with lectin-standardized mistletoe extract (sME) proved to be a well tolerated optimization of standard tumor-destructive therapies, mainly improving quality of life and relapse-free intervals in defined UICC stages.


Assuntos
Antineoplásicos Fitogênicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Preparações de Plantas/uso terapêutico , Proteínas de Plantas , Toxinas Biológicas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/radioterapia , Neoplasias da Mama/cirurgia , Estudos de Coortes , Terapia Combinada , Terapias Complementares/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Proteínas Inativadoras de Ribossomos Tipo 2
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