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Scientific guidelines for preclinical research on potentised preparations manufactured according to current pharmacopoeias-the PrePoP guidelines

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Journal of Integrative Medicine 2024年第5期22卷 533-544页

作者： Alexander L.Tournier Leoni V.Bonamin Susann Buchheim-Schmidt Steven Cartwright Christoph Dombrowsky Paul Doesburg Carla Holandino Maria Olga Kokornaczyk Everine Bvan de Kraats Jesús Antonio López-Carvallo Papiya Nandy JoséManuel Mazón-Suástegui Fateme Mirzajani Bernard Poitevin Claudia Scherr Karin Thieves sandra Würtenberger Stephan Baumgartner Institute of Complementary and Integrative Medicine University of Bern3010 BernBernSwitzerland Institute of Integrative Medicine Witten/Herdecke University58455 WittenNorth Rhine–WestphaliaGermany Homeopathy Research Institute London SW74EFUnited Kingdom Graduate Program on Environmental and Experimental Pathology Paulista UniversitySão Paulo 01504-000São PauloBrazil Department of Medical Science Deutsche Homöopathie-Union DHU-Arzneimittel GmbH&Co.KG76227 KarlsruheBaden-WürttembergGermany Cherwell Laboratory for Fundamental Research in Homeopathy Oxford OX28NUOxforeshireUnited Kingdom Society for Cancer Research Hiscia Research Institute4144 ArlesheimBaselSwitzerland Laboratório Multidisciplinar de Ciências Farmacêuticas Universidade Federal do Rio de JaneiroRio de Janeiro 21941-902Rio de JaneiroBrazil World Water Community Rotterdam 3029AKthe Netherlands Departamento de Acuicultura Facultad de Ciencias del MarUniversidad Católica del Norte1790437 CoquimboElquiChile Centre for Interdisciplinary Research and Education KolkataWest Bengal 700068West BengalIndia Laboratorio de Homeopatía Acuícola y Semillas Marinas Centro de Investigaciones Biológicas del NoroesteLa Paz 23096Baja California SurMexico Protein Research Center Shahid Beheshti UniversityTehran ***Iran Department of Medical Laboratory Science College of ScienceKnowledge University44001 ErbilErbilIraq SociétéSavante d’Homéopathie 75009 ParisFrance Sola Salus Institute for Homeopathic Research52511 GeilenkirchenNorth Rhine–WestphaliaGermany Scientific Society for Homeopathy 06366 KöthenSaxony-AnhaltGermany

Objective Pharmacopoeias regulate the manufacture of potentised pharmaceutical preparations used in different branches of complementary and integrative *** physicochemical properties and biological activity of these preparations are often investigated in preclinical research,yet no guidelines for experimental research currently exist in this *** present PrePoP guidelines aim to provide recommendations to promote high-quality,statistically sound,and reproducible preclinical research on potentised *** Input was gathered from researchers nominated by the relevant scientific societies using a simplified Delphi consensus approach covering the most relevant aspects of basic research methodology in the field including appropriate controls,sample preparation and handling,and *** three rounds of feedback,a consensus was finally reached on the most important aspects and considerations for conducting high-quality research on potentised *** We present a series of recommendations on a range of topics including experimental controls,system stability,blinding and randomisation,environmental influences,and procedures for the preparation of potentised samples and controls,and we address some specific challenges of this research *** This expert consensus process resulted in a robust set of methodological guidelines for research on potentised preparations and provides a valuable framework that will inform and improve the quality of subsequent research in this emerging field.

关键词： Research guidelines Fundamental research Basic research Complementary and integrative medicine Potentisation Potentised preparations

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Gut microbiota in preterm infants receiving breast milk or mixed feeding

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World Journal of Clinical Pediatrics 2024年第2期13卷 135-145页

作者： sandra Gabriela Sánchez-González Bárbara Gabriela Cárdenas-del-Castillo Elvira Garza-González Gerardo R Padilla-Rivas Isaías Rodríguez-Balderrama Consuelo Treviño-Garza Fernando Félix Montes-Tapia Gerardo C Palacios-Saucedo Anthony Gutiérrez-Rodríguez Manuel Enrique de-la-O-Cavazos Department of Pediatrics Hospital Universitario“Dr.JoséEleuterio González”Universidad Autónoma de Nuevo LeónMonterrey 64460Nuevo LeónMéxico Departamento de Bioquímica y Medicina Molecular Universidad Autónoma de Nuevo LeónMonterrey 64460Nuevo LeónMéxico Department of Biochemistry and Molecular Medicine Universidad Autónoma de Nuevo LeónMonterrey 64460Nuevo LeónMéxico Department of Pediatric Surgery Hospital Universitario"Dr.JoséEleuterio González"Monterrey 64460Nuevo LeónMéxico

BACKGROUND Preterm birth is the leading cause of mortality in newborns,with very-low-birthweight infants usually experiencing several *** milk is considered the gold standard of nutrition,especially for preterm infants with delayed gut colonization,because it contains beneficial microorganisms,such as Lactobacilli and *** To analyze the gut microbiota of breastfed preterm infants with a birth weight of 1500 g or *** An observational study was performed on preterm infants with up to 36.6 wk of gestation and a birth weight of 1500 g or less,born at the University Hospital ***éEleuterio González at Monterrey,Mexico.A total of 40 preterm neonates were classified into breast milk feeding(BM)and mixed feeding(MF)groups(21 in the BM group and 19 in the MF group),from October 2017 to June *** samples were collected before they were introduced to any feeding *** full enteral feeding was achieved,the composition of the gut microbiota was analyzed using 16S rRNA gene *** variables were compared using Student’s t-test or using the Mann–Whitney U test for nonparametric ***,evenness,equitability,Margalef’s index,Fisher’s alpha,Chao-1 index,and Shannon’s diversity index were also *** No significant differences were observed at the genus level between the *** comparison indicated higher counts of Alphaproteobacteria and Betaproteobacteria in the initial compared to the final sample of the BM group(P<0.011).In addition,higher counts of Gammaproteobacteria were detected in the final than in the initial sample(P=0.040).According to the Margalef index,Fisher’s alpha,and Chao-1 index,a decrease in species richness from the initial to the final sample,regardless of the feeding type,was observed(P<0.050).The four predominant phyla were Bacteroidetes,Actinobacteria,Firmicutes,and Proteobacteria,with Proteobacteria being the most ***,no significant differences were

关键词： Gut microbiota Human milk Preterm infant Proteobacteria Very low birth weight 16S rRNA

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Assessment of food supplementation and surveillance as techniques to reduce damage caused by black capuchin monkeys Sapajus nigritus to forest plantations

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Current Zoology 2014年第5期60卷 581-590页

作者： sandra Bos MIKICH Laboratory of Ecology (Laborat6rio de Ecologia) Embrapa Florestas Caixa Postal 319 CEP 83411-000 Colombo PR Brazil Black Capuchin Monkey Program (Programa Macaco-prego) National Fund for the Control of Forest Pests (Fundo Nacional de Controle de Pragas Florestais) Dieter Liebsch Environmental Consulting (Dieter Liebsch Consultoria Ambiental) Curitiba PR Brazil dieterliebsch@yahoo.com.br

Black capuchin monkeys Sapajus nigritus are among several mammalian species that damage forest plantations, pri- marily plantations of pine trees （Pinus spp.） in South Brazil. Management practices to reduce these damages include supplemen- tary food offerings and plantation surveillance. To assess the efficiency of these techniques, four treatments were evaluated： feeding （F, with supplementary bananas and maize）, surveillance （S, in situ, wherein men patrolled the plantations, deterring the monkeys）, feeding ＋ surveillance （FS） and control （no procedures）（C）. The efficiency assessment of each treatment involved the number of recorded primate sightings in the treatments with the presence of guards （S and FS） and a damage inventory of the outskirts of the experimental points immediately before and after the experiment. These data were complemented by a simulta- neous study of the availability of fruit, the primary item in the diet of this primate species, in the remnant native forest in the study area. Most sightings of S. nigritus occurred early in the morning, and in general, sightings were inversely proportional to the availability of native fruits. This trend was most evident in treatment FS, most likely due to the presence of food. Treatments F and FS exhibited higher percentages of damage, indicating that these are inefficient management techniques. Treatment S exhi- bited the lowest damage rate, but at a high cost, making this technique difficult to apply over large expanses. The development of other management techniques, such as environmental enrichment and the use of deterrents, is recommended to minimize the damage caused by capuchins in forest plantations [Current Zoology 60 （5）： 581-590, 2014].

关键词： Cebus Damage control Wildlife management Pinus Food provisioning

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Effect of music therapy on short-term psychological and physiological outcomes in mechanically ventilated patients:A randomized clinical pilot study

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Journal of Intensive Medicine 2024年第4期4卷 515-525页

作者： Mark Ettenberger Rosangela Casanova-Libreros Josefina Chávez-Chávez Jose Gabriel Cordoba-Silva William Betancourt-Zapata Rafael Maya Lizeth Alexa Fandino-Vergara Mario Valderrama Ingrid Silva-Fajardo sandra Milena Hernández-Zambrano SONO-Centro de Musicoterapia BogotáColombia Vice-Rectorate for Research Fundación Universitaria de Ciencias de la SaludBogotáColombia Department of Biomedical Engineering University of Los AndesBogotáColombia Department of Rehabilitation Sociedad de Cirugía de Bogotá Hospital de San JoséBogotáColombia Faculty of Nursing Fundación Universitaria de Ciencias de la SaludBogotáColombia

Background:Elevated anxiety levels are common in patients on mechanical ventilation(MV)and may challenge *** suggests music-based interventions may reduce anxiety during ***,studies inves-tigating specific music therapy techniques,addressing psychological and physiological well-being in patients on MV,are ***:This three-arm randomized clinical pilot study was conducted with MV patients admitted to the intensive care unit(ICU)of Hospital San Joséin Bogotá,Colombia between March 7,2022,and July 11,*** were divided into three groups:intervention group 1(IG1),music-assisted relaxation;intervention group 2(IG2),patient-preferred therapeutic music listening;and control group(CG),standard *** main outcome measure was the 6-item State-Anxiety *** outcomes were:pain(measured with a visual analog scale),resilience(measured with the Brief Resilience Scale),agitation/sedation(measured with the Richmond Agitation-Sedation Scale),vital signs(including heart rate,blood pressure,oxygen saturation,and respiratory rate),days of MV,extubation success,and days in the ***,three patients underwent electroencephalography during the ***:Data from 23 patients were analyzed in this *** age range of the patients was 24.0-84.0 years,with a median age of 66.0 years(interquartile range:57.0-74.0).Of the 23 patients,19 were female(82.6%).No statistically significant differences between the groups were observed for anxiety(P=0.330),pain(P=0.624),resilience(P=0.916),agitation/sedation(P=0.273),length of ICU stay(P=0.785),or vital signs.A statistically significant difference between the groups was found for days of MV(P=0.019).Electroencephalography mea-surements showed a trend toward delta and theta band power decrease for two patients and a power increase on both beta frequencies(slow and fast)in the frontal areas of the brain for one ***:In this pilot study,music therapy did not sig

关键词： Music therapy Mechanical ventilation Intensive care unit Anxiety Pain

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Brain antigens in functionally distinct antigen-presenting cell populations in cervical lymph nodes in MS and EAE

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世界最新医学信息文摘 2017年第30期 281-281页

作者： Marloes van Zwam Ruth Huizinga Marie-José Melief Annet F.Wierenga-Wolf Marjan van Meurs Jane S.Voerman Knut P.H.Biber Hendrikus W G.M.Boddeke Uta E.H?pken Christian Meisel Andreas Meisel Ingo Bechmann Rogier Q.Hintzen Bert A.'t Hart sandra amor Jon D.Laman Leonie A.Boven

Drainage of central nervous system(CNS) antigens to the brain-draining cervical lymph nodes(CLN) is likely crucial in the initiation and control of autoimmune responses during multiple sclerosis(MS).We demonstrate neuronal antigens within CLN of MS *** monkeys and mice with experimental autoimmune encephalomyelitis(EAE) and in mouse models with non-inflammatory CNS damage,the type and extent of CNS damage was associated with the frequencies of CNS antigens within the cervical lymph *** addition,CNS antigens drained to the spinal-cord-draining lumbar lymph *** human MS CLN,neuronal antigens were present in pro-inflammatory antigen-presenting cells(APC),whereas the majority of myelincontaining cells were *** may reflect a different origin of the cells or different drainage ***,neuronal antigen-containing cells in human CLN did not express the lymph node homing receptor CCR7,whereas myelin antigen-containing cells in situ and in vitro ***,CLN from EAE-affected CCR7-deficient mice contained equal amounts of myelin and neuronal antigens as wild-type *** conclude that the type and frequencies of CNS antigens within the CLN are determined by the type and extent of CNS ***,the presence of myelin and neuronal antigens in functionally distinct APC populations within MS CLN suggests that differential immune responses can be evoked.

关键词： Neuroinflammation Immune regulation Autoreactive Tcells Tolerance Chemokines Cytokines

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Catalytic domain of PDC-E2 contains epitopes recognized by antimitochondrial antibodies in primary biliary cirrhosis

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World Journal of Gastroenterology 2010年第8期16卷 973-981页

作者： sandra Braun Christoph Berg sandra Buck Michael Gregor Reinhild Klein Department of Internal Medicine University of Tuebingen Department of Internal Medicine University of Tuebingen

AIM:To search for further immunodominant peptides of the pyruvate dehydrogenase complex E2-component (PDC-E2) recognized by antimitochondrial antibodies (AMA) in primary biliary cirrhosis (PBC). METHODS:Sera from 95 patients with PBC were tested by enzyme-linked immunosorbent assay against 33 synthetic overlapping peptides (25 amino acids; aa) covering the entire length of the E2-subunit of PDC-E2. Furthermore,the inner lipoyl peptide 167-184 was used in an unlip oylated and a lipoylated form as well as coupled to ovalbumin. Sera from 11 AMA negative/ANA posit ive PBC patients,63 patients with other liver disorders and 22 healthy blood donors served as ***:Of the 95 PBC-sera,74% reacted with the peptide 475-499 and 58% with the pept ide 407-431 located within the catalytic domain of PDC-E2. Patients with other disorders or healthy controls were positive in only up to 18%. Antibodies to the unlipoylatedand lip oylated pept ide 167-184 within the inner lipoyl domain were found in only 5% and 11% of the PBC sera,respectively; using ovalbumin-coupled peptides,the incidence increased up to 57% (unlipoylated form). CONCLUSION:Peptides within the catalytic site of PDC-E2 rather than the previously reported lipoyl binding peptide 167-184 may represent major immunodomin ant epitopes recognized by AMA in PBC.

关键词： Anti-M2 Epitope mapping E2-subunit Pyruvate dehydrogenase complex Inner lipoyl domain Active site Catalytic domain Primary biliary cirrhosis

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Brain antigens in functionally distinct antigen-presenting cell populations in cervical lymph nodes in MS and EAE

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世界最新医学信息文摘 2016年第11期 8-8页

作者： Marloes van Zwam Ruth Huizinga Marie-José Melief Annet F.Wierenga-Wolf Marjan van Meurs Jane S.Voerman Knut P.H.Biber Hendrikus W.G.M.Boddeke Uta E.H?pken Christian Meisel Andreas Meisel Ingo Bechmann Rogier Q.Hintzen Bert A.‘t Hart sandra amor Jon D.Laman Leonie A.Boven

Drainage of central nervous system(CNS) antigens to the brain-draining cervical lymph nodes(CLN) is likely crucial in the initiation and control of autoimmune responses during multiple sclerosis(MS). We demonstrate neuronal antigens within CLN of MS patients. In monkeys and mice with experimental autoimmune encephalomyelitis(EAE) and in mouse models with non-inflammatory CNS damage, the type and extent of CNS damage was associated with the frequencies of CNS antigens within the cervical lymph nodes. In addition, CNS antigens drained to the spinal-cord-draining lumbar lymph nodes. In human MS CLN, neuronal antigens were present in pro-inflammatory antigen-presenting cells(APC), whereas the majority of myelincontaining cells were anti-inflammatory. This may reflect a different origin of the cells or different drainage mechanisms. Indeed, neuronal antigen-containing cells in human CLN did not express the lymph node homing receptor CCR7, whereas myelin antigen-containing cells in situ and in vitro did. Nevertheless, CLN from EAE-affected CCR7-deficient mice contained equal amounts of myelin and neuronal antigens as wild-type mice. We conclude that the type and frequencies of CNS antigens within the CLN are determined by the type and extent of CNS damage. Furthermore, the presence of myelin and neuronal antigens in functionally distinct APC populations within MS CLN suggests that differential immune responses can be evoked.

关键词： Neuroinflammation Immune regulation Autoreactive Tcells Tolerance Chemokines Cytokines

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Pork Meat Quality of Preto Alentejano and Commercial Largewhite Landrace Cross

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Journal of Integrative Agriculture 2013年第11期12卷 1961-1971页

作者： Alfredo Teixeira sandra Rodrigues Veterinary and Animal Reserch Centre (CECAV) Agrarian School of Polytechnic Institute of BraganaCampus Sta Apolónia Apt.1172Bragan a 5301-855Portugal Mountain Research Centre(CIMO) Agrarian School of Polytechnic Institute of BraganaCampus Sta Apolónia Apt.1172Bragan a 5301-855Portugal

This work aimed to evaluate the physical-chemical characteristics of pork from a local breed （Portuguese black pork called Preto Alentejano） and a commercial breed. Sixteen animals were used, 4 females and 4 males from each breed. Animals had 80-100 kg of live weight. The longissimus muscle between the 5th thoracic vertebra and the 10th lumbar vertebra was used in the analysis. Samples were analysed for protein, fat, pigments, ashes, dry mater, water-holding capacity, and texture. Results of fat and pigments contents indicate signiifcant （P〈0.05 and P〈0.01） differences for all treatments. For protein, ashes, dry mater, water-holding capacity and texture, no signiifcant differences were found for sex. In the analysis of fatty acids composition, ten were detected, being the main ones C16：0, C18：0, C16：1, C18：1, C18：2. There was a predominance of monounsaturated fatty acids （MUFA）, followed by saturated （SFA） and polyunsaturated （PUFA）. Differences were signiifcant for sex （P〈0.01） and breed （P〈0.01）. Preto Alentejano breed and females presented the higher percentages of SFA （P〈0.01） and MUFA （P〈0.001） fatty acids. Differences between breeds might be due to breed production system and feed differences.

关键词： breed sex pork meat quality

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Hyper-chaos encryption using convolutional masking and model free unmasking

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Chinese Physics B 2014年第5期23卷 161-166页

作者：齐国元 sandra Bazebo Matondo Department of Electrical Engineerin Tshwane University of Technology Pretoria

In this paper, during the masking process the encrypted message is convolved and embedded into a Qi hyper-chaotic system characterizing a high disorder degree. The masking scheme was tested using both Qi hyper-chaos and Lorenz chaos and indicated that Qi hyper-chaos based masking can resist attacks of the filtering and power spectrum analysis, while the Lorenz based scheme fails for high amplitude data. To unmask the message at the receiving end, two methods are proposed. In the first method, a model-free synchronizer, i.e. a multivariable higher-order differential feedback controller between the transmitter and receiver is employed to de-convolve the message embedded in the receiving signal. In the second method, no synchronization is required since the message is de-convolved using the information of the estimated derivative.

关键词： Qi hyper-chaos masking high-order differentiator chaos-based encryption

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Compaction analysis and optimisation of convex-faced pharmaceutical tablets using numerical techniques

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Particuology 2019年第6期17卷 10-21页

作者： Ahmad Baroutaji sandra Lenihan Keith Bryan School of Engineering Faculty of Science and EngineeringUniversity of WolverhamptonTelfordUK School of Mechanical Electrical and Process EngineeringCork Institute of TechnologyCorkIreland

Capping failure,edge chipping,and non-uniform mechanical properties of convex-faced pharmaceutical tablets are common problems in the pharma *** this paper,the finite element method(FEM)and design of experiment techniques are used to determine the optimal shape of convex-faced(CF)pharmaceutical tablet which has more uniform mechanical properties and less capping and chipping *** effects of different geometrical parameters and friction on the compaction responses of convex-faced pharmaceutical tablets were first identified and *** FEM model of the tabletting process was generated using the implicit code ABAQUS and validated against experimental *** surface methodology was used to establish the relationship between the design variables,represented by the geometrical parameters and friction coefficient,and compaction responses of interest including residual die pressure,relative density variation within a tablet,and relative shear stress at the edge of a tablet.A statistical-based optimisation approach was then used to optimise the shape of CF *** obtained results demonstrated how the geometrical parameters and friction coefficient of CF pharmaceutical tablets strongly affect their compaction behaviour and quality.

关键词： Capping failure Edge chipping Tabletting FEM Optimisation Residual radial pressure

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