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Impact of endoscopy-based research on quality of life in healthy volunteers
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作者 Alexander Link Gerhard Treiber +2 位作者 Brigitte Peters Thomas Wex Peter Malfertheiner 《World Journal of Gastroenterology》 SCIE CAS CSCD 2010年第4期467-473,共7页
AIM:To study the impact of an endoscopy-based long-term study on the quality of life in healthy volunteers(HV).METHODS:Ten HV were included into a long-term prospective endoscopy-based placebo-controlled trial with 15... AIM:To study the impact of an endoscopy-based long-term study on the quality of life in healthy volunteers(HV).METHODS:Ten HV were included into a long-term prospective endoscopy-based placebo-controlled trial with 15 endoscopic examinations per person in 5 different drug phases.Participants completed short form-36(SF-36) and visual analog scale-based questionnaires(VAS) for different abdominal symptoms at days 0,7 and 14 of each drug phase.Analyses wereperformed according to short-and long-term changes and compared to the control group.RESULTS:All HV completed the study with duration of more than 6 mo.Initial quality of life score was comparable to a general population.Analyses of the SF-36 questionnaires showed no significant changes in physical,mental and total scores,either in a short-term perspective due to different medications,or to potentially endoscopic procedure-associated long-term cumulative changes.Analogous to SF-36,VAS revealed no significant changes in total scores for pathological abdominal symptoms and remained unchanged over the time course and when compared to the control population.CONCLUSION:This study demonstrates that quality of life in HV is not significantly affected by a longterm endoscopy-based study with multiple endoscopic procedures. 展开更多
关键词 Endoscopy research ETHICS healthy volunteers Quality of life
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Multi-frequency magnetic resonance elastography of the pancreas:measurement reproducibility and variance among healthy volunteers 被引量:1
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作者 Si-Ya Shi Liqin Wang +7 位作者 Zhenpeng Peng Yangdi Wang Zhi Lin Xuefang Hu Jiaxin Yuan Li Huang Shi-Ting Feng Yanji Luo 《Gastroenterology Report》 SCIE EI 2022年第1期413-419,共7页
Background Patients with chronic pancreatitis often have irreversible pancreatic insufficiency before a clinical diagnosis.Pancreatic cancer is a fatal malignant tumor in the advanced stages.Patients having high risk ... Background Patients with chronic pancreatitis often have irreversible pancreatic insufficiency before a clinical diagnosis.Pancreatic cancer is a fatal malignant tumor in the advanced stages.Patients having high risk of pancreatic diseases must be screened early to obtain better outcomes using new imaging modalities.Therefore,this study aimed to investigate the reproducibility of tomoelastography measurements for assessing pancreatic stiffness and fluidity and the variance among healthy volunteers.Methods Forty-seven healthy volunteers were prospectively enrolled and underwent two tomoelastography examinations at a mean interval of 7 days.Two radiologists blindly and independently measured the pancreatic stiffness and fluidity at the first examination to determine the reproducibility between readers.One radiologist measured the adjacent pancreatic slice at the first examination to determine the reproducibility among slices and measured the pancreas at the second examination to determine short-termrepeatability.The stiffness and fluidity of the pancreatic head,body,and tail were compared to determine anatomical differences.The pancreatic stiffness and fluidity were compared based on sex,age,and body mass index(BMI).Results Bland–Altman analyses(all P>0.05)and intraclass correlation coefficients(all>0.9)indicated near perfect reproducibility among readers,slices,and examinations at short intervals.Neither stiffness(P=0.477)nor fluidity(P=0.368)differed among the pancreatic anatomical regions.The mean pancreatic stiffness was 1.45±0.09 m/s;the mean pancreatic fluidity was 0.83±0.06 rad.Stiffness and fluidity did not differ by sex,age,or BMI.Conclusion Tomoelastography is a promising and reproducible tool for assessing pancreatic stiffness and fluidity in healthy volunteers. 展开更多
关键词 tomoelastography PANCREAS healthy volunteers STIFFNESS FLUIDITY
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Pharmacokinetics of metadoxine for injection after repeated doses in healthy volunteers
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作者 Lü Yuan KANG Zi-sheng LIU Yan LI Tian-yun XIAO Yong-hong 《Chinese Medical Journal》 SCIE CAS CSCD 2007年第2期166-168,共3页
Alcohol-induced liver disease is one of the main .epidemic problems nowadays. Metadoxine is apyridoxine-pyrrolidone carboxylate with significant scavenging property. Metadoxine is able to accelerate the elimination of... Alcohol-induced liver disease is one of the main .epidemic problems nowadays. Metadoxine is apyridoxine-pyrrolidone carboxylate with significant scavenging property. Metadoxine is able to accelerate the elimination of alcohol from the blood and tissues, help restore the functional structure of the liver and relieve neuro-psychological disorders associated with alcohol intoxication.The purpose of the study was to assay the pharmacokinetics of domestic metadoxine after repeated doses. 展开更多
关键词 METADOXINE repeated doses PHARMACOKINETICS healthy volunteer
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Pharmacokinetic study of single and multiple oral dose administration of antofloxacin hydrochloride in healthy male volunteers 被引量:6
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作者 LU Yuan KANG Zi-sheng ZHU Yan ZHANG Ming LIU Yan ZHANG Man LI Tian-yun XIAO Yong-hong 《Chinese Medical Journal》 SCIE CAS CSCD 2011年第2期242-245,共4页
Background A new fluroquinolone antibacterial agent,antofloxacin hydrochloride,developed in China,is an 8-NH2 derivant of levofloxacin.The purpose of the study was to evaluate the pharmacokinetic characteristics of si... Background A new fluroquinolone antibacterial agent,antofloxacin hydrochloride,developed in China,is an 8-NH2 derivant of levofloxacin.The purpose of the study was to evaluate the pharmacokinetic characteristics of single and multiple oral doses of antofloxacin hydrochloride in Chinese healthy male volunteers.Methods An open-label,non-randomized,single and multiple dose clinical trial was conducted.In single dose study,12 subjects took 200 mg antofloxacin hydrochloride.In multiple dose study,12 subjects took antofloxacin hydrochloride 400 mg once on day 1 and 200 mg once daily from day 2 to day 7.HPLC was used to assay the serum and urinary concentrations of antofloxacin.Results In single dose study,the maximum concentration of drug in serum (Cmax),the time to reach Cmax (Tmax),and the area under the serum concentration-time curve (AUC (O-∞)) of antofloxacin were (1.89±0.65) mg/L,(1.29±0.26) hours,39.1%.In multiple dose study,blood concentration of antofloxiacin achieved stable state on day 2 after dosing.The minimum concentration drug in serum (Cmin),AUCss,mean concentration of drug in serum (Cav),and degree offluctuation (DF) were (0.73±0.18) mg/L, (47.59±7.85) mg·h^-1·L^-1, (1.98±0.33) mg/L, and 1.74±0.60, respectively. On day 7 after dosing, Tmax ,Cmax and AUC (0-∞) was (1.14±0.50) hours, (2.52±0.38) mg/L, and (48.77±8.44) mg·h^-1·L^-1, respectively. Accumulating elimination rate of antofloxaxin from urine within 120 hours after the last dosing was 60.06%.Conclusions The regimen of 400 mg loading dose given on the first treatment day and then 200 mg dose once daily results in satisfactory serum drug concentration. 展开更多
关键词 antofloxaxcin hydrochloride single dose multiple dose PHARMACOKINETICS healthy volunteer
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Nature and mechanism of immune boosting by Ayurvedic medicine: A systematic review of randomized controlled trials
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作者 B N Vallish Dimple Dang Amit Dang 《World Journal of Methodology》 2022年第3期132-147,共16页
BACKGROUND Many Ayurvedic preparations are claimed to have immune-boosting properties,as suggested in various published randomized clinical trials(RCTs)AIM To compile evidence on the nature and mechanism of immune sys... BACKGROUND Many Ayurvedic preparations are claimed to have immune-boosting properties,as suggested in various published randomized clinical trials(RCTs)AIM To compile evidence on the nature and mechanism of immune system enhancement by Ayurvedic preparations in healthy and sick individuals.METHODS After prospectively registering study protocol with PROSPERO,we searched PubMed,DOAJ,Google Scholar,three dedicated Ayurveda research portals,two specialty Ayurveda journals,and reference lists for relevant records published until February 6,2021 using appropriate search strategies.Baseline features and data pertaining to the nature and mechanism of immune system function were extracted from all eligible records.Methodological quality was assessed using the Cochrane RoB-2 tool.RESULTS Of 12554 articles screened,19 studies reporting 20 RCTs(17 parallel group design,three crossover design)with 1661 unique patients were included;11/19 studies had Indian first authors.Healthy population was included in nine studies,of which one study included pregnant women and two included pediatric population;remaining studies included patients with different health conditions,including one study with coronavirus disease 2019 patients.A total of 21 Ayurvedic interventions were studied,out of which five were composite mixtures.The predominant route of administration was oral;dose and frequency of administration of the intervention varied across the studies.The results reported with five RCTs exploring five Ayurvedic interventions were incomplete,ambiguous,or confusing.Of the remaining 16 interventions,indirect evidence of immune enhancement was reported with four interventions,while lack of the same was reported with two interventions.Enhancement of T helper cells and natural killer cells was reported with three and four interventions,respectively,while the pooled results did not clearly point toward enhancement of other components of the immune system,including cytotoxic T cells,B lymphocytes,immunoglobulins,cytokines,complement components,leucocyte counts,and other components.Nine of the 20 RCTs had a high risk of bias,and the remaining 11 RCTs had some concerns according to RoB-2.CONCLUSION Various Ayurvedic preparations appear to enhance the immune system,particularly via enhancements in natural killer cells and T helper cells. 展开更多
关键词 Immune enhancement AYURVEDA Immune system healthy volunteers Composite preparations NK cells
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Use of the Multispecies Probiotic Winclove 500/BactoSan pro FOS Leads to Less Gastrointestinal Complaints in Adults—An Observational In Vivo Pilot Study
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作者 Fritz Grossenbacher Agim Gashi Isolde Besseling-van der Vaart 《Advances in Microbiology》 2016年第14期975-985,共12页
The potential benefit of probiotics on the gut microbiota and on various gastrointestinal disorders is well documented. It has become clear that these probiotic effects are strain-specific, underlying the necessity fo... The potential benefit of probiotics on the gut microbiota and on various gastrointestinal disorders is well documented. It has become clear that these probiotic effects are strain-specific, underlying the necessity for a well-founded strain selection for research and clinical practice. Whether probiotics also have a positive effect on parameters of gastrointestinal function in a healthy population is less investigated. The objective of this in vivo observational study was to investigate the effect of a 6-week intervention with a multispecies probiotic product on gut health and quality of life (QoL) in a population of otherwise healthy adults and to evaluate the feasibility of conducting a controlled trial on probiotic effects in this population. A total of 40 participants from 3 different health centres were included in the study. After a 1-week inclusion phase, participants were supplemented for a 6-week period with Winclove 500/BactoSan pro FOS. During the run-in phase and each week during the observational period, gastrointestinal functional parameters were documented by an adapted version of the Eypasch questionnaire. Data on QoL was collected at baseline and at the end of the intervention period. The total gastrointestinal (GI) symptom score was reduced from 10 (4 - 21) at baseline to 6 (0 - 15) (p < 0.05) after 6 weeks intervention. More specifically, after the probiotic intervention the percentage of participants which were fully resolved of a particular symptom significantly increased to 27.5% (p < 0.02) for gastrointestinal pain, to 25% (p < 0.03) for epigastric fullness/bloating and to 20% (p < 0.02) for flatulence, compared to baseline. The treatment was well-tolerated. This observational study provides important information on the ability to investigate potential effects of a probiotic product in otherwise healthy adults. The promising results Winclove 500/BactoSan pro FOS showed on gut health and QoL in this target group should be further investigated in a randomized, placebo-controlled study. 展开更多
关键词 PROBIOTICS healthy volunteers Gut Health Quality of Life and Abdominal Pain
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