Caffeine is a commonly ingested psychoactive substance which affects alertness and cognition. A clinical study was conducted to determine the effect of orally ingested caffeine on visual analogue scale (VAS) responses...Caffeine is a commonly ingested psychoactive substance which affects alertness and cognition. A clinical study was conducted to determine the effect of orally ingested caffeine on visual analogue scale (VAS) responses in healthy, moderate caffeine-consuming volunteers through the use of population pharmacokinetic-pharmacodynamic (PK-PD) modeling. Twelve subjects were recruited for a three-period cross-over study which utilized caffeine containing beverages. Each visit included 8-hour blood plasma and VAS response collection for PK and PD assessment respectively. The VAS used in the study, also called the caffeine analog scale, has been previously validated for caffeine. Population PK-PD modeling was conducted with NONMEM 7.2. Simultaneous and sequential modeling of PK-PD was attempted. Final model selection was based on parameter estimate precision, diagnostic plots, and visual predictive check (VPC) plots. Results showed that a one-compartment open model with first-order absorption and elimination best described the pharmacokinetics of caffeine. Sequential PK-PD modeling was successful and an effect compartment model with linear slope and baseline parameter best described caffeine pharmacodynamics. Diagnostic plots showed no major bias and VPC plots showed agreement between observations and predictions. The model was able to link VAS responses to caffeine concentration in healthy volunteers and may be useful in clinical trial simulations and design.展开更多
Introduction: The Liebowitz Social Anxiety Scale (LSAS), used to assess the severity of social anxiety disorder (SAD), requires considerable effort and time to complete. The aims of this study were: 1) to investigate ...Introduction: The Liebowitz Social Anxiety Scale (LSAS), used to assess the severity of social anxiety disorder (SAD), requires considerable effort and time to complete. The aims of this study were: 1) to investigate whether a visual analogue scale (VAS) could be linear with the LSAS and substitute for the LSAS, 2) to relate such a VAS instrument to patient demographics. Methods: Fifty SAD patients were assessed using the LSAS and VAS instruments completed by both patients and doctors at the same session. We then drew distributions and calculated the Spearman’s ρ and κ coefficient values (divided at the median for each scale) between patient and doctor assessments. Next, each pair among the scores for the LSAS, the patient VAS and the doctor VAS was compared using Wilcoxon rank sum tests according to patient life profile data. Results: Scatter plots of pairs of scores were obtained. Spearman’s ρ was 0.661 between the LSAS and the patient VAS, 0.461 between the LSAS and the doctor VAS, and 0.494 between VAS scores of patients and doctors. The κ coefficients were 0.501 between the LSAS and patient VAS, 0.251 between the LSAS and doctor VAS, and 0.425 between patient VAS and doctor VAS (for all six, p < 0.001). The Wilcoxon rank sum tests indicated a significant difference between the groups with/ without “employment” (LSAS, patient/doctor VAS), with/without “graduation from junior college/university” (doctor VAS) (p < 0.05) and with/without marital history (the age of first consultation) (p < 0.01). Conclusions: A patient VAS may substitute for the LSAS and offer the versatility necessary to capture patient states and life profiles.展开更多
目的研究针刺联合悬吊运动治疗非特异性下腰痛(nonspecific low back pain,NLBP)的临床效果。方法采用随机数字表法,将2020年3月至2023年1月在湖南中医药大学第一附属医院针灸推拿康复科进行治疗的60例NLBP患者分为观察组、对照组,各30...目的研究针刺联合悬吊运动治疗非特异性下腰痛(nonspecific low back pain,NLBP)的临床效果。方法采用随机数字表法,将2020年3月至2023年1月在湖南中医药大学第一附属医院针灸推拿康复科进行治疗的60例NLBP患者分为观察组、对照组,各30例。两组患者在常规处理的基础上,对照组采用针刺治疗,观察组采用针刺联合悬吊运动治疗,均治疗4周。观察两组患者疼痛视觉模拟评分(visual analogue scale,VAS)、功能障碍问卷(roland morris disability questionnaire,RMDQ)、中医症候积分、肌肉紧张度、生物力学特征、生活质量综合评定问卷(generic quality of life inventory 74,GQOL-74)、生活活动能力(Barthel指数)及疗效。结果治疗后,两组患者VAS、RMDQ评分、中医症候积分、两侧竖脊肌、多裂肌紧张度及腰背屈/伸比值(flexion/extension,F/E)均较治疗前下降(P<0.05),且观察组上述指标均低于对照组(P<0.05);治疗后,两组患者腰背伸状态下峰力矩(peak torque,PT)、平均功率(average power,AP)、GQOL-74及Barthel评分较治疗前升高(P<0.05),且观察组上述指标均高于对照组(P<0.05);经过治疗后,观察组总有效率(93.33%)高于对照组的(73.33%)(P<0.05)。结论单纯针刺和针刺联合悬吊运动在治疗NLBP上均有一定的疗效,可有效缓解患者疼痛,改善竖脊肌、多裂肌主动活动功能,提高生活质量,且针刺结合悬吊运动疗效优于单纯针刺治疗,值得临床推广应用。展开更多
文摘Caffeine is a commonly ingested psychoactive substance which affects alertness and cognition. A clinical study was conducted to determine the effect of orally ingested caffeine on visual analogue scale (VAS) responses in healthy, moderate caffeine-consuming volunteers through the use of population pharmacokinetic-pharmacodynamic (PK-PD) modeling. Twelve subjects were recruited for a three-period cross-over study which utilized caffeine containing beverages. Each visit included 8-hour blood plasma and VAS response collection for PK and PD assessment respectively. The VAS used in the study, also called the caffeine analog scale, has been previously validated for caffeine. Population PK-PD modeling was conducted with NONMEM 7.2. Simultaneous and sequential modeling of PK-PD was attempted. Final model selection was based on parameter estimate precision, diagnostic plots, and visual predictive check (VPC) plots. Results showed that a one-compartment open model with first-order absorption and elimination best described the pharmacokinetics of caffeine. Sequential PK-PD modeling was successful and an effect compartment model with linear slope and baseline parameter best described caffeine pharmacodynamics. Diagnostic plots showed no major bias and VPC plots showed agreement between observations and predictions. The model was able to link VAS responses to caffeine concentration in healthy volunteers and may be useful in clinical trial simulations and design.
文摘Introduction: The Liebowitz Social Anxiety Scale (LSAS), used to assess the severity of social anxiety disorder (SAD), requires considerable effort and time to complete. The aims of this study were: 1) to investigate whether a visual analogue scale (VAS) could be linear with the LSAS and substitute for the LSAS, 2) to relate such a VAS instrument to patient demographics. Methods: Fifty SAD patients were assessed using the LSAS and VAS instruments completed by both patients and doctors at the same session. We then drew distributions and calculated the Spearman’s ρ and κ coefficient values (divided at the median for each scale) between patient and doctor assessments. Next, each pair among the scores for the LSAS, the patient VAS and the doctor VAS was compared using Wilcoxon rank sum tests according to patient life profile data. Results: Scatter plots of pairs of scores were obtained. Spearman’s ρ was 0.661 between the LSAS and the patient VAS, 0.461 between the LSAS and the doctor VAS, and 0.494 between VAS scores of patients and doctors. The κ coefficients were 0.501 between the LSAS and patient VAS, 0.251 between the LSAS and doctor VAS, and 0.425 between patient VAS and doctor VAS (for all six, p < 0.001). The Wilcoxon rank sum tests indicated a significant difference between the groups with/ without “employment” (LSAS, patient/doctor VAS), with/without “graduation from junior college/university” (doctor VAS) (p < 0.05) and with/without marital history (the age of first consultation) (p < 0.01). Conclusions: A patient VAS may substitute for the LSAS and offer the versatility necessary to capture patient states and life profiles.
