PURPOSE: The purpose of this study was to evaluate the effects of reminiscence therapy on depressive symptoms in older adults with dementia using a systematic review and meta-analysis. METHODS: Randomized controlled trials (RCTs) published from January 2000 to January 2018 were searched through Research Information Sharing Service (RISS), Korean Studies Information Service System (KISS), Korean Medical Database (KMbase), KoreaMed, PubMed, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Ovid MEDLINE. Two researchers independently performed the search, selection, and coding. Comprehensive Meta-Analysis 3.0 was used for meta-analysis, and Review Manager program 5.3 was used for quality assessment. RESULTS: Out of the 1,250 retrieved articles, 22 RCTs were selected for analysis. The overall effect size of reminiscence therapy for mitigating depressive symptoms in older adults with dementia was −0.62 (95% Cl: −0.92 to −0.31). The effect size was greater in older adults under 80, those with less disease severity, and those for whom the therapy session lasted less than 40 minutes. CONCLUSION Reminiscence therapy is an effective non-pharmacological therapy to improve depressive symptoms in older adults with dementia. Because its effectiveness is also influenced by age, disease severity, and application method, it is necessary to consider treatment designs based on individual characteristics as well as methodological approaches.

PURPOSE: The purpose of this study was to evaluate the effects of reminiscence therapy on depressive symptoms in older adults with dementia using a systematic review and meta-analysis. METHODS: Randomized controlled trials (RCTs) published from January 2000 to January 2018 were searched through Research Information Sharing Service (RISS), Korean Studies Information Service System (KISS), Korean Medical Database (KMbase), KoreaMed, PubMed, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Ovid MEDLINE. Two researchers independently performed the search, selection, and coding. Comprehensive Meta-Analysis 3.0 was used for meta-analysis, and Review Manager program 5.3 was used for quality assessment. RESULTS: Out of the 1,250 retrieved articles, 22 RCTs were selected for analysis. The overall effect size of reminiscence therapy for mitigating depressive symptoms in older adults with dementia was −0.62 (95% Cl: −0.92 to −0.31). The effect size was greater in older adults under 80, those with less disease severity, and those for whom the therapy session lasted less than 40 minutes. CONCLUSION: Reminiscence therapy is an effective non-pharmacological therapy to improve depressive symptoms in older adults with dementia. Because its effectiveness is also influenced by age, disease severity, and application method, it is necessary to consider treatment designs based on individual characteristics as well as methodological approaches.
Adult ; Clinical Coding ; Dementia ; Depression ; Humans ; Information Dissemination ; Information Services ; Mental Recall ; Methods ; Nursing

Characterizing the time course of baseline or pre-drug blood pressure is important in acquiring unbiased estimates of antihypertensive drug effect. In this study, we recruited 23 healthy male volunteers and measured systolic (SBP) and diastolic blood pressure (DBP) over 24 hours on an hourly basis. Using a non-linear mixed effects model, circadian rhythm observed in blood pressure measurements was described by incorporating two cosine functions with periods 24 and 12 hours. A mixture model was applied to identify subgroups exhibiting qualitatively different circadian rhythms. Our results suggested that 78% of the study population, defined as ‘dippers’, demonstrated a typical circadian profile with a morning rise and a nocturnal dip. The remaining 22% of the subjects defined as ‘non-dippers’, however, were not adequately described using the typical profile and demonstrated an elevation of blood pressure during night-time. Covariate search identified weight as being positively correlated with mesor of SBP. Visual predictive checks using 1,000 simulated datasets were performed for model validation. Observations were in agreement with predicted values in ‘dippers’, but deviated slightly in ‘non-dippers’. Our work is expected to serve as a useful reference in assessing systematic intra-day blood pressure fluctuations and antihypertensive effects as well as assessing drug safety of incrementally modified drugs.
Blood Pressure ; Circadian Rhythm ; Dataset ; Humans ; Male ; Volunteers

One of the important purposes in population pharmacokinetic studies is to investigate the relationships between parameters and covariates to describe parameter variability. The purpose of this study is to evaluate the model's ability to correctly detect the parameter-covariate relationship that can be observed in phase I clinical trials. Data were simulated from a two-compartment model with zero-order absorption and first-order elimination, which was built from valsartan's concentration data collected from a previously conducted study. With creatinine clearance (CLCR) being used as a covariate to be tested, 3 different significance levels of 0.001 Absorption ; Clinical Trials, Phase I as Topic* ; Creatinine ; Dataset ; Healthy Volunteers ; Hope

In generic drug development, comparative pharmacokinetic (PK) studies are conducted to assess equivalence in pharmacokinetics and safety profiles between test and reference formulations. However, there is no established quantitative approach available for safety assessment. This study aimed to propose a method for drug safety evaluation in generic drug development, as assessed by drug influence on blood pressure and heart rate change. Data were taken from a randomized, open label, 2-way cross-over comparative PK study for megestrol conducted in 39 healthy male volunteers. Vital signs of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at 0 (pre-dose), 4, 8, 12, 24, 48, 72, 96 and 120 hours after the dose. Safety parameters used in the analysis were area under vital sign change versus time curve to the last measured time (AUVlast) and maximum vital sign change (Vmax). Considering highly variable nature of vital signs, the scaled bioequivalence approach developed by US FDA was adopted as a decision rule for safety evaluation between formulations. With the FDA scaled approach, 90% confidence intervals of geometric mean ratio for DBP, 0.7969~1.0377 for Vmax and 0.7304~1.0660 for AUVlast, were both included in the equivalence ranges of 0.7694~1.2997 and 0.6815~1.4674, respectively, and similarly, those for HR were included in their respective scaled equivalence limits, while SBP satisfied the conventional equivalence criterion of 0.8-1.25. These results illustrate the feasibility of applying the suggested approach in cardiovascular safety evaluation in a generic drug.
Blood Pressure ; Heart Rate ; Humans ; Male ; Megestrol ; Pharmacokinetics ; Therapeutic Equivalency ; Vital Signs ; Volunteers

BACKGROUND: The hemodynamic responses to endotracheal intubation are associated with sympathoadrenal activity. Polymorphisms in the beta1-adrenergic receptor (beta1AR) gene can alter the pathophysiology of specific diseases. The aim of this study is to investigate whether the Ser49Gly and Arg389Gly polymorphism of the beta1AR gene have different cardiovascular responses during endotracheal intubation under sevoflurane anesthesia. METHODS: Ninety-one healthy patients undergoing general anesthesia were enrolled. Patients underwent slow inhalation induction of anesthesia using sevoflurane in 100% oxygen. Vecuronium 0.15 mg/kg was given for muscle relaxation. Endotracheal intubation was performed by an anesthesiologist. The mean arterial pressure (MAP), heart rate (HR), and the corrected QT (QTc) interval were measured before induction, before laryngoscopy, and immediately after tracheal intubation. Genomic DNA was isolated from the patients' peripheral blood and then evaluated for the beta1AR-49 and beta1AR-389 genes using an allele-specific polymerase chain reaction method. RESULTS: No differences were found in the baseline values of MAP, HR, and the QTc interval among beta1AR-49 and beta1AR-389, respectively. In the case of beta1AR-49, the QTc interval change immediately after tracheal intubation was significantly greater in Ser/Ser genotypes than in Ser/Gly genotypes. No differences were observed immediately after tracheal intubation in MAP and HR for beta1AR-49 and beta1AR-389. CONCLUSIONS: We found an association between the Ser49 homozygote gene of beta1AR-49 polymorphism and increased QTc prolongation during endotracheal intubation with sevoflurane anesthesia. Thus, beta1AR-49 polymorphism may be useful in predicting the risk of arrhythmia during endotracheal intubation in patients with long QT syndrome.
Anesthesia ; Anesthesia, General ; Arrhythmias, Cardiac ; Arterial Pressure ; DNA ; Genotype ; Heart Rate ; Hemodynamics ; Homozygote ; Humans ; Inhalation ; Intubation ; Intubation, Intratracheal ; Laryngoscopy ; Long QT Syndrome ; Methyl Ethers ; Muscle Relaxation ; Oxygen ; Polymerase Chain Reaction ; Vecuronium Bromide

OBJECTIVE: Posttraumatic embitterment disorder (PTED), a subgroup of an adjustment disorder, is a feeling with anger and helplessness. Hemodialysis may be a trigger event leading to PTED. We investigated the prevalence of PTED in patients with each categorized stages of chronic kidney disease (CKD) and the association between PTED and depression and functional impairment. METHODS: Patients were categorized into three groups according to the stages of CKD (stage I–II, III–IV, and V). CKD (I–II) group was defined as estimated glomerular filtration rate (eGFR) >60 ml/min/1.73 m², CKD (III–IV) group as eGFR <60 ml/min/1.73 m², and CKD (V) group as CKD stage V including patients ongoing hemodialysis. Patients were assessed for the prevalence of PTED, depression, and decreased quality of life by using the scale of PTED, Patient Health Questionnaire-9 (PHQ-9), and EuroQol Five Dimensional Questionnaires, Visual Analogue Scale (EQ-5D-VAS), respectively. RESULTS: A total of 445 patients were analyzed. The number of patients in CKD (I–II) was 166, CKD (III–IV) was 172, and CKD (V) was 107. Multivariate analysis by binomial logistic regression demonstrated that CKD (V) was significantly associated with the prevalence of PTED (odds ratio, 4.13; 95% confidence interval, 1.56–15.6; p=0.006) after adjustment for age, gender, and diabetes mellitus. Also, a significant correlation existed between PTED and EQ-5D-VAS in all stages, but the correlation was nonsignificant between PTED and PHQ-9 score in group CKD (V). CONCLUSION: The findings suggest that PTED is underdiagnosed in CKD patients. Acknowledgment and diagnosis of PTED in CKD patients may lead to a better quality of life.
Adjustment Disorders ; Anger ; Depression ; Diabetes Mellitus ; Diagnosis ; Dialysis ; Glomerular Filtration Rate ; Humans ; Logistic Models ; Multivariate Analysis ; Prevalence ; Quality of Life ; Renal Dialysis ; Renal Insufficiency, Chronic

Background and Objectives: This study compared nasal provocation test (NPT) results between groups with and without chronic rhinosinusitis with nasal polyps (CRSwNP) to investigate whether CRSwNP affects the response to the intranasal allergen challenge. Methods: We reviewed the medical records of patients who had undergone the NPT, multiple allergen simultaneous test (MAST), and paranasal sinus computed tomography. Patients were diagnosed with CRSwNP based on findings from nasal endoscopy and paranasal sinus computed tomography. The NPT for house dust mites was conducted, and a positive MAST diagnosis was determined when the levels of immunoglobulin E specific to Dermatophagoides farinae and Dermatophagoides pteronyssinus were equal to or greater than 2 positives or at least 0.70 IU/mL. We statistically analyzed the NPT results and their correlation with MAST outcomes, comparing the CRSwNP group to the non-CRSwNP group. Results: Out of 99 participants, 30 had CRSwNP and 69 did not. There were no significant differences between the groups regarding MAST positivity, eosinophil count, eosinophil cationic protein levels, or responses to intranasal house dust mite challenges. The presence of CRSwNP did not significantly influence the correlation between NPT outcomes and MAST results. Conclusion The presence of CRSwNP did not influence the outcomes of the NPT or its correlation with the results of the MAST. Additional large-scale, longitudinal studies are warranted to validate these findings.

In this study, the effect of particle size of genistein-loaded solid lipid particulate systems on drug dissolution behavior and oral bioavailability was investigated. Genistein-loaded solid lipid microparticles and nanoparticles were prepared with glyceryl palmitostearate. Except for the particle size, other properties of genistein-loaded solid lipid microparticles and nanoparticles such as particle composition and drug loading efficiency and amount were similarly controlled to mainly evaluate the effect of different particle sizes of the solid lipid particulate systems on drug dissolution behavior and oral bioavailability. The results showed that genistein-loaded solid lipid microparticles and nanoparticles exhibited a considerably increased drug dissolution rate compared to that of genistein bulk powder and suspension. The microparticles gradually released genistein as a function of time while the nanoparticles exhibited a biphasic drug release pattern, showing an initial burst drug release, followed by a sustained release. The oral bioavailability of genistein loaded in solid lipid microparticles and nanoparticles in rats was also significantly enhanced compared to that in bulk powders and the suspension. However, the bioavailability from the microparticles increased more than that from the nanoparticles mainly because the rapid drug dissolution rate and rapid absorption of genistein because of the large surface area of the genistein-solid lipid nanoparticles cleared the drug to a greater extent than the genistein-solid lipid microparticles did. Therefore, the findings of this study suggest that controlling the particle size of solid-lipid particulate systems at a micro-scale would be a promising strategy to increase the oral bioavailability of genistein.
Absorption* ; Animals ; Biological Availability* ; Drug Liberation ; Genistein* ; Nanoparticles* ; Particle Size* ; Powders ; Rats

OBJECTIVE: Clear depiction of the common bile duct is important when evaluating neonatal cholestasis in order to differentiate biliary atresia from other diseases. During MR cholangiopancreatography, the T2-shortening effect of gadolinium can increase the contrast-to-noise ratio (CNR) of the bile duct and enhance its depiction. The purpose of this study was to confirm, by performing a phantom study, the T2-shortening effect of gadolinium, to evaluate the effect of different gadolinium chelates with different gadolinium concentrations and different magnetic field strengths for investigating the optimal combination of these conditions, and for identifying the maximum CNR for the evaluation of the biliary system. MATERIALS AND METHODS: MR imaging using a T2-weighted single-shot fast spin echo sequence and T2 relaxometry was performed with a sponge phantom in a syringe tube. Two kinds of contrast agents (Gd-DTPA and Gd-EOB-DTPA) with different gadolinium concentrations were evaluated with 1.5T and 3T scanners. The signal intensities, the CNRs and the T2 relaxation time were analyzed. RESULTS: The signal intensities significantly decreased as the gadolinium concentrations increased (p < 0.001) with both contrast agents. These signal intensities were higher on a 3T (p < 0.001) scanner. The CNRs were higher on a 1.5T (p < 0.001) scanner and they showed no significant change with different gadolinium concentrations. The T2 relaxation time also showed a negative correlation with the gadolinium concentrations (p < 0.001) and the CNRs showed decrease more with Gd-EOB-DTPA (versus Gd-DTPA; p < 0.001) on a 3T scanner (versus 1.5T; p < 0.001). CONCLUSION: A T2-shortening effect of gadolinium exhibits a negative correlation with the gadolinium concentration for both the signal intensities and the T2 relaxation time. A higher CNR can be obtained with Gd-DTPA on a 1.5T MRI scanner.
Analysis of Variance ; Biliary Atresia/diagnosis ; Cholangiopancreatography, Magnetic Resonance/*methods ; Cholestasis/diagnosis ; Contrast Media/*administration & dosage/diagnostic use ; Diagnosis, Differential ; Gadolinium DTPA/*administration & dosage/diagnostic use ; Humans ; Image Processing, Computer-Assisted ; Linear Models ; *Phantoms, Imaging