1.Systemic Literature Review Study on the Efficacy and Safety of Novel Alzheimer’s Disease Treatments
Shinung PARK ; Harin CHANG ; HyunSoon SOHN ; MiKyong SHIM
Korean Journal of Clinical Pharmacy 2023;33(4):290-304
Background:
Innovative Alzheimer’s disease drugs received approval in the United States in 2021 and 2023. This study aims to assess the safety and efficacy of these novel treatments, elucidate their mechanisms of action, and compare their impact on cognitive function improvement with approved drugs.
Methods:
We conducted a comprehensive search of pivotal clinical studies related to Alzheimer’s disease treatments in PubMed/Medline, Embase, and the Cochrane Library databases from January 1st, 2020 to December 31st, 2022. Meta-analysis was performed using RevMan 5.4 software.
Results:
A total of 14 studies were included in this systematic review. When compared to the placebo, the new drugs did not exhibit a statistically significant effect on MMSE (MiniMental State Examination) (mean difference= −0.04, 95% confidence intervals [CIs]: −0.31, 0.23, N=3662, I2 =0%). However, they demonstrated a significant impact on ADAS-cog (Alzheimer’s Disease Assessment Scale-Cognitive Subscale) (standardized mean difference= −0.15, 95% CIs: −0.2, −0.1, N=6710, I2 =17%). When compared to the approved drugs, the new drugs showed a statistically significantly lower effect on MMSE (test for subgroup difference Chi2 =23.13, N = 5870, p<0.00001) but showed only a trend of decreased efficacy on ADAS-cog (Chi2 =1.16, N = 8670, p=0.28).
Conclusion
New drugs yielded diverse clinical endpoint results compared to the placebo, and in comparison to existing approved drugs, they exhibited lower efficacy in improving cognitive function. The safety profile of these new drugs, as reported in clinical trials, was generally well-tolerated.
2.25-Hydroxyvitamin D Status Based on Estimated Glomerular Filtration Rate in Patients with Chronic Kidney Disease.
Jung Hee KOH ; Ihm Soo KWAK ; Sang Heon SONG ; Soo Bong LEE ; Harin RHEE ; Eun Young SEONG ; Chang Jun PARK ; Tae Kyun KIM ; Sang Bo OH
Korean Journal of Medicine 2012;83(6):740-751
BACKGROUND/AIMS: Accumulating data suggest that vitamin D deficiency is prevalent in patients with chronic kidney disease (CKD). However, comprehensive data are lacking for Koreans. The aim of this study was to survey vitamin D deficiency among patients with CKD in Korea and to identify the relationships among various factors. METHODS: We conducted a retrospective cohort study of 444 patients who were divided into four subgroups by estimated glomerular filtration rate (eGFR) for comparisons of mean 25-hydroxyvitamin D [25(OH)D] level and other parameters. In addition, non-dialyzed patients were categorized into four groups based on 25(OH)D levels (<10, 10-19, 20-29, and > or =30 ng/mL), and risk factors for severe vitamin D deficiency (<10 ng/mL) were investigated. RESULTS: Of patients with an eGFR > or = 60 mL/min/1.73 m2, 43% (34/79) showed severe 25(OH)D deficiency, and the mean 25(OH)D level was 11.7 +/- 5.3 ng/mL. In CKD3 group, 53.2% (41/77) showed severe 25(OH)D deficiency, with a mean level of 11.3 +/- 7.2 ng/mL. In CKD4 group, 53.3% (49/92) had severe 25(OH)D deficiency, with a mean level of 11.0 +/- 6.2 ng/mL. Approximately 71% (139/196) of patients in CKD5 group showed severe deficiency, and the mean level was 9.2 +/- 5.9 ng/mL. Severe 25(OH)D deficiency was affected by winter season, renal function, diabetes, and low-density lipoprotein cholesterol. The serum parathyroid hormone level was inversely correlated with the 25(OH)D level, such that 25(OH)D <20 ng/mL were associated with a steep increase in parathyroid hormone. CONCLUSIONS: Vitamin D deficiency is highly prevalent in the Korean population. Few patients met a sufficient 25(OH)D concentration, even in the early stages of CKD. Our data suggest that 25(OH)D level of 20 ng/mL is a threshold for a rapid increase in parathyroid hormone levels.
Cholesterol
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Cohort Studies
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Glomerular Filtration Rate
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Humans
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Korea
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Lipoproteins
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Parathyroid Hormone
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Renal Insufficiency, Chronic
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Retrospective Studies
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Risk Factors
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Seasons
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Vitamin D
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Vitamin D Deficiency
3.Validation of a Video Based Scale for Measuring Social Cognition in Schizophrenia.
Jungsun LEE ; Harin KIM ; Myong Wuk CHON ; Joon Ho AHN ; Yeon Ho JOO ; Chang Yoon KIM
Journal of Korean Neuropsychiatric Association 2016;55(2):122-130
OBJECTIVES: Social cognition plays an important role in psychiatric symptoms and prognosis in patients with schizophrenia. Diagnostic scales are predominantly text-based or intended for the evaluation of theoretical concepts, with limited usefulness in clinical settings. We therefore developed a video based social cognition scale. METHODS: Our scale consists of 20 video clips portraying frequently experienced social interactions in real life. Patients were asked which interactions were socially unnatural and the reasons for lies told by actors. Our scale was validated and social cognition and its relationship with symptoms was evaluated using item response theory. RESULTS: A total of 209 participants (schizophrenia, 101 ; bipolar disorder, 49 ; healthy controls 59) were enrolled. Our scale showed high reliability and concurrent validity compared with the order subtest of the short form of the Weschler Adult Intelligence scale. Internal validity also was high (Cronbach's alpha=0.904). Most items were easy to answer and highly discriminative. The test information curve showed our scale to be more informative in patients with low social cognition ability. CONCLUSION: Our scale may aid in the study of pathology and social cognition deficits in patients with schizophrenia.
Adult
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Bipolar Disorder
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Cognition*
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Humans
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Intelligence
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Interpersonal Relations
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Pathology
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Prognosis
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Schizophrenia*
;
Theory of Mind
;
Weights and Measures
4.Cancer-Related Dysfunctional Beliefs About Sleep Mediate the Influence of Sleep Disturbance on Fear of Progression Among Patients With Surgically Resected Lung Cancer
Harin KIM ; Wonjun JI ; Jong Won LEE ; Min-Woo JO ; Sung-Chol YUN ; Sei Won LEE ; Chang-Min CHOI ; Geun Dong LEE ; Hui Jeong LEE ; Eulah CHO ; Yura LEE ; Seockhoon CHUNG
Journal of Korean Medical Science 2023;38(31):e236-
Background:
Lung cancer is associated with significant psychological distress, including fear of progression (FoP). Because insomnia and depression are highly prevalent and associated with FoP, we examined the association between FoP, insomnia, and depression in cancer patients. Furthermore, we tested the mediation effect of cancer-related dysfunctional beliefs about sleep (C-DBS) on this association.
Methods:
We analyzed data collected from patients with surgically resected non-small cell lung cancer from a single-center randomized controlled study investigating digital healthcare applications. Baseline demographic and clinical variables were collected. In addition, selfreported questionnaires including the Fear of Progression Questionnaire-Short Form, Patients Health Questionnaire-9 items (PHQ-9), Insomnia Severity Index, and C-DBS were administered.
Results:
Among the 320 enrolled patients with lung cancer, a regression model showed that FoP was predicted by age (β = −0.13, P = 0.007), PHQ-9 (β = 0.35, P < 0.001), and C-DBS (β = 0.28, P < 0.001). Insomnia did not directly influence FoP, but C-DBS mediated the association. Depression directly influenced FoP, but C-DBS did not mediate this association.
Conclusion
Among patients with surgically resected lung cancer, C-DBS mediated the effects of severity of insomnia on FoP. Depression directly influenced FoP, but C-DBS did not influence this association. To reduce FoP among patients with lung cancer, C-DBS should be addressed in the cognitive behavioral therapy module.