How to conduct well-designed clinical research / 고신대학교의과대학학술지

Clinicians and healthcare decision-makers conduct their clinical practice based on the results of clinical trials. However, some health problems remain unresolved; in such cases, further research is required. To ensure reliable research results, it is important to understand the study design and conduct well-designed clinical trials. Many study designs can be chosen within the two broad categories of observational and interventional. Clinical studies have a variety of designs, including case series, case-control, cross-sectional, and prospective and retrospective cohort studies. Well-designed clinical studies can clarify important differences between treatment options and provide data on long-term drug efficacy and safety. Interpreting the results of clinical trials can be difficult because weaknesses in research design, data collection methods, analytic methods, and reporting can compromise their value and usefulness. However, although randomized controlled trials are limited owing to ethical and practical issues, they are optimal for investigating the effects of therapy and establishing causality. Here we present an overview of different clinical research designs and review their advantages and limitations.

Complex influences of gut microbiome metabolism on various drug responses

The gut microbiome closely interacts with the host, and it has a major influence on drug response. Many studies have reported the possible microbial influences on drugs and the possible influences of drugs on the microbiome. This knowledge has led to a better understanding of intra- and inter-individual variabilities in clinical pharmacology. For a more precise understanding of the complex correlation between the microbiome and drugs, in this review, we summarized the current knowledge on the interactions between the gut microbiome and drug response. Moreover, we suggest gut microbiome-derived metabolites as possible modulators of drug response and recommend metabolomics as a powerful tool to achieve such understanding.

First case report of latent tuberculosis reactivation complicating treatment with nilotinib in chronic myeloid leukemia

No abstract available.

Impact of Model-Based Iterative Reconstruction on the Correlation between Computed Tomography Quantification of a Low Lung Attenuation Area and Airway Measurements and Pulmonary Function Test Results in Normal Subjects

OBJECTIVE: To compare correlations between pulmonary function test (PFT) results and different reconstruction algorithms and to suggest the optimal reconstruction protocol for computed tomography (CT) quantification of low lung attenuation areas and airways in healthy individuals. MATERIALS AND METHODS: A total of 259 subjects with normal PFT and chest CT results were included. CT scans were reconstructed using filtered back projection, hybrid-iterative reconstruction, and model-based IR (MIR). For quantitative analysis, the emphysema index (EI) and wall area percentage (WA%) were determined. Subgroup analysis according to smoking history was also performed. RESULTS: The EIs of all the reconstruction algorithms correlated significantly with the forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) (all p < 0.001). The EI of MIR showed the strongest correlation with FEV1/FVC (r = −0.437). WA% showed a significant correlation with FEV1 in all the reconstruction algorithms (all p < 0.05) correlated significantly with FEV1/FVC for MIR only (p < 0.001). The WA% of MIR showed the strongest correlations with FEV1 (r = −0.205) and FEV1/FVC (r = −0.250). In subgroup analysis, the EI of MIR had the strongest correlation with PFT in both ever-smoker and never-smoker subgroups, although there was no significant difference in the EI between the reconstruction algorithms. WA% of MIR showed a significantly thinner airway thickness than the other algorithms (49.7 ± 7.6 in ever-smokers and 49.5 ± 7.5 in never-smokers, all p < 0.001), and also showed the strongest correlation with PFT in both ever-smoker and never-smoker subgroups. CONCLUSION: CT quantification of low lung attenuation areas and airways by means of MIR showed the strongest correlation with PFT results among the algorithms used, in normal subjects.

A Case of Improved Leukocytoclastic Vasculitis after Successful Treatment of Hepatocellular Carcinoma and Membranous Obstruction of Inferior Vena Cava

Vasculitis is a heterogeneous group of diseases that destroy blood vessel walls by inflammation. Approximately half of vasculitis cases are idiopathic, but sometimes associated with genetic factors, medicines, chronic infection, autoimmune diseases, and malignancies. Although the mechanism remains unclear, vasculitis secondary to malignancy, also known as paraneoplastic vasculitis, has been reported. It is generally associated with hematologic malignancies rather than solid malignancies and commonly presents as leukocytoclastic vasculitis or polyarteritis nodosa. We experienced a case of leukocytoclastic vasculitis in a patient with hepatocellular carcinoma and membranous obstruction of the inferior vena cava. Here, we report this case with a brief review of literature.