• Korean Journal of Clinical Pharmacy
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• v.8 no.1
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• pp.1-12
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• 1998

Rheumatoid arthritis (RA) is a common systemic inflammatory disease which DMARDS have been widely used as a treatment modality both as monotherapy and combination therapy Bucillamine, one of newer DMARDS, has recently proven its efficacy as monotherapy in the treatment of RA. The objective of this study was to compare the efficacy and the safety of bucillamine monotherapy and bucillamine plus methotrexate combination therapy in the treatment of rheumatoid arthritis. Forty-nine mild RA patients were enrolled in this prospective, open-trial and were assigned to receive bucillamine 200 mg/day (n=18) or bucillamine 200 mg/day and methotrexate 7.5-15 mg/week (n=31) orally for 16 weeks. Concomitant use of NSAID and prednisolone <5 mg/day or equivalent dose of steroid were allowed. Both monotherapy group and combination therapy group have shown significant improvement in disease activities (Ritchie index, painful joints, swollen joints, morning stiffness, grip strength, ESR, RF, CRP, patient's self assessment of pain, physician's global assessment of disease activity) from the baseline. However, there was no statistically significant difference between two groups. The adverse effects were more frequently shown in combination therapy group than monotherapy group. In conclusion, in patients with mild RA monotherapy has shown to be equally efficacious as combination therapy with less side effects.

• Journal of Gastric Cancer
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• v.19 no.2
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• pp.183-192
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• 2019

Purpose: Due to adverse events, dose reduction or withdrawal of adjuvant chemotherapy is required for some patients. To identify the predictive factors for tolerability to postoperative adjuvant S-1 monotherapy in gastric cancer (GC) patients, we evaluated the predictive values of blood indicators. Materials and Methods: We analyzed 98 patients with pStage II/III GC who underwent postoperative adjuvant S-1 monotherapy. We retrospectively analyzed correlations between 14 parameters obtained from perioperative routine blood tests to assess their influence on the withdrawal of postoperative adjuvant S-1 monotherapy, within 6 months after discontinuation. Results: Postoperative adjuvant chemotherapy was discontinued in 21 patients (21.4%) within 6 months. Univariable analysis revealed that high preoperative albumin-bilirubin (ALBI) scores had the highest odds ratio (OR) for predicting the failure of adjuvant S-1 chemotherapy (OR, 6.47; 95% confidence interval [CI], 2.08-20.1; cutoff value, -2.696). The high ALBI group had a significantly shorter time to failure of postoperative adjuvant S-1monotherapy (hazard ratio, 3.48; 95% CI, 1.69-7.25; P=0.001). Multivariable analysis identified high preoperative ALBI score as an independent prognostic factor for tolerability (OR, 10.3; 95% CI, 2.33-45.8; P=0.002). Conclusions: Preoperative ALBI shows promise as an indicator associated with the tolerability of adjuvant S-1 monotherapy in patients with pStage II/III GC.

• Journal of Periodontal and Implant Science
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• v.52 no.1
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• pp.77-87
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• 2022

Purpose: This pilot study assessed the immediate in vivo effect of high peak pulse power neodymium-doped yttrium aluminum garnet (Nd:YAG) laser monotherapy on selected red/orange complex periodontal pathogens in deep human periodontal pockets. Methods: Twelve adults with severe periodontitis were treated with the Laser-Assisted New Attachment Procedure (LANAP®) surgical protocol, wherein a free-running, digitally pulsed, Nd:YAG dental laser was used as the initial therapeutic step before mechanical root debridement. Using a flexible optical fiber in a handpiece, Nd:YAG laser energy, at a density of 196 J/cm² and a high peak pulse power of 1,333 W/pulse, was directed parallel to untreated tooth root surfaces in sequential coronal-apical passes to clinical periodontal probing depths, for a total applied energy dose of approximately 8-12 joules per millimeter of periodontal probing depth at each periodontal site. Subgingival biofilm specimens were collected from each patient before and immediately after Nd:YAG laser monotherapy from periodontal pockets exhibiting ≥6 mm probing depths and bleeding on probing. Selected red/orange complex periodontal pathogens (Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia/nigrescens, Fusobacterium nucleatum, Parvimonas micra, and Campylobacter species) were quantified in the subgingival samples using established anaerobic culture techniques. Results: All immediate post-treatment subgingival biofilm specimens continued to yield microbial growth after Nd:YAG laser monotherapy. The mean levels of total cultivable red/orange complex periodontal pathogens per patient significantly decreased from 12.0% pretreatment to 4.9% (a 59.2% decrease) immediately after Nd:YAG laser monotherapy, with 3 (25%) patients rendered culture-negative for all evaluated red/orange complex periodontal pathogens. Conclusions: High peak pulse power Nd:YAG laser monotherapy, used as the initial step in the LANAP® surgical protocol on mature subgingival biofilms, immediately induced significant reductions of nearly 60% in the mean total cultivable red/orange complex periodontal pathogen proportions per patient prior to mechanical root instrumentation and the rest of the LANAP® surgical protocol.

• Journal of Yeungnam Medical Science
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• v.37 no.3
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• pp.230-235
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• 2020

Systemic therapy for metastatic triple-negative breast cancer (TNBC) still remains challenging because there are no targeted agents or endocrine therapies currently available. The present case report documents the successful use of cisplatin monotherapy to manage a heavily pretreated TNBC patient showing poor response to therapy. The patient was a 51-year-old woman who had already undergone several lines of systemic chemotherapy for widespread TNBC. Although the mutation analysis performed on DNA isolated from blood cells and progressed lesion samples confirmed the tumor to be germline BRCA wild-type, cisplatin monotherapy was administered based on the increasing evidence of safety and efficacy of platinum for breast cancer. After three cycles of cisplatin treatment, the patient's metastatic lesions dramatically improved without any major toxicity, and she completed 17 cycles with good response. This case study indicates that patients with heavily pretreated TNBC can potentially achieve a good response to cisplatin monotherapy.

• Korean Journal of Clinical Pharmacy
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• v.33 no.2
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• pp.113-121
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• 2023

Background: Globally, the number of patients with aspergillosis is increasing, and the mortality rate remains high. This study aimed to investigate prescribing patterns of antifungal drugs for patients with aspergillosis in South Korea using real-world data. Methods: This retrospective cross-sectional study was performed using National Patient Sample (NPS) data collected by the Health Insurance Review and Assessment Service (HIRA) during 2011-2020. The use of antifungal drugs in patients with aspergillosis was investigated. Results:A total of 1374 patients were identified: 333 patients with invasive pulmonary aspergillosis (IPA) (24.2%), 436 patients with other PA (31.7%), 73 patients with other forms of aspergillosis (5.3%), and 532 patients with unspecified aspergillosis (38.7%). The odds of receiving an antifungal prescription were higher for IPA than for other PA (aOR, 0.233; p<0.001), and higher for hematologic malignancies than for respiratory disorders other than cancer or infections (aOR, 10.018; p<0.001). During each hospitalization period, 56.1% (97/173) and 6.4% (11/173) of IPA hospitalizations received voriconazole and itraconazole monotherapy, respectively, whereas 44.3% (27/61) and 27.9% (17/61) of other PA hospitalizations received itraconazole and voriconazole monotherapy, respectively. Among outpatients with IPA, 67.5% (85/126) and 26.2% (33/126) received voriconazole and itraconazole alone, respectively, whereas among outpatients with other PA, 86.1% (68/79) and 12.7% (10/79) received itraconazole and voriconazole alone, respectively, during the year. Conclusion: In Korea, voriconazole monotherapy was preferred in IPA inpatients, and itraconazole monotherapy was preferred in other PA inpatients. In the ambulatory care settings for IPA and other PA, itraconazole monotherapy was preferred.

• Korean Journal of Clinical Pharmacy
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• v.27 no.4
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• pp.207-213
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• 2017

Background: It is recommended to use aerosolized (AS) colistin in patients undergoing mechanical ventilation therapy as an adjunctive in the latest guidelines, in spite of high nephrotoxicity and limited studies. In this study, systematic reviews and meta-analyzes were conducted to evaluate the safety and efficacy of AS colistin in patients with ventilator-associated pneumonia Methods: Two authors independently searched related literature published from Pubmed and EMBASE until July 2016 and included a study comparing adjunctive AS colistin with intravenous (IV) colistin monotherapy. The primary outcome was the clinical response rate, the secondary outcome was the overall mortality, and nephrotoxicity. The publication bias was evaluated using the Egger's test. Results: Of the total 279 articles, nine were finally included in the final analysis. There was a significant difference between the adjunctive AS colistin group and the IV colistin monotherapy group for the treatment-response rate (odds ratio (OR), 1.56; 95% CI, 1.14-2.14; p = 0.005; $I^2=36%$), although there was no significant difference in overall mortality (OR, 0.77; 95% CI, 0.57-1.04; p = 0.09; $I^2=20%$). However, there was no significant difference between the two groups in nephrotoxicity (OR, 1.13; 95% CI, 0.74-1.74; p = 0.57; $I^2=4%$). Conclusion: The addition of aerosolized colistin to IV colistin monotherapy showed better results in terms of efficacy than IV colistin monotherapy and did not show any significant difference in terms of total mortality and nephrotoxicity. Additional large-scale studies of this need to be verified.

• Clinical and Experimental Pediatrics
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• v.54 no.9
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• pp.380-384
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• 2011

Purpose: To investigate the efficacy of topiramate monotherapy in West syndrome prospectively. Methods: The study population included 28 patients (15 male and 13 female children aged 2 to 18 months) diagnosed with West syndrome. After a 2-week baseline period for documentation of the frequency of spasms, topiramate was initiated at 2 mg/kg/day. The dose was increased by 2 mg/kg every week to a maximum of 12 mg/kg/day. Clinical assessment was based on the parents' report and a neurological examination every 2 weeks for the first 2 months of treatment. The baseline electroencephalograms (EEGs) were compared with the post-treatment EEGs at 2 weeks and 1 month. Results: West syndrome was considered to be cryptogenic in 7 of the 28 patients and symptomatic in 21 patients. After treatment, 11 patients (39%) became spasm-free, 6 (21%) had more than 50% spasms-reduction, 3 (11%) showed less than 50% reduction, and 8 (29%) did not respond. The effective daily dose for achieving more than 50% reduction in spasm frequency, including becoming spasm-free, was found to be $5.8{\pm}1.1$ mg/kg/day. Nine patients (32%) showed complete disappearance of spasms and hypsarrhythmia, and 11 (39%) showed improved EEG results. Despite adverse events (4 instances of irritability, 3 of drowsiness, and 1 of decreased feeding), no patients discontinued the medication. Conclusion: Topiramate monotherapy seems to be effective and well tolerated as a first line therapy for West syndrome and is not associated with serious adverse effects.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.81-87
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• 2018

Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance center in the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlled analgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative pain management. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain management after orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drug reactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for the incidence rate of adverse drug reaction in the fentanyl TTS combination therapy group was 3.04 (95 % CI: 2.4-4.00, P < 0.0001), which was approximately 3-fold higher than that reported for fentanyl PCA monotherapy. Only 60 % of the adverse drug reactions were reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There is a need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regional pharmacovigilance centre would aid in appropriate drug utilization by patients.

• Korean Journal of Clinical Pharmacy
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• v.29 no.3
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• pp.186-192
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• 2019

Background: Diabetes is associated with cancer risk in the aging population. Observational studies have indicated the beneficial effects of metformin against breast cancer, making studies on the anticancer potential of antidiabetic drugs worthwhile. This study investigated cancer incidence in patients on antidiabetic monotherapy. Methods: Using National Health Insurance Service data (2002-2013), a retrospective cohort study that included type 2 diabetes mellitus (T2DM) patients was conducted. Study subjects were enrolled if they were ${\geq}30$ years old, on monotherapy for diabetes, and cancer-free. They were followed up for cancer occurrence or death, until December 31st, 2013. A Cox proportional hazard model analysis was conducted between metformin and sulfonylurea (including meglitinide) users, to determine cancer risk, with adjustment for age, gender, comorbidity index, dyslipidemia, hypertension, and T2DM duration. Results: The number of antidiabetic monotherapy-treated T2DM patients without a history of cancer was 9,554 (metformin, n = 5,825; sulfonylurea, n = 3,225; others, n = 504). During the follow-up period (mean, 2.04; IQR, 3.18 years), the cancer incidence rate was 5.48/100 and 5.45/100 patient-years for metformin and sulfonylurea, respectively. The hazard ratio (HR) for risk of cancer incidence in the metformin group was 0.74 (95% confidence interval [CI], 0.66-0.83; p < 0.0001), compared with sulfonylurea. Additionally, the HRs for risks of lung, liver, and stomach cancer were respectively 0.46 (95% CI, 0.31-0.66; p < 0.0001), 0.41 (95% CI, 0.31-0.54; p < 0.0001), and 0.51 (95% CI, 0.35-0.73; p = 0.0003). Conclusion: Antidiabetic therapy with metformin reduces cancer risk by 26%, specifically for lung, liver, and stomach cancer.

• Journal of Oriental Neuropsychiatry
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• v.33 no.1
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• pp.79-111
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• 2022

Major depressive disorder (MDD) causes a persistent feeling of sadness and loss of interest. It can lead to emotional and physical problems. Treatments such as antidepressant and cognitive behavioral therapy for MDD have many limitations. Traditional East Asian Herbal Medicine (TEAM) is a representative modality of Complementary and Integrative Medicine (CIM) which can be used for MDD. However, no study has systematically reviewed the efficacy or safety of TEAM for MDD so far. Therefore, we performed a systematic review and meta-analysis to evaluate effectiveness and safety of TEAM as a monotherapy for MDD. We only included TEAM that could be used in context of clinical setting in Korean Medicine. Outcomes were the Hamilton Depression Rating Scale (HAMD) and total effective rate (TER). After comprehensive electronic search of 11 databases, we included 28 randomized controlled trials (RCTs) that compared HM as monotherapy with antidepressant for MDD. Meta-analysis showed that TEAM had significant benefits in reducing HAMD (MD=-0.40, 95% CI: -0.67 to -0.13, p=0.003, I²=85%) and improving TER (RR=1.06, 95% CI: 1.02 to 1.10, p=0.003, I²=0%). It also appeared to be safer than antidepressant in terms of adverse effects. Methods used for RCTs were poor and the quality of evidence was graded 'low' or 'moderate'. These findings indicate that the use of HM as a monotherapy might have potential benefits in MDD treatment as an alternative to antidepressant. However, considering the methodological quality of included RCTs, the clinical evidence is uncertain. Further well-designed RCTs are required to confirm these findings.