• 한국임상약학회지
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• 제8권1호
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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.

• 한국임상약학회지
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• 제29권2호
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• pp.71-78
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• 2019

Objective: This study aimed to provide efficacy and safety information on the use of erenumab for prevention of episodic and chronic migraines. Methods: The keywords "Erenumab and migraine" were used to search the PubMed database to then compile efficacy and safety data for erenumab. Data from relevant Phase 2 and Phase 3 clinical trials were analyzed, using RevMan for statistical analysis. Results: Three clinical trials (one Phase 2 and two Phase 3 studies) were retrieved. All three trials used the same primary endpoint (change from baseline in monthly migraine days (CBMD)) to evaluate efficacy and safety of erenumab use for prevention of episodic and chronic migraines. Subcutaneous doses of erenumab (70 or 140 mg) were administered monthly in each trial, for 3 months (Studies 2, and 3) or 6 months (Study 1). The mean differences in CBMD in the 70 mg and 140 mg erenumab arms were -1.36 and -1.98, respectively, compared to that in the placebo arm. Some adverse events, such as nasopharyngitis and upper respiratory tract infection, were reported, but no differences in safety between erenumab and placebo were found to be significant. Conclusions: Erenumab showed superior efficacy in prevention of migraines compared to placebo. However, additional information regarding the long-term safety of erenumab should be collected. Therefore, post-marketing surveillance for adverse events is needed.

• 한국임상약학회지
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• 제22권2호
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• pp.131-136
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• 2012

Objective: This study evaluated and compared the adherence to the CONSORT for quality of reports on the randomized controlled trials (RCT) abstracts by four major Korean Science Citation Index (SCI) journals and The New England Journal of Medicine (NEJM). Methods: A descriptive analysis of published RCT abstracts in Korean SCI journals and NEJM from 2007/01 to 2011/06 was conducted by two reviewers, independently extracting data from a PubMed search. A modification of CONSORT for abstract was used including 16 checklist items. Reporting of checklist items for individual group was conducted to compare adherence patterns between two groups. Results: We identified the potential 57 RCT abstracts from Korean SCI and 50 from NEJM meeting our inclusion criteria; among them, three abstracts from Korean SCI and one from NEJM were excluded. Among total 16 checklist items based on CONSORT statement, Korean SCI journals and NEJM were statistically equivalent in 4 items; Korean journals were better in three items and NEJM were in nine. The methodological quality domains were inadequately reported in both journals: allocation concealment about 1.9% and 4.0%, and blinding 44.4% and 40.8%. In general, The CONSORT adherence of NEJM was better than that of Korean SCI in the method and result domain (p < 0.0001). Conclusions: The quality of NEJM reporting of RCT abstracts was better than that of Korean SCI, in general. This study on adherence of RCT reports from Korean SCI journals and NEJM abstracts to the CONSORT statement reveals that there is a need for improvement, especially Korean SCI. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

• 한국임상약학회지
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• 제31권2호
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• pp.136-144
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• 2021

Background: Zinc is known for modulating antiviral and antibacterial immunity and regulating inflammatory response. This study aimed to examine the effect of zinc supplementation on clinical outcomes of hospitalized COVID-19 patients through systematic literature review and meta-analysis. Methods: PubMed/Medline, Embase, and Cochrane library databases were searched for studies comparing zinc supplement group versus control group for clinical outcomes of COVID-19 up to November 3, 2020. The search results were updated on February 9, 2021. The meta-analysis was performed by RevMan 5.4 software. Results: Total 4 studies were included in this systematic review. The zinc administered group had a significantly lower mortality rate compared with the control group (odds ratio [OR] 0.63, 95% confidence interval [95% CI] 0.53-0.75, p<0.001), with significantly higher discharge rate (OR 1.32, 95% Cl 1.15-1.52, p<0.001). However, there were no significant differences in the intensive care unit admission rate (OR 1.07, 95% Cl 0.26-4.48, p=0.92), mechanical ventilation rate (OR 0.80, 95% Cl 0.45-1.41, p=0.44), and length of hospital stay (mean difference 0.75, 95% Cl -0.64 to 2.13, p=0.29) between the two groups. Conclusion: The meta-analysis of zinc administration showed positive clinical effects on the discharge rate and mortality of COVID-19 hospitalized patients. However, large-scale randomized controlled trial should be conducted for zinc to be considered as one of the adjuvant treatments.

• Journal of Pharmaceutical Investigation
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• 제36권1호
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• pp.23-29
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• 2006

A rapid, selective and sensitive reversed-phase HPLC method for the determination of promethazine in human serum was developed, validated, and applied to the pharmacokinetic study of promethazine. Promethazine and internal standard, chlorpromazine, were extracted from human serum by liquid-liquid extraction with n-hexane containing 0.8% isopropanol and analyzed on a Capcell Pak CN column with the mobile phase of acetonitrile-0.2 M potassium dihydrogen phosphate (42:58, v/v, adjusted to pH 6.0 with 1 M NaOH). Detection wavelength of 251 nm and flow rate of 0.9 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed promethazine concentration (10 ng/mL) with respect to its peak area and retention time. In addition, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 1-40 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 1 mL of serum was 1 ng/mL, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 96.15 to 105.40% for promethazine with overall precision (% C.V.) being 6.70-11.22%. The relative mean recovery of promethazine for human serum was 63.54%. Stability (freeze-thaw and short-term) studies showed that promethazine was stable during storage, or during the assay procedure in human serum. However, the storage at $-80^{\circ}C$ for 4 weeks showed that promethazine was not stable. Extracted serum sample and stock solution were not allowed to stand at ambient temperature for 12 hr prior to injection. The peak area and retention time of promethazine were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of promethazine in human serum samples for the pharmacokinetic studies of orally administered Himazin tablet (25 mg as promethazine hydrochloride) at three different laboratories, demonstrating the suitability of the method.

• Journal of Ginseng Research
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• 제35권3호
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• pp.339-343
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• 2011

Polycyclic aromatic hydrocarbons (PAHs) are well known environmental carcinogens. PAH metabolites, especially BaP-7,8- dihydrodiol, 9,10 epoxide, initiate carcinogenesis via high specificity binding to DNA to form DNA adducts. The Korean red ginseng (KRG) from Panax ginseng has been suggested to protect against damages due to PAH exposure but the mechanism is unknown. Therefore, we investigated effects of KRG on PAH exposure using toxicokinetic methods and changes of PAH-induced oxidative damage during a 2 week-clinical trial (n=21 healthy young female, $23.71{\pm}2.43$ years). To analyze antioxidative effects of KRG, we measured changes in the levels of urinary malondialdehyde (MDA) before and after KRG treatment. We observed a significant positive association between levels of urinary MDA and 1-hydroxypyrene, a biomarker of PAH exposures (slope=1.47, p=0.03) and confirmed oxidative stress induced by PAH exposures. A reverse significant correlation between KRG treatment and level of urinary MDA was observed (p=0.03). In summary, results of our clinical trial study suggest that KRG plays a significant role in antioxidative as well as toxicokinetic pathways against PAHs exposure.

• 한국임상약학회지
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• 제12권2호
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• pp.65-70
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• 2002

Prophylactic antibiotics in acute nonperforated appendicitis have been used for preventing infection after appendectomy. However, duration of antibiotic administration for surgical prophylaxis in Korea has been noted to be longer than those recommended in other countries. The objective of this study was to identify appropriate duration of prophylactic antibiotics in acute nonperforated appendicitis by comparing two different antibiotic regimens for their wound infection rates. Eighty-four acute nonperforated appendicitis patients were enrolled in this prospective, randomized, open trial and were assigned to one of two antibiotic regimens: cefoxitin 1 g every 8 hours given intravenously for 24hours or cefoxitin 1 g every 8 hours given intravenously plus sisomicin 75 mg every 12 hours given jntramuscularly for 72 hours. First doses were given just prior to the induction of anesthesia. Postoperative wound infections were detected in $4.8\%$ of the 72-hour-treated group (n=42), whereas none occurred in the 24-hour-treated group (n=42). However, the difference in the rates of wound infections between two groups was not statistically significant. The most frequently isolated microorganism from appendiceal tissues was E coli. In conclusion, administration of cefoxitin alone for 24 hours is sufficient as surgical prophylaxis in nonperforated appendicitis.

• 한국임상약학회지
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• 제21권4호
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• pp.297-304
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• 2011

배경: 골다공증은 골대사의 불균형으로 인해 골 흡수가 골 형성보다 많아져 골밀도가 감소함으로서 발생한다. 골다공증의 이상적인 치료목표는 골형성을 증가시키거나 골소실을 방지하여 골량을 현 상태로 유지하는 것이다. 따라서 향후 발생되는 골소실을 에방하는 것이 골다공증의 원칙적이고 효과적인 치료방법이 될 것이다. 본 연구에서는 흑효모 중 $Aureobasidium$ $pullulans$으로부터 유래한 폴리칸(베타-글루칸)이 중년여성의 골대사에 미치는 영향을 규명하고자 하였다. 연구방법: 골대사에 대한 폴리칸의 효과를 규명하기 위해 12주간의 무작위배정, 이중눈가림, 플라세보 대조 임상연구를 수행하였다. 총 60명(폴리칸 투여군30명, 플라세보 투여군 30명)의 중년 여성 피험자가 등록되어 이 중 총 58명의 피험자가 최종적으로 12주간의 임상연구를 종료하였다. 결 과: 폴리칸(150 mg/d) 투여 12주 후, 폴리칸 투여군은 요 중 Deoxypyridinoline (DPD) 농도가 유의적인 감소를 보였다($P$=0.014). 혈청 중 Osteocalcin(OSC) 농도는 두 군 모두에서 유의적으로 증가하였으며, bone-specific alkaline posphatase (bALP) 와 collagen type 1 cross-linked C-telopeptide (CTx)는 유의적 변화가 보이지 않았다. 폴리칸은 골밀도(BMD)와 혈청 부갑상선 호르몬(iPTH)에 대해 유의적인 변화를 보이지 않았으나, 24시간 요 중 Ca 배설량은 폴리칸 투여군에서 유의하게 감소되었다($P$=0.028). 또한 폴리칸 투여군에서 고밀도지단백 콜레스테롤(HDL-cholesterol) 농도의 증가 경향 및 중성지방(triglyceride)의 유의적인 감소가 보였다. 임상연구 기간 중에 발생한 이상반응은 두 군간에 유의적인 차이를 보이지 않았다. 결 론: 본 연구에서는 폴리칸이 골대사 및 지질에 대해 일부 개선효과가 있음을 보여주었다. 그러나, 골다공증 예방 측면에서 보다 장기적인 임상연구와 피험자 수를 확대하여 골대사 및 지질대사에 대한 폴리칸의 예방적 효과를 규명할 필요가 있을것으로 사료된다.

• Journal of Ginseng Research
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• 제44권2호
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• pp.229-237
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• 2020

Background: We investigated the tolerability and pharmacokinetic properties of various ginsenosides, including Rb1, Rb2, Rc, Rd, and compound K, after single or multiple administrations of red ginseng extract in human beings. Methods: Red ginseng extract (dried ginseng > 60%) was administered once and repeatedly for 15 days to 15 healthy Korean people. After single and repeated administration of red ginsengextract, blood sample collection, measurement of blood pressure and body temperature, and routine laboratory test were conducted over 48-h test periods. Results: Repeated administration of high-dose red ginseng for 15 days was well tolerated and did not produce significant changes in body temperature or blood pressure. The plasma concentrations of Rb1, Rb2, and Rc were stable and showed similar area under the plasma concentration-time curve (AUC) values after 15 days of repeated administration. Their AUC values after repeated administration of red ginseng extract for 15 days accumulated 4.5- to 6.7-fold compared with single-dose AUC. However, the plasma concentrations of Rd and compound K showed large interindividual variations but correlated well between AUC of Rd and compound K. Compound K did not accumulate after 15 days of repeated administration of red ginseng extract. Conclusion: A good correlation between the AUC values of Rd and compound K might be the result of intestinal biotransformation of Rb1, Rb2, and Rc to Rd and subsequently to compound K, rather than the intestinal permeability of these ginsenosides. A strategy to increase biotransformation or reduce metabolic intersubject variability may increase the plasma concentrations of Rd and compound K.

• Genomics & Informatics
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• 제21권3호
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• pp.31.1-31.8
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• 2023

Multiple myeloma (MM) is a hematological malignancy. It is widely believed that genetic factors play a significant role in the development of MM, as investigated in numerous studies. However, the application of genomic information for clinical purposes, including diagnostic and prognostic biomarkers, remains largely confined to research. In this study, we utilized genetic information from the Genomic-Driven Clinical Implementation for Multiple Myeloma database, which is dedicated to clinical trial studies on MM. This genetic information was sourced from the genome-wide association studies catalog database. We prioritized genes with the potential to cause MM based on established annotations, as well as biological risk genes for MM, as potential drug target candidates. The DrugBank database was employed to identify drug candidates targeting these genes. Our research led to the discovery of 14 MM biological risk genes and the identification of 10 drugs that target three of these genes. Notably, only one of these 10 drugs, panobinostat, has been approved for use in MM. The two most promising genes, calcium signal-modulating cyclophilin ligand (CAMLG) and histone deacetylase 2 (HDAC2), were targeted by four drugs (cyclosporine, belinostat, vorinostat, and romidepsin), all of which have clinical evidence supporting their use in the treatment of MM. Interestingly, five of the 10 drugs have been approved for other indications than MM, but they may also be effective in treating MM. Therefore, this study aimed to clarify the genomic variants involved in the pathogenesis of MM and highlight the potential benefits of these genomic variants in drug discovery.