• Korean Journal of Radiology
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• v.25 no.6
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• pp.565-574
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• 2024

Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

• Korean Journal of Biological Psychiatry
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• v.2 no.2
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• pp.281-286
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• 1995

Objects : Manic phase of bipolar disorder is treated with a combination of mood stabilizer and antipsychotic drug, especially in the acute phase. Such combined treatment is often required for the clinical management of manic symptoms until therapeutic effects of mood stabilizer become evident. The present study was the first open trial to evaluate the efficacy of risperidone, and safety of the combination of mood stabilizer and risperidone in the treatment of acute manic patients. Method : This study was performed as an open clinical study. The subjects of this study were 42 patients who had been admitted with first manifestations or acute exacerbations of illness were selected, using DSM-III-R criteria for bipolar disorder, manic episode. Patients were rated using the the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI), Extrapyramidal Symptom Rating Scale(ESRS). Other adverse events were assessed by a symptom checklist and by observation by medical personnel. Vital signs were monitored in a standard way and electrocardiography, routine laboratory analysis were performed. Results : Thirty patients(67%) completed the 12-week trial period. The CGI showed a good therapeutic effect with a minimal incidence or severity of side effects. The majority of patients showed a continuos reduction in their BPRS scores. The extrapyramidal symptoms assessed on ESRS generally showed mild to moderate degree. laboratory porameters showed no significant changes during the course of treatment. Conclusion : The results of the study showed a good efficacy of the risperidone in manic patients and further controlled studies are warranted.

• Journal of Pharmaceutical Investigation
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• v.37 no.3
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• pp.167-171
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• 2007

Itraconazole is one of the most potent antifungal agents available in the market today. However, the low bioavailability due to its poor-water solubility calls for an alternative formulation to the current oral type. A topical itra-conazole-containing formulation may be of use for several reasons including the opportunity to reduce adverse events and generate high local tissue levels, more rapid drug delivery, and lower systemic exposure. The purpose of the present study was to investigate the vehicles for topical skin delivery of itraconazole. The effect of formulations on the hairless mouse skin permeation and deposition of itraconazole was determined using Franz diffusion cells at $37^{\circ}C$. Benzyl alcohol in micro-emulsion significantly increased the solubility of itraconazole, thereby increasing the skin permeation rate. However, lipo-some formulation showed the lowest solubility and permeation rate of itraconazole. Although the solubility of itraconazole in hydrogel formulation was lower than that in microemulsion, skin permeation rate was significantly higher probably due to its adhesive property. Therefore, microemulsion-based hydrogel formulation is expected to synergistically increase the skin permeation rate and skin deposition of itraconazole.

• Korean Journal of Clinical Pharmacy
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• v.26 no.3
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• pp.207-212
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• 2016

Objective: Prescription rate of dabigatran and rivaroxaban, which are the direct oral anticoagulants (DOAC), has increased. We have analyzed the prescription trend and medication use of dabigatran and rivaroxaban in patients with non-valvular atrial fibrillation (NVAF). Methods: It was retrospectively studied from September 2012 to April 2014 using the electronic medical records and the progress notes. Patients with NVAF (n=424) were evaluated on the medication use, prescribing preferences, adverse drug reactions (ADRs) and the availability of prescription reimbursement of dabigatran (n=210) and rivaroxaban (n=214). Results: Dabigatran was prescribed higher than rivaroxaban (23.3% versus 7.5%, p<0.001) in the neurology department, but rivaroxaban was prescribed higher compared to dabigatran in the cardiology department (87.4% versus 74.3%, p<0.001). Dabigatran was prescribed more than rivaroxaban in high risk patients with CHADS2 score ${\geq}3$ (44.3% versus 31.3%, p=0.006). Dabigatran patients seemed to have more ADRs than patients with rivaroxaban (25.2% versus 11.2%, p<0.001), but no serious thrombotic events and bleeding were found. Only 35.6% (n=151) were eligible for prescription reimbursement by the National Health Insurance (NHI). Bridging therapy (86, 31.5%) and direct-current cardioversion (57, 20.2%) were main reasons of ineligibility for reimbursement. Conclusion: Prescription preferences were present in choosing either dabigatran or rivaroxaban for patients with NVAF. Inpatient protocols and procedures considering patient-factors in NVAF need to be developed.

• The Journal of Korean Medicine
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• v.27 no.1 s.65
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• pp.78-90
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• 2006

Background : Traditional herbal medicine is used extensively among the Korean populations, and other Asian countries employ similar therapies as well. In recent years, extensive focus was laid on adulteration of the herbal medicine with liver damage. The use of herbal preparations as remedies for various medical conditions has continuously increased in Korea. Large proportions of Korean patients use herbal medicinal products, folk remedies, and health food. However, studies on the safety of herbal products are conducted on a less than sufficient basis even in the countries like Korea where herbal medicine is being used extensively. Some of the reports on the safety of herbs were done by the doctors of western medicine but lack of knowledge and misclassification led to misunderstandings. Objectives : This study aims to verify the evidences on safety of frequently used 4 herbal medications (Sipjeondaebo-tang, Bojungikgi-tang, Ohjeok-San, Yukmaijihwang-tang) in the lab animal model. Methods : Sprague-Dawley rats was treated by 4 herbal medications during 31 days. After 1 month, we checked body weight, liver weight, and serum enzyme associated with liver function. Results : There is no significant difference in body weight and liver weight after 1 month of administrations. In all experimental groups, no abnormal findings was observed in histotogical research and lab liver Functions test(AST, ALT etc). Conclusions : These four herbal medications, frequently used in oriental medicine clinics and hospitals, are safe from hepatoxic events in the lab animal model.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.3
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• pp.1513-1517
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• 2016

Background: A combination of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the most effective front-line therapies to treat B-cell non-Hodgkin's lymphoma (NHL). The aim of this trial was to evaluate overall survival (OS), progression free survival (PFS) and toxicity of R-CHOP-14 compared to R-CHOP-21 in untreated stage III and IV B-cell NHL patients with Iranian ethnicity. Materials and Methods: In phase III trial, patients with previously untreated stage III and IV indolent and aggressive B-cell NHL were randomly assigned by using a minimization method to receive six to eight cycles of either R-CHOP-21 (administered every 21 days) or R-CHOP-14 (administered every 14 days with granulocyte colony-stimulating factor). Results: A total of 143 patients were randomly enrolled in our study (66 patients in R-CHOP-14 group and 77 patients in R-CHOP-21), between 2011 and 2014. The mean follow-up was 45 months at the time of treatment analysis. The 2-year and 5-year PFS rates for the R-CHOP-14 group were 83.6% vs 73.6% and for R-CHOP-21 group were 75% vs 54%. The 2-year and 5-year OS rates for R-CHOP-14 group were 98% vs 89% and for R-CHOP-21 group were 84.4% vs 67.5%. There was a significant correlation for PFS and OS in the two arms. There was no significant difference between adverse events with the two regimens. Conclusions: In our research improved survival was found with CHOP-14 as compared to CHOP-21. It is possible that drug metabolism in different races/ethnicities may be one important factor.

• The Journal of Internal Korean Medicine
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• v.40 no.6
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• pp.1081-1100
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• 2019

Objectives: This study is an overview of the meta-analysis and systematic review of randomized controlled trials investigating the clinical effectiveness and safety of pharmacopuncture for patients with stroke. Methods: Core electronic databases were searched from their inception to 21 May 2019. A measurement tool to assess systematic reviews (AMSTAR 2) was applied to screen high-quality studies. The results of these studies were summarized, and additional meta-analysis was conducted. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was used to evaluate the certainty of evidence. Results: Sixteen studies met eligibility criteria. Four were excluded owing to insufficiency of AMSTAR 2 or low data reliability. The finally selected 12 studies were about pharmacopuncture using either a single herb extract, such as Dengzhan xixin, Sanch, Ginkgo biloba, or Acanthopanax, or a mixture of herbs, such as Compound danshen, Shenxiong, Xingnaojing, or Mailuoning. Most of the patients were from China, with acute ischemic stroke. All the studies using a pharmacopuncture versus a non-pharmacopuncture design reported the significant superiority of pharmacopuncture on every outcome measure. On the other hand, in a few studies, pharmacopuncture was inferior to active control in improving neurological deficit. Few studies reported adverse events. Conclusions: It is difficult to apply the results of this study directly to Korea, because the level of evidence is generally low and the clinical settings and social acceptance of pharmacopuncture therapy differ in Korea and China. Further studies are warranted to confirm the domestic applicability of evidence generated in China and to create evidence that supports the domestic situation.

• Journal of Korean Neurosurgical Society
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• v.48 no.5
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• pp.429-433
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• 2010

Objective : This prospective study evaluated the use of continuous sedation using propofol and remifentanil when carpal tunnel release (CTR) was performed under local anesthesia. Methods : We sedated 60 patients undergoing CTR using local anesthesia with remifentanil at loading and continuous doses of $0.5\;{\mu}g\;kg^{-1}$ and $0.05\;{\mu}g\;kg^{-1}min^{-1}$, respectively, and propofol, using a target controlled infusion (TCI) pump set to a target of $2\;{\mu}g\;mL^{-1}$ (group A), or with the same drug doses except that the continuous remifentanil dose was $0.07\;{\mu}g\;kg^{-1}min^{-1}$ (group B) or $0.1\;{\mu}g\;kg^{-1}min^{-1}$ (group C). Results : In group B, the levels of pain when local anesthetics were administered (p = 0.001), intraoperative pain (p < 0.001) and anxiety (p = 0.001) were significantly lower than those of group A. Furthermore, the incidence of adverse events, including desaturation (p < 0.001) and vomiting (p = 0.043), was significantly lower in group B than in group C. Conclusion : Continuous sedation using an appropriate dose of remifentanil and propofol can be used as safe, efficacious ambulatory anesthesia in cases of CTR under local anesthesia, performed using only 2 mL of local anesthetic, with a high degree of patient satisfaction.

• Reproductive and Developmental Biology
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• v.35 no.4
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• pp.435-439
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• 2011

Sildenafil citrate (SIL) a phosphodiesterase 5 inhibitor (PDE5I) has been used for long time as a first line oral drug for erectile dysfunction. Though it has beneficial effects on erectile organ it also has some adverse effects in other cells and/or tissues related to reproductive system when exposed to longer duration. The objective of the present study is to evaluate the long term effect of SIL on sperm parameters in Wistar albino rat. The animals are divided into two groups, for group I - rats were treated with saline (vehicle alone) and group - II oral administration of 5 mg/kg b.w. of SIL was administrated orally once in a day for 120 days. At the end of the trial period animals were sacrificed and epididymal sperm were subjected to various analysis. Results showed significant reduction in sperm count, motility, viability and morphologically intact sperm in long term PDE5I exposed animals when compared to control. Acrosomal status and fertility test also showed significant reduction in long term PDE5I exposed animals. The present study clearly indicated that long term SIL has shown to induce alteration in sperm quality and quantity, leading to decline in fertility rate. Indicate that SIL impinge on spermatogenesis as well as epididymal function. Understanding the molecular down-stream events involved in long-term exposure to PDE5 inhibitor can be valuable to supervise on related infertility issues and to suggest corrective measures.

• The Journal of Korean Medicine
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• v.38 no.3
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].