• Journal of Korean Foot and Ankle Society
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• v.18 no.4
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• pp.195-201
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• 2014

Purpose: The purpose of this study is to develop guidelines for clinical trial of the total ankle replacement system for premarket approval. Materials and Methods: We selected and analyzed nine peer-reviewed articles whose quality had been proven in a previous phase. Two investigators extracted parameters for guideline criteria, including number of cases, patient age, follow-up period, failure rate, radiographic osteolysis rate, residual pain rate, and percentage of satisfaction. In addition, the inclusion and exclusion criteria were analyzed and developed. Results: Eight level IV studies and one level II study were included. The average number of cases was 159 cases and the mean patient age was 63.5 years. The mean follow-up period was 4.2 years, ranging from two to nine. The average failure rate of total ankle replacement in mid- to long-term follow-up was approximately 13% (2%~32.3%). The rate of osteolysis was approximately 18%. Residual pain was common (21.4%~46%), but overall patient satisfaction was approximately 85.6% (67.5%~97%). Conclusion: The results could be used as criteria for designing the clinical studies, such as number of cases, patient age (over 60 years), and follow-up period (minimum two years). The clinical scoring system and 36-item short form health survey (SF-36) was the most commonly used method for clinical evaluation for total ankle arthroplasty. In addition, the overall results, including failure rate, osteolysis rate, and patient satisfaction, could be used as a parameter of guidelines for premarket approval.

• Journal of Dental Anesthesia and Pain Medicine
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• v.23 no.5
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• pp.287-291
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• 2023

Sugammadex has shown faster reversal of steroidal neuromuscular blockade (NMB) than neostigmine, a traditional reversal agent for NMB, even in the intense block phase. This efficiency is possible because of the unique mechanism of action by encapsulating the NMB molecules. Therefore, with the use of sugammadex, we can also expect to avoid direct interactions with the cholinergic system and its subsequent side effects, which are disadvantages of traditional drugs. However, despite these benefits and US Food and Drug Administration (FDA) approval in 2015, rare adverse events associated with sugammadex have been reported. Herein, we report a case of bronchospasm that developed immediately after sugammadex administration.

• Journal of Pharmacopuncture
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• v.18 no.3
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• pp.63-67
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• 2015

Objectives: This study was performed to analyze the single-dose oral toxicity of the super key (processed sulfur). Methods: All experiments were conducted at Medvill, an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate the oral toxicity of super key. We administered it orally to Sprague-Dawley (SD) rats. The SD rats were divided into four groups of five male and five female animals per group: group 1 being the control group and groups 2, 3, and 4 being the experimental groups. Doses of super key 500 mg/kg, 1,000 mg/kg and 2,000 mg/kg were administered to the experimental groups, and a dose of normal saline solution, 10 mL/kg, was administered to the control group. We examined the survival rates, weights, clinical signs, gross findings and necropsy findings. This study was conducted under the approval of the Institutional Animal Ethics Committee. (Approval number: A01-14018). Results: No deaths or abnormalities occurred in any of the four groups. Although slight decreases in the weights of some female rats were noted, no significant changes in weights or differences in the gross findings between the control group and the experimental groups were observed. To check for abnormalities in organs, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs. Conclusion: The results of this research showed that administration of 500 - 2,000 mg/kg of super key did not cause any changes in the weights or in the results of necropsy examinations. Neither did it result in any mortalities. The above findings suggest that treatment with super key is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

• Clinical and Experimental Reproductive Medicine
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• v.50 no.4
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• pp.223-229
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• 2023

Endometriosis is characterized by the implantation of endometrial cells outside the uterus. This hormone-dependent disease is highly prevalent among women of reproductive age. Clinical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility, which can negatively impact the overall quality of life of those affected. The medical treatment of endometriosis serves as an important therapeutic option, aimed at alleviating pain associated with the condition and suppressing the growth of endometriotic lesions. As such, it is employed as an adjuvant therapy following surgery or an empirical treatment after the clinical diagnosis of endometriosis. Dienogest, a fourth-generation progestin, has received approval for the treatment of endometriosis in many countries. A growing body of evidence has demonstrated its efficacy in managing endometriosis-associated pain, preventing symptoms, and reducing lesion recurrence. In this review, we examine the clinical efficacy, safety, and tolerability of dienogest in treating endometriosis. We also provide updated findings, drawing from clinical studies that focus on the long-term use of this medication in patients with endometriosis.

• Korea Journal of Hospital Management
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• v.2 no.1
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• pp.1-21
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• 1997

In order to analyze the shifts in the volume and profits of Computed Tomography(CT) and Magnetic Resonance Imaging(MRI) utilization for a year before and after the implementation of insurance coverage for CT, this study has been undertaken examining CT and MRI cost data from 'Y' University Hospital situated in Seoul, Korea. Following are the results of this study: 1. The medical insurance payment for CT, implemented on January 1, 1996, increased CT utilization from January 1996 to April 1996 due to low insurance premiums: however, from May 1996 the number of CT cases significantly decreased as a result of strengthened medical cost reviews and the new 'Detailed standards for approval of CT' announced near the end of April 1996 by the insurer. 2. Since the implementation of insurance coverage for CT, CT fee reduction rates for reimbursements by the insurer to the hospital were 50% and 40% for January and February, respectively, and 31% and 15% for March and April. A significant point in the lowering of the reduction rate was reached in May at 11%; furthermore, since June the reduction rate fell below the average reduction rate for reimbursements for all procedures. If the 'Detailed standards for approval of CT' had been announced before the implementation of insurance coverage for CT, CT utilization would not have been so high due to the need to meet those 'standards'. In addition, loss of hospital profits resulting from the reduction for reimbursements would not have occurred. 3. The shifts in MRI utilization showed that there was no particular change with the beginning of insurance coverage for CT, and the introduction of the 'Detailed standards for approval of CT' made MRI utilization increase because MRI is free of restrictions imposed by the insurer. 4. The relationship between CT utilization and MRI utilization showed that they were supplementary to each other before insurance coverage for CT, but that CT was substituted for MRI because of strengthened medical cost reviews after t~e beginning of insurance coverage for CT. 5. The shifts in volume by patient characteristics showed that the number of inappropriate case patients, according to the insurer's "Standards for approval", decreased more than the number of appropriate case patients after the introduction of insurance coverage for CT. Therefore, the health insurance fee schemes for CT have influenced patient care. 6. The shifts in profits from CT utilization showed a net profit decrease of 31.6%. In order to match the pre-coverage profit level, 5,471 more cases would need to be seen and productivity would need to be increased by 32.7%. This profit decrease resulted from a decrease of CT utilization and low reimbursements. With insurance coverage, net profits from CT were 24.4%, and a margin of safety ratio was 39.6%. Because of the net profits and margin of safety ratio, CT utilization fees for insured appropriate cases could not be considered inappropriate. 7. The shifts in profits from MRI utilization before and after the introduction of CT coverage showed that in order to match pre-CT coverage profit levels, 2,011 more cases would need to be seen and productivity would need to be increased by 9.2%. The reasons for needing to increase the number of cases and productivity result from cost burdens created by adding new MRI units. But with CT coverage already begun, MRI utilization increased. Combined with a minor increase in the MRI fee schedule, MRI utilization showed a net profit increase of 18.5%. Net profits of 62.8% and a 'margin of safety ratio' of 43.1% for MRI utilization showed that the hospital relied on this non-covered procedure for profits. 8. The shifts in profits from CT and MRI utilization showed the net profits from CT decreased by 2.33billion Won while the net profits from MRI increased by 815.7million Won. Overall, these two together showed a net profit decrease of 1.51billion Won. The shifts in utilization showed a functional substitutionary relationship, but the shifts in profits did not show a substitutionary relationship. From these results, We can conclude that if insurance is to be expanded to include previously uncovered procedures using expensive medical equipment, detailed standards should be prepared in advance. The decrease in profits from the shifts in coverage and changes in fees is a difficult burden that should be shared, not carried by the hospital alone. Also, a new or improved fee schedule system should include revised standards between items listed and the appropriateness of the fee schedule should constantly be ensured. This study focused on one university hospital in Seoul and is therefore limited in general applicability. But it is valuable for considering current issues and problems, such as the influence of CT coverage on hospital management. Future studies will hopefully expand the scope of the issues considered here.

• Journal of Physiology & Pathology in Korean Medicine
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• v.26 no.5
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• pp.765-772
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• 2012

In this study, a patient with both motor and vocal tic disorders of onset at age 34 was treated for a total of 316 days. The characteristics of the tic symptoms of the patient were examined and treated two to three times a week with herbal medicine, acupuncture, cupping, and habit reversal treatment along with western medication prescribed to the patient from a psychiatric clinic. Furthermore, the condition of the patient was evaluated once a week by the Yale Global Tic Severity Scale(YGTSS-K). Both motor and vocal tic symptoms deceased to a great amount after treatment and the patient was able to lower the dosage of western medication with the approval of her psychiatric doctor. This case suggests that Oriental medical treatment undergone with habit reversal treatment could improve tic disorders better than sole western medication treatment.

• Nuclear Medicine and Molecular Imaging
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• v.40 no.2
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• pp.53-57
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• 2006

Radionuclide therapy has been used for more than 50 years and proved to be a safe and effective modality. However, the patients' right to have the excellent medical service is seriously disturbed by excessive regulations of government institutions such as Korea Institute of Nuclear Safety (KINS), Health Insurance Review Agency (HIRA) and Korea Food and Drug Administration (KFDA). For example, the patients should wait for more than 6 months to have I-131 treatment in many hospitals it is strongly recommended to mitigate the regulations to resonable levels to solve the problems. If HIRA allow the hospitals to charge reasonable rate for radionuclide therapy room, then more hospitals would invest to build the radionuclide therapy rooms and the patients' waiting time would decrease. The waiting time would also decrease, if KINS allow 2 patients to share a radionuclide therapy room. Finally, it is strongly recommended to lower the threshold for approval of new therapeutic radiopharmaceuticals by KFDA, which would allow new effective therapeutic raoiopharmaceuticals to be introduced to clinical practices more easily.

• Korean Journal of Environmental Agriculture
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• v.27 no.3
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• pp.285-291
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• 2008

A global binding agreement was adopted with the leading of United Nations Environment Program (UNEP) on May 22, 2001 in Stockholm to regulate the production and distribution on persistent organic pollutants (POPs). The agreement took effectuation with the ratification of 59 countries from the approval of 151 countries on May 17, 2004. After the approval on October 4, 2001, South Korea performed systematical investigation on POP-related substances such as chlordane, dichloro diphenyl trichloroethane (DDT), hexachlorobenzenes (HCB), heptachlor, polychlorinated biphenyls (PCBs) to get ready for the ratification of the convention with country-specific exemption. The domestic distributions of those chemical substances have been officially prohibited since the late 1960s to the early 1980s. Although there were occasional reports for the detection of some of those chemical substances, those performed minute signification in their existence in the environment. A series of investigation with documentary examination and fact-finding survey showed the possibility for the ratification on the convention without country-specific exemption.

• The Journal of Korean Medicine
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• v.38 no.1
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• pp.21-33
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• 2017

Objectives: The purpose of this study is to present the needs for New Health Technology in Korean medicine field and suggest the strategy to raise the application and selection rate. Methods: In this study, we reviewed the application status of New Health Technology application from April 27, 2007 to June 30, 2016. And we analyzed the assessment methods, procedures, and failure factors through the two Research stage technologies reports in Korean medicine field. Results: In Korean medicine field, the application status of New Health Technology is very small as 2% of the whole applications. Moreover, 62.9% of the applied technology were either an existing technology or an early technology, so did not enter the assessment process. Two technologies categorized as Research stage technology also had failed to adopt New Health Technology because they were lacking evidences or need more research to prove effectiveness. Conclusions: In order to develop New Health Technology in Korean medicine, more efforts should be made to activate research that can prove the safety and effectiveness of medical technology, and to create a quantitative or qualitative basis for the results of the research. Also, it is necessary to increase researchers' awareness of New Health Technology. And the strategy to positively utilize the "Limited Approval" to promote clinical studies.

• Journal of Korean Medicine for Obesity Research
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• v.24 no.1
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• pp.87-93
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• 2024

Objectives: Obesity is a globally prevalent public health issue. Hence, there is a need for the development of safer and more effective anti-obesity drugs. Lythrum salicaria, a traditional medicinal herb used for centuries, has been reported to improve lipid metabolism and fat accumulation. It also has a low toxicity profile. Therefore, its potential as a functional ingredient in health functional foods needs to be evaluated. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 90 participants will be randomly assigned to either the experimental or control group. Each subject will orally receive L. salicaria extract (1,350 mg/day) (500 mg L. salicaria+850 mg lactose as vehicle) or lactose (1,350 mg/day) as a hard capsule formula for 84 days (12 weeks). The primary outcome will be body fat mass (kg), which will be assessed using dual-energy x-ray absorptiometry (DXA) (performed only at visits 2 and 4). Secondary outcomes include body mass index, body weight, waist-to-hip ratio, body fat percentage (%) measured using DXA, lean body mass (kg) measured using DXA (assessed only at visits 2 and 4), lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and calculated low-density lipoprotein cholesterol), free fatty acid, high sensitivity C-reactive protein, adiponectin, and leptin. Conclusions: This protocol will be implemented after approval of Institutional Review Board of Pusan National University Korean Medicine Hospital (approval number: PNUKHIRB-2022-08-002) and registration with the Korean National Clinical Research Information Service (CRIS) (CRIS-KCT0008060). The results of this trial will provide potential of L. salicaria as a new anti-obesity functional food with fat-reducing effects and low toxicity.