• Title/Summary/Keyword: Clinical safety

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Application of low-crystalline carbonate apatite granules in 2-stage sinus floor augmentation: a prospective clinical trial and histomorphometric evaluation

  • Nakagawa, Takayuki;Kudoh, Keiko;Fukuda, Naoyuki;Kasugai, Shohei;Tachikawa, Noriko;Koyano, Kiyoshi;Matsushita, Yasuyuki;Sasaki, Masanori;Ishikawa, Kunio;Miyamoto, Youji
    • Journal of Periodontal and Implant Science
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    • v.49 no.6
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    • pp.382-396
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    • 2019
  • Purpose: The purpose of this study was to elucidate the efficacy and safety of carbonate apatite (CO3Ap) granules in 2-stage sinus floor augmentation through the radiographic and histomorphometric assessment of bone biopsy specimens. Methods: Two-stage sinus floor augmentation was performed on 13 patients with a total of 17 implants. Radiographic assessment using panoramic radiographs was performed immediately after augmentation and was also performed 2 additional times, at 7±2 months and 18±2 months post-augmentation, respectively. Bone biopsy specimens taken from planned implant placement sites underwent micro-computed tomography, after which histological sections were prepared. Results: Postoperative healing of the sinus floor augmentation was uneventful in all cases. The mean preoperative residual bone height was 3.5±1.3 mm, and this was increased to 13.3±1.7 mm by augmentation with the CO3Ap granules. The mean height of the augmented site had decreased to 10.7±1.9 mm by 7±2 months after augmentation; however, implants with lengths in the range of 6.5 to 11.5 mm could still be placed. The mean height of the augmented site had decreased to 9.6±1.4 mm by 18±2 months post-augmentation. No implant failure or complications were observed. Few inflammatory cells or foreign body giant cells were observed in the bone biopsy specimens. Although there were individual differences in the amount of new bone detected, new bone was observed to be in direct contact with the CO3Ap granules in all cases, without an intermediate layer of fibrous tissue. The amounts of bone and residual CO3Ap were 33.8%±15.1% and 15.3%±11.9%, respectively. Conclusions: In this first demonstration, low-crystalline CO3Ap granules showed excellent biocompatibility, and bone biopsy showed them to be replaced with bone in humans. CO3Ap granules are a useful and safe bone substitute for two-stage sinus floor augmentation.

Bioactive characteristics of an implant surface coated with a pH buffering agent: an in vitro study

  • Pae, Hyung-Chul;Kim, Su-Kyoung;Park, Jin-Young;Song, Young Woo;Cha, Jae-Kook;Paik, Jeong-Won;Choi, Seong-Ho
    • Journal of Periodontal and Implant Science
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    • v.49 no.6
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    • pp.366-381
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    • 2019
  • Purpose: The purpose of this study was to evaluate the effectiveness of conventional sandblasted, large-grit, acid-etched (SLA) surface coated with a pH buffering solution based on surface wettability, blood protein adhesion, osteoblast affinity, and platelet adhesion and activation. Methods: Titanium discs and implants with conventional SLA surface (SA), SLA surface in an aqueous calcium chloride solution (CA), and SLA surface with a pH buffering agent (SOI) were prepared. The wetting velocity was measured by the number of threads wetted by blood over an interval of time. Serum albumin adsorption was tested using the bicinchoninic acid assay and by measuring fluorescence intensity. Osteoblast activity assays (osteoblast adhesion, proliferation, differentiation, mineralization, and migration) were also performed, and platelet adhesion and activation assays were conducted. Results: In both the wetting velocity test and the serum albumin adsorption assay, the SOI surface displayed a significantly higher wetting velocity than the SA surface (P=0.000 and P=0.000, respectively). In the osteoblast adhesion, proliferation, differentiation, and mineralization tests, the mean values for SOI were all higher than those for SA and CA. On the osteoblast migration, platelet adhesion, and activation tests, SOI also showed significantly higher values than SA (P=0.040, P=0.000, and P=0.000, respectively). Conclusions: SOI exhibited higher hydrophilicity and affinity for proteins, cells, and platelets than SA. Within the limits of this study, it may be concluded that coating an implant with a pH buffering agent can induce the attachment of platelets, proteins, and cells to the implant surface. Further studies should be conducted to directly compare SOI with other conventional surfaces with regard to its safety and effectiveness in clinical settings.

A Study on the Activation·Specification of 119 Rescue & Care in JeJu (제주도 119구조·구급대의 활성화 및 전문화 방안)

  • Koh, Jae-Moon;Kim, Tae-Min;Kim, Hyo-Sik;Lee, Young-A
    • The Korean Journal of Emergency Medical Services
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    • v.6 no.1
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    • pp.153-168
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    • 2002
  • Since 1992, conventional fire fighting businesses have been converted into a metropolitan autonomous fire fighting system to be ready for a variety of disasters. However, the corresponding investment has been overlapped due to the non-integration of businesses to prevent any potential disasters, and a series of collaborative systems have been not functioning so well. In the meantime, our fire fighting sector has been trying to set up its own clean and faithful position by abolishing any inconvenient system or outsourcing private sectors, and expanded its work scope from conventional fire fighting even to rescue and emergency works. While focusing on handling disaster, the fire fighting sector has been widely trusted and reliable throughtout our nation. Moreover, our fire fighting sector has secured nation wide mobile organizations, technical personnel by field, special equipments and independent communication network. In addition, the fire fighting sector has knowledges, expertise and capabilities required for managing disasters, while in charge of almost every disaster management works including fire, explosion, collapse, disaster and flood. It becomes an organization for comprehensive disaster management under an absolute national trust, which is based on the system for prevention, preparation and countermeasure against a variety of disasters. Thus, our fire fighting sector must make many efforts and try to modernize conventional education and training. The ways to facilitate rescue and emergency works may include the nurture of technical fire fighting personnel along with modernized equipments, the reinforcement of rescue and emergency education, the facilitation of operating civil defense corps, the facilitation of operating volunteer fire fighting corps, the better arrangement of 119 briefing room for public healthcare in provincial offices, the sterilization of rescue instruments and equipments the better repair education for emergency rescue member, the establishment of regional emergency assistant system and the expansion of fire fighting personnel and equipments. In terms of reinforcing the functions and services of rescue 119 and emergency corps, we must review the following considerations: Building up security system along with operational expansion, building up a system for emergency medical treatment, building up a comprehensive information management system for rescue and emergency, constructing a provincial safety museum and so forth. For the ways to better the works of rescue 119 we can review the following considerations : Improving the education for fire fighting training corps under Jeju Provincial Fire and Disaster Management Department, providing rescue members with more opportunities for clinical practices, enhancing the morale of rescue members, installing a comprehensive briefing room for emergency rescue members, building up medical networks along with reasonable policies for information service, operating the consulting system for rescue 119 and so on. If these requirements are met, it is expected that the fire fighting departments in Jeju province can cope with every accident and disaster a little more rapidly and quickly in compliance with local needs, so that they can keep their own position as a public fire fighting organization which may be trusted by the public.

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Evaluation of Magnetic Resonance Imaging using Image Co-registration in Stereotactic Radiosurgery (정위방사선수술시 영상공동등록을 이용한 자기공명영상 유용성 평가)

  • Jin, Seongjin;Cho, Jihwan;Park, Cheolwoo
    • Journal of the Korean Society of Radiology
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    • v.11 no.4
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    • pp.235-240
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    • 2017
  • The purpose of this study is to confirm the safety of the clinical application of image co - registration in steteotactic radiosurgery by evaluating the 3D positioning of magnetic resonance imaging using image co-registration. We performed a retrospective study using three-dimensional coordinate measurement of 32 patients who underwent stereotactic radiosurgery and performed magnetic resonance imaging follow-up using image co-registration. The 3 dimensional coordinate errors were $1.0443{\pm}0.5724mm$ (0.10 ~ 1.89) in anterior commissure and $1.0348{\pm}0.5473mm$ (0.36 ~ 2.24) in posterior commissure. The mean error of MR1 (3.0 T) was lower than that of MR2 (1.5 T). It is necessary to minimize the error of magnetic resonance imaging in the treatment planning using the image co - registration technique and to confirm it.

Effects of Licorice on Embryonic and Fetal Development in Rats (감초가 랫드의 배 · 태자 발생에 미치는 영향)

  • Shin Sunhee;Jang Ja Young;Baek In-Jeoung;Yon Jung-Min;Nam Sang-Yoon;Yun Young Won;Cho Dae-Hyun;Kim Soon-Sun;Rhee Gyu-Seek;Kwack Seung-Jun;Kim Yun-Bae
    • Toxicological Research
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    • v.21 no.4
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    • pp.325-332
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    • 2005
  • The developmental toxicity of water extract of licorice (Glycyrrhiza glabra) was evaluated in rats. Licorice extract (500, 1,000 or 2,000 mg/kg) was dissolved in drinking water and orally administered to male rats from 9 weeks before mating to the day of copulation, and to females from 2 weeks before mating to gestational day 19. On gestational day 20, the animals were sacrificed for Cesarian section, and maternal and fetal abnormalities were examined. Licorice extract neither induce clinical signs, nor affect the body weight gain, feed and water intake, estrous cycle, copulation and fertility rates, blood $17\beta-estradiol$ level and organ weights of dams. Also, the implantation and development including body weights, absorption and death of embryos and fetuses were not influenced by in utero exposure to licorice. In addition, there were no increases in external, visceral and skeletal abnormalities of fetuses. Taken together, it is suggested that no observed adverse effect level of licorice extract is higher than 2,000 mg/kg, and that long-term in utero exposure to licorice might not cause developmental toxicities of embryos and fetuses.

Estimation of the Flash Point for n-Pentanol + n-Propanol and n-Pentanol + n-Heptanol Systems by Multiple Regression Analysis (다중회귀분석법을 이용한 n-Pentanol + n-Propanol계 및 n-Pentanol + n-Heptanol계의 인화점 예측)

  • Ha, Dong-Myeong;Lee, Sungjin
    • Fire Science and Engineering
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    • v.30 no.6
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    • pp.31-36
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    • 2016
  • The flash point is one of the most important properties for characterizing the fire and explosion hazard of liquid solutions. In this study, the flash points of two flammable binary mixtures, n-pentanol + n-propanol and n-pentanol + n-heptanol systems were measured using a Seta flash closed cup tester. The flash point was estimated using the methods based on Raoult's law and multiple regression analysis. The measured flash points were also compared with the predicted flash points. The absolute average errors (AAE) of the results calculated by Raout's law were $1.3^{\circ}C$ and $1.3^{\circ}C$ for the n-pentanol + n-propanol and n-pentanol + n-heptanol mixtures, respectively. The absolute average errors of the results calculated by multiple regression analysis were $0.4^{\circ}C$ and $0.3^{\circ}C$ for the n-pentanol + n-propanol and n-pentanol + n-heptanol mixtures, respectively. According to the AAE, the calculated values based on multiple regression analysis were better than those based on Raoult's law.

The Clinical Effects of Cefpirome for the Treatment of Acute Lower Respiratory Infection (병원 입원 폐렴 환자에 대한 Cefpirome의 임상적 평가)

  • Shin, Kyeong-Cheol;Hong, Young-Hoon;Lee, Eun-Young;Park, Ki-Do;Kim, Sung-Dong;Chung, Jin-Hong;Lee, Choong-Ki;Lee, Kwan-Ho;Sung, Cha-Kyung;Lee, Hyun-Woo
    • Journal of Yeungnam Medical Science
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    • v.16 no.2
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    • pp.219-227
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    • 1999
  • Background: In contrast to a healthy person, patients who have acute lower respiratory tract infection with underlying pulmonary diseases have various pathogens, a rapidly progressive downhill course, and a poor response to prior antimicrobial therapy. Broad spectrum antibacterial therapy is needed for full evaluation. Materials and Methods: To evaluate the efficacy and safety of cefpirome, we administered 1gm cefpirome, twice a day to 30 patients, who had signs and symptoms of acute lower respiratory infection regardless of their underlying disease, except to those who had an allergic history to antibiotics or severe systemic diseases. Results: The results were as follows: 1) Among 30 cases, 21 cases(70.0%) showed excellent improvement, and 7 cases(23.3%) showed good improvement in their symptoms and signs of acute lower respiratory infection. 2) In 14 cases with isolated pathogens, we observed bacteriologic eradication in 11 cases(78. 6%). 3) Significant side effects were not found. Conclusion: Above results suggest that cefpirome was effective as a monotherapy in patients with acute lower respiratory infection, especially on those with an underlying chronic obstructive pulmonary disease(COPD).

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The Clinical Effect of Sparfloxacin for the Treatment of Acute Respiratory Infection (호흡기 감염 질환에서 Sparfloxacin의 임상효과)

  • Lee, Hak-Jun;Park, Hye-Jung;Shin, Chang-Jin;Shin, Kyeong-Cheol;Chung, Jin-Hong;Lee, Kwan-Ho;Lee, Hyun-Woo
    • Journal of Yeungnam Medical Science
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    • v.15 no.2
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    • pp.246-253
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    • 1998
  • Sparfloxacin is a new synthetic quinolone antimicrobial developed at the Research Laboratories of Dainippon Pharmaceutical Co, Ltd. To evaluate the efficacy and safety of sparfloxacin in acute pulmonary infection, we administered sparfloxacina(100mg) twice in a day to 30 patients who had signs and symptoms of acute pulmonary infectious diseases regardless of their underlying lung disease for 7 days. The results were as follows: 1) A total 30 patients were enrolled in the trial. Among them, 24 cases(80%) had underlying lung problems such as chronic obstructive pulmonary disease(36.4%), bronchiectasis(36.4%), bronchial asthma(3.3%), or lung cancer(3.3%). 2) In 26 cases(86.6%), we observed effective improvement, and 4 cases(13.4%) show mildly effective improvement of symptoms and signs of respiratory infection. 3) In 23 cases(73.4%), we observed bacteriological eradication in culture or decreased the number of bacteria by Gram stain which found dominantly in previous Gram stain. 4) The significant side effect was not noted. The above results suggested that sparfloxacin was effective as a first line therapy in patients with acute respiratory infection.

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Diagnosis of the ORF Virus Using a Mixture of Sieving Gel Matrixes in Microchip Gel Electrophoresis (마이크로칩젤 전기영동에서 충진젤 혼합물을 이용한 ORF 바이러스의 진단)

  • Kim, Yun-Jeong;Chae, Joon-Seok;Kang, Seong-Ho
    • Journal of the Korean Chemical Society
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    • v.48 no.5
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    • pp.483-490
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    • 2004
  • We have developed a novel polymerase chain reaction (PCR)-microchip gel electrophoresis (MGE) method based on the sieving gel mixture of commercially available poly(vinylpyrrolidone) (PVP) and hydroxy ethyl cellulose (HEC) for the rapid detection and diagnosis of the orf virus (ORFV) from Korean indigenous goat. After amplification of 594-bp DNA fragment from the B2L gene of ORF virus, the amplicon was analyzed by the MGE separation. The glass microfluidic chip (64 mm total length (36 mm effective length)${\times}$90 ${\mu}$m width${\times}$20 ${\mu}$m depth) allowed the fast detection and diagnosis of ORFV in the mixture of 1.0% PVP ($M_r$ 360,000) and 1.0% HEC ($M_r$250,000) as a sieving matrix with better resolution and reproducibility of DNA fragments. Under the electric field of 277.8 V/cm, the 594-bp DNA was analyzed within 4 min. Compared to traditional slab gel electrophoresis, the PCR-MGE method was twenty times faster and an effective clinical method for the quantitative analysis of ORFV.

Preclinical Study of DA-5018, a Non-narcotic Analgesic Agent

  • Kim, Soon-Hoe
    • Proceedings of the PSK Conference
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    • 2000.04a
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    • pp.70-81
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    • 2000
  • DA-5018 is a synthetic capsaicin derivative under development as a non-narcotic a analgesic ag$\varepsilon$nt. DA-50 18 showed a potent analgesic activity against acute and chronic pain m model(Tablel, 2.), but it had a narrow margin of safety. DA-5018 did not bind to opioid(${\kappa}, {\delta}, {\mu}$), NKl, CGRP receptors in vitro and its analgesic effect was not antagonized by naloxone, a and it did not develop analgesic tolerance. In addition DA-5018 had no inhibitory effects against c cyclooxygenase and 5-lipooxygenase activities. DA-5018 significantly increased the relcase of substance P from the slices of the rat spinal cord. These results suggest that DA-50 18 is not a narcotic nor aspirin-like analgesic and the release of substance P is one of analgesic mechanism of action of DA-5018. We found that DA-5018 was almost ten times more potent and was at l least IOO-times less irritable compared to capsaicin. Accordingly development of topical formula was adopted. Topical formula was desiged and screened by flux test of DA-5018 using hairless mouse skin and several formulas were selected. With these topical formulas we a assessed the analgesic efficacy and carried out the toxicity, skin irritation and pharmacokinetic studies. In streptozotocin-induced hyperalgesic rat and 50 % galactose-fed hyperalgesic rat as diabetic pain models, DA-5018 cream increased the pain thresh이ds up to 77.0% and 24.4% respectively, while Zostrix-HP(capsaicin cream) incr$\varepsilon$as cd by 65.9% and 21.0%. DA-5018 c cream showed a good analgesic effect as welI in FCA-induced arthritic rat. DA-5018 cream did not show any toxicological signs in acute and chronic toxicity test and had little skin irritation in car swclIing and scratching t$\varepsilon$st. Pharmacokinetics of DA-50 18 were studied after topical application of ${14}^C$-Iabelled or unlabelIed DA-5018 cream. Plasma and skin concentrations c except applied skin wcre below the dctection limit and after 7-day cummulative application, plasma concentrations were also below detection limit DA-50 18 may have an advantag$\varepsilon$ ov$\varepsilon$r c capsaicin and is now being developed as a topical agent for the treatment of pains. DA-50 18 cream was approved for Korean IND and is now under a Phase II clinical study for arthritic pain a after finising Phase I study. DA-50 18 was also liscensed out to Stiefel Company in America in

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