• Title/Summary/Keyword: Clinical safety

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Measurement of Maximum Mouth Opening in 2 to 6 year-old Korean Children (2-6세 한국 어린이의 최대 개구량 측정)

  • Choi, Hyejin;Kim, Chusung;Lee, Daewoo;Yang, Yeonmi;Kim, Jaegon
    • Journal of the korean academy of Pediatric Dentistry
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    • v.42 no.3
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    • pp.242-248
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    • 2015
  • Maximum mouth opening is regarded as an important tool used to evaluate the clinical function of temporomandibular joint and the masticatory system. It has been reported that children can also exhibit severe dysfunction or pain in some cases of temporomandibular disorder. The purpose of this study was to measure the normal maximum mouth opening in Korean children and to analyze the correlations between mouth opening and the associated factors. Maximum mouth opening was measured from 151 healthy children between the ages of 2 and 6 years old. Age, height, weight, and mouth width were also recorded. As a result, the mean maximum mouth-opening was $37.72{\pm}5.10mm$. While the values were greater in boys than in girls without statistical significance, the increases of maximum mouth opening based on age, height, weight, and mouth width were significant (p < 0.05). In children, positive correlation coefficients were observed between maximum mouth opening and the associated factors and height showed the highest correlation. In conclusion, we collected data of the normal range of maximum mouth opening in Korean children, and this study can be utilized as a basis in diagnosing pediatric temporomandibular disorder and safety standard of mouth opening during dental procedures.

Paraspinal Muscle Sparing versus Percutaneous Screw Fixation: A Prospective and Comparative Study for the Treatment of L5-S1 Spondylolisthesis

  • Jang, Kun-Soo;Kim, Heyun-Sung;Ju, Chang-Il;Kim, Seok-Won;Lee, Sung-Myung;Shin, Ho
    • Journal of Korean Neurosurgical Society
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    • v.49 no.3
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    • pp.163-166
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    • 2011
  • Objective : Both the paraspinal muscle sparing approach and percutaneous screw fixation are less traumatic procedures in comparison with the conventional midline approach. These techniques have been used with the goal of reducing muscle injury. The purpose of this study was to evaluate and to compare the safety and efficacy of the paraspinal muscle sparing technique and percutaneous screw fixation for the treatment of L5-S1 spondylolisthesis. Methods : Twenty patients who had undergone posterior lumbar interbody fusion (PLIF) at the L5-S1 segment for spondylolisthesis were prospectively studied. They were divided into two groups by screw fixation technique (Group I : paraspinal muscle sparing approach and Group II: percutaneous screw fixation). Clinical outcomes were assessed by Low Back Outcome Score (LBOS) and Visual Analogue Scale (VAS) for back and leg pain at different times after surgery. In addition, modified MacNab's grading criteria were used to assess subjective patients' outcomes 6 months after surgery. Postoperative midline surgical scarring, intraoperative blood loss, mean operation time, and procedure-related complications were analyzed. Results : Excellent or good results were observed in all patients in both groups 6 months after surgery. Patients in both groups showed marked improvement in terms of LBOSs all over time intervals. Postoperative midline surgical scarring and intraoperative blood loss were lower in Group II compared to Group I although these differences were not statistically significant. Low back pain (LBP) and leg pain in both groups also showed significant improvement when compared to preoperative scores. However, at 7 days and 1 month after surgery, patients in Group II had significantly better LBP scores compared to Group I. Conclusion : In terms of LBP during the early postoperative period, patients who underwent percutaneous screw fixation showed better results compared to ones who underwent screw fixation via the paraspinal muscle sparing approach. Our results indicate that the percutaneous screw fixation procedure is the preferable minimally invasive technique for reducing LBP associated with L5-S1 spondylolisthesis.

Is higher dose always the right answer in stereotactic body radiation therapy for small hepatocellular carcinoma?

  • Lee, Kyung Hwa;Yu, Jeong Il;Park, Hee Chul;Park, Su Yeon;Shin, Jung Suk;Shin, Eun Hyuk;Cho, Sungkoo;Jung, Sang Hoon;Han, Young Yih;Lim, Do Hoon
    • Radiation Oncology Journal
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    • v.36 no.2
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    • pp.129-138
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    • 2018
  • Purpose: This study was conducted to compare clinical outcomes and treatment-related toxicities after stereotactic body radiation therapy (SBRT) with two different dose regimens for small hepatocellular carcinomas (HCC) ${\leq}3cm$ in size. Materials and Methods: We retrospectively reviewed 44 patients with liver-confined HCC treated between 2009 and 2014 with SBRT. Total doses of 45 Gy (n = 10) or 60 Gy (n = 34) in 3 fractions were prescribed to the 95% isodose line covering 95% of the planning target volume. Rates of local control (LC), intrahepatic failure-free survival (IHFFS), distant metastasis-free survival (DMFS), and overall survival (OS) were calculated using the Kaplan-Meier method. Results: Median follow-up was 29 months (range, 8 to 64 months). Rates at 1 and 3 years were 97.7% and 95.0% for LC, 97.7% and 80.7% for OS, 76% and 40.5% for IHFFS, and 87.3% and 79.5% for DMFS. Five patients (11.4%) experienced degradation of albumin-bilirubin grade, 2 (4.5%) degradation of Child-Pugh score, and 4 (9.1%) grade 3 or greater laboratory abnormalities within 3 months after SBRT. No significant difference was seen in any oncological outcomes or treatment-related toxicities between the two dose regimens. Conclusions: SBRT was highly effective for local control without severe toxicities in patients with HCC smaller than 3 cm. The regimen of a total dose of 45 Gy in 3 fractions was comparable to 60 Gy in efficacy and safety of SBRT for small HCC.

Autonomic Nervous Properties of Atropine and Glycopyrrolate on Heart Rate Variability during Anesthesia with Ketamine-Xylazine in Dogs (개에서 케타민-자일라진 마취동안 심박변이도에 대한 아트로핀과 글리코피롤레이트의 자율신경적 특성)

  • Park, Woo-Young;Bae, Chun-Sik;Lee, Soo-Han;Park, Woo-Dae
    • Journal of Veterinary Clinics
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    • v.26 no.3
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    • pp.212-219
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    • 2009
  • Anticholinergics, which are commonly given as a pre-anesthetic medication to prevent adverse effects in canine anesthesia, can cause cardiac adverse effects. To determine the effects of atropine and glycopyrrolate on the balance of sympathetic nervous tone and parasympathetic nervous tone of the heart during ketamine anesthesia in beagle dogs, heart rate variability(HRV), duration of anesthesia and behavioral changes were evaluated. There were no significant temporal domain differences between atropine and glycopyrrolate. Concerning the frequency domain component, atropine and glycopyrrolate effects were significantly lower(P<0.05) than the control saline-treated group. However, the root mean square of the interval differences between consecutive R peaks(RMSSD) and the standard deviation of Poincare plot perpendicular to the line-of-identity(SD1) in atropine were significantly decreased(P<0.05) from the baseline value, and the low frequency/high frequency ratio(LF:HF ratio) in glycopyrrolate was significantly increased from baseline value(P<0.05). The change of SD1 agreed with that of the high frequency(HF) in the frequency domain component and also with those of respiratory rate and $SpO_2-R$. Our results prove that glycopyrrolate is more suitable as a pre-anesthetic anticholinergic in ketamine anesthesia of dogs with respect to safety and duration of action.

Evaluation of a Sample-Pooling Technique in Estimating Bioavailability of a Compound for High-Throughput Lead Optimazation (혈장 시료 풀링을 통한 신약 후보물질의 흡수율 고효율 검색기법의 평가)

  • Yi, In-Kyong;Kuh, Hyo-Jeong;Chung, Suk-Jae;Lee, Min-Haw;Shim, Chang-Koo
    • Journal of Pharmaceutical Investigation
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    • v.30 no.3
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    • pp.191-199
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    • 2000
  • Genomics is providing targets faster than we can validate them and combinatorial chemistry is providing new chemical entities faster than we can screen them. Historically, the drug discovery cascade has been established as a sequential process initiated with a potency screening against a selected biological target. In this sequential process, pharmacokinetics was often regarded as a low-throughput activity. Typically, limited pharmacokinetics studies would be conducted prior to acceptance of a compound for safety evaluation and, as a result, compounds often failed to reach a clinical testing due to unfavorable pharmacokinetic characteristics. A new paradigm in drug discovery has emerged in which the entire sample collection is rapidly screened using robotized high-throughput assays at the outset of the program. Higher-throughput pharmacokinetics (HTPK) is being achieved through introduction of new techniques, including automation for sample preparation and new experimental approaches. A number of in vitro and in vivo methods are being developed for the HTPK. In vitro studies, in which many cell lines are used to screen absorption and metabolism, are generally faster than in vivo screening, and, in this sense, in vitro screening is often considered as a real HTPK. Despite the elegance of the in vitro models, however, in vivo screenings are always essential for the final confirmation. Among these in vivo methods, cassette dosing technique, is believed the methods that is applicable in the screening of pharmacokinetics of many compounds at a time. The widespread use of liquid chromatography (LC) interfaced to mass spectrometry (MS) or tandem mass spectrometry (MS/MS) allowed the feasibility of the cassette dosing technique. Another approach to increase the throughput of in vivo screening of pharmacokinetics is to reduce the number of sample analysis. Two common approaches are used for this purpose. First, samples from identical study designs but that contain different drug candidate can be pooled to produce single set of samples, thus, reducing sample to be analyzed. Second, for a single test compound, serial plasma samples can be pooled to produce a single composite sample for analysis. In this review, we validated the issue whether the second method can be applied to practical screening of in vivo pharmacokinetics using data from seven of our previous bioequivalence studies. For a given drug, equally spaced serial plasma samples were pooled to achieve a 'Pooled Concentration' for the drug. An area under the plasma drug concentration-time curve (AUC) was then calculated theoretically using the pooled concentration and the predicted AUC value was statistically compared with the traditionally calculated AUC value. The comparison revealed that the sample pooling method generated reasonably accurate AUC values when compared with those obtained by the traditional approach. It is especially noteworthy that the accuracy was obtained by the analysis of only one sample instead of analyses of a number of samples that necessitates a significant man-power and time. Thus, we propose the sample pooling method as an alternative to in vivo pharmacokinetic approach in the selection potential lead(s) from combinatorial libraries.

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Use of Non-Contact Type Diode Laser on Assisted Hatching of Mouse Embryos (생쥐 수정란의 보조부화술에 있어서 Non-Contact Type인 Diode Laser의 이용)

  • Kim, D.H.;Lee, M.S.;Kang, H.G.;Han, S.W.;Kim, M.K.;Park, W.I.;Lee, H.T.;Chung, K.S.;Lee, H.J.
    • Clinical and Experimental Reproductive Medicine
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    • v.26 no.2
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    • pp.185-192
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    • 1999
  • The present study was performed to investigate the efficacy and safety of laser assisted hatching (AH) on mouse embryos. Non-contact $1.48{\mu}m$ diode laser system used to create a precise hole on zona pellucida. 2-cell embryos were collected from the mice (ICR) that had the coitus vaginal plug confirmed at 48 hours after hCG injection. Collected 2-cell embryos were cultured in the HTF medium supplemented with 0.4% BSA. For experiments, embryos at 8-cell stage were used after 18-22 hours in culture. After assisted hatching, the embryos were further cultured in HTF medium containing 0.1% PVP (anti-hatching system) for 3 days. For evaluate efficiency of laser on mouse embryo hatching, the effect of AH methods (acidic tyrode, pronase and laser), the number of artificial holes (1, 2 and 3 hole) and the irradiation time of laser (2, 4, 6, 8 and 10 ms) were examined. Hatching rates of laser AH group (95.2%) was significantly higher than that of control group (50.8%), but there was no differences among the laser (95.2%), acidic tyrode (100%) and pronase (98.5%) groups. Hatching rates of the number of zona pellucida opening by laser, there were no differences among the 1 hole (87.5%),2 hole (92.1%) and 3 hole (85.9%) groups. Developmental and hatching rates of embryos according to laser irradiation time were similar in the treatment groups. Therefore, these results suggest that laser AH using non-contact $1.48{\mu}m$ diode laser is a simple and accurate and effective procedure for AH. Based on these results, laser AH could be use safely for human ART program.

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The Improvement of Short- and Long-term Memory of Young Children by BF-7 (천연 소재 BF-7의 어린이 장.단기 기억력 향상 효과)

  • Kim, Do-Hee;Kim, Ok-Hyeon;Yeo, Joo-Hong;Lee, Kwang-Gill;Park, Geum-Duck;Kim, Dae-Jin;Chung, Yoon-Hee;Kim, Kyung-Yong;Lee, Won-Bok;Youn, Young-Chul;Chung, Yoon-Hwa;Lee, Sang-Hyung;Hyun, Joo-Seok
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.39 no.3
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    • pp.376-382
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    • 2010
  • It has been shown that BF-7 enhances short- and long-term memory and attention in normal person. BF-7 was addressed to clinical study for children if BF-7 is also effective to children, since accumulated verification of safety and effectiveness is needed for young ages, in special. We administered BF-7 and a placebo control to two different groups of children (7-12 years old, 9.78 on averages). Their memory enhancement was tested with Rey-Kim Memory Test for Children before and after the administration of BF-7 and a placebo, in a double blinded way. The results showed that long- and short-term memories were significantly improved by the administration of BF-7. Interestingly, the degree of memory preservation, the ability of memory application and awareness of complex thing were also significantly improved. These results indicate that BF-7 is a promising substance from natural resource improving learning and memory of children as well as cognitive function of adults

Clinical Analysis of Tissue Biopsy Under Fiberoptic Bronchoscopy (기관지내시경하에 시행한 조직생검에 대한 고찰)

  • 고건성;유장열;박석근;조태권;노관택;김홍기
    • Proceedings of the KOR-BRONCHOESO Conference
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    • 1978.06a
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    • pp.5.1-5
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    • 1978
  • Since Ikeda in traduced flexible fiberoptic bronchoscope in 1968, use of bronchoscopy was expanded rapidly. Wide use of flexible bronchoscopy enabled us to get tissue diagnosis with more ease and safety. Authors analyzed 71 cases of tissue biopsy of 233 bronchoscopies from June '76 to. Jan. '78 and concluded as following : 1. 233 bronchoscopies af 20 Month duration, cases which needed tissue biopsy were 71 cases (30.5%). 2. Chief complaints af above cases are coughing, dyspnea, sputum, chest pain, hemoptysis in frequency. 3. Biopsy sites were as following in frequency: Rt.upper lobe, Lt. main bronchus, Lt. upper lobe, Rt. main bronchus, Lt. lower lobe. 4. The final diagnosis of biopsied cases were cancer 80%, tuberculosis 15%, and malignant mesothelioma, anthracosis, aspergillosis, were one case each. 5. Among 57 case of lung cancer, biopsy confirmed cases were 36 cases (63%). 6. Pathologic finding of 36 case of Biopsy confirmed lung cancer was as following: Squamous cell ca : 64% Anaplastic ca : 25% Adeno ca : 2.8% Unclassified: 2.8% 7. Bronchographies were done in 36cases (51%), one quarter of cases before biopsy, and three quarters of cases after biopsy. 8. Cytology was requested in 76% of cases with following results; PAP class V 15%, class IV 7.5%, class III 1.8%.

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Utilization Behaviour and Influencing Factors of Complementary and Alternative Medicine Therapies Among the Elderly (일부 노인의 보완대체요법 이용행태와 영향요인)

  • Moon, Gi-Won;Kim, Jun-Ho;Kim, Chun-Bae
    • Journal of agricultural medicine and community health
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    • v.38 no.1
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    • pp.25-38
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    • 2013
  • Objectives: The aim of this study is to analyze the utilization behaviour and influencing factors of complementary and alternative medicine (CAM) therapies among elderly people with chronic diseases. Methods: The study population was selected among 9 welfare facilities for the aged in 2 cities among Daegu Metropolitan City & Gyeongsangnam Province by two-stage cluster sampling. 250 senior citizens participated in a face-to-face interview using a structured questionnaire. Logistic regression analysis was performed to examine the association between the utilization of CAM therapies and various characteristics of the elderly. All statistics were analyzed using the PASW (ver 18.0). Results: Among 233 elderly peoples, 70.4% (164 persons) had used various kinds of CAM therapies (including nutritional methods, pharmacologic and biologic treatments, etc.) more than once during the last year. 48.8% (64 persons) ~ 60.7% (88 persons) of the elderly used CAM therapies without health and medical experts' counsel. The elderly with perceptions of CAM therapy used it 2 times more than those without knowledge of CAM therapies. The number of chronic diseases was more likely to increase the usage of nutritional methods (OR=2.92, 95% CI: 1.07-7.97), manipulative and body-based practices (OR=5.85, 95% CI: 1.97-17.34), pharmacologic and biologic treatments (OR=2.92, 95% CI: 1.49-8.17). Elderly with diabetes used nutritional methods 3.76 (95% CI: 1.49-9.47) more than elderly without diabetes. Conclusions: CAM therapies use in the aged with chronic diseases appears common. The findings suggest that the clinical efficacy and safety of CAM therapies on medical management of chronic disease may be investigated and that patient-physician communication need to be strengthened.

The Effect of Dextranase-Containing Mouthwash in Human Experimental Gingivitis (실험적 치은염에서 dextranase 함유 구강 세정액의 양치 효과)

  • Son, Eun-Ju;Kim, Young-Jun;Kim, Do-Man;Chung, Hyun-Ju
    • Journal of Periodontal and Implant Science
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    • v.31 no.2
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    • pp.401-420
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    • 2001
  • A novel glucanhydrolase from a mutant of Lipomyces starkeyi(KSM 22)has been shown effective in hydrolysis of mutan, reduction of mutan formation by Streptococcus mutans and removal pre-formed sucrose-dependent adherent microbial film and Lipomyces starkeyi KSM 22 dextranase has been strongly bound to hydroxyapatitie. These in vitro properties of Lipomyces starkeyi KSM 22 dextranase are desirable for its application as a dental plaque control agent. This study was performed to determine oral hygiene benefits and safety of dextranase(Lipomyces starkeyi KSM 22 dextranase)-containing mouthwash in human experimental gingivitis. This 3-week clinical trial was placebo-controlled double-blind design evaluating 1U/ml dextranase mouthwash and 0.12% chlorhexidine mouthwash. A total 39 systemically healthy subjects, who had moderate levels of plaque and gingivitis were included. At baseline, 1, 2 and 3 weeks, subjects were scored for plaque(Silness and $L{\ddot{o}e$ plaque index and plaque severity index), gingivitis($L{\ddot{o}e$ and Silness gingival index), and at baseline and 3 weeks of experiment, subjects were scored for plaque(Turesky-Quingley-Hein's plaque index and plaque severity index), tooth stain(Area and severity index system by Lang et al). Additionally, oral mucosal examinations were performed and subjects questioned for adverse symptoms. Two weeks after pre-experiment examinations and a professional prophylaxis, the subjects provided with allocated mousewash and instructed to use 20-ml volumes for 30s twice dailywithout toothbrushing. All the groups showed significant increase in plaque accumulation since 1 week of experiment. During 3 weeks' period, the dextranase group showed the least increase in plaque accumulation of Silness and $L{\ddot{o}e$ plaque index, compared to the chlorhexidine and placebo groups, but chlorhexidine group showed the least increase inplaque accumulation of Turesky-Quingley-Hein's plaque index. As for gingival inflammation, all the groups showed significant increase during 3 weeks of experiment. The dextranase group also showed the least increase in gingival index score, compared to the chlorhexidine as well as the placebo groups. Whereas the tooth stain was increased significantly in the chlorhexidine group, compared to the baseline score and the placebo group since 3 weeks of mouthrinsing. It was significantly increased after 3 weeks in the dextranase group, still less severe than the chlorhexidine group. As for the oral side effect, the dextranase group showed less tongue accumulation, bad taste, compared to the chlorhexidine group. From these results, mouthrinsing with Lipomyces starkeyi KSM 22 dextranase was comparable to 0.12% chlorhexidine mouthwashin inhibition of plaque accumulation and gingival inflammation and local side effects were if anything less frequent and less intense than chlorhexidine, in human experimental gingivitis. All data had provided positive evidence for Lipomyces starkeyi KSM 22 dextranase as an antiplaque agent and suggested that further development of dextranase formulations for plaque control are warranted.

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