• Title/Summary/Keyword: Prospective clinical evaluation

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Evaluation of Prescription Data for Development of Warfarin Nomogram in Korean Patients with Cerebral Infarction (뇌졸중 환자군의 Warfarin Nomogram 설정을 위한 실제 처방전 평가)

  • Jang, Ju-Young;Ko, Kyung-Mi;Yoon, Ji-Yeon;Han, Ok-Yeon;Lim, Sung-Cil
    • YAKHAK HOEJI
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    • v.53 no.2
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    • pp.83-88
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    • 2009
  • Warfarin is the most widely used oral anticoagulant in the world but maintenance of proper therapeutic range and prevention of adverse drug events always need to be careful. Especially, in Korea, warfarin dosing for patients with cerebral infarction is currently based on the nomogram which is done by foreign clinical trials not for the Korean. Therefore we evaluate warfarin dose of patients in the neurology and eventually get the base data of warfarin nomogram for Korean with stroke. We performed this study retrospectively on reviewing the medical charts to evaluate the prescribed loading dose (LD) and maintenance dose (MD) of warfarin and each responding International Normalized Ratio (INR) with any bleeding adverse drug reaction including of patient's characteristics for total 75 patients with stroke in the department of neurology of Kangnam ST. Mary's Hospital from January 2005 to June 2008. All evaluated patients should not be treated with warfarin in the past at all and should be initiated warfarin therapy first.ly at this time. All evaluated patients were divided as two classes by wafarin LD which is; 1) HDG - a high loading dosing group prescribed over 5mg, and 2) LDG - a low loading dosing group prescribed 5mg or below. As a result, average LD was $9.34{\pm}0.22$ mg (p=0.000) in HDG and $4.25{\pm}0.39$ mg (p=0.000) in LDG. Average baseline INR was $0.91{\pm}0.05$ (p=0.161) in HDG and $1.26{\pm}0.14$ (p=0.002) in LDG. On the first and second week, daily MD was $4.21{\pm}0.14$ mg (p=0.000) and $2.96{\pm}0.19$ mg (p=0.696) in HDG and also in LDG, $2.95{\pm}0.29$ mg (p=0.000) and $3.14{\pm}0.36$ mg (p=0.696). Also average reacting daily INR was respectively $2.53{\pm}0.12$ (p=0.141) and $2.51{\pm}0.16$ (p=0.678) in HDG, and in LDG, $2.11{\pm}0.17$ (p=0.141) and $2.42{\pm}0.14$ (p=0.678). After the second week, INR was not measured in regularly. Also most of underlying diseases were hypertension (n=38), diabetes mellitus (n=14), dyslipidemia (n=8) in order. Four ADRs with simple hemorrhage were occurred and those were due to drug interaction by comedication. In the conclusion, proper starting LD for Korean with stroke is 10 mg if baseline INR is around 1.0 or 5 mg if over 1.3. Proper MD need to be more evaluated in the future for setting up warfarin nomogram to make prospective study.

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.

Prospective Evaluation of the G-protein $\beta$3 Subunit (GNB3) Gene 825T Polymorphism is Associated With Cerebral Infarction in Korean Population (한국인의 G Protein $\beta$3 Subunit유전자의 다형성과 뇌혈관 질환과의 상관성에 대한 연구)

  • Choi Min Hee;Lee Jin Woo;Lee Kyung Jin;Lee Hyo Jung;Rho Sam Woong;Choi Hyun;Cho Ki Ho;Hong Moo Chang;Shin Min Kyu;Kim Young Suk;Bae Hyun Su
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.17 no.3
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    • pp.719-727
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    • 2003
  • Background and purpose: Hypertension and obesity has been implicated in the most important risk factors for stroke. The original finding that the G-protein beta3 subunit (GNB3) C825T allele associates with essential hypertension and obesity has been confirmed in several different populations. Hence, our objective was to determine whether the GNB3 C825T polymorphism predicts interindividual variation in stroke. Method: We recruited 361 stroke patients (cerebral infarction, n=278; intracerebral hemorrhage (ICH), n=83) and 199 healthy control subjects. Subjects were genotyped for GNB3 C825T mutation and findings were investigated for association with stroke. Result: The GNB3 T/T type was significantly associated with cerebral infarction prevalence (OR, 1.98; 95% Cl, 1.14-3.46; p=0.015). While, ICH was not found to be significantly associated with GNB3 T/T type (OR, 1.63; 95% ICH, 0.74-3.56; p=0.219). Similarly, no significant association was determined between GNB T/C type, and cerebral infarction (OR, 1.09; 95% Cl, 0.68-1.74; p=0.716), and ICH (OR, 1.14; 95% Cl, 0.59-2.21; p=0.697). Conclusion: In clinical characteristics, this study shows no differences among GNB3 genotypes, that are BMI, WH ratio. hypertension rate, and ischemic heart disease rate, total lipid level, triglycerides level, total cholesterol level, HDL cholesterol level, prothrombine time, with the exception of LDL cholesterol concentrations. However, our subjects showed an inverse relationship between LDL cholesterol level and the risk of cerebral infarction. We have shown that the GNB3 T/T genotype is strongly associated with cerebral infarction. (OR, 1.98; 95% Cl, 1.14-3.46; p=0.015).

Management of Enteral Nutrition in the Pediatric Intensive Care Unit: Prokinetic Effects of Amoxicillin/Clavulanate in Real Life Conditions

  • Chiusolo, Fabrizio;Capriati, Teresa;Erba, Ilaria;Bianchi, Roberto;Atti, Marta Luisa Ciofi degli;Picardo, Sergio;Diamanti, Antonella
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.6
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    • pp.521-530
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    • 2020
  • Purpose: Malnutrition is a common feature in critically ill children. Enteral nutrition (EN) is the main strategy to nutritionally support critical ill children, but its use can be hindered by the development of intolerance. The study aimed to assess the effectiveness and safety of amoxicillin/clavulanate (A/C) to treat EN intolerance. Methods: We retrospectively evaluated patients admitted to the pediatric intensive care unit from October 2018 to October 2019. We conducted a case-control study: in the first 6 months (October 2018-April 2019) we implemented the nutritional protocol of our Institution with no drug, whereas in the second half (May 2019-October 2019) we employed A/C for 1 week at a dose of 10 mg/kg twice daily. Results: Twelve cases were compared with 12 controls. At the final evaluation, enteral intake was significantly higher than that at baseline in the cases (from 2.1±3.7 to 66.1±27.4% of requirement, p=0.0001 by Wilcoxon matched-pairs signed rank test) but not in the controls (from 0.2±0.8 to 6.0±14.1% of the requirement, p=NS). Final gastric residual volume at the end of the observation was significantly lower in the cases than in the controls (p=0.0398). The drug was well tolerated as shown by the similar safety outcomes in both cases and controls. Conclusion: Malnutrition exposes critically ill children to several complications that affect the severity of disease course, length of stay, and mortality; all may be prevented by early EN. The development of intolerance to EN could be addressed with the use of A/C. Future prospective clinical trials are needed to confirm these conclusions.

Initial Changes of Implant Stability from Installation during Early Bone Healing (임플란트 식립 후 초기 안정성의 변화)

  • Park, Chan-Jin;Kim, Dae-Gon;Cho, Lee-Ra
    • Journal of Dental Rehabilitation and Applied Science
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    • v.29 no.3
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    • pp.272-279
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    • 2013
  • The concept of implant stability was basically originated from the relative condition of bone-implant interface and has some meanings for evaluation of that interface. In addtion, it has been used for the investigation of initial bone healing process after fixture installation because a degree of micromotion around interface can affect unfavorable clinical results. The purpose of this study is to investigate the mode of initial bone healing from fixture installation through prospective trial. Thirty fixtures were consecutively installed in mandibles of 26 patients with single tooth loss area and then healing abutment were secured for one-stage surgery meothod. Resonance frequency analysis was performed with one week interval during 12 weeks and periapical radiographs were taken at each month. Although marginal bone level change was not shown through observation period (P>0.05), statistical difference of implant stability was shown through 4 and 6 week (P<0.05) and was not shown after 6 week (P>0.05) according to the bone quality. Initial bone healing process is a successive process of bone resorption and favorable bone healing result might be postulated at 4 week interval after installation through RFA.

Effect of a Proton Pump Inhibitor on Tumor Bleeding Prevention in Unresectable Gastric Cancer Patients: a Double-Blind, Randomized, Placebo-Controlled Trial

  • Kim, Young-Il;Kim, Mi-Jung;Park, Sook Ryun;Kim, Hark Kyun;Cho, Soo-Jeong;Lee, Jong Yeul;Kim, Chan Gyoo;Kim, Gwang Ha;Park, Moo In;Nam, Byung-Ho;Park, Young Iee;Choi, Il Ju
    • Journal of Gastric Cancer
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    • v.17 no.2
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    • pp.120-131
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    • 2017
  • Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

An Experimental Study for Performance Evaluation in Dogs of Preventive Contrast Media Extravasation with a Strain Gage Based Prototype Extravasation Detection Accessory System (잡견에서 조영제 혈관외유출 예방을 위한 스트레인 게이지 기반의 EDA 시스템 성능 평가를 위한 실험적 연구)

  • Kweon, D.C.;Yoo, B.G.;Lee, J.S.;Cho, M.S.;Yang, S.H.
    • Journal of Biomedical Engineering Research
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    • v.29 no.1
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    • pp.66-72
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    • 2008
  • The major risk associated with the use of automated power injectors is the well known complication of contrast material extravasation at the injection site. Automated injection of computed tomography (CT) contrast media can produce the compartment syndrome. The purpose of this study was to assess the ability of this device during clinically important episodes of extravasation. The extravasation detection accessory (EDA) system was composed of a strain gage, an amplifier and a computer based system. A strain gage pliable adhesive patch was applied to the skin aver the intravenous catheter and the catheter was connected to the power injector with a cable to monitor the resolution data. If the programmed monitoring, which was developed with MS Visual C++, at the extravasation occurred, then the injection was interrupted the auto injector. CT was used to demonstrate the clinically important extravasation. This study was a prospective, observational study in which the EDA system was used to monitor the automated mechanical injection of contrast material in 7 dogs. There were two true-positive cases (range of extravasation volumes: $18{\sim}22ml$), twenty three true-negative cases, three false-positive cases and no false-negative cases. The EDA system had a sensitivity of 100% and a specificity of 88% for the detection of clinically important extravasation. The EDA system had good sensitivity for the detection of clinically important extravasation and the EDA system has the clinical potential for the early detection of extravasation of the contrast medium that is administered with power injectors. The EDA system is easy to use safe and accurate for the monitoring extravasation of the intravenous injections, and this system may prove especially useful in CT applications.

Classification of Deep Inferior Epigastric Perforator Courses Based on Computed Tomography Angiography: Incidences and Clinical Implications (컴퓨터 단층 촬영 혈관 조영술을 이용한 심하복벽 혈관과 천공지의 박리 용이성에 따른 분류)

  • Lee, Yeonhoon;Kim, Sung Chan;Eom, Jin Sup;Kim, Eun Key
    • Archives of Hand and Microsurgery
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    • v.23 no.4
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    • pp.281-289
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    • 2018
  • Purpose: Preoperative surgical planning utilizing computed tomography angiography (CTA) has now become a routine in many practices. We analyzed the course of the deep inferior epigastric artery (DIEA) and its perforators (DIEP) that would either facilitate or hinder flap dissection based on CTA to aid surgical planning. Methods: The 115 consecutive patients who underwent abdominally based free flap breast reconstruction were enrolled in this prospective study. DIEA/P courses were categorized mainly according to their intramuscular courses and their incidences were investigated. Results: A total of 425 perforators were identified preoperatively on the CTA, with an average number of 3.7 distinctly visualized in the entire flap territory. Eighty-nine perforators (20.9%) had a favorable (less than 1 cm intramuscular course) pattern, namely long submuscular (34.8% of the patients), long subfascial (15.6%), and total circummuscular (13.9%). Overall 56.5% of the patients had at least one favorable DIEA/P. On the other hand, absence of DIEA and absence of adequate (>1 mm) DIEP was reported in 3 and 8 hemiabdomen. Conclusion: Preoperative CTA evaluation of DIEA/P can be used to identify favorable as well as unfavorable courses for dissection to aid surgical planning.

Reduction of Radiation Dose to Eye Lens in Cerebral 3D Rotational Angiography Using Head Off-Centering by Table Height Adjustment: A Prospective Study

  • Jae-Chan Ryu;Jong-Tae Yoon;Byung Jun Kim;Mi Hyeon Kim;Eun Ji Moon;Pae Sun Suh;Yun Hwa Roh;Hye Hyeon Moon;Boseong Kwon;Deok Hee Lee;Yunsun Song
    • Korean Journal of Radiology
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    • v.24 no.7
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    • pp.681-689
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    • 2023
  • Objective: Three-dimensional rotational angiography (3D-RA) is increasingly used for the evaluation of intracranial aneurysms (IAs); however, radiation exposure to the lens is a concern. We investigated the effect of head off-centering by adjusting table height on the lens dose during 3D-RA and its feasibility in patient examination. Materials and Methods: The effect of head off-centering during 3D-RA on the lens radiation dose at various table heights was investigated using a RANDO head phantom (Alderson Research Labs). We prospectively enrolled 20 patients (58.0 ± 9.4 years) with IAs who were scheduled to undergo bilateral 3D-RA. In all patients' 3D-RA, the lens dose-reduction protocol involving elevation of the examination table was applied to one internal carotid artery, and the conventional protocol was applied to the other. The lens dose was measured using photoluminescent glass dosimeters (GD-352M, AGC Techno Glass Co., LTD), and radiation dose metrics were compared between the two protocols. Image quality was quantitatively analyzed using source images for image noise, signal-to-noise ratio, and contrast-to-noise ratio. Additionally, three reviewers qualitatively assessed the image quality using a five-point Likert scale. Results: The phantom study showed that the lens dose was reduced by an average of 38% per 1 cm increase in table height. In the patient study, the dose-reduction protocol (elevating the table height by an average of 2.3 cm) led to an 83% reduction in the median dose from 4.65 mGy to 0.79 mGy (P < 0.001). There were no significant differences between dose-reduction and conventional protocols in the kerma area product (7.34 vs. 7.40 Gy·cm2, P = 0.892), air kerma (75.7 vs. 75.1 mGy, P = 0.872), and image quality. Conclusion: The lens radiation dose was significantly affected by table height adjustment during 3D-RA. Intentional head off-centering by elevation of the table is a simple and effective way to reduce the lens dose in clinical practice.

Hypothyroidism Following Surgery and Radiation Therapy for Head and Neck Cancer (두경부암 환자에서 수술 및 방사선치료 후 갑상선 기능 저하)

  • Park, In-Kyu;Kim, Jae-Cheol
    • Radiation Oncology Journal
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    • v.15 no.3
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    • pp.225-231
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    • 1997
  • Purpose : Radiation therapy in combination with surgery has an important role in the therapy of the head and neck cancer We conducted a prospective study for patients with head and neck cancer treated with surgery and radiation to evaluate the effect of therapies on the thyroid gland, and to identify the factors that might influence the development of hypothyroidism. Materials and Methods : From September 1986 through December 1994, 71 patients with head and cancer treated with surgery and radiation were included in this prospective study. Patients' age ranged from 32 to 73 years with a median age of 58 years. There were 12 women and 59 men. The primary tumor sites were larynx in 34 patients, hypopharynx in 13 patients, oral cavity in 12 patients, unknown primary of the neck in 6 patients, salivary gland in 3 patients, maxillary sinus in 2 patients, and oropharynx in 1 patient. Total laryngectomy with neck dissection was carried out in 45 patients and neck dissection alone in 26 patients. All patients were serially monitored for thyroid function (T3, T4, free T4, TSH, antithyroglobulin antibody and antimicrosomal antibody) before and after radiation therapy. Radiation dose to the thyroid gland ranged from 40.6Gy to 60Gy with a median dose of 50Gy The follow-up duration was 3 to 80 months. Results :The overall incidence of hypothyroidism was 56.3\%$);7 out of 71 patients $(9.9\%)$ developed clinical hypothyroidism and 33 patients $(46.4\%)$ developed subclinical hypothyroidism. No thyroid nodules, thyroid cancers, or hyperthyroidism was detected. Hypothyroidism developed earlier in patients who underwent total laryngectomy with neck dissection than in patients with neck dissection alone (P<0.05). The risk factor that significantly influenced the incidence of hypothyroidism was a combination of surgery (total laryngectomy with neck dissection) and radiation therapy (P=0.0000), Four of 26 patients $(15.4\%)$ with neck dissection alone developed hypothyroidism while 36 of 45 patients $(80\%)$ with laryngectomy and neck dissection developed hypothyroidism. Conclusion : The hypothyroidism following surgery and radiation therapy was a relatively common complication. The factor that significantly influenced theincidence of hypothyroidism was combination of surgery and radiation therapy. Evaluation of thyroid function before and after radiation therapy with periodic thyroid function tests is recommended for an early detection of hypothyroidism and thyroid hormone replacement therapy is recommended whenever hypothyroidism develops.

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