• Title/Summary/Keyword: Clinical safety

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Complete Myocardial Revascularization Utilizing Parallel Secluential Anastomoses (Parallel sequential anastomosis를 이용한 관상동맥 우회수술의 성적)

  • 박계현;김관민
    • Journal of Chest Surgery
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    • v.30 no.7
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    • pp.647-655
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    • 1997
  • We evaluated the feasibility and safety of this method by reviewing the early outcome of the patients who underwent coronary artery bypass grafting(CABG) utili ing parallel sequential anastomoses with saphenous vein grafts, comparing with the outcome of the patients revascularized with grafts having only single distal anastomosis. During the one-year period of 1995, a total of 79 patients underwent isolated CABG, among whom 39 patients with sequential vein grafts(sequential group) and 40 patients without sequential grafts(non-sequential group). There was no difference between the two groups in terms of preoperative status, except in the extent of the coronary disease; 87.2% of the sequential group and 45.0% of the non-sequential group had left main andlor triple vessel involvement. 318 distal coronary anastomoses were done; 198 for the sequential group(5.1/patient) and 120 for the non-sequential group(3.0/patient). In the sequential group, the mean durations of cardiopulmonary bypass and aortic clamp per one distal anastomosis were 33.5 and 21.1 minutes, respectively. In the non-sequential group, these were 41.8 and 22.7 minutes. There were two operative deaths, both in the non-sequential group. There was no difference in the incidence of postoperative complications including myocardial infarction. During the follow-up period(2 to 15 months), 8 patients(3 in the sequential and 5 in the nonsequential group) complained of residual or recurrent angina. Comparison of preoperative and postoperative ."'Thallium myocardial perfusion scans in 30 patients showed improved or normal perfusion reserve in 83.3% of segments bypassed with sequential grafts and 82.5% of segments bypassed with non-sequential graft(5), These results show that, utilizing parallel sequential anastomoses with saphenous vein grafts, we could achieve satisfactory short-term clinical results in patients with extensive coronary stenoses. So, we conclude that this technique is a safe, technically feasible strategy for CABG, which can achieve the aim of complete myocardial revascularization with a limited length of graft.raft.

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Characteristics of Intravenous Midazolam Sedation with Nitrous Oxide in Pediatric Dental Treatment (소아환자에서 midazolam 정주 및 아산화질소 흡입진정법 하 치과치료의 특성)

  • Kim, Hyuntae;Song, Ji-Soo;Hyun, Hong-Keun;Kim, Young-Jae;Kim, Jung-Wook;Jang, Ki-Taeg;Lee, Sang-Hoon;Shin, Teo Jeon
    • Journal of the korean academy of Pediatric Dentistry
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    • v.47 no.1
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    • pp.53-61
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    • 2020
  • Midazolam is a short-acting benzodiazepine that is widely used in pediatric dental sedation. However, its clinical effectiveness as an intravenous sedative agent in children has not been widely documented. A retrospective study was conducted to evaluate the efficacy and safety of intravenous midazolam and nitrous oxide inhalation sedation in pediatric dental treatment. The subjects were 115 patients (118 cases) who received dental treatment under intravenous midazolam and nitrous oxide inhalation sedation. Demographic factors, general health status, sedation time, midazolam and nitrous oxide dosage, and success rate of sedation were evaluated from electronic medical records. Behavioral management was the main reason of choosing sedation. Mean duration of sedation was 56.7 minutes for surgical treatment, and 74.4 minutes for restorative treatment. The initial dosage of intravenous midazolam was 0.051 ± 0.019 mg/kg. In 34 cases (28.8%), additional midazolam of 0.036 ± 0.057 mg/kg was delivered during the treatment. The concentration of nitrous oxide was maintained between 40% and 50%. The success rate of sedation was 99% (n = 117). In 1 case, laryngospasm occurred and the patient was reversed with benzodiazepine antagonist, flumazenil. Intravenous midazolam sedation with nitrous oxide was shown to be clinically effective for the dental treatment in children, if administered by trained personnel and patients are carefully selected in accordance with guidelines.

Decitabine in the Treatment of Acute Myeloid Leukemia and Myelodysplastic Syndromes, Which Combined with Complex Karyotype Respectively

  • Gao, Su;Li, Zheng;Fu, Jian-Hong;Hu, Xiao-Hui;Xu, Yang;Jin, Zheng-Ming;Tang, Xiao-Wen;Han, Yue;Chen, Su-Ning;Sun, Ai-Ning;Wu, De-Pei;Qiu, Hui-Ying
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.15
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    • pp.6627-6632
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    • 2015
  • Background: We conducted a study exploring the clinical safety and efficacy of decitabine in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), combined with a complex karyotype. Materials and Methods: From April 2009 to September 2013, a total of 35 patients with AML/MDS combined with a complex karyotype diagnosed in the First Affiliated Hospital of Soochow University were included for retrospective analysis. All patients were treated with decitabine alone ($20mg/m^2$ daily for 5 days) or combination AAG chemotherapy (Acla 20mg qod*4d, Ara-C $10mg/m^2$ q12h*7d, G-CSF $300{\mu}g$ qd, the dose of G-CSF adjusted to the amount in blood routinely). Results: In 35 patients, 15 exhibited a complete response (CR), and 6 a partial response (PR), the overall response rate (CR+PR) being 60% (21 of 35). Median disease-free survival was 18 months and overall survival was 14 months. In the 15 MDS patients with a complex karyotype, the CR rate was 53.3% (8 of 15); in 20 AML patients with complex karyotype, the overall response rate was 65% (13 of 20). The response rate of decitabine alone (22 cases) was 56.5% (13 of 22), while in the combination chemotherapy group (13 cases), the effective rate was 61.5% (8 of 13)(P>0.05). There are 15 patients with chromosome 7 aberration, after treatment with decitabine, 7 CR, 3 PR, overall response rate was 66.7% (10 of 15). Of 18 patients with 3 to 5 kinds of chromosomal abnormalities, 66.7% demonstrated a response; of 17 with more than 5 chromosomal abnormalities, 52.9% had a response. In the total of 35 patients, with one course (23 patients) and ${\geq}$two courses (12 patients), the overall response rate was 40.9% and 92.3% (P<0.05). Grade III to IV hematological toxicity was observed in 27 cases (75%). Grade III to IV infections were clinically documented in 7 (20%). Grades I to II non-hematological toxicity were infections (18 patients), haematuria (2 patients), and bleeding (3 patients). With follow-up until September 2013, 7 patients were surviving, 18 had died and 10 were lost to follow-up. In the 6 cases who underwent allogeneic hematopoietic stem cell transplantation (HSCT) all were still relapse-free survivors. Conclusions: Decitabine alone or combination with AAG can improve outcome of AML/MDS with a complex karyotype, there being no significant difference decitabine in inducing remission rates in patients with different karyotype. Increasing the number of courses can improve efficiency. This approach with fewer treatment side effects in patients with a better tolerance should be employed in order to create an improved subsequent chance for HSCT.

Favorable Outcome in Elderly Asian Patients with Metastatic Renal Cell Carcinoma Treated with Everolimus: The Osaka Urologic Oncology Group

  • Inamoto, Teruo;Azuma, Haruhito;Nonomura, Norio;Nakatani, Tatsuya;Matsuda, Tadashi;Nozawa, Masahiro;Ueda, Takeshi;Kinoshita, Hidefumi;Nishimura, Kazuo;Kanayama, Hiro-Omi;Miki, Tsuneharu;Tomita, Yoshihiko;Yoshioka, Toshiaki;Tsujihata, Masao;Uemura, Hirotsugu
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.4
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    • pp.1811-1815
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    • 2014
  • Background: In clinical trials with no upper age limit, the proportion of older patients is usually small, probably reflecting the more conservative approach adopted by clinicians when treating the elderly. An exploratory analysis of elderly patients in the RECORD-1 Trial showed that patients ${\geq}$ 65 y.o. had superior median PFS than overall RECORD-1 population (5.4 months and 4.9 months, respectively). We investigated the efficacy, relative benefit and safety of Everolimus (EVE) as sequential therapy after failure of VEGFr-TKI therapy for older patients with metastatic renal cell cancer (mRCC), in daily practice. Materials and Methods: 172 consecutive IRB approved patients with mRCC (median age 65, M:F 135/37, 78% clear cell) who received salvage EVE at 39 tertiary institutions between October 2009 and August 2011 were included in this analysis. Some 31% had progressed on sunitinib, 22% on sorafenib, 1% on axitinib, 41% on sequential therapy, and 5% had received other therapy. Patients with brain metastases were not included and 95% of the patients had a ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0 or 1. Previous radiotherapy was an exclusion criterion, but prior chemotherapy was permitted. Adequate organ function and hematologic parameters were mandatory. EVE administration was approved by the institutional review board at each participating institution and signed informed consent was obtained from all patients. Results: Median time of the whole cohort to last follow-up was 3.5 months (range 0.4-15.2 months). Forty four percent were continuing to take EVE at last followup. There were 86 (50%) patients ${\geq}$ 65 y.o. and 86 (50%) <65 y.o. The percentage of patients who showed PR/SD was higher in the older group than in the younger one (5.9%/61.2% vs 1.2%/46.5%, respectively). Median survival of older patients was also significantly longer (3.5 +/- 0.31 vs 3.1 +/- 0.34, hazard ratio=0.45, CI; 0.255-0.802). Analysis using Cox regression model adjusted for gender, PS, number of metastases, site of metastases, histology, smoking history and age detected an association between age and PFS (p=0.011). The frequency of adverse events in elderly patients treated with EVE was no greater than that in younger patients, although such toxicity may have had a greater impact on their quality of life. Conclusions: Older patients should not generally be excluded from accepted therapies (mTOR inhibitors after failure of VEGFr-TKI therapy) for mRCC.

The Development of On-Line Statistics Program for Radiation Oncology (방사선종양학과 On-line 통계처리프로그램의 개발)

  • Kim Yoon-Jong;Lee Dong-Hoon;Ji Young-Hoon;Lee Dong-Han;Jo Chul-Ku;Kim Mi-Sook;Ru Sung-Rul;Hong Seung-Hong
    • Radiation Oncology Journal
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    • v.19 no.4
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    • pp.369-380
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    • 2001
  • Purpose : By developing on-line statistics program to record the information of radiation oncology to share the information with internet. It is possible to supply basic reference data for administrative plans to improve radiation oncology. Materials and methods : The information of radiation oncology statistics had been collected by paper forms about 52 hospitals in the past. Now, we can input the data by internet web browsers. The statistics program used windows NT 4.0 operation system, Internal Information Server 4.0 (IIS4.0) as a web server and the Microsoft Access MDB. We used Structured Query Language (SQL), Visual Basic, VBScript and JAVAScript to display the statistics according to years and hospitals. Results : This program shows present conditions about man power, research, therapy machines, technics, brachytherapy, clinic statistics, radiation safety management, institution, quality assurance and radioisotopes in radiation oncology department. The database consists of 38 inputs and 6 outputs windows. Statistical output windows can be increased continuously according to user's need. Conclusion : We have developed statistics program to process all of the data in department of radiation oncology for reference information. Users easily could input the data by internet web browsers and share the information.

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Effects of Boostin-250 Supplementation on Milk Production and Health of Dairy Cows (재조합 Bovine Somatotropin 250 mg 제제의 투여가 젖소의 산유량 및 건강에 미치는 영향)

  • Kim, Yo-Han;Kim, Doo
    • Journal of Veterinary Clinics
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    • v.29 no.3
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    • pp.213-219
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    • 2012
  • The recombinant bovine somatotropin (rbST) has been used for increasing milk production of dairy cows without adverse health effects. This study was conducted to compare effects of supplementation with $Boostin^{(R)}$-250 containing 250 mg of rbST on milk production with those of $Posilac^{(R)}$ and $Boostin^{(R)}$-S. And safety of rbST supplementation on target animals was also observed. Each twenty-five lactating dairy cows were assigned randomly to one of four groups. $Boostin^{(R)}$-250 and vehicle (control) were administered weekly. $Boostin^{(R)}$-S and $Posilac^{(R)}$ were administered two week intervals. Milk yield, milk components, milk somatic cell count, health status, and body condition score of cows were examined. Supplementation with $Posilac^{(R)}$, $Boostin^{(R)}$-S, and $Boostin^{(R)}$-250 induced more milk yield than control group by 2.9 kg/day (12.3%), 4.2 kg/day (17.9%), and 4.1 kg/day (17.4%), respectively. There was a significant difference in milk yield among three rbST treatment groups and control group (${\alpha}$ = 0.05). The rbST supplementation did not increase the incidence of clinical mastitis and milk somatic cell counts. Supplementation with rbST did not significantly affect milk components (milk fat, protein, and solid not fat). The rbST supplementation of the dairy cows after peak milk yield did not cause negative effect on BCS. However, some cows less than 100 days in milking had decreased BCSs after rbST supplementation. In conclusion, milk production in 250 mg of rbST administered cows every week was similar to that of 500 mg of rbST administered cows every 2 weeks. And supplementation of 250 mg of rbST every week could reduce metabolic stress in cows.

Endovenous Laser Treatment (EVLT) with High Ligation of an Incompetent Small Saphenous Vein (소복재정맥 역류에서 고위결찰술을 동반한 정맥내 레이저 치료)

  • Jeong, Jae-Han;Kim, Kun-Il;Lee, Won-Yong;Kim, Hyoung-Soo;Cho, Sung-Woo;Lee, Hee-Sung
    • Journal of Chest Surgery
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    • v.43 no.2
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    • pp.150-155
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    • 2010
  • Background: Endovenous laser treatment (EVLT) has recently been introduced as a less invasive technique for treating an incompetent small saphenous vein and many good results have been reported. The purpose of this study is to assess the efficacy and safety of EVLT combined with high ligation in patients with an incompetent small saphenous vein. Material and Method: The study included 60 patients (66 limbs) who were treated with EVLT combined with high ligation of an incompetent small saphenous vein between January 2006 and May 2009. The preoperative clinical findings, the postoperative results and the postoperative ultrasonography follow up results at 1 and 3 months were reviewed. Result: Postoperative complications were observed in 17 patients (15 limbs, 28.3%) and postoperative paresthesia occurred in 5 limbs (7.6%), but there was no deep vein thrombosis. Ultrasonography follow up at 3 month was performed in 93.9% of the limbs (62/66). The vein occlusion rate at 1 and 3 months were found to be 91.9% (57/62) and 90.3% (56/62), respectively. Conclusion: We performed EVLT combined with high ligation and ambulatory phlebectomy in patients with an incompetent small saphenous vein, and this all revealed relatively satisfactory results with a low complication rate, but it showed a relatively low cure rate even though we also performed EVLT combined with high ligation altogether. We need to determine whether EVLT combined with a high ligation procedure will improve the venous occlusion rate. We also need to investigate how we can minimize the occurrence of nerve injury.

The immunogenicity and reactogenicity of Td booster vaccination in Korean preadolescents, aged with 11-12 years old (국내 11-12세 소아에서 Td 백신 추가접종의 면역원성과 안전성 평가)

  • Lee, Soo Young;Kwak, Ga Young;Mok, Hye Rin;Kim, Jong Hyun;Hur, Jae Kyun;Lee, Kyung Il;Park, Joon Su;Ma, Sang Hyuk;Kim, Hwang Min;Kang, Jin Han
    • Clinical and Experimental Pediatrics
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    • v.51 no.11
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    • pp.1185-1190
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    • 2008
  • Purpose : This study was undertaken to evaluate the immunogenicity and reactogenicity of Td booster immunization in early preadolescents of Korea. Methods : Healthy preadolescents, who had been vaccinated with 4 or 5 doses of DTaP vaccines until 6 years old age, were enrolled in this study from August 2006 to April 2007. Diphtheria and tetanus anti-toxoid antibodies in sera were measured by ELISA just before vaccination and 4 weeks after vaccination to evaluate immunogenicity. Local and systemic adverse reactions observed for 4 weeks after vaccination to access reactogenicity. Results : 183 preadolescents were enrolled and mean age was $11.40{\pm}0.51$ years old. All subjects achieved seroprotective diphtheria and tetanus anti-toxoid antibodies (titers ${\geq}0.1IU/mL$) after Td booster vaccination. Among 183 vaccinees, 73.8% showed local adverse reactions and 37.2% systemic adverse reactions. Pain at injection site (66.1%) was the most common local reaction, and the most commonly shown systemic reaction was myalgia (17.5%). The adverse reactions were spontaneously relieved within three days after vaccination. Conclusion : Td vaccine in this study was high immunogenic and showed an acceptable tolerance in Korean preadolescents. Td booster vaccination at 11-12 years old is the most effective method to increase compliance of the vaccination and to decrease the incidence of diphtheria and tetanus.

The Diagnosis of Pneumoniae Following Bone Marrow Transplantation by Bronchoscopy (골수이식후 기관지내시경을 이용한 폐렴의 진단)

  • Kim, Tae-Yon;Yoon, Hyeong-Kyu;Moon, Hwa-Sik;Park, Sung-Hak;Min, Chang-Ki;Kim, Chun-Choo;Jung, Jung-Im;Song, Jeong-Sup
    • Tuberculosis and Respiratory Diseases
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    • v.49 no.2
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    • pp.198-206
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    • 2000
  • Background : Pulmonary complications following bonemarrow transplantation (BMT) are common and associated with a high mortality rate. We investigated the yield, safety, and impact of fiberoptic bronchoscopy (FOB) for diagnosis of postBMT pneumoniae. Methods : From May 1997 to April 2000, 56 FOBs were performed in 52 post BMT patients for clinical pneumoniae. BMT patients with respiratory symptoms and/or pulmonary infiltrates had a thoracic HRCT(high resolution computed tomography) and bronchoscopic examination including BAL (bronchoalveolar lavage), TBLB (transbronchial lung biopsy), PSB (protected specimen brush). Results : The characteristics of the subjects were as follows : 37 males, 15 females, mean age of 31.3 years(l7-45), 35 sibling donor allogenic BMTs, 15 nonrelated donor allogenic BMTs, and 2 autologous BMTs. Fiftynine percent of FOBs (33 FOBs, 31 patients) were diagnostic. Isolated pathogens included the following : 12 cytomegalovirus (CMV) (21.4 %), 7 pneumocystis carinii (PC) (12.5 %), 11 CMV with PC (19.6 %), 2 Mycobacaterium tuberculosis (3.6%), and 1 streptococcus (1.8%). Most of the radiographic findings were diffuse interstitial lesions. CMV pneumoniae had mainly diffuse interstitial nodular lesion, and PC pneumoniae had diffuse, interstitial ground glass opacity(GGO). When CMV was accompanied by PC, a combined pattern of nodular and GGO was present. Of the 56 cases (23.2%), 13 died of CMV pneumoniae (n=2), PCP (n=2),mixed infection with CMV and PC (n=3), underlying GVHD (n=1), underlying leukemia progression (n=1), or respiratory failure of unknown origin (n=4). There was no major complication by bronchoscopy. Only 3 cases developed minor bleeding and 1 episode temporary hypoxemia. Conclusion : Based on our findings, CMV and PC are the major causes of postBMT pneumoniae. In addition, BAL can be considered a safe and accurate procedure for the evaluation of pulmonary complications after BMT.

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EFFECTS OF SEDATIVE DRUGS FOR MANAGEMENT IN CHILDREN (약물 투여시 아동의 행동조절 효과)

  • Choi, Nam-Ki;Jeong, Byung-Cho;Yang, Kyu-Ho
    • Journal of the korean academy of Pediatric Dentistry
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    • v.29 no.3
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    • pp.304-312
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    • 2002
  • The purpose of this study was to assess the sedative effects of four kinds of medication for management in the uncooperative 64 children aged from 18 to 92 months(ASA class I) and weighting between 10 and 32 kg. They were given randomly a dose of chloral hydrate 75mg/kg and hydroxyzine 25mg orally(group 1), midazolam 0.1mg/kg intramuscularly and $N_2O$(group 2), group 1 with additional $N_2O$(group 3) and group 1 with additional midazolam 0.5cc intranasally(group 4), respectively. According to rating scale, sleep, crying, movement and overall behavior were checked for evaluation of the clinical sedative effects. They were restraind with Pediwrap and were monitored by pulse oximeter for safety during treatment period. The results were as follows : 1. In the evaluation of sleep, rating scale of chloral hydrate and hydroyzine combination group was superior to midazolam and $N_2O$ combination group(p<0.001), but there was no significant difference between chloral hydrate, hydroxyzine and $N_2O$ combination group and chloral hydrate, hydroxyzine and midazolam combination group. 2. In the evaluation of crying, movement and overall behavior, there were significant differences between chloral hydrate and hydroxyzine combination group and midazolam and $N_2O$ combination group(p<0.05), but no significant difference between chloral hydrate, hydroxyzine and $N_2O$ combination group and chloral hydrate, hydroxyzine and midazolam combination group. 3. In the evaluation of overall behavior, the mean score of chloral hydrate and hydroyzine combination group was 2.94, midazolam and $N_2O$ combination group 2.07, chloral hydrate, hydroxyzine and $N_2O$ combination group 2.47 and chloral hydrate, hydroxyzine and midazolam combination group 2.24, respectively. 4. Evidence of adverse effect was not detected or reported during and/or after dental treatment.

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