• Title/Summary/Keyword: spontaneous methods

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Patterns of Spontaneous Adverse Events Reporting on Human Papillomavirus Vaccines according to the Applicability of Brighton Collaboration Criteria in Korea from 2008 to 2017 (국내 사람유두종바이러스백신 접종 후 자발적 이상반응 보고사례의 Brighton Collaboration 기준 활용 가능성 연구)

  • Kim, Myo-Song;You, Seung-Hun;Park, Hye Min;Lee, Min-Taek;Kang, Ye-Jin;Koo, Hyunji;Jung, Sun-Young
    • Korean Journal of Clinical Pharmacy
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    • v.30 no.1
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    • pp.19-30
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    • 2020
  • Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

Surgery versus Conservative Treatment for Spontaneous Supratentorial Intracerebral Hemorrhage in Spot Sign Positive Patients

  • Kim, Hui-Tae;Lee, Jong-Myong;Koh, Eun-Jeong;Choi, Ha-Young
    • Journal of Korean Neurosurgical Society
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    • v.58 no.4
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    • pp.309-315
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    • 2015
  • Objective : An advantage of surgical treatment over conservative treatment of spontaneous intracerebral hemorrhage (ICH) is controversial. Recent reports suggest that contrast extravasations on CT angiography (CTA) might serve as a crucial predictor of hematoma expansion and mortality. The purpose of this study was aimed at investigating the efficacy of surgical treatment in patients with spot sign positive ICH. Methods : We used our institutional medical data search system to identify all adult patients who admitted for treatment of ICH between January 1, 2007 and January 31, 2012. Patients were classified two groups into a surgical group (n=27) and a conservative treatment group (n=28). Admission criteria were the following: age 20-79 years, spontaneous supratentorial ICH, Glasgow Coma Score Ranging from 9 to 14, ICH volume ${\geq}20mL$, and treatment within 24 hours. Results : Fifty-five patients were analyzed. There was no significant difference in the ICU stay between the conservative treatment group ($7.36{\pm}3.66days$) and the surgical treatment group ($6.93{\pm}2.20days$; p=0.950). There was a significant difference in the in-hospital stay between the conservative treatment group ($13.93{\pm}8.87days$) and the surgical treatment group ($20.33{\pm}6.37days$; p=0.001). Overall mortality at day 90 after ICH was 36.4%; this included 16 of 28 patients (57.1%) in the conservative group and 4 of 27 patients (14.8%) in the surgical group. In univariate analysis, there was a positive effect of the surgical treatment in reducing mortality at 90 days (p=0.002), Glasgow Outcome Scale (GOS) at 90-day (p=0.006), and modified Rankin Scale (mRS) at 90-day (p=0.023). In multivariate logistic analysis, there was a significant difference in mortality (odds ratio, 0.211; 95% confidence interval, 0.049-0.906; p=0.036) between the groups at 90-day follow-up. However, there was no significant difference in GOS (odds ratio, 0.371; 95% confidence interval, 0.031-4.446; p=0.434) and mRS (odds ratio, 1.041; 95% confidence interval, 0.086-12.637; p=0.975) between the groups at 90-day follow-up. Conclusion : In this study of surgical treatment of supratentorial ICH in patients with spot sign positive in CTA was associated with less mortality despite of long duration of in-hospital stay. We failed to show that clinical outcome benefit of surgical treatment compared with conservative treatment in patients with spot sign positive ICH.

Comparative Analysis of Spontaneous Infectious Spondylitis : Pyogenic versus Tuberculous

  • Lee, Yangwon;Kim, Bum-Joon;Kim, Se-Hoon;Lee, Seung-Hwan;Kim, Won-Hyung;Jin, Sung-Won
    • Journal of Korean Neurosurgical Society
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    • v.61 no.1
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    • pp.81-88
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    • 2018
  • Objective : Spondylitis is often chemotherapy resistant and requires long-term treatment. Without adequate chemotherapy, the outcome can be fatal or result in severe neurologic damage. Therefore, differentiating the etiology of spondylitis is very important, particularly in spontaneous cases. As the prevalence of tuberculosis in Korea has decreased in recent years, updated clinical research about spondylitis is warranted. Methods : From April 2010 to March 2016, data from spondylitis patients were collected retrospectively. In total, 69 patients (51 with pyogenic spondylitis and 18 with tuberculous spondylitis) were included. Clinical data, laboratory findings including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) level, measurements of Cobb angles at the initial and final follow-up, and radiologic features on magnetic resonance imaging (MRI) scans were evaluated. To test differences between the pyogenic and tuberculous groups, numerical data were compared using the student's t-test and Mann-Whitney U test, and categorical data were compared using the chi-square test and Fisher's exact test. Results : The patients' mean age was 60.0 years. Male sex was slightly predominant (56.5%). There was no difference in mean age and sex between the two groups. The pyogenic group had a relatively higher proportion of immunocompromised patients. The peak CRP value was higher in the pyogenic group than in the tuberculous group (14.08 mg/dL and 8.50 mg/dL, respectively, p=0.009), whereas the ESR was not significantly different between the groups (81.5 mm/h and 75.6 mm/h, respectively, p=0.442). Radiologically, the presence of disc space sparing and vertebral body collapse differed between the groups. In the tuberculous group, the disc was more commonly preserved on contrast-enhanced MRI (50% and 23.5%, respectively, p=0.044), and vertebral body collapse was more common (66.6% and 15.7%, respectively, p<0.001). The mean length of hospitalization was longer in the pyogenic group (56.5 days and 41.2 days, respectively, p=0.001). Four mortality cases were observed only in the pyogenic group. The most commonly isolated microorganism in the pyogenic group was Staphylococcus aureus(S. aureus) (methicillin susceptible S. aureus and methicillin resistant S. aureus [MRSA] in 8 and 4 cases, respectively). Conclusion : The clinical and radiological manifestations of spontaneous spondylitis differ based on the causative organism. Pyogenic spondylitis patients tend to have a higher CRP level and a more severe clinical course, whereas tuberculous spondylitis patients present with destruction of the vertebral body with disc sparing more frequently. The presence of MRSA is increasing in community-acquired spondylitis cases.

Surgical Treatment for Spontaneous Pneumothoraxl (자연기흉의 수술적 치료 -123례의 분석-)

  • 장인석;김성호
    • Journal of Chest Surgery
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    • v.29 no.4
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    • pp.403-407
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    • 1996
  • One hundred and twenty three patients underwent 137 thoracostomies for spontaneous pneumothorax in the department of Thoracic and Cardiovascular Surgery, Gyeongsang National University from January 1987 to December 1994. There were 118 men and 6 women and average age was )2.4 years. The two most common surgical Indications were recurrent pneumothorax and continuous air leakage. Other indications were visible bullae on simple X-ray, previous contralateral pneumothorax, incomplete expansion of the lung, and bilateral pneumothoraces. Methods of thoracotomy were subaxillary thoracotomy in 82 cases, lateral minithoracotomy in 12 cases and posterolateral thoracotomy in 43 cases. Operation time was 63.0 $\pm$ 30.8, 98.3 $\pm$ 37.9, 186.9 $\pm$ 87.9 minutes respectively, and postoperative chest tube keeping time was 5.2 $\pm$ 4.1 days in subaxillary thoracotomy, 6.2 $\pm$ 5.0 days in minithoracotomy and 10.0 $\pm$ 5.8 days in posterolateral thoracotomy Bullae were present mostly at the apex in spontaneous and tuberculous pneumothorax comparred to the cases of chronic obstructive or emphysematous lung disease, where there were no redilection of presence of bullae (p< 0.01). Operative procedures were wedge resection, bullae obliteration and lobectomy. Postoperative complications were continuous air leakage, bleeding, brachial plexus injury, empyema, and wound infection, but all the complications were cured by the time of discharge. There was no mortality.

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Polymorphisms of 5,10-Methylenetetrahydrofolate Reductase (MTHFR C677T and A1298C) Gene in Recurrent Spontaneous Abortion (5,10-Methylenetetrahydrofolate Reductase (MTHFR C677T와 A1298C) 유전자 돌연변이의 반복자연유산 관련성 연구)

  • Kim, Nam-Keun;Nam, Yoon-Sung;Lee, Su-Man;Kim, Sun-Hee;Shin, Seung-Joo;Chang, Sung-Woon;Kim, Se-Hyun;Cha, Kwang-Yul;Oh, Do-Yeun
    • Clinical and Experimental Reproductive Medicine
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    • v.29 no.3
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    • pp.215-222
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    • 2002
  • Objective : Previous studies have suggested that hyperhomocysteinemia and methylenetetrahydrofolate reductase (MTHFR C677T) mutations are associated with increased risk of recurrent spontaneous abortion (RSA). Recently, a second site polymorphism in MTHFR, 1298A-->C, which changes a glutamic acid into an alanine residue, was shown to be associated with a decreased enzyme activity. We tested whether the variant alleles of MTHFR C677T and A1298C are risk factor (biomarker) for RSA. Materials and Methods: We analyzed DNA from a case-control study in the Korean DNA was extracted from blood samples of 118 patients with RSA and 123 healthy fertile patients as the controls. MTHFR variant alleles were determined by a PCR-restriction fragment length polymorphism assay. Results: We found no evidence for an association between 677TT genotype and risk of RSA (OR=1.95, 95% CI=$0.84{\sim}4.50$, p=0.12). However, the MTHFR 1298AC (OR=0.36, 95% CI=$0.20{\sim}0.63$, p=0.0004) and 1298AC+CC (OR=0.35, 95% CI=$0.20{\sim}0.61$, p=0.0002) genotypes were lower among 118 RSA cases compared with 123 controls, conferring a 2.8-fold decrease in risk of RSA, respectively. Moreover, the combined genotypes of MTHFR 677CC/1298AC (OR=0.30, 95% CI=$0.10{\sim}0.88$, p=0.029) and 677CT/1298AC (OR=0.77, 95% CI=$0.60{\sim}0.99$, p=0.043) also showed significantly lower risk than those with MTHFR 677CC/1298AA type. Conclusion: MTHFR 1298AC, MTHFR 677CC/1298AC and 677CT/1298AC genotypes may represent genetic markers for the protection of RSA at least in Korean women.

Usefulness of Small Caliber Catheter Insertion for a Spontaneous Pneumothorax (자연 공기가슴증 치료에서 소구경 도관 흉강삽입술의 유용성)

  • Kim, Eun Jung;Yoon, Sung Ho;Lee, Seung Il;Kwon, Yong Eun
    • Tuberculosis and Respiratory Diseases
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    • v.67 no.1
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    • pp.27-31
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    • 2009
  • Background: The large caliber catheter used in the treatment of pneumothorax causes great damage to the chest wall and organs. The purpose of this study was to prove that the use of a smaller caliber catheter is effective in treating pneumothorax with decreasing admission period and that the recurrence rate of spontaneous pneumothorax is low. Methods: Patients who had been admitted for treatment of first time occurrence of pneumothorax between May, 2004 and December, 2008 were included in the study. The caliber of catheter used this study is 18 Guage (1.2mm). The efficacy of treatment, admission period and recurrence rate of treating pneumothorax with small caliber catheter were compared to the control group using a tube thoracostomy for treatment. Results: The admission period for primary spontaneous pneumothorax was 10.8$\pm$3.6 days for the group (n=68) using tube thoracostomy compared to 4.5$\pm$1.3 days for the group (n=31) using the small caliber catheter (p<0.05). There was no statistically significant difference in recurrence rate between the two groups. Conclusion: The use of a smaller caliber catheter for the treatment of pneumothorax reduces the admission period without a significant increase in recurrence rates.

Influence Factors for Duration of Vancomycin Resistant Enterococci's Spontaneous Decolonization (반코마이신 저항 장구균의 자발적 집락 소실 기간에 대한 영향 인자)

  • Lee, Jae Sun;Kim, Dong Soo;Kim, Ki Hwan
    • Pediatric Infection and Vaccine
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    • v.22 no.1
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    • pp.16-22
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    • 2015
  • Purpose: The aim of this study was to identify the factors influencing the spontaneous decolonization period of vancomycin resistant enterococcus (VRE) species in pediatric patients. Methods: The medical records of patients presenting positive VRE cultures between January 2005 and November 2010 at a tertiary hospital in Seoul, Korea, were reviewed retrospectively. The subjects were divided into two groups according to the average number of days for decolonization (325 days). Clinical characteristics were compared between shorter VRE colonization patients (<325 days, n=41) and prolonged VRE colonization patients (>325 days, n=110). Results: There were 151 patients who had more than 1 year of follow up period or confirmed of VRE decolonization among patients who were identified with VRE. The average age at the time of initial VRE colonization was significantly younger in shorter decolonization group than in prolonged decolonization group (44.9 months vs 40.9 months, P =0.040). The prolonged decolonization group received more vancomycin treatments after VRE colonization in comparison with patients in shorter decolonization group (7.0% vs 27.2%, P =0.008). Conclusion: For the duration of VRE colonization, it was found that the initial age of acquiring VRE and use of antibiotics were important factors. Antibiotics should be used properly and precisely in order to treat infectious diseases and to control the colonization of antibiotic resistant bacteria.

Association of Interleukin-27 rs 153109 Single Nucleotide Polymorphism with Spontaneous Resolution of Hepatitis C Virus - Genotype 4a Infection in Egyptian Patients

  • Fawzy, Mariam M;Wahid, Ahmed;Nazmy, Maiiada H;Hashem, Mohamed;Waked, Imam;Abdelwahab, Sayed F
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.4
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    • pp.2093-2097
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    • 2016
  • Background: HCV is a major global health problem. IL-27 is a member of the IL-6/IL-12 cytokine family with a broad range of anti-inflammatory properties. Recent studies highlighted the effect of a SNP in the IL-27 promoter region on modulating the progression of infectious diseases and individual responses to therapy. Aim of the work: The present study investigated the potential role of (-964 A/G) SNP in the promoter region of IL-27p28 gene (alleles rs153109) on the outcome of HCV infection among genotype 4a infected patients. Materials and Methods: HCV genotyping confirmed that all of the HCV-infected patients had genotype 4a infection. Genomic DNA was extracted from 111 patients with chronic HCV infection, 42 spontaneous resolvers (SR) and 16 healthy controls. IL- 27p28.rs153109 genotyping was assessed using PCR-RFLP then confirmed by DNA sequencing. Results: The frequency of IL-27-p28.rs153109AA, AG, and GG genotypes among chronically infected subjects were 74.8 %, 25.2%, and 0% while among the SR, they were 57.1%, 35.7%, and 7.14%, respectively. Our data show the unique presence of G/G genotype in the SR group (3 patients; 7.14%). Moreover, the "G" allele frequencies among chronic and resolved subjects were 12.6% and 25.0%, respectively (p=0.0136). Importantly, subjects with the GG genotype were more likely to clear their HCV infection than those with the AA genotype (p=0.0118). Conclusions: HCV genotype 4a subjects with the IL-27-p28.rs153109 A/G and G/G genotype were more likely to clear their HCV infection. Therefore, we propose IL- 27p28.rs153109SNPas a genetic biomarker for predicting HCV infection outcome.

Morphological Studies on Hair Growth Effect of Samultang-gamibang (사물탕가미방(四物湯加味方)이 원형탈모 생쥐의 발모효과에 관한 형태학적 연구)

  • Kwon, Gang-Joo;Lee, Chang-Hyun;Lee, Moon-Won;Mun, Yeun-Ja;Choi, Doo-Ho;Lee, Hak-Jae;Kim, Ho-Min;Woo, Won-Hong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.19 no.3
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    • pp.696-704
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    • 2005
  • This experiment examined the effect of Samultang-gamibang (SGB) on hair growth in spontaneous alopecia areata C57BL/6N mice. We first investigated hair growth effect of SGB compare to control groups after apply to oral administration for 10 weeks and regional treatment in skin for last 4 weeks. We second investigated the number of hair follicle and mast cells after treatment of SGB in spontaneous alopecia areata C57BL/6N mice for 10 weeks. We third investigated immunoreactive density of neuropeptides in skin of spontaneous alopecia areata C57BL/6N mice by immunohistochemical methods. The results were as follows : Hair growing effect of experimental group was observed from 7 weeks after administration of SGB (87.5%). In experimental group, the number of mast cells and eosinophils was significantly decreased compare to control group. Immunoreactive density of substance P and corticotropin releasing factor (CRF) in skin of experimental group was weakly stained in epidermis and subcutaneous tissue compare to control group. Immunoreactive density of CRF-receptor (CRF-R), CRF-binding protein (CRF-BP) in skin of experimental group was increased in epidermis, sebaceous gland, inner root sheath, outer root sheath and secondary hair germ epithelium compare to control group. These results suggest that SGB may be used in treatment of alopecia areata.

Comparison of Sugammadex and Neostigmine on First Spontaneous Breathing and Adverse Effects for Laparoscopic Cholecystectomy (Laparoscopic Cholecystectomy 수술 후 Sugammadex와 Neostigmine 간에 첫 자발호흡과 부작용 발현 연구)

  • Park, HyunSuk;Park, Moon Soo;Kim, Min Jung;Kim, Kwi Suk;Cho, Yoon Sook;Bae, Seng Sim;Rhie, Sandy Jeong
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.2
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    • pp.101-106
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    • 2018
  • Objective: The purpose of the study was to investigate the time from the injection of muscle relaxants to the first spontaneous respiration between sugammadex and conventional reversal for patients undergoing laparoscopic cholecystectomy. Methods: This study was retrospectively conducted on patients who were diagnosed with gallbladder stone (N802) between January 2014 and April 2017. The data were collected from the electronic medical records of a total of 186 patients (84 patients in the neostigmine group and 102 patients in the sugammadex group). Results: The time required for the first spontaneous respiration in the sugammadex group was shorter than that in the neostigmine group (3.6 min vs 4.9 min; p<0.05). After the injection of intermediate muscle relaxants, the comparison of heart rate and mean arterial pressure in the sugammadex and neostigmine groups revealed that the heart rate in the neostigmine group was higher than in the sugammadex group after 5 min (p<0.05). The mean arterial pressure in the neostigmine group was higher than in the sugammadex group after 10 min (p<0.05). A significant adverse effect of tachycardia was observed in the neostigmine group (p<0.05), but the frequency of rescue antiemetic in the sugammadex group was significantly higher than in the neostigmine group (p<0.05). Conclusion: In this study, the unwanted effect of neostigmine group was tachycardia; therefore, in the case of patients with hemodynamic instability, sugammadex is recommended. At 12 hours after the injection of sugammadex to patients, more antiemetics were required than in the neostigmine group; therefore, more research should be conducted on postoperative nausea and vomiting.