• 제목/요약/키워드: Adverse reactions

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Plateletpheresis: the Process, Devices, and Indicators of Product Quality (혈소판성분채집술: 채집과정, 장비, 성분채집혈소판 질의 지표들)

  • Jang, Chul-Soo;Kim, Sung-In;Kim, Hyun-Kyung;Kweon, Chang-Oh;Kim, Byung-Won;Kim, Dong-Chan;Kim, Yoon Suk;Rhee, Ki-Jong;Ryu, Jae-Ki
    • Journal of Life Science
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    • v.24 no.9
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    • pp.1030-1038
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    • 2014
  • Platelet products are used to treat hemorrhagic or platelet dysfunction diseases. Plateletpheresis involves collecting the platelet components of blood using an apheresis blood-collection system. Various indicators are available for evaluating the qualities of the apheresis platelets. The productivity of platelet collection is evaluated through both the collection efficiency and collection rates. Platelet storage quality can be evaluated in vitro using several indicators, including visual appearance, metabolic activities, volume, platelet count, white blood cell count, microparticles, and various platelet activation markers. Platelet activation markers have been used as indicators of storage quality in various studies. Post-transfusion platelet quality can be evaluated based on the corrected count increment and the percentage of platelet recovery. Although various studies have investigated the aspects of plateletpheresis, no article has systemically presented assessments of the platelet products obtained from different plateletpheresis devices. The present study provides a review of plateletpheresis, including the specifics of the process, the types of devices employed, the platelet quality, the overall efficacy, and the evaluation indicator qualities. Furthermore, the differences in functionality among the different apheresis devices are discussed. Although adverse reactions to the citrate anti-coagulant have been reported, apheresis processing may provide a safer option for donors who are at a high risk for presyncopal or syncopal reactions related to whole blood collection.

Economic Value of the Sirolimus Eluting Stent($CYPHER^{TM}$) in Treating Acute Coronary Heart Disease (관상동맥질환 치료를 위한 시롤리무스 방출 스텐트 ($CYPHER^{TM}$)의 경제성 분석)

  • Lee, Hoo-Yeon;Park, Eun-Cheol;Park, Ki-Dong;Park, Ji-Eun;Kim, Young;Lee, Sang-Soo;Kang, Hye-Young
    • Journal of Preventive Medicine and Public Health
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    • v.36 no.4
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    • pp.339-348
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    • 2003
  • Objective : To quantify the economic value of the Sirolimus fluting Stent ($CYPHER^{TM}$) in treating acute coronary heart disease (CMD), and to assist in determining an adequate level of reimbursement for $CYPHER^{TM}$ in Korea. Methods : A decision-analytical model, developed by the Belgium Health Economics Disease Management group, was used to investigate the incremental cost-effectiveness of $CYPHER^{TM}$ versus conventional stenting. The time horizon was five years. The probabilities for clinical events at each node of the decision model were obtained from the results of large, randomized, controlled clinical trials. The initial care and follow-up direct medical costs were analyzed. The initial costs consisted of those for the initial procedure and hospitalization, The follow-vp costs included those for routine follow-up treatments, adverse reactions, revascularization and death. Defending on the perspective of the analysis, the costs were defined as insurance covered or total medical costs (=sum of insurance covered and uncovered medical costs). The cost data were obtained from the administrative data of 449 patients that received conventional stenting from five participating Korean hospitals during June 2002. Sensitivity analyses were peformed for discount rates of 3, 5 and 7%. Since the major clinical advantage of $CYPHER^{TM}$ over conventional stenting was the reduction in the revascularization rates, the economic value of $CYPHER^{TM}$, in relation to the direct medical costs of revascularization, were evaluated. If the incremental cost of $CYPHER^{TM}$ per revascularization avoided, compared to conventional stenting, was no higher than that of a revascularization itself, $CYPHER^{TM}$ would be considered as being cost-effective. Therefore, the maximum acceptable level for the reimbursement price of $CYPHER^{TM}$ making the incremental cost-effectiveness ratio equal to the cost of a revascularization was identified. Results : The average weighted initial insurance covered and total medical costs of conventional stenting were about 6,275,000 and 8,058,000 Won, respectively. The average weighted sum of the initial and 5-year follow-up insurance covered and total medical costs of conventional stenting were about 13,659,000 and 17,353,000 Won, respectively. The estimated maximum level of reimbursement price of $CYPHER^{TM}$ from the perspectives of the insurer and society were $4,126,897{\sim}4,325,161$ and $4,939,939{\sim}5,078,181$ Won, respectively. Conclusion : By evaluating the economic value of $CYPHER^{TM}$, as an alternative to conventional stenting, the results of this study are expected to provide a scientific basis for determining the acceptable level of reimbursement for $CYPHER^{TM}$.

The Effect of Adjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma after Induction Chemotherapy (국소진행 두경부 상피세포암에서 선행유도약물요법 후 보조약물요법의 효과)

  • Kim Cheol-Woo;Roh Jae-Kyung;Ahn Joong-Bae;Park Joon-Oh;Chung So-Young;Lee Seok;Lee Hey-Ran;Lee Kyung-Hee;Chung Hyun-Cheol;Kim Joo-Hang;Kim Byung-Soo;Suh Chang-Ok;Kim Gwi-Eon
    • Korean Journal of Head & Neck Oncology
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    • v.10 no.1
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    • pp.13-24
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    • 1994
  • Despite optimal local therapy such as surgery and/or radiotherapy, the long term outcome is poor for patients with advanced squamous cell carcinomma of head and neck, due to frequent loco-regional recurrence and distant metastases. We studied to determine whether the combination chemotherapy, especially as an adjuvant chemotherapy, would improve the survival of these patients. Between January, 1986 and December, 1992, 57 patients with previously untreated, locally advanced squamous cell arcinoma of head and neck were assigned to receive 2-3 cycles of induction chemotherapy consisting of 5-fluorouracil(F) and cisplatin(P) every 3 weeks and standard local therapy such as surgery and/or radiotherapy followed by adjuvant chemotherapy with the same FP regimens. Of the 57 enroled patients, 45 patients were evaluable. The obtained results were as following: 1) Among 45 evaluable patients, 18 patients finished all treatment protocol including adjuvant chemotherapy and 27 patients had no adjuvant chemotherapy. The difference of age, sex, performance status, disease stage, and tumor differentiation was not significant statistically between adjuvant chemotherapy group and no-adjuvant chemotherapy group. 2) After induction chemotherapy, 7/45(15.4%), 30/45(67%) achieved complete remission and partial remission respectively with 82.4% overall response rates in entire patients. 3) The 4year progression free survival was 43.3% in adjuvant chemotherapy group and 24.1% in no-adjuvant chemotherapy group(p>0.05). The 4year overall survival was 56.9% and 25.5% respectively(p>0.05). There was no significant different in the patterns of local recurrence and distant metastasis between the two groups. 4) Adverse reactions from combination chemotherapy included nausea, vomiting, mucositis, diarrhea and hematologic bone marrow depression. These were mild and tolerated by patients, and these was no episode of any life threatening toxicities. In conclusion, adjuvant chemotherapy after induction chemotherapy and local therapy did not show statistically significant survival improvement, but there was trend of prolongation of survival when compared to no adjuvant chemotherapy. Thus, large scale phase III randomized controlled studies are strongly recommended.

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The Effectiveness of Intravenous Immunoglobulin for Clinically Suspected Neonatal Sepsis (임상적으로 의심되는 신생아 패혈증에서 정맥용 면역 글로불린의 치료 효과)

  • Na, Hyun Jung;Kim, Ji Young;Lee, Gyeong Hoon;Lee, Jun Hwa;Choi, Eun Jin;Kim, Jin Kyung;Chung, Hai Lee;Kim, Woo Taek
    • Clinical and Experimental Pediatrics
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    • v.48 no.11
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    • pp.1187-1192
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    • 2005
  • Purpose : The purpose of this study is to determine the effectiveness of intravenous immunoglobuin (IVIG) administration in fullterm neonates having clinically suspected neonatal sepsis. Methods : Forty full-term neonates admitted to the neonatal intensive care unit with clinically suspected neonatal sepsis, who had at least two positive diagnostic criteria were enrolled. Twenty neonates were enrolled into the IVIG arm and 20 in the placebo arm. Neonates with a gestational age of less than 36 weeks and those with any major congenital malformation were excluded. The neonates were randomized to receive 1 g/kg of IVIG or equivalent amount of normal saline. The treatments including antibiotics and supportive care were administered. Results : The neonates in the therapy and placebo groups were comparable in terms of birth weight, gestational age, sex distribution, duration of antibiotics therapy and admission, elevation of serum IgG level, mortality rate, change of CBC, and serum level of acute phase reactants etc. Conclusion : Serum IgG values increased significantly 5 days after administration of IVIG in the IVIG-treated group and decreased significantly 5 days after administration of normal saline in the placebo group. However, there was no significant difference in the duration of antibiotics therapy and admission, or of mortality between the IVIG-treated and placebo groups. No adverse reactions to the IVIG infusions were noted during the study. Our preliminary observations suggest that the administration of 1 g/kg IVIG to neonates had some effect on augmentation of humural immune status in neonates with clinically suspected sepsis. But further study is needed to verify the benefit of IVIG infusion to neonatal sepsis.

Montelukast as an add-on therapy in bronchopulmonary dysplasia (기관지폐 이형성증의 추가 치료제로서의 Montelukast)

  • Kim, He Min;Song, Ji Eun;Lee, Soon Min;Park, Min Soo;Park, Kook In;Namgung, Ran;Lee, Chul
    • Clinical and Experimental Pediatrics
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    • v.52 no.2
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    • pp.181-186
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    • 2009
  • Purpose : Inflammation plays a potential role in the pathogenesis of bronchopulmonary dysplasia (BPD). Strategies for preventing BPD include respiratory management, antioxidants, nutritional treatment, and others such as anti-inflammatory agents. We aimed to assess the safety, tolerability, and efficacy of montelukast (MK), a cysteinyl leukotriene 1 receptor antagonist, as an add-on therapy in BPD. Methods : In addition to currently available standard measures such as oxygen supplementation, bronchodilators, nutritional support, and/or diuretics, montelukast was administered to 15 preterm infants with BPD. MK was given orally (1 mg/kg/d) for a mean period of 12 weeks. We compared safety and efficacy parameters with historical controls. Results : All 15 patients survived, and no differences were found in the incidence of adverse reactions between the 2 groups. The ventilation index was significantly improved after 2 weeks in MK group compared with historical controls. There were no significant differences in other respiratory parameters (MAP, oxygen dependency, and ventilator dependency) between the groups, but the MK group showed trends of greater improvement. Conclusion : Administration of MK 1 mg/kg/d was well tolerated in preterm BPD patients as an add-on therapy. We demonstrated that after 2 weeks of MK administration of 1 mg/kg/d, MK had beneficial therapeutic effects on BPD patients as an add-on to the standard therapy. Further multicenter randomized controlled clinical trials are needed to confirm the efficacy and safety of MK as a useful supplement to standard therapy for BPD patients.

A CASE OF TREATMENT-RESISTANT CHILDHOOD-ONSET SCHIZOPHRENIA WITH LONG-TERM TRIAL OF CLOZAPINE (치료저항성 소아기 발병 정신분열증의 Clozapine 장기치험 1례)

  • Jang, Soon-Ah;Kim, Kyung-Hee;Lee, Hong-Shick;Song, Dong-Ho
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.9 no.1
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    • pp.98-104
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    • 1998
  • A 12-year-old girl with a 6 year history of childhood-onset schizophrenia required 2 hospitalizations and long-term clozapine trial due to inadequate responses to combinations of typical neuroleptics and traditional treatments of schizophrenic disorder. On admission, she had continuous auditory and visual hallucinations, persecutory delusion, emotional instability, regression of behaviors including temper tantrums as well as specific developmental delays in learning, language, and motor coordination. The clozapine trial significantly reduced most of the positive symptoms, and facilitated in successful discharge from the hospital. During the 4 year clozapine treatment, no significant adverse reactions were noted, and she returned to a structured school setting with minimal degrees of schizophrenic symptoms. From this clinical experience, we suggest that clozapine might be safe and effective in treating treatment-refractory schizophrenic children.

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THE EFFECT OF RISPERIDONE ON SALIVARY GLAND CELLS (리스페리돈이 타액선 세포에 미치는 영향)

  • Lee, Yeon-Joo;Kim, Yeong-Jae;Kim, Jung-Wook;Jang, Ki-Taek;Kim, Chong-Chul;Hahn, Se-Hyun;Lee, Sang-Hoon
    • Journal of the korean academy of Pediatric Dentistry
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    • v.35 no.1
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    • pp.47-56
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    • 2008
  • Risperidone is a widely prescribed atypical antipsychotic agent. Approved by the FDA as the first drug to treat irritability associated with autism in children, it is also used to treat tic disorder and Tourette's syndrome. Its adverse reactions related to dentistry include dry mouth, the mechanism of which is yet to be identified. The aim of this study is to identify, at the cellular level, how and to what extent risperidone affects intracellular free calcium concentration ($[Ca^{2+}]_i$), an primary intracellular factor in the regulation of fluid secretion in salivary gland cells. The human salivary gland cell line (HSG) was grown in MEM supplemented with 10% BCS. In order to measure $[Ca^{2+}]_i$, Fura-2/AM was loaded in the HSG, and fluorescence at 340 nm/380 nm excitation was measured in the 500 nm emission ratio. After every experiment, a calibration experiment was conducted in order to readjust the ratio to the actual $[Ca^{2+}]_i$. Changes in $[Ca^{2+}]_i$ were measured in the presence of carbachol, ATP and histamine. The researcher then explored how the pretreatment of risperidone affected such changes. Findings of this study include: 1. In HSG, $[Ca^{2+}]_i$ increased due to the addition of carbachol, ATP and histamine. The presence of risperidone inhibited the action of histamine on this process, while making little effect on that of carbachol and ATP. 2. A quantification of $[Ca^{2+}]_i$ in relation to histamine of different concentrations indicates that the effect of histamine was concentration dependent with an $EC_{50}$ of $3.3{\pm}0.5\;{\mu}M$. 3. The inhibitory effect of risperidone on histamine-induced $[Ca^{2+}]_i$ was concentration-dependent with an $IC_{50}$ of $104.4{\pm}14\;nM$. 4. Risperidone inhibits histamine-induced Ca2+ release from endoplasmic reticulum and influx of extracellular $Ca^{2+}$ in HSG cells(p<0.05).

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Improvement of Melanin Production and Skin Tone by Fullerene Serum (플러린 함유 세럼의 멜라닌색소 및 피부톤 개선 효과)

  • Lim, Hyun-Sook;Lee, Mi-Bun;Lee, Jae-Nam
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.6
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    • pp.455-464
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    • 2018
  • This study investigated whether the whitening effects of fullerene serum occurred through improvement of melanin production and skin tone and evaluated its potential for use as a cosmetic material for adult women aged 30-55 with dull skin color and pigmentation. Subjects were divided into a control group with fullerene-less serum (B) and an experimental group with serum containing 0.1% fullerene (A) and evaluated over 8 weeks. Visual assessment and measurement of skin conditions (melanin index, skin brightness) were conducted before use of and 4 and 8 weeks after use of the product, and a questionnaire survey and safety assessment were conducted at the end of the experiment. The results revealed that the highest decrease was 0.37% in the experimental group (A) after eight weeks of use of the product, but that this difference was not statistically significant. Moreover, no significant differences were observed upon inter-group comparison. Evaluation of changes in the melanin index and inter-group comparison revealed a significant decline in the experimental group (A) at all time points. Additionally, the $L^*$ value (skin brightness) of the experimental group (A) showed a significant increase (improvement) after eight weeks, while in inter-group comparison revealed a significant increase (improvement) at all time points (4 and 8 weeks later) (p<0.05). Based on a questionnaire survey of efficacy, positive response rates such as improvement of the target parts on week 8 were high in terms of 'improvement of skin color.' Moreover, the safety assessment revealed no adverse reactions. In conclusion, serum containing 0.1% fullerene revealed improved melanin production and skin tone (brightness) and confirmed its potential for use as a cosmetic material with brightening efficacy. Taken together, the results of this study indicate systematic investigation of the effective application and cosmetics formulations of this product are warranted.

Pharmacogenetic Impact on Korean Patients Receiving Antiepileptic Drugs (항전간제를 투여받은 한국인 환자에서의 약리유전학적 영향)

  • Kim, Jeong-Oh;Lee, Han-Hee;Shin, Jung-Young;Zhang, Xiang Hua;Oh, Ji-Eun;Kim, Yeong-In;Lee, Jeong-Hyun;Kang, Jin-Hyoung
    • Journal of Life Science
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    • v.22 no.8
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    • pp.1057-1063
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    • 2012
  • Epilepsy is the most prevalent chronic neurological disorder and can be controlled by antiepileptic drugs (AEDs) in up to 70% of patients. We performed an association study between adverse drug reactions and the genetic polymorphisms of CYP2C9, CYP2C19, ABCB1, and SCN1A. The clinical data of 83 epilepsy patients who had received AEDs containing carbamazepine (CBZ) were collected. We extracted genomic DNA from peripheral blood and then genotyped CYP2C9 ($CYP2C9^*2$, $CYP2C9^*3$), CYP2C19 ($CYP2C9^*2$, $CYP2C9^*3$), ABCB1 (C3435T), and SCN1A (IVS5N+5 G>A) using direct sequencing. The allele frequencies of $CYP2C9^*3$, $CYP2C9^*2$, $CYP2C9^*3$, ABCB1 (3435C>T), and SCN1A (IVS5N+5 G>A) were 0.93, 0.72, 0.91, 0.61, and 0.55, respectively. Statistically significant differences were indicated from the data obtained. Patients with SCN1A genotype CC or CT were compared with patients with SCN1A genotype TT while using more than 500mg of carbamazepine. We have associated functional polymorphisms with the dose used in regular clinical practice for Korean epilepsy patients who had received antiepileptic drugs (AEDs) containing carbamazepine. For AEDs, we found that one of the SCN1A genotypes is associated with a 500 mg dose. There was no association found with CNS ADR caused by AEDs.

A Follow-Up Study of Cow's Milk-Sensitive Enteropathy: Clinical Outcome (우유 과민성 장병증(cow's milk-sensitive enteropathy)의 장기 추적관찰)

  • Song, Ae-Ryong;Choi, Eun-Jin;Han, Chang-Ho;Chung, Hai-Lee;Kwon, Young-Dae;Hwang, Jin-Bok
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.4 no.1
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    • pp.47-53
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    • 2001
  • Purpose: Following up the cases of cow's milk-sensitive enteropathy (CMSE), We observed the development of clinical tolerance with cow's milk and other foods. We investigated the clinical outcome of CMSE. Methods: We reviewed the clinical records of patients who had been admitted and diagnosed as CMSE by responses to cow's milk challenge and elimination test and the findings of small intestinal biopsy at Department of Pediatrics, Taegu Catholic University Hospital from March 1992 to March 1997. All of them were being fed with protein hydrolysate before 6 months old, and tried cow's milk and other foods challenge test at following each two month. Twenty-one cases of them returned to be followed. The age at admission was $30.7{\pm}8.8$ (18~47) days old and at survey was $43.4{\pm}23.7$ (16~84) months old. Results: 1) Although the body weight at birth of the patients was 25~75 percentile, all on admission was below 3 percentile. The body weight on interview was 25~75 percentile. 2) The development of clinical tolerance in cow's milk was observed at 16~24 months of age and the tolerance rate was 61% at 12 months of age, 90% at 16 months of age. The development of clinical tolerance in other foods was observed at 10~24 months of age and the tolerance rate was 33% at 12 months of age, 80% at 18 months of age. 3) Adverse reactions after challenge test with cow's milk were observed at 19 cases, manifestated as vomiting (31%), diarrhea (31%), irritability or lethargy (21%), skin rash (10%), and abdominal distention (5%). 4) Comparing serum IgE and milk RAST positive group on admission (5 cases) and negative group on admission (16 cases), there was no significant difference at the age of tolerance in cow's milk (p>0.05), the age of tolerance in other foods (p>0.05), allergy history in family, and the incidence of other allergic diseases. 5) The history of family allergy was observed in 3 cases (14%) in 21 patients and 3 cases (14%) showed rhinitis, urticaria or asthma through a follow-up interview. Conclusion: The development of clinical tolerance in cow's and other foods was sharply increased at 12 months of age and most of all tolerated within 24 months of age. CMSE is a temporary disorder of infancy.

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