• Title/Summary/Keyword: Adverse reactions

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Concomitant open distal clavicle excision is associated with greater improvement in range of motion without increased risk of acromial stress fracture after reverse total shoulder arthroplasty: a retrospective cohort study

  • Ajay C. Kanakamedala;Dhruv S. Shankar;Neil Gambhir;Matthew R. Boylan;Michael Boin;Matthew G. Alben;Mandeep S. Virk;Young W. Kwon
    • Clinics in Shoulder and Elbow
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    • v.26 no.4
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    • pp.357-365
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    • 2023
  • Background: The purpose of this study was to evaluate the effect of concomitant open distal clavicle excision (DCE) on postoperative clinical outcomes and incidence of acromial and scapular stress fractures (ASFs) in patients with symptomatic acromioclavicular joint osteoarthritis (ACJ OA) undergoing reverse total shoulder arthroplasty (RTSA). Methods: A single-surgeon retrospective cohort study was conducted including patients who underwent primary elective RTSA with or without DCE from 2015 to 2019 with a minimum 6-month follow-up period. Shoulder active range of motion (AROM) and visual analog scale (VAS) pain were recorded preoperatively and postoperatively. ASFs and other adverse events were identified using postoperative notes and/or radiographs. Characteristics and outcomes were compared between the RTSA and RTSA-DCE groups. Results: Forty-six RTSA patients (mean age, 67.9±8.7 years; 60.9% male; mean follow-up, 24.9±16.6 months) and 70 RTSA-DCE patients (mean age, 70.2±8.9 years; 20.0% male; mean follow-up, 22.7±12.9 months) were included. There were no significant intergroup differences in rates of ASF (RTSA, 0.0% vs. RTSA-DCE, 1.4%; P=1.00), stress reactions (RTSA, 8.7% vs. RTSA-DCE, 11.4%; P=0.76), reoperation, revision, or infection (all P>0.05), or in pre-to-postoperative reduction in VAS pain (P=0.17) at latest follow-up. However, the RTSA-DCE group had greater pre-to-postoperative improvement in flexion AROM (RTSA, 43.7°±38.5° vs. RTSA-DCE, 59.5°±33.4°; P=0.03) and internal rotation (IR) AROM (P=0.02) at latest follow-up. Conclusions: Concomitant DCE in RTSA improves shoulder flexion and IR AROM, alleviates shoulder pain, and does not increase the risk of ASFs. Level of evidence: III.

The Incidence Rate of Lymphadenitis after Bacille Calmette-Guérin (BCG) Vaccination (Bacille Calmette-Guérin (BCG) 백신 접종 후 림프절염의 발생 빈도)

  • Kim, Jaehong;Lee, Kyujin;Kim, Jong-Hyun;Kim, Seong Joon;Lee, Soo Young;Lee, Hye Jin;Cho, Kyung Soon;Kwon, Young Joo;Lee, Byoung Chan;Jo, Sang Min;Ha, Jeong Hun;Lee, Yoon Kyung;Seung, So Jin
    • Pediatric Infection and Vaccine
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    • v.23 no.1
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    • pp.54-61
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    • 2016
  • Purpose: Bacille Calmette-$Gu{\acute{e}}rin$ (BCG) lymphadenitis is a relatively frequent local adverse reactions after BCG vaccination. Its incidence rate is usually <1%. However, this rate may be different according to BCG strain, vaccination method or skill, etc. In the Republic of Korea, two BCG strains are used: intradermal Danish-1331 or percutaneous Tokyo-172. We surveyed the incidence rates of BCG lymphadenitis. Methods: This survey was performed in total 25 centers (5 general hospitals, 20 private pediatric clinics). Immunized type of BCG strain in study subjects was verified by directly observing the scar. The occurrence of BCG lymphadenitis was asked to their parent. In cases of BCG lymphadenitis, location, diameter size, progression of suppuration, and treatment method were investigated, as well. Results: The total number of study subjects was 3,342. Among these, the subjects suitable for enrollment criteria (total 3,222; Tokyo strain 2,501, Danish strain 721) were analyzed. BCG lymphadenitis regardless of its size developed in each five of subjects per strains, therefore, its incidence rate was 0.20% in Tokyo and 0.69% in Danish strain, respectively (P=0.086). However, when applying the WHO criteria - the development of lymph node swelling with diameter 1.5 cm or more, the incidence rate of BCG lymphadenitis was 0.16% (4 cases) in Tokyo and 0.42% (3 cases) in Danish strain, respectively. Conclusions: The incidence rate of lymphadenitis in two BCG types, percutaneous Tokyo and intradermal Danish strain BCG, is 0.20% and 0.69%, respectively. Both rates are acceptable.

Study of sedation according to neurologic and non-neurologic pediatric patients (소아연령에서 질환별 진정에 관한 연구)

  • Kim, Jeong Hwa;Kim, Min Seon;Lee, Dae-Yeol;Kim, Sun Jun
    • Clinical and Experimental Pediatrics
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    • v.51 no.10
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    • pp.1047-1051
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    • 2008
  • Purpose : This study aims to evaluate the efficacy and safety of sedatives for pediatric patients using noninvasive procedures. Methods : We performed a prospective study in 446 (aged 1 month-21 y) consecutive pediatric patients undergoing sedation to study noninvasive sedation techniques from February to August 2007. We reviewed demographic data, sedative drugs, dosage, complications, and successful rates of sedation according to the underlying diseases. Results : The overall successful rate of sedation was 435/446 (97.5%). The overall rate of successful sedation using chloral hydrate was 99.1% (420/424), and was 70.6% (12/17) and 60.0% (3/5) with ketamine and midazolam, respectively. Of the neurologic patients (n=172, aged 1 month to 21 years), 136 patients were sedated for EEGs, 5 patients for renal scans, and 31 patients for neuroimaging studies such as brain CT or MRI. All non-neurological patients (n=274, aged 1 month to 5 years) were diagnosed with urinary tract infection and sedated for renal scan. The overall success rate of sedation for this group was 99.6% (273/274). A total of 14 adverse events were observed (3.1%). Most adverse reactions were mild in severity and clinically insignificant. Conclusion : Using chloral hydrate alone has enough effect to sedate non-neurologic patients. However, neurologic patients in the severe course group, especially those suffering from intractable epilepsy, autism, or severe cerebral palsy, must be medicated with chloral hydrate 2 times at most; instead, injections of ketamine or midazolam in the early stage may result in a more promising outcome.

Cyclophosphamide in the Treatment of Idiopathic UIP and NSIP (통상성 간질성 폐렴과 비특이성 간질성 폐렴의 치료에 있어 Cyclophosphamide의 역할)

  • Jeon, Kyeongman;Chung, Man Pyo;Shin, Sung-Chul;Yu, Chang Min;Koh, Won-Jung;Suh, Gee Young;Kim, Hojoong;Kwon, O Jung;Kim, Tae Sung;Lee, Kyung Soo;Han, Joungho
    • Tuberculosis and Respiratory Diseases
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    • v.55 no.2
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    • pp.175-187
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    • 2003
  • Background : Although corticosteroid and cytotoxic agent such as cyclophosphamide have been used for the treatment idiopathic interstitial pneumonia (IIP), efficacy of these toxic drugs are unclear because previous reports included the patients who did not undergo surgical lung biopsy and none evaluated the response according to histopathologic entities of IIP. To answer this, we retrospectively analyzed the treatment response and side effects of corticosteroids and cyclophosphamide therapy in patients with idiopathic UIP and NSIP. Methods : Among 61 patients with UIP and 26 patients with NSIP diagnosed by surgical lung biopsy at Samsung Medical Center from July 1996 to June 2002, those who received corticosteroid or cyclophosphamide therapy for at least 6 months and were followed for at least one year after the initiation of treatment were enrolled (32 UIP, 23 NSIP). Treatment response of 55 patients was assessed by ATS response criteria (clinical symptoms, pulmonary function test and radiological findings). Adverse reactions to either agent (42 cases of cyclophosphamide${\pm}$low-dose prednisolone, 49 cases of prednisolone alone) were also analyzed. Results : Irrespective of treatment regimen, NSIP showed more favorable response than UIP (6 months: 78.3% vs. 9.4%, 12 months: 69.6% vs. 9.4%, p<0.001). Cyclophosphamide showed comparable response to corticosteroid in NSIP while its efficacy was as poor as those of corticosteroid therapy in UIP. Significant adverse reaction to drug more frequently occurred in corticosteroid group (35.7%) than cyclophosphamide group (14.3%) (p=0.017). Conclusion : Cyclophosphamide is effective and more tolerable than corticosteroids in the treatment of idiopathic nonspecific interstitial pneumonia.

Efficacy of Darbepoetin alfa in Anemia Developed during Chemotherapy for Lung Cancer (폐암 환자에서 항암화학치료 중 발생한 빈혈에 대한 Darbepoetin alfa의 효과)

  • Ban, Hee-Jung;Chi, Su-Young;Park, Cheol-Kyu;Kim, Eun-Young;Kim, Yoon-Hee;Kim, Kyu-Sik;Ju, Jin-Young;Kwon, Yong-Soo;Oh, In-Jae;Kim, Yu-Il;Lim, Sung-Chul;Kim, Young-Chul
    • Tuberculosis and Respiratory Diseases
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    • v.66 no.2
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    • pp.104-109
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    • 2009
  • Background: Anemia is quite common in lung cancer patients and known to decrease the quality of life. Darbepoetin alfa is an erythropoiesis-stimulating protein approved for administration to cancer patients. This study examined the efficacy and safety of darbepoetin alfa in lung cancer patients with a hemoglobin concentration <10 g/dl during chemotherapy. Methods: Lung cancer patients (n=178) received darbepoetin alfa at doses of 1.91 ${\mu}g/kg$ per week until the hemoglobin concentration increased to >10 g/dl. The efficacy and safety were measured by comparing the hemoglobin concentration and assessing the adverse events. Results: After chemotherapy, the hemoglobin concentration decreased to 9.03${\pm}$0.64 g/dl. With the darbepoetin alfa treatment, the hemoglobin concentration increased to 10.09${\pm}$1.17 g/dl after 4 weeks reaching a peak hemoglobin concentration of 10.45${\pm}$1.18 g/dl. The changes in hemoglobin after 4 and 8 weeks with treatment were 1.08${\pm}$1.24 g/dl and 1.38${\pm}$1.59 g/dl (p<0.01). At least a 1 g/dl or more increase in hemoglobin was observed in 62.4% of patients. There were no serious adverse effects except for some mild reactions. Conclusion: Darbepoetin alfa administered to lung cancer patients appears to be an effective, well-tolerated treatment for chemotherapy induced anemia.

The Clinical Aspects of Regional Lymphadenitis following BCG Vaccination (BCG 접종 후 국소 림프절염의 임상양상)

  • Bae, Sun Young;Park, Yang Joon;Kim, Jong-Hyun;Oh, Jin Hee;Koh, Dae Kyun;Kang, Jin Han
    • Pediatric Infection and Vaccine
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    • v.13 no.2
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    • pp.137-146
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    • 2006
  • Purpose : A regional lymphadenitis is the most frequent adverse reaction of BCG. In order to find out developmental factors and establish a strategy of management, we investigated the clinical courses of children with lymphadenitis following BCG on the aspect of BCG strains, suppurative rates according to the sizes of lymph node and the clinical difference with or without treatment. Methods : From January 1997 to June 2004, 52 children less than 24 month-age-old diagnosed as BCG lymphadenitis in Department of Pediatrics, St. Vincent's Hospital, The Catholic University of Korea were enrolled. The type of BCG strain, place of vaccination, location and size of lymphadenitis were assessed with medical records, retrospectively. Finally, we analysed the correlations between BCG strains or the sizes of lymph node and natural remission or suppuration. Results : The first detected mean age of BCG lymphadenitis was 5.5 month-age. The larger of the measurement was at the first visiting, the younger of age that was first presented. The most frequent location was the same sided axillary region of BCG injection. Among 52 subjects, 46 cases(88.5%) were vaccinated with intradermal Pastuer strain, and only 5 cases(9.6%) were done with percutaneous multipunctured Tokyo strain. Twenty eight cases(53.8%) were regressed naturally, otherwise 24 cases(46.2%) were suppurated. The larger those were sized, the higher freqeuncies those were suppurated on, significantly. Treatment with medications could not prevent the suppuration and could not shorten the healing periods. Conclusion : We predict that there are differences between the occurrent rate of BCG lymphadenitis and BCG strains or methods. Treatment with medication is not recommended owing to its ineffectiveness. Especially, in case of non-suppurative lymphadenitis should be onlyless influence on the tuberculin skin test, cause less adverse reactions, and is inexpensive. observed without treatment, because it could be regressed naturally. An ideal BCG makes a scar, We should make an effort to choose the best BCG strain that can fulfill such requirements.

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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.