• Title/Summary/Keyword: Injection Site

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Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years

  • Yoo, Byung Wook;Kim, Chang Oh;Izu, Allen;Arora, Ashwani Kumar;Heijnen, Esther
    • Infection and chemotherapy
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    • v.50 no.4
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    • pp.301-310
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    • 2018
  • Backgroud: Influenza vaccination is recommended for adults aged ${\geq}65$ years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as $FLUAD^{(R)}$ and $VANTAFLU^{(R)}$, in South Korean subjects aged ${\geq}65$ years. Materials and Methods: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29). Results: Of the 770 subjects enrolled ($FLUAD^{(R)}$, n = 389; $VANTAFLU^{(R)}$, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). Conclusion: These results show that the MF59-adjuvanted influenza vaccine known as $FLUAD^{(R)}$ or $VANTAFLU^{(R)}$ had acceptable safety profiles in older adults (aged ${\geq}65$ years) in South Korea.

Suitability of denervated muscle flaps as recipient sites for pancreatic islet cell transplantation

  • Park, Jong-Lim;Kim, Taewoon;Kim, Baek-Kyu
    • Archives of Plastic Surgery
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    • v.48 no.1
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    • pp.133-143
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    • 2021
  • Background Extensive research has been conducted on islet transplantation as a possible cure for diabetes. Islet transplantation in the liver via the portal vein has shown remarkable results, but numerous other recipient sites are currently being investigated. We aimed to show the effectiveness of using a muscle flap as a recipient site for islet transplantation. Methods Islet cells were harvested from 12 isogenic Lewis rats, and then diabetes was induced in another 12 isogenic Lewis rats by streptozotocin injection. In six rats, 3,000 islets were transplanted into gastrocnemius muscle flaps, and in the other six rats, the same number of islets were transplanted into the gastrocnemius muscle. The transplanted islet cell function between the two groups was compared by means of blood glucose tests, glucose tolerance tests, immunohistochemistry, and real-time reverse transcription polymerase chain reaction. Results In the muscle flap group, blood glucose levels significantly decreased after islet transplantation. Blood glucose levels were significantly different between the two groups at 3 weeks after transplantation. The muscle flap group showed nearly normoglycemic results upon the glucose tolerance test, whereas the muscle group was hyperglycemic. Immunohistochemical evaluation showed positive results against insulin and glucagon in biopsies of both groups, and the islet cell density was higher in the muscle flap group. There were no statistically significant differences between the two groups in real-time reverse transcription polymerase chain reaction results. Conclusions Our results suggest that muscle flaps are promising candidates for islet cell transplantation.

One injection for a great projection: a quick and simple procedure for nipple reconstruction

  • Tanini, Sara;Calabrese, Sara;Lucattelli, Elena;Russo, Giulia Lo
    • Archives of Plastic Surgery
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    • v.48 no.2
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    • pp.179-184
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    • 2021
  • Women attach great importance to the presence of a three-dimensional nipple upon completion of the breast reconstruction process. To meet patients' expectations, nipple-areolar complex reconstruction should achieve symmetry in position, size, shape, texture, and color, as well as minimizing donor-site morbidity. However, it is well known that regardless of the reconstructive technique, loss of nipple projection can be reasonably expected. We developed and evaluated a quick, simple, and innovative technique using injectable Integra Flowable Wound Matrix to increase nipple projection after reconstruction. Twenty breast cancer patients who underwent nipple reconstruction resulting in unsatisfactory projection were enrolled in our retrospective study. Nipple projection was measured at the time of surgery and after 6 and 12 months. A visual analogue scale was used to assess patients' satisfaction. Our technique yielded reliable results in terms of the long-lasting maintenance of nipple projection. This method is high-priced, but cost-effective, since one kit may suffice for three patients. Furthermore, our patients were very appreciative of this technique as a single-step, minimally invasive, painless procedure with no reported necessity of re-intervention.

Adult-Onset Primary Focal Foot Dystonia Improved with Custom Made Ankle-Foot Orthosis (맞춤형 단하지보조기 적용으로 호전된 성인형 일차성 국소성 족부 근긴장이상증)

  • Lee, Seunghwan;Lee, Yong Min;Uhm, Kyeong Eun;Lee, Jongmin
    • Clinical Pain
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    • v.19 no.1
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    • pp.40-44
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    • 2020
  • The foot or lower extremity is rarely the initial site in adult-onset dystonia, whereas dystonia in children often begins in the foot. Isolated lower extremity dystonia in adults is rarely on a primary basis. Oral anti-dystonic medications have been found unsatisfactory in providing adequate symptomatic relief. On the other hand, botulinum toxin injections have been reported as beneficial. It is also known that personalized orthosis can be an effective solution for patients of dystonia. The purpose of this report is to demonstrate a case of primary focal foot dystonia that was effectively treated with botulinum toxin injection and the custom-made ankle-foot orthosis.

Evans' Syndrome Induced by Rabies Vaccination in a Dog

  • Yeji Kim;Jihyun Kim;Yunji Song;Songju Oh;Ha-Jung Kim
    • Journal of Veterinary Clinics
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    • v.40 no.4
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    • pp.288-293
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    • 2023
  • A 11-year-old neutered male Maltese dog was vaccinated with a rabies vaccine (Rabisin®, Boehringer Ingelheim International GmbH, Germany) subcutaneously at a local animal hospital. One hour after vaccination, purpura with edema was observed at the injection site and severe thrombocytopenia (0 K/μL) was noted on a complete blood count (CBC). No specific findings were found in serum chemistry, electrolyte, blood gas analysis, and coagulation tests. The patient was hospitalized and administered antihemorrhagic agents (vitamin K, desmopressin), antihistamines (chlorpheniramine) and corticosteroids (methylprednisolone sodium succinate). On a repeat CBC, mild anemia had developed, thrombocytopenia was still noted, and autoagglutination was observed on a saline agglutination test (SAT). A polymerase chain reaction panel for infectious agents (e.g., Babesia spp.) was negative. The diagnosis was secondary immune-mediated thrombocytopenia (IMT) with immune-mediated hemolytic anemia (IMHA) associated with vaccination. Therefore, the immunosuppressants (prednisolone, and mycophenolate mofetil) were administered. Six days after drug administration, new lesion was not observed, and the previous lesions were significantly improved. It gradually improved and 4 weeks after hematocrit and platelet recovered to normal levels. It was maintained for 6 months without recurrence of related symptoms. Based on patient's history and test results, the patient was diagnosed with Evans' syndrome associated with rabies vaccine.

Pharmacokinetic/Pharmacodynamic Analysis of Metoprolol in Dogs (실험견에서 Metoprolol 약리효과의 약동/력학적 검토)

  • Oh, Dong-Jin;Jang, In-Jin;Lee, Kyung-Hun;Yim, Dong-Seok;Kim, Hyung-Kee;Shin, Sang-Goo;Park, Chan-Woong;Shin, Jae-Gook
    • The Korean Journal of Pharmacology
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    • v.31 no.2
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    • pp.251-259
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    • 1995
  • Pharmacokinetics and pharmacodynamics of metoprolol, a selective beta-l blocker, were examined for 360 minutes after intravenous bolus administration of metoprolol to 6 dogs. Plasma concentration and excreted amount in the urine metoprolol were measured by liquid chromatography with fluorescence detection. PR interval and heart rate were measured by ECG monitoring. Blood pressure was monitored through intraarterial catheter in femoral artery and cardiac output by thermodilution method using Swan-Ganz catheter. To analyze the effect site concentration-response relationship, plasma concentration and pharmacological effects were simultaneously fitted to a two pharmacokinetic compartment linked to pharmacodynamic model with NONLIN program. Results are as follows. 1) The plasma concentration of metoprolol after intrvenous injection decreased biexponentially. The terminal half-life estimated was $1.33{\pm}0.40$ hours and the volume of distribution at steady state (Vdss) and the total body clearance were $1.04{\pm}0.4\;L/kg,\;6.55{\pm}2.21\;L/hr$, respectively. The central compartment volume of distribution and peripheral compartment volume of distribution were $0.35{\pm}0.14L/kg\;and\;0.69{\pm}0.34L/kg$. The renal clearance and intercompartment clearance were $0.53{\pm}0.25\;L/min\;and\;0.35{\pm}0.19\;L/min$. 2) Simulated biophase concentration-response curve shows hyperbolic relationship and the estimated concentration-effect relationship was best explained by Emax model when the prolongation of PR interval and the reduction of the heart rate were used as pharmacodynamic parameters. Emax and EC50 were estimated to be $26.3{\pm}4.7\;msec\;and\;88.8{\pm}82.3\;g/ml$ for PR interval, and $48.7{\pm}18.8\;beats/min\;and\;113.5{\pm}78.7\;ng/ml$ for heart rate, respectively. 3) The changes of cardiac output-effect site concentration relationship was best fitted by a linear model and the slope of the relationship was $0.005{\pm}0.003$. Diastolic blood pressure-effect site concentration relationship was also explained by the linear model and the slope of the relationship was $0.038{\pm}0.034$.

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Anti-cancer Effects of Cultivated Orostachys japonicus on Human Colon Cancer Cell Line SW480 (인체대장암세포주 SW480에 대한 재배 와송의 항암효과 연구)

  • Park, Sookyoung;Won, Jinyoung;Park, Kanghui;Hong, Yonggeun
    • Journal of Life Science
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    • v.28 no.7
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    • pp.819-826
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    • 2018
  • Orostachys japonicus (OJ) is a medicinal herb with immunoregulatory, anti-aging, anti-oxidative, and many other therapeutic properties. The purpose of this study was to elucidate the anti-cancer property of cultivated OJ. SW480 cell viability was significantly reduced by cumulative exposure to OJ extract. We also observed inhibitory effects of OJ after 72 hr through the growth and migration of SW480 cells using scratch assay. SW480 cells in OJ-free medium began to move into the scratch site at 24 hr; however, cells in medium containing OJ did not migrate into the scratch site until 48 hr. Male C57BL/6 mice (4 weeks old) were orally administered OJ extract for 31 days before injection of SW480 cells. At 7, 14, and 28 days after subcutaneous injection of SW480 cells, tumor weight and volume were analyzed. The body weight of the OJ-treated group was continuously increased during administration of the OJ extract relative to the control group. Injection of SW480 cells caused a reduction in body weight in all groups; however, the OJ-treated group exhibited a significant increase in body weight after 14 days. Tumor weight and volume were lower in the OJ-treated group than in the control group after 28 days. Although these results suggest that OJ suppresses the proliferation and migration of human colon cancer cells, additional studies are required to provide preclinical evidence before launching clinical trials evaluating OJ as an anti-cancer biohealth product.

Detection of Potential Flow Paths of Leaked CO2 from Underground Storage Using Electrical Resistivity Survey (전기비저항탐사 방법에 의한 지중 저장 이산화탄소 누출 가능 경로 탐지)

  • Lim, Woo-Ri;Hamm, Se-Yeong;Hwang, Hak-Soo;Kim, Sung-Wook;Jeon, Hang-Tak
    • The Journal of Engineering Geology
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    • v.28 no.1
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    • pp.69-79
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    • 2018
  • The Korean government attempts to reduce $CO_2$ emissions by 37% to 314.7 Mt $CO_2$, down from the estimated 850.6 Mt $CO_2$ until 2030 in order to confront green house effect. In this context, in 2014, Korean government launched $CO_2$ Storage Environmental Management Research (K-COSEM) Center for carrying out pilot-scale research on $CO_2$ leakage from underground $CO_2$ storage facilities. For the detection of $CO_2$ leakage, it is necessary to identify hydrologeological and geophysical characteristics of the subject area. In the study site of Naesan-ri, Daeso-myeon, Eumseong-gun, Chungbuk Province, two times injection tests (June 28-July 24, 2017 and August 07-September 11, 2017) of $CO_2$ and $SF_6$ dissolved waters, respectively, was conducted to understand the leakage behavior of $CO_2$ from underground. The injection well was drilled to a depth of 24 m with a 21-m casing and screen interval of 21~24 m depth. Two times resistivity surveys on August 18, 2017 and September 1, 2017, were conducted for revealing the flow of the injected water as well as the electrical properties of the study site. The study results have shown that the high-resistivity zone and the low-resistivity zone are clearly contrasted with each other and the flow direction of the injected water is similar to natural groundwater flow. Besides, the low resistivity zone is widely formed from the depth of injection to the shallow topsoil, indicating that the weathered zone of high permeability has high $CO_2$ leakage potential.

Security and Safety Assessment of the Small-scale Offshore CO2 Storage Demonstration Project in the Pohang Basin (포항분지 해상 중소규모 CO2 지중저장 실증연구 안전성 평가)

  • Kwon, Yi Kyun;Chang, Chandong;Shinn, Youngjae
    • The Journal of Engineering Geology
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    • v.28 no.2
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    • pp.217-246
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    • 2018
  • During the selection and characterization of target formations in the Small-scale Offshore $CO_2$ Storage Demonstration Project in the Pohang Basin, we have carefully investigated the possibility of induced earthquakes and leakage of $CO_2$ during the injection, and have designed the storage processes to minimize these effects. However, people in Pohang city have a great concern on $CO_2$-injection-intrigued seismicity, since they have greatly suffered from the 5.4 magnitude earthquake on Nov. 15, 2017. The research team of the project performed an extensive self-investigation on the safety issues, especially on the possible $CO_2$ leakage from the target formation and induced earthquakes. The target formation is 10 km apart from the epicenter of the Pohang earthquake and the depth is also quite shallow, only 750 to 800 m from the sea bottom. The project performed a pilot injection in the target formation from Jan. 12 to Mar. 12, 2017, which implies that there are no direct correlation of the Pohang earthquake on Nov. 15, 2017. In addition, the $CO_2$ injection of the storage project does not fracture rock formations, instead, the supercritical $CO_2$ fluid replaces formation water in the pore space gradually. The self-investigation results show that there is almost no chance for the injection to induce significant earthquakes unless injection lasts for a very long time to build a very high pore pressure, which can be easily monitored. The amount of injected $CO_2$ in the project was around 100 metric-tonne that is irrelevant to the Pohang earthquake. The investigation result on long-term safety also shows that the induced earthquakes or the reactivation of existing faults can be prevented successfully when the injection pressure is controlled not to demage cap-rock formation nor exceed Coulomb stresses of existing faults. The project has been performing extensive studies on critical stress for fracturing neighboring formations, reactivation stress of existing faults, well-completion processes to minimize possible leakage, transport/leakage monitoring of injected $CO_2$, and operation procedures for ensuring the storage safety. These extensive studies showed that there will be little chance in $CO_2$ leakage that affects human life. In conclusion, the Small-scale Offshore $CO_2$ Storage Demonstration Project in the Pohang Basin would not cause any induced earthquakes nor signifiant $CO_2$ leakage that people can sense. The research team will give every effort to secure the safety of the storage site.

Ultrasound-Guided Local Steroid Injection Therapy for Acute Calcific Tendinitis of Shoulder (초음파를 이용한 급성 극상근 석회화 건염의 스테로이드 국소 주사 요법)

  • Kim, Jung-Man;Nam, Ho-Jin;Ra, Ki-Hang;Kang, Min-Ku
    • The Journal of Korean Orthopaedic Ultrasound Society
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    • v.2 no.2
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    • pp.85-89
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    • 2009
  • Purpose: To analyze the clinical outcome after ultrasound guided multiple dry needlings and local steroid injection for acute calcific tendinitis of shoulder. Materials and Methods: Twenty patients with acute episode of pain by calcific tendinitis of shoulder with average age 58.2 (50~70 years) and follow-up of 18 months in average (range, 12~24) were included in study. There were 18 patients with right and 2 with left sided involvement. All patients had calcific deposits in the supraspinatus tendon. All patients underwent standardized nonoperative treatment protocol, consisting of 5~12 MHz high resolution ultrasound guided multiple dry needlings with 18 guage needle, followed by 2% lidocaine 1cc and 40 mg/ml depomedrol 1cc injection at site of calcific tendinitis. The outcome was assessed by UCLA shoulder score, range of motion and VAS score. A statistical analysis with ANOVA and Tukey's post-hoc test with the significance level at 5% was performed using SAS 9.1 software (SAS Institute, Cary, NC). Results: All patients got continuous relief of pain right after the procedures until final follow-up. Before the procedures, the UCLA scores were fair in 15 patients and poor in 5. After the procedures, the UCLA scores were excellent in 16 patients and good in 4. All cases revealed no limitation of shoulder function. The average VAS score decreased from 8.9 before the procedures to 0.5 at final follow-up (p<0.0001). No complication was encountered. Conclusion: An ultrasound guided local steroid injections following multiple dry needlings would be one of the useful treatment modality for the acute calcific tendinitis of shoulder.

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