• 제목/요약/키워드: Drug administration cost

검색결과 58건 처리시간 0.038초

항암 면역 치료제에 관한 최근 임상 정보 (Updates to Clinical Information on Anticancer Immunotherapy)

  • 최은주;양재욱
    • 한국임상약학회지
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    • 제28권1호
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    • pp.65-75
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    • 2018
  • Objective: Over the last several years, immunotherapy has become one of the most promising therapeutic options for cancer. This study aims to summarize the updates on cancer immunotherapy focusing on immune checkpoint inhibitors, such as programmed cell death-1 (PD-1), programmed death-ligand 1 (PD-L1), and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors, which have received attention as new anticancer therapeutic agents. Methods: A literature survey was carried out on PubMed to identify high-impact papers on cancer immunotherapy from 2010. The most recent data on clinical efficacy and safety have been included highlighting the response characteristics to recently approved immunotherapeutic agents. Results: In various cancers, immune checkpoints are a means for cancer cells to evade the immune system. Furthermore, CTLA-4 and PD-L1 can be overexpressed, allowing malignant cells to evade T-cells. Numerous clinical trials have been performed to seek appropriate indication of these products in various cancer types. Among them, the most conspicuous types are melanoma, non-small-cell lung cancer, and head and neck cancer. The approval of ipilimumab by Food and Drug Administration (FDA) commenced a new era of cancer immunotherapy. This was followed by the approval of nivolumab and pembrolizumab. Currently, combination therapies are being investigated for various cancer types. Conclusion: In this study, we reviewed recently reported scientific and clinical evidence for currently approved immune checkpoint inhibitors. Although these novel checkpoint inhibitors are ever evolving for cancer therapies, there exist limitations that need to be overcome, indicating the necessity for further studies aiming to improve their efficacy, toxicity, and cost.

Profiling of Recovery Efficiencies for Three Standard Protocols (FDA-BAM, ISO-11290, and Modified USDA) on Temperature-Injured Listeria monocytogenes

  • Lee, Hai Yen;Chai, Lay Ching;Pui, Chai Fung;Wong, Woan Chwen;Mustafa, Shuhaimi;Cheah, Yoke Kqueen;Issa, Zuraini Mat;Nishibuchi, Mitsuaki;Radu, Son
    • Journal of Microbiology and Biotechnology
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    • 제21권9호
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    • pp.954-959
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    • 2011
  • There have been a number of studies conducted in order to compare the efficiencies of recovery rates, utilizing different protocols, for the isolation of L. monocytogenes. However, the severity of multiple cell injury has not been included in these studies. In the current study, L. monocytogenes ATCC 19112 was injured by exposure to extreme temperatures ($60^{\circ}C$ and $-20^{\circ}C$) for a one-step injury, and for a two-step injury the cells were transferred directly from a heat treatment to frozen state to induce a severe cell injury (up to 100% injury). The injured cells were then subjected to the US Food and Drug Administration (FDA), the ISO-11290, and the modified United States Department of Agriculture (mUSDA) protocols, and plated on TSAyeast (0.6% yeast), PALCAM agar, and CHROMAgar Listeria for 24 h or 48 h. The evaluation of the total recovery of injured cells was also calculated based on the costs involved in the preparation of media for each protocol. Results indicate that the mUSDA method is best able to aid the recovery of heat-injured, freeze-injured, and heat-freeze-injured cells and was shown to be the most cost effective for heat-freeze-injured cells.

신생아의 TPN 요법 시 발생되는 Cholestasis 치료를 위한 Ursodeoxycholic Acid의 약물사용 평가 (Drug Evaluation of Ursodeoxycholic Acid Use for Treatment of Cholestasis Associated with TPN Therapy in Neonate)

  • 이정옥;송태범;이명구;임성실
    • 약학회지
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    • 제54권4호
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    • pp.270-281
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    • 2010
  • Total parenteral nutrition (TPN) is necessary to neonates in neonatal intensive care unit (NICU) for survival and growth because of impossible of enteral feeding. Long-term TPN can be associated with a broad spectrum of hepatobiliary disorder, ranging from mild hepatic dysfunction to severe end-stage liver disease. Cholestasis developed most commonly in neonate, ursodeoxycholic acid (UDCA) is widely used in adult with cholestatic and non-cholestatic liver diseases but there have been limited data on the effects in neonate with PNAC. This study was performed retrospectively to review all medical histories of the total 30 neonates with was administrated UDCA for treatment to parenteral nutrition associated cholestasis (PNAC) at Chungbuk National University Hospital NICU from April 2002 to December 2008. UDCA was administrated at bilirubin is over 2 mg/dl. The criterias for drug evaluation were included hepatic biochemical marker such as direct bilirubin, total bilirubin, AST, ALT, ALP and GGT, TPN therapy period, cholestasis development period, UDCA treatment period, UDCA dosage and adverse effect. In the results, Post-UDCA treatment significant was decreased direct bilirubin, total bilirubin, AST and ALP (p<0.05), and was decreased GGT (p>0.05) and slightly was increased ALT (p>0.05). Reffective timect biDCA was appear at mean $10.5{\pm}1.3$ days, iDCA administration period was mean $64.4{\pm}5.9$ days, cholestasis period was mean $71.9{\pm}6.4$ days and UDCA dosage was mean $22.9{\pm}0.9$ mg/kg/day. Common adverse effects is diarrhea, 5 patients arised mild diarrhea but it possible also related with increased enteral feeding. In conclusion, iDCA can decrease direct bilirubin that major parameter t bcholestasis and oher hepatic biochemical makers. UDCA is effective on PNAC without any serious side effect and cost-effective. Although no greatly shortening cholestasis period, but can protect to develop into severe liver disease and other complication or death. Based on these result, UDCA is recommended for treatment of cholestasis at direct bilirubin is over 2 mg/dl.

Polyjet과 DLP-SLA 3D 프린터를 이용한 인쇄 각도에 따른 마이크로니들 제작의 비교 및 평가 (Comparison and Evaluation of Printing Angle Dependent Fabrication of Microneedles Using Polyjet and DLP-SLA 3D Printers)

  • 안승희;정헌호
    • 공업화학
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    • 제35권5호
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    • pp.423-428
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    • 2024
  • 마이크론 크기의 미세바늘 배열로 구성된 마이크로니들은 최소 침습성 통증으로 활성 의약품 성분을 경피 투여하기 위한 새로운 기술이다. 지난 수년간 마이크로니들의 구조를 정확히 제조하기 위해 다양한 적층 제조 기술이 사용되었지만 기존의 기술은 시간과 비용이 많이 드는 것뿐만 아니라 제한적인 재료 호환성과 생체 이용률에 대한 한계성이 있었다. 본 연구에서는 생분해성 PCLDA/PEGDA 마이크로니들의 정확한 제조를 위해 Polyjet과 DLP-SLA 3D 프린팅 방법의 해상도를 비교하였다. 두 3D 프린팅 방식을 기반으로 마이크로니들의 구조적 정확성을 향상시키기 위해 3D 프린팅 각도, 바늘 높이 및 직경을 포함한 3D 프린팅 조건을 비교 및 평가하였다. 최적화된 3D 프린팅 조건을 적용하여 날카로운 바늘 끝을 가진 마이크로니들 몰드를 제작하였으며, 복제 성형 공정을 통해 고분자 마이크로니들을 제작하였다. 최종적으로, 광경화성 PCLDA와 PEGDA를 이용한 생분해성/생체적합성 마이크로니들을 제작하였으며, PCLDA 농도에 따른 기계적 특성 제어를 통해 피부 삽입에 필요한 강도를 평가하였다. 본 연구에서는 3D 프린팅을 이용해 고해상도 마이크로니들을 저비용 및 효율적으로 제작하여 경피 약물 전달 분야에 응용할 수 있음을 증명하였다.

일개 3차 의료기관의 혈액투석 간호행위규명 및 간호원가 산정 (Search of hemodialysis nursing behaviors and Estimation of hemodialysis nursing costs at a tertiary hospital)

  • 심원희;박정호
    • 간호행정학회지
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    • 제5권2호
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    • pp.297-316
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    • 1999
  • The purpose of this study is searching for hemodialysis nursing bahaviors by hemodialysis room nurses and analyzing them. Then, it estimates hemodialysis nursing costs and obtains basic data for development of proper nursing costs. First, it searched for hemodialysis nursing behaviors at a tertiary hospital hemodialysis room in Seoul and classified them. After the content validity was verified by 6 experts, Tool of hemodialysis nursing behaviors was developed. patients who recived hemodialysis were classified by dialysis patient classification tool. The searcher observed hemodialysis nursing behaviors applied to classified patients per 5 minutes. Then hemodialysis nursing hours spent to classified patients were calculated respectively. The direct expenditures and indirect expenditures were estimated. Ultimately, hemodialysis nursing costs were estimated. The results of the study were as follows ; 1. hemodialysis nursing behaviors were grouped by the same knowledge and skills. then, the content validity of them was verified by evaluation tool of nursing intervention classification by expert groups. They consisted of 9 hemodialysis activity domains and 71 hemodialysis nursing behaviors. The predialysis activity domain included 15 nursing behaviors, the activity domain of start-dialysis included 12 nursing behaviors, the activity domain of during- dialysis included 9 nursing behaviors, the activity domain of finish-dialysis included 5 nursing behaviors, the activity domain of after-dialysis included 5 nursing behaviors, the nursing documentation & undertaking and transfering included 5 nursing behaviors, the supply, drug, equipment & environment management activity domain included 7 nursing behaviors, the patient emotional support & education activity domain included 4 nursing behaviors, the emergency activity domain included 9 nursing behaviors. 2. The acute hemodialysis nursing hours were 106.42 minutes per a dialysis and the chroni hemodialysis nursing hours were 72.23 minutes per a dialysis. 3. The direct expenditure was 11.971 won per hour and indirect expenditure was 288won. 4. Finally, the cost of acute hemodialysis was 21,745 won and that of chronic hemodialysis was 14,759 won. By search of hemodialysis nursing behaviors, they will be used as hemodialysis nursing care standard and will be tended toward high qualitative care. Estimation of hemodialysis nursing costs will be used as fundamental data for development of proper nursing costs.

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소아 성장호르몬결핍증 치료에 사용되는 성장호르몬 서방형 주사제의 경제성 평가 (Economic evaluation of a weekly administration of a sustained-release injection of recombinant human growth hormone for the treatment of children with growth hormone deficiency)

  • 강혜영;김덕희;양세원;김윤남;김미선
    • Clinical and Experimental Pediatrics
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    • 제52권11호
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    • pp.1249-1259
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    • 2009
  • 목 적:소아 성장호르몬결핍증의 저신장 치료에 사용되는 성장호르몬 생물학적 제제인 서방형 주사제의 비용-효과성을 사회적 관점에서 기존 매일 주사제와 비교하여 평가하고자 한다. 방 법:성장 호르몬 치료를 받는 환아를 대상으로 시각화 척도 방법에 의해 건강 관련 효용을 측정하였다. 2008년 7월, 이 연구에 참여한 2개 병원에서 저성장증 치료를 받고 있는 149명의 환아 보호자에게 매일 주사제에 대한 효용과 주 1회 주사제를 사용할 경우 기대되는 효용을 인터넷을 통해 설문조사 하였다. 성장호르몬 주사요법 중 매일 주사제와 주 1회 주사제 투여에 소요되는 직․간접 비용은 차이가 없으므로, 두 제형의 의약품비만을 비교하였다. 결 과:매일 주사제에서 주 1회 주사제로 전환할 경우 예상되는 효용값은 0.584에서 0.784로 증가하며, 연평균 추가비용은 4,060,811원이 발생한다. 점증적 비용-효용비는 20,304,555원/QALY (quality-adjusted life year gained)로 계산되었다. 시나리오 분석 결과, 점증적 비용-효용비는 최소 15,751,198원/QALY에서 최대 25,489,929원/QALY이다. 결 론:Base case 및 시나리오 분석결과에서 제시하는 점증적 비용-효용비는 우리 나라 1인당 GDP의 0.85-1.37배 범위 내에 있으므로 매우 안정적으로 비용-효과성이 있는 것으로 판단된다. 따라서, 매일 주사제에서 주1회 주사제로의 투약방법 변경은 비용-효과적이라 할 수 있으며, 주 1회 주사제가 추가 비용을 부담하더라도 경제성이 우수하다고 결론지을 수 있다.

Angiogenesis Markers in Breast Cancer - Potentially Useful Tools for Priority Setting of Anti-Angiogenic Agents

  • Keyhani, Elahe;Muhammadnejad, Ahad;Behjati, Farkhondeh;Sirati, Fereidoon;Khodadadi, Faranak;Karimlou, Masoud;Moghaddam, Fatemeh A.;Pazhoomand, Reza
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권12호
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    • pp.7651-7656
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    • 2013
  • Background: Breast cancer is the most common malignancy among women in both developed and developing countries. The burden is increasing in low-income and middle-income countries (LMCs) and threatens the public health of such societies. Introduction of expensive monoclonal antibodies to cancer treatment regimens poses a real challenge in the health systems of LMCs. Despite controversy of cost-effectiveness of bevacizumab in breast cancer, some studies indicate gain of patients from this drug. The present study aimed to propose a priority setting model for administration of anti-angiogenic agents in breast cancer via assessment of tumor angiogenesis by the microvessel density (MVD) method and associations with clinicopathological characteristics (including simultaneous mutations of TP53 and HER-2 genes). Materials and Methods: Age, axillary lymph nodes status, tumor size, stage and grade, estrogen and progesterone receptors status, HER-2/neu status (by immunohistochemistry and FISH test), TP53 mutation, Ki-67 (for proliferation assay) and CD34 (for angiogenesis assay) were assessed in 111 breast cancer patients. The molecular subtype of each tumor was also determined and correlations of simultaneous mutations of HER-2 and p53 genes with angiogenesis and other clinicopathological characteristics were evaluated. Results: There were significant associations between simultaneous mutations of HER-2 and p53 genes and all other parameters except tumor size. The degree of angiogenesis in the ERBB2 subtype was greater than the others. Younger patients showed a higher angiogenesis rate rather those older than 50 years. Conclusions: Our results demonstrated that patients with simultaneous mutations of HER-2 and p53 genes, those with ERBB2 molecular subtype and also younger women (often triple negative) seem more eligible for obtaining anti-angiogenic agents. These results suggest a model for priority setting of patients with breast cancer for treatment with anti-angiogenic drugs in LMCs.

첨단 디지털 헬스케어 의료기기를 진료에 도입할 때 평가원칙 (Principles for evaluating the clinical implementation of novel digital healthcare devices)

  • 박성호;도경현;최준일;심정석;양달모;어홍;우현식;이정민;정승은;오주형
    • 대한의사협회지
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    • 제61권12호
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    • pp.765-775
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    • 2018
  • With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.