• 제목/요약/키워드: therapeutic efficacy monitoring

검색결과 20건 처리시간 0.021초

향정신성약물의 치료적 약물농도 검사 (Therapeutic Drug Monitoring (TDM) of Psychotropic Drugs)

  • 양병환
    • 생물정신의학
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    • 제5권1호
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    • pp.56-65
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    • 1998
  • Clinicians can use therapeutic drug monitoring(TDM) to optimise dosage decisions with psychotropic drugs, in order to maximize efficacy and prevent toxicity, especially when individuals are nonresponsive to treatment or vulnerable to adverse reactions with standard doses because age, disease states or drug interactions. Currently, therapeutic drug concentrations have been established for the TCA and lithium. There is also evidence for the usefulness of TDM with carbamazepine, valproic acid and some antipsychotic drugs. However for most psychotropic drugs this approach remains experimental. TDM-assisted psychiatric treatment is potentially useful and cost effective, particularly when applied by psychiatrists who are knowledgeable of pharmacokinetics and pharmacodynamics.

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Facile and Rapid Glycosylation Monitoring of Therapeutic Antibodies Through Intact Protein Analysis

  • Oh, Myung Jin;Seo, Nari;Seo, JungA;Kim, Ga Hyeon;An, Hyun Joo
    • Mass Spectrometry Letters
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    • 제12권3호
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    • pp.85-92
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    • 2021
  • The therapeutic antibody drug market has experienced explosive growth as mAbs become the main therapeutic modality for a variety of diseases. Characterization of glycosylation that directly affects the efficacy and safety of therapeutic monoclonal antibodies (mAbs) is critical for therapeutics development, bioprocess system optimization, lot release, and comparability evaluation. The LC/MS approach has been widely used to structurally characterize mAbs, and recently attempts have been made to obtain comprehensive information on the primary structure and post-translational modifications (PTMs) of mAbs through intact protein analysis. In this study, we performed state-of-the-art LC/MS based intact protein analysis to readily identify and characterize glycoforms of various mAbs. Different glycoforms of mAbs produced in different expression cell lines including CHO, SP2/0 and HEK cells were monitored and compared. In addition, the comparability of protein molecular weight, glycoform pattern, and relative abundances of glycoforms between the commercialized trastuzumab biosimilar and the original product was determined in detail using the given platform. Intact mAb analysis allowed us to gain insight into the overall mAb structure, including the complexity and diversity of glycosylation. Furthermore, our analytical platform with high reproducibility is expected to be widely used for biopharmaceutical characterization required at all stages of drug development and manufacturing.

Evaluation of Muscle Tension in Hemiplegia Patients with a Real-time Monitoring System during High Intensity Laser Therapy

  • Lee, Sang-Kwan;Lee, Hyeong-O;Youn, Jong-In
    • Journal of the Optical Society of Korea
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    • 제19권3호
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    • pp.277-283
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    • 2015
  • In this study, we evaluated the muscle tension in hemiplegia patients using a real-time monitoring system combined with high-intensity laser treatment (HILT) device. Five hemiplegia patients were treated with HILT in the left forearm muscle for 8 minutes, and the muscle was relaxed for 8 minutes following the treatment. Both the gradient of the force-displacement curves and the muscle hardness decreased during the therapy, and the effects were maintained following the treatment. The results show that muscle tension decreased rapidly during laser irradiation, and the efficacy of the treatment depended on the duration of the illness. Consequently, we conclude that this combined HILT and real-time muscle tension monitoring system is useful for evaluating the therapeutic procedure and for treatment of muscle pain.

침습성 아스페르길루스증의 치료 목적으로 voriconazole을 단독으로 투여받는 폐이식 환자에서 voriconazole 약물혈중농도 모니터링의 유효성 검증 (Validation of Voriconazole Therapeutic Drug Monitoring in Lung Transplant Recipients Receiving Voriconazole alone for Treatment of Invasive Aspergillosis)

  • 손유정;이경아;조주희;김재송;손은선;박무석
    • 한국임상약학회지
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    • 제29권2호
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    • pp.89-100
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    • 2019
  • Background: Invasive aspergillosis (IA) is associated with high morbidity and mortality, particularly among immunocompromised patients, such as lung transplant recipients. Voriconazole, the first-line therapy for IA, shows a non-linear pharmacokinetic profile and has a narrow therapeutic range. Careful and appropriate administration is necessary, primarily because it is used for critically ill patients; however, the clinical usefulness of therapeutic drug monitoring (TDM) has not been sufficiently verified. Therefore, in this study, we validated the safety and efficacy of voriconazole TDM in lung transplant recipients receiving only voriconazole for IA treatment. Methods: The electronic medical records of lung transplant recipients (${\geq}19$ years of age) administered only voriconazole for > 7 days for treatment of IA from June 1, 2013 to May 31, 2018 were analyzed retrospectively. Results: Among the 54 patients, 27 each were allocated to TDM and non-TDM groups, respectively. There were no significant differences in patient characteristics between the two groups except for ICU-hospitalization status. Of the TDM group patients, 81.5% needed adjustment of voriconazole dosage because the levels were out of target range. Comparison of two groups showed that treatment response was higher throughout treatment and switching rates of second-line agents were significantly lower in the TDM group, but it was insufficient to confirm safety improvements through voriconazole TDM. Conclusions: Considering that the treatment response tended to be higher and the rates of switching to second-line antifungal agents were lower in the TDM group, voriconazole TDM may increase the therapeutic effect on IA in lung transplant patients.

심방세동 환자의 심율동전환 시행 전·후 warfarin 치료의 적절성 평가 (Evaluation of Peri-procedural Warfarin Therapy Undergoing Cardioversion in Patients with Atrial fibrillation)

  • 문정연;김보람;조은정;조윤숙;한현주;최의근
    • 한국임상약학회지
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    • 제26권3호
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    • pp.201-206
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    • 2016
  • Objective: Direct current cardioversion for atrial fibrillation could be associated with the risk of thromboembolic events. Anticoagulation therapy with warfarin (INR 2.0-3.0) is recommended 3 weeks before and 4 weeks after cardioversion to reduce the risk of thromboembolism. This study evaluated warfarin therapy in pharmacist-managed anticoagulant services (ACS). Methods: This retrospective study was performed in 106 patients with atrial fibrillation from 2012 to 2013. The primary efficacy endpoint was the composite of stroke, transient ischemic attack, myocardial infarction, and cardiovascular death. The primary safety measure was major bleeding. To evaluate the peri-procedural effects of warfarin treatment, we studied whether target INR was maintained, as well as the maintenance period of the therapeutic range. Quality of treatment was measured by time in therapeutic range (TTR) by using the Rosendaal method. Results: There were no thromboembolic events, but TEE examination at time of cardioversion showed a left atrial thrombus in three patients (2.8%). Bleeding complications after cardioversion occurred in 2 patients (1.9%). The average INR value at the time of cardioversion was $2.59{\pm}0.8$, and was within the therapeutic range in 83 patients (78%). Analysis of the patients in whom the value was within the therapeutic range twice consecutively showed that the ratio of TTR was 80% and the therapeutic range was maintained in 67 patients (63%) for an average of 4.90 weeks prior to cardioversion. Similarly, 76 patients (72%) had a stable INR within the therapeutic range for an average of 5.70 weeks and a mean TTR of 83%. Conclusion: Pharmacists significantly contributed to appropriate warfarin treatment with close monitoring during cardioversion. Likewise, active pharmacist monitoring and systemic management should be considered to reduce thromboembolism and bleeding complications in the peri-cardioversion period.

음성-텍스트 변환 어플리케이션을 이용한 원격 모니터링이 건강한 성인의 작업균형에 미치는 효과 (Effects of the Tele-Monitoring With the Speech-to-Text Application on Occupational Balance in Healthy Adults : Feasibility Study)

  • 나남희;이성아;이영현;이상헌;황도연;박진혁
    • 재활치료과학
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    • 제11권3호
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    • pp.93-106
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    • 2022
  • 목적 : 본 연구의 목적은 음성-텍스트 변환 어플리케이션을 이용한 원격 모니터링이 건강한 성인의 작업균형에 미치는 효과를 알아보기 위함이다. 연구방법 : 총 7명의 건강한 성인을 대상으로 연구를 진행하였다. 대상자는 실험에 참여 전, 원하는 작업 활동을 선택하였고 이를 스마트폰에 설치한 음성-텍스트 변환 어플리케이션에 등록하였다. 음성-텍스트 변환 어플리케이션은 미리 등록된 작업 활동을 시간에 맞춰 수행 여부를 확인할 수 있도록 알람을 제공하였고 대상자는 음성으로 수행 여부를 등록하였다. 원격 모니터링은 일주일 동안 진행하였고 일주일 뒤, 작업 활동의 변화를 살펴보았다. 결과 : 대상자 모두 일주일 동안 어플리케이션 사용에 높은 순응도와 만족도를 보였다. 또한 일주일 뒤, 건강과 관련된 작업 활동의 균형이 유의하게 향상되었다(p<.05). 결론 : 본 연구 결과는 스마트폰을 이용한 원격 모니터링이 코로나19로 인한 봉쇄 기간 동안 작업 균형을 회복하는 방법으로 사용 가능함을 시사한다.

A prospective study to assess the efficacy and safety of oral propranolol as first-line treatment for infantile superficial hemangioma

  • Yun, Yeong Ju;Gyon, Yun Hee;Yang, Sohyoung;Lee, Youn Kyung;Park, Joohyun;Park, Meerim
    • Clinical and Experimental Pediatrics
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    • 제58권12호
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    • pp.484-490
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    • 2015
  • Purpose: To determine the efficacy and safety of oral propranolol as a first-line treatment for superficially located infantile hemangioma (IH) and propose an assessment tool to measure treatment response. Methods: Patients with superficial IH under 1 year of age were prospectively recruited between May 2012 and December 2013 at the Department of Pediatrics of Chungbuk National University Hospital. Propranolol was administered to 12 infants (median age, 3.8 months) while monitoring cardiovascular and adverse metabolic effects. If a patient showed no adverse events, the dosage was gradually increased up to 3 mg/kg/day and maintained for 1 year. We used our own scoring system to assess treatment response using parameters like change in color, and longest diameter, and thickness of the IH. Results: Eleven out of 12 patients completed the protocol with consistent improvement of hemangiomas during therapy. Patients on propranolol showed a more than 50% involution in the first 3 months, with additional steady involution until 1 year. Patients with the highest scores at 1 month maintained their score and showed better responses until treatment termination. The patient with the lowest score at 1 month did not show any further regression and stopped propranolol treatment 4 months after initiation. In two children with recurrences after successful therapeutic regression, propranolol was effective after being reintroduced. Propranolol treatment was not interrupted in any patient due to adverse events. Conclusion: Oral propranolol at 3 mg/kg/day showed a consistent, rapid, and therapeutic effect on superficial IHs without significant adverse events.

폐구균 단백 결합 백신의 효능 및 효과 (Efficacy and effectiveness of pneumococcal conjugate vaccine in children)

  • 이환종
    • Clinical and Experimental Pediatrics
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    • 제49권3호
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    • pp.235-241
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    • 2006
  • Streptococus pneumoniae is an important cause of invasive infections as well as non-invasive infections such as acute otitis media and sinusitis both in children and adults. Resistance of S. pneumoniae to multiple antimicrobials is increasing and poses therapeutic challenges, and prevention became more important. 23-valent polysaccharide vaccine has been used for the last several decades, but is not effective in children <2 years of age, the highest risk group of invasive diseases. Recently, a 7-valent pneumococcal protein conjugate vaccine(PCV) which is effective in infants and young children has been developed. The efficacy of PCVs against invasive pneumococcal disease and pneumonia is well established and is documented in several well-conducted studies. However, the effect of PCVs on otitis media is less obvious and more complex. PCVs clearly reduce diseases caused by vaccine-type(VT) pneumococci, but replacement of VT serotypes by non-VT serotypes in nasopharyngeal carriage of S. pneumoniae is responsible for the increase in acute otitis media caused by non-VT serotypes. Three years after introduction of PCV in the US, some increase of invasive infections with serotype 19A possibly due to serotype switching within certain vaccine type strains has been noted. Since most antibiotic-resistance in S. pneumoniae is confined to VT serotypes, vaccine use also reduces antibiotic resistance. With development of PCV, there was a great advance in the prevention of pneumococcal diseases, but replacement with potential virulent organisms and development of antibiotic resistance in non-VT pneumococci is a possibility that needs careful monitoring.

신부전 개에서 자동 복막투석기를 이용한 복막투석에 대한 평가 (Therapeutic Efficacy and Complications of Automated Peritoneal Dialyzer in Dogs with Renal Failure)

  • 권희정;최원진;이동국;데이비드 탄;현창백
    • 한국임상수의학회지
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    • 제32권5호
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    • pp.399-403
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    • 2015
  • 복막투석은 혈액에서부터 오는 체액과 노폐물을 교환하는 복강내의 막인 복막을 이용한 투석방법으로, 신부전과 중독증 환자에서의 치료법이다. 본 연구에서는 신부전증 개에서 자동투석기를 이용한 복막투석의 치료효율과 합병증에 대해 평가하였다. 10마리의 개를 대상으로 Swan neck 카테터(Neonatal, Coviden)와 자동 복막투석기를 사용하여 복막투석을 실시하였고, 그 효과는 요소감소율(urea reduction ratio)로 평가하였다. 평균 크레아틴닌 감소율과 평균 요소감소율은 $7.09{\pm}3.84$$145.8{\pm}48.5$였다. 평균 투석횟수는 $6{\pm}1$회 였다. 투석치료후 유의성 있는 요소의 감소가 7/10 개에서 관찰되었고, 유의성 있는 크레아틴의 감소가 9/10 개에서 관찰되었다. 요소의 감소율이 크레아틴 감소율보다 더 높게 관찰되었다. 1회 투석당 요소와 크레아틴닌의 감소율은 $0.064{\pm}0.023$$0.065{\pm}0.023$이 였다. 본 연구에서의 복막투석에 따른 합병증은 카테터 막힘, 투석액의 피하누출, 패혈성 복막염, 저알부민혈증, 과수화 등이었다. Swan neck 카테터와 자동 복막투석기를 이용한 복막투석은 임상에서 적용 가능하였으며 본 연구를 통하여 성공적인 복막투석의 가능성을 보여주었다. 하지만 합병증을 최소화하기 위해서는 주의 깊은 모니터링이 필요할 것으로 판단된다.

Rapid Detection and Monitoring Therapeutic Efficacy of Mycobacterium tuberculosis Complex Using a Novel Real-Time Assay

  • Jiang, Li Juan;Wu, Wen Juan;Wu, Hai;Ryang, Son Sik;Zhou, Jian;Wu, Wei;Li, Tao;Guo, Jian;Wang, Hong Hai;Lu, Shui Hua;Li, Yao
    • Journal of Microbiology and Biotechnology
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    • 제22권9호
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    • pp.1301-1306
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    • 2012
  • We combined real-time RT-PCR and real-time PCR (R/P) assays using a hydrolysis probe to detect Mycobacterium tuberculosis complex (MTBC)-specific 16S rRNA and its rRNA gene (rDNA). The assay was applied to 28 non-respiratory and 207 respiratory specimens from 218 patients. Total nucleic acids (including RNA and DNA) were extracted from samples, and results were considered positive if the repeat RT-PCR threshold cycle was ${\leq}35$ and the ratio of real-time RT-PCR and real-time PCR load was ${\geq}1.51$. The results were compared with those from existing methods, including smear, culture, and real-time PCR. Following resolution of the discrepant results between R/P assay and culture, the overall sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) of all samples (including non-respiratory and respiratory specimens) were 98.2%, 97.2%, 91.7%, and 99.4%, respectively, for R/P assay, and 83.9%, 89.9%, 72.3%, and 94.7%, respectively, for real-time PCR. Furthermore, the R/P assay of four patient samples showed a higher ratio before treatment than after several days of treatment. We conclude that the R/P assay is a rapid and accurate method for direct detection of MTBC, which can distinguish viable and nonviable MTBC, and thus may guide patient therapy and public health decisions.