• Title/Summary/Keyword: therapeutic efficacy monitoring

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

  • Yang, Byung-Hwan
    • Korean Journal of Biological Psychiatry
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    • v.5 no.1
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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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    • v.12 no.3
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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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    • v.19 no.3
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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.

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

  • Son, Yu Jeong;Lee, Kyung A;Jo, Ju Hee;Kim, Jae Song;Son, Eun Sun;Park, Moo Suk
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.2
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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.

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

  • Moon, Jung-Yeon;Kim, Bo-Ram;Jo, Eun-Jung;Cho, Yoon-Sook;Han, Hyun-Joo;Choi, Eue-Keun
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.3
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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.

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

  • Na, Nam Heui;Lee, Seong A;Lee, Yeong Hyun;Lee, Sang-Heon;Hwang, Do-Yeon;Park, Jin-Hyuck
    • Therapeutic Science for Rehabilitation
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    • v.11 no.3
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    • pp.93-106
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    • 2022
  • Objective : The COVID-19 pandemic has brought non-face-to-face healthcare service delivery system. Research into telehealth system and its efficacy remains unclear. Methods : Seven healthy adults participated in this study to investigate effects of tele-monitoring with the speech-to-text (STT) application to induce changes in occupational activities on occupational balance in healthy adults. Subjects were requested to choose occupational activities they wanted to have researched and then register them to the STT application. The STT application provided an alarm to check whether the pre-registered activities were performed on time, and whether the subjects performed it by their voice. The subjects were followed for 1 week, with assessments at baseline, and after 1-week's tele-monitoring. Results : Our findings showed that the subjects were willing to participate in tele-monitoring with the STT application with high adherence and satisfaction. In addition, there was a significant improvement in occupational activities related to health (p<.05). Specifically, adherence, satisfaction, and efficacy of the tele-monitoring with the STT application could successfully bring occupational balance in short-term periods. Conclusion : These findings highlight that tele-monitoring with a smartphone could be considered as one promising way to restore occupational balance in lockdown after the COVID-19 outbreak.

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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    • v.58 no.12
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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.

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

  • Lee, Hoan Jong
    • Clinical and Experimental Pediatrics
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    • v.49 no.3
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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.

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

  • Kwon, Heejung;Choi, Wonjin;Lee, Dong-Guk;Tan, David;Hyun, Changbaig
    • Journal of Veterinary Clinics
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    • v.32 no.5
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    • pp.399-403
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    • 2015
  • Peritoneal dialysis (PD) is a treatment for renal failure and acute poisoning, and uses the patient's peritoneum in the abdomen as a membrane across which fluids and dissolved substances are exchanged from the blood. In this study, we evaluated the therapeutic efficacy and complications of automated peritoneal dialyzer (APD) in dogs with renal failure. PD was performed in 10 dogs using a swan neck catheter (Neonatal, Coviden) and automatic APD. The efficacy for each dog was assessed by calculating urea reduction ratio (URR) and creatinine reduction ratio (CRR). Mean concentrations of pre-dialysis creatinine and blood urea (BUN) were $7.09{\pm}3.84$ and $145.8{\pm}48.5$, respectively. The mean number of peritoneal dialysis cycles applied was $6{\pm}1$ cycles. Peritoneal dialysis resulted in a significant decrease in BUN concentration in 7/10 dogs, while a significant decrease in creatinine concentration in 9/10 dogs. The mean of URR was higher than that of CRR ($0.39{\pm}0.16$ vs $0.38{\pm}0.13$). The mean CRR and URR per dialysis cycles were $0.064{\pm}0.023$ and $0.065{\pm}0.023$, respectively. Complications found in this study were catheter occlusion, subcutaneous dialysate leakage, septic peritonitis, hypoalbuminemia and overhydration. This study found PD using a swan neck catheter and APD machine showed acceptable efficacy for successful peritoneal dialysis in dogs. However, close monitoring is required to minimize the risk of complication.

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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    • v.22 no.9
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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.